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Clinical Trial Results:
A Phase III, randomized, multicenter, parallel-group, non-inferiority, open-label study evaluating the efficacy, safety, and tolerability of switching to long-acting cabotegravir plus long acting rilpivirine from current INI- NNRTI-, or PI-based antiretroviral regimen in HIV-1-infected adults who are virologically suppressed

Summary
EudraCT number	2016-001647-39
Trial protocol	ES DE SE IT
Global end of trial date

Results information
Results version number	v2(current)
This version publication date	27 Nov 2019
First version publication date	09 Jun 2019
Other versions	v1
Version creation reason

Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information

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Trial information

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Sponsor protocol code

201585

ISRCTN number

US NCT number

WHO universal trial number (UTN)

Sponsor organisation name

ViiV Healthcare

Sponsor organisation address

980 Great West Road, Brentford, Middlesex, United Kingdom,

Public contact

GSK Reponse Center, ViiV Healthcare, 1 8664357343, GSKClinicalSupportHD@gsk.com

Scientific contact

GSK Reponse Center, ViiV Healthcare, 1 8664357343, GSKClinicalSupportHD@gsk.com

Is trial part of an agreed paediatric investigation plan (PIP)

Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?

Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?

Analysis stage

Interim

Date of interim/final analysis

14 Sep 2018

Is this the analysis of the primary completion data?

Yes

Primary completion date

29 May 2018

Global end of trial reached?

Main objective of the trial

To demonstrate the non-inferior antiviral activity of switching to intramuscular CAB LA + RPV LA every 4 weeks (monthly) compared to continuation of current first line antiretroviral regimen over 48 weeks in HIV-1 infected antiretroviral therapy (ART)- experienced participants

Protection of trial subjects

Not applicable

Background therapy

Evidence for comparator

Actual start date of recruitment

28 Oct 2016

Long term follow-up planned

Independent data monitoring committee (IDMC) involvement?

Yes

Number of subjects enrolled per country

Country: Number of subjects enrolled

Argentina: 16

Country: Number of subjects enrolled

Australia: 19

Country: Number of subjects enrolled

Canada: 34

Country: Number of subjects enrolled

France: 32

Country: Number of subjects enrolled

Germany: 48

Country: Number of subjects enrolled

Italy: 28

Country: Number of subjects enrolled

Mexico: 10

Country: Number of subjects enrolled

Korea, Republic of: 19

Country: Number of subjects enrolled

Russian Federation: 106

Country: Number of subjects enrolled

South Africa: 71

Country: Number of subjects enrolled

Spain: 62

Country: Number of subjects enrolled

Sweden: 15

Country: Number of subjects enrolled

United States: 156

Worldwide total number of subjects

616

EEA total number of subjects

185

Number of subjects enrolled per age group

In utero

Preterm newborn - gestational age < 37 wk

Newborns (0-27 days)

Infants and toddlers (28 days-23 months)

Children (2-11 years)

Adolescents (12-17 years)

Adults (18-64 years)

601

From 65 to 84 years

85 years and over

Subject disposition

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Recruitment details

This was a phase III, randomized, open-label, active-controlled, multi-center, parallel-group, non-inferiority study to evaluate the antiviral activity and safety of two long-acting (LA) injectable drugs, cabotegravir (CAB) plus rilpivirine (RPV) when compared to current standard of care conducted in virologically suppressed human immunodeficiency.

Screening details

A total of 618 participants were enrolled in the study. Two randomized participants did not receive study treatment. A total of 616 participants contributed to the Intent-to-treat exposed Population and Safety Population. The results presented are based on Week 48 primary analysis.

Period 1 title

Overall Study (overall period)

Is this the baseline period?

Yes

Allocation method

Randomised - controlled

Blinding used

Not blinded

Are arms mutually exclusive

Yes

CAB LA+RPV LA (Q4W)

Arm description

During Maintenance phase (Day 1-Week 52), participants received oral CAB 30 milligram (mg)+RPV 25 mg once daily from Day 1 for 4 weeks. At Week 4B, the participants were given the last dose of oral CAB+RPV and the first dose of CAB LA 600 mg+RPV LA 900 mg injections within 2 hours of the final oral dose. Participants received intramuscular (IM) injections of CAB LA 400 mg and RPV LA 600 mg every four weeks (Q4W) through Week 52. After completion of Maintenance phase, participants who chose to enter Extension phase continued to receive both CAB LA and RPV LA. Participants withdrawn from study treatment who received at least one CAB LA+RPV LA injection were required to enter a 52-week long term follow-up period

Arm type

Experimental

Investigational medicinal product name

Carbotegravir oral

Investigational medicinal product code

Other name

Pharmaceutical forms

Tablet

Routes of administration

Oral use

Dosage and administration details

Participants received both CAB 30 mg tablets once daily from Day 1 to Week 4b approximately the same time each day with a meal

Investigational medicinal product name

Rilpivirine oral

Investigational medicinal product code

Other name

Pharmaceutical forms

Buccal tablet, Tablet

Routes of administration

Oral use

Dosage and administration details

Participants received both RPV 25 mg tablets once daily from Day 1 to Week 4b approximately the same time each day with a meal

Investigational medicinal product name

Carbotegravir Injection

Investigational medicinal product code

Other name

Pharmaceutical forms

Injection

Routes of administration

Intramuscular use

Dosage and administration details

Participants received CAB 3 mL IM injection at Week 4b after the last dose of CAB oral regimen. Participants then received CAB 2 milliliter(mL) injections every 4 weeks from Week 8 to Week 52

Investigational medicinal product name

Rilpivirine Injection

Investigational medicinal product code

Other name

Pharmaceutical forms

Injection

Routes of administration

Intramuscular use

Dosage and administration details

Participants received RPV 3 mL IM injection at Week 4b after the last dose of RPV oral regimen. Participants then received RPV 2 mL injections every 4 weeks from Week 8 to Week 52

Current ART

Arm description

During Maintenance phase (Day 1 - Week 52), participants continued to receive current antiretroviral therapy (ART) (protease inhibitor [PI] or integrase inhibitor [INI] or non-nucleoside reverse transcriptase inhibitor [NNRTI]) plus 2 NRTIs for 52 weeks. After completion of the Maintenance phase, participants who chose to enter the Extension phase switched to CAB LA+RPV LA

Arm type

Active comparator

Investigational medicinal product name

Current anti-retroviral

Investigational medicinal product code

Other name

Pharmaceutical forms

Tablet

Routes of administration

Oral use

Dosage and administration details

Participants received 2 NRTIs + INI or 2 NRTIs + NNRTI or 2 NRTIs + PI once daily from Day 1 to Week 52.

Number of subjects in period 1	CAB LA+RPV LA (Q4W)	Current ART
Started	308	308
Completed	281	290
Not completed	27	18
Adverse event, serious fatal	-	1
Consent withdrawn by subject	1	5
Physician decision	2	-
Adverse event, non-fatal	13	4
Ongoing	1	-
Protocol-specified withdrawal criterion	1	-
Lost to follow-up	1	1
Protocol deviation	5	3
Lack of efficacy	3	4

Baseline characteristics

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Reporting group title

CAB LA+RPV LA (Q4W)

Reporting group description

Reporting group title

Current ART

Reporting group description

Reporting group values	CAB LA+RPV LA (Q4W)	Current ART	Total
Number of subjects	308	308	616
Age categorical
Units: Subjects
In utero	0	0	0
Preterm newborn infants (gestational age < 37 wks)	0	0	0
Newborns (0-27 days)	0	0	0
Infants and toddlers (28 days-23 months)	0	0	0
Children (2-11 years)	0	0	0
Adolescents (12-17 years)	0	0	0
Adults (18-64 years)	303	298	601
From 65-84 years	5	10	15
85 years and over	0	0	0
Age Continuous
Units: Years
arithmetic mean (standard deviation)	41.6 ± 9.99	43.2 ± 11.43	-
Sex: Female, Male
Units: Subjects
Female	99	104	203
Male	209	204	413
Race/Ethnicity, Customized
Units: Subjects
American Indian (AI) or Alaska Native (AN)	8	8	16
Asian-Central South Asian Heritage	1	0	1
Asian-Japanese/East/South-East Asian Heritage	21	13	34
Black or African American	62	77	139
Native Hawaiian or other Pacific Islander	0	1	1
White	214	207	421
AI or AN & Black/African American	0	1	1
AI or AN & Black/African American & White	1	1	2
Black/African American or White	1	0	1

End points

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Reporting group title

CAB LA+RPV LA (Q4W)

Reporting group description

Reporting group title

Current ART

Reporting group description

Subject analysis set title

CAB LA

Subject analysis set type

Sub-group analysis

Subject analysis set description

Participants received IM injections of CAB LA 400 mg every four weeks through Week 52.

Subject analysis set title

RPV LA

Subject analysis set type

Sub-group analysis

Subject analysis set description

Participants received IM injections of RPV LA 900 mg every four weeks through Week 52.

Primary: Number of participants with virologic failure (HIV-1 ribonucleic acid [RNA] >=50 copies per milliliter [c/mL]) using snapshot algorithm at Week 48

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End point title

Number of participants with virologic failure (HIV-1 ribonucleic acid [RNA] >=50 copies per milliliter [c/mL]) using snapshot algorithm at Week 48

End point description

Number of participants with virologic failure endpoint (HIV-1 RNA>=50 c/mL) as per Food and Drug Administration (FDA) snapshot algorithm at Week 48 was assessed to demonstrate the non-inferior antiviral activity of switching to intramuscular (IM) CAB LA+RPV LA every 4 weeks compared to continuation of current ART regimen over 48 weeks in HIV-1 infected ART-experienced participants. The HIV-1 RNA >=50 copies/mL per snapshot algorithm was determined by the last available on-treatment HIV-1 RNA measurement within the analysis visit window of interest. Intent-to treat exposed (ITT-E) participants included all randomized participants who received at least one dose of Investigational Product (IP) during the maintenance phase. Participants were analyzed according to the randomized treatment regardless of what treatment actually received

End point type

Primary

End point timeframe

Week 48

End point values	CAB LA+RPV LA (Q4W)	Current ART
Number of subjects analysed	308 ^[1]	308 ^[2]
Units: Participants	5	3

Notes
[1] - ITT-E Population.
[2] - ITT-E Population

Statistical Analysis 1

Statistical analysis description

Non-inferiority in the proportion of participants with virologic failure at Week 48 (per FDA’s snapshot algorithm for assessing HIV-1 RNA >=50 copies/mL) can be concluded if the upper bound of a two-sided 95% confidence interval for the difference in failure rates between the two treatment arms (CAB – current ART) is not more than 6%.

Comparison groups

CAB LA+RPV LA (Q4W) v Current ART

Number of subjects included in analysis

616

Analysis specification

Pre-specified

Analysis type

non-inferiority ^[3]

Method

Parameter type

Adjusted difference in proportion

Point estimate

0.6

Confidence interval

level

95%

sides

2-sided

lower limit

-1.2

upper limit

2.5

Notes
[3] - Adjusted difference in proportion was based on Cochran-Mantel Haenszel stratified analysis adjusting for the following Baseline stratification factors: sex at birth (Male, Female) and Baseline third agent (PI, NNRTI, INI).

Secondary: Number of participants with HIV-1 RNA <50 copies/mL using snapshot algorithm at Week 48

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End point title

Number of participants with HIV-1 RNA <50 copies/mL using snapshot algorithm at Week 48

End point description

Plasma samples were collected for quantitative analysis of HIV-1 RNA. Number of participants with plasma HIV-1 RNA <50 copies/mL at Week 48 using FDA snapshot algorithm was assessed to demonstrate antiviral and immunologic activity of switching to IM CAB LA+RPV LA every 4 weeks compared to continuation of current ART. The HIV-1 RNA <50 copies/mL per snapshot algorithm was determined by the last available on-treatment HIV-1 RNA measurement within the analysis visit window of interest.

End point type

Secondary

End point timeframe

Week 48

End point values	CAB LA+RPV LA (Q4W)	Current ART
Number of subjects analysed	308 ^[4]	308 ^[5]
Units: Participants	285	294

Notes
[4] - ITT-E Population
[5] - ITT-E Population

Statistical Analysis 1

Statistical analysis description

Non-inferiority in the proportion of participants with HIV-1 RNA<50 c/mL at Week 48 (per FDA’s snapshot algorithm) can be concluded if the lower bound of a two-sided 95% confidence interval for the difference in success rates between the two treatment arms (CAB – current ART) is more than -10%.

Comparison groups

CAB LA+RPV LA (Q4W) v Current ART

Number of subjects included in analysis

616

Analysis specification

Pre-specified

Analysis type

non-inferiority ^[6]

Method

Parameter type

Adjusted difference in proportion

Point estimate

-3

Confidence interval

level

95%

sides

2-sided

lower limit

-6.7

upper limit

0.7

Notes
[6] - Adjusted difference in proportion was based on Cochran-Mantel Haenszel stratified analysis adjusting for the following Baseline stratification factors: sex at birth (Male, Female) and Baseline third agent (PI, NNRTI, INI).

Secondary: Number of participants with HIV-1 RNA <200 copies/mL using snapshot algorithm at Week 48

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End point title

Number of participants with HIV-1 RNA <200 copies/mL using snapshot algorithm at Week 48

End point description

Number of participants with plasma HIV-1 RNA <200 copies/mL at Week 48 using the snapshot algorithm was assessed based on the antiviral and immunologic activity of switching to IM CAB LA+RPV LA every 4 weeks compared to continuation of current ART.

End point type

Secondary

End point timeframe

Week 48

End point values	CAB LA+RPV LA (Q4W)	Current ART
Number of subjects analysed	308 ^[7]	308 ^[8]
Units: Participants	286	295

Notes
[7] - ITT-E Population
[8] - ITT-E Population

No statistical analyses for this end point

Secondary: Number of participants with confirmed virologic failure (CVF)

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End point title

Number of participants with confirmed virologic failure (CVF)

End point description

The CVF is defined as rebound as indicated by two consecutive plasma HIV-1-RNA levels >=200 copies/mL after prior suppression to <200 copies/mL. The outcome displays only visits during which at least one new CVF occurs. Plasma samples were collected for quantitative analysis of HIV-1 RNA.

End point type

Secondary

End point timeframe

Weeks 8, 12, 20, 24, 32 and 40

End point values	CAB LA+RPV LA (Q4W)	Current ART
Number of subjects analysed	308 ^[9]	308 ^[10]
Units: Participants
Week 8	1	0
Week 12	2	0
Week 20	2	2
Week 24	3	2
Week 32	3	3
Week 40	3	4

Notes
[9] - ITT-E Population
[10] - ITT-E Population

No statistical analyses for this end point

Secondary: Absolute values for plasma HIV-1 RNA at Week 48

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End point title

Absolute values for plasma HIV-1 RNA at Week 48

End point description

Logarithm to base 10 (log10) values for plasma HIV-1 RNA has been presented. Only those participants with data available at the specified data points were analyzed

End point type

Secondary

End point timeframe

Week 48

End point values	CAB LA+RPV LA (Q4W)	Current ART
Number of subjects analysed	265 ^[11]	292 ^[12]
Units: log10 copies/mL
arithmetic mean (standard deviation)	1.505 ± 0.0470	1.518 ± 0.1123

Notes
[11] - ITT-E Population
[12] - ITT-E Population

No statistical analyses for this end point

Secondary: Change from Baseline values for plasma HIV-1 RNA

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End point title

Change from Baseline values for plasma HIV-1 RNA

End point description

Plasma for quantitative HIV-1 RNA were collected at indicated time points. Baseline value is defined as the latest pre-treatment assessment with a non-missing value. Change from Baseline was defined as: HIV-1 RNA(log 10) at Week 48 - HIV-1 RNA(log 10) at Baseline.

End point type

Secondary

End point timeframe

Baseline and Week 48

End point values	CAB LA+RPV LA (Q4W)	Current ART
Number of subjects analysed	265 ^[13]	292 ^[14]
Units: log10 copies/mL
arithmetic mean (standard deviation)	-0.013 ± 0.1940	0.012 ± 0.1201

Notes
[13] - ITT-E Population
[14] - ITT-E Population

No statistical analyses for this end point

Secondary: Absolute values for CD4+ lymphocyte count at Week 48

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End point title

Absolute values for CD4+ lymphocyte count at Week 48

End point description

End point type

Secondary

End point timeframe

Week 48

End point values	CAB LA+RPV LA (Q4W)	Current ART
Number of subjects analysed	263 ^[15]	290 ^[16]
Units: Cells per cubic millimeter
arithmetic mean (standard deviation)	685.3 ± 262.97	716.7 ± 292.85

Notes
[15] - ITT-E Population
[16] - ITT-E Population

No statistical analyses for this end point

Secondary: Change from Baseline values for CD4+ lymphocyte count at Week 48

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End point title

Change from Baseline values for CD4+ lymphocyte count at Week 48

End point description

Blood samples were collected and CD4+ cell count assessment by flow cyclometry was carried out to evaluate the immunologic activity of switching to IM CAB LA+RPV LA every 4 weeks compared to current ART.Baseline value is defined as the latest pre-treatment assessment with a non-missing value. Change from Baseline was defined as post-dose visit value at Week 48 minus Baseline value. Only those participants with data available at the specified data points were analyzed

End point type

Secondary

End point timeframe

Baseline (Day 1) and Week 48

End point values	CAB LA+RPV LA (Q4W)	Current ART
Number of subjects analysed	263 ^[17]	290 ^[18]
Units: Cells per cubic millimeter
arithmetic mean (standard deviation)	9.9 ± 187.24	19.4 ± 168.80

Notes
[17] - ITT-E Population
[18] - ITT-E Population

No statistical analyses for this end point

Secondary: Number of participants with disease progression

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End point title

Number of participants with disease progression

End point description

Disease progression was defined as HIV-associated conditions, acquired immunodeficiency syndrome (AIDS), and death through 48 Weeks. Data of participants who experienced disease progression to Centers for Disease Control and Prevention (CDC) Stage III or death has been presented.

End point type

Secondary

End point timeframe

Up to Week 48

End point values	CAB LA+RPV LA (Q4W)	Current ART
Number of subjects analysed	308 ^[19]	308 ^[20]
Units: Participants	8	8

Notes
[19] - ITT-E Population
[20] - ITT-E Population

No statistical analyses for this end point

Secondary: Number of participants with non-serious adverse events (non-SAEs) and serious adverse events (SAEs)

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End point title

Number of participants with non-serious adverse events (non-SAEs) and serious adverse events (SAEs)

End point description

An adverse event (AE) is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. A SAE is defined as any untoward medical occurrence that, at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent disability/incapacity, is a congenital anomaly/birth defect, associated with liver injury and impaired liver function or any other situations as per medical or scientific judgement. Safety Population comprised of all randomized participants who received at least one dose of IP during the maintenance phase of the study (on or after Day 1 visit). Participants will be assessed according to actual treatment received.

End point type

Secondary

End point timeframe

Up to Week 48

End point values	CAB LA+RPV LA (Q4W)	Current ART
Number of subjects analysed	308 ^[21]	308 ^[22]
Units: Participants
Any non-SAE	263	117
Any SAE	13	14

Notes
[21] - Safety Population
[22] - Safety Population

No statistical analyses for this end point

Secondary: Number of participants with severity of adverse events

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End point title

Number of participants with severity of adverse events

End point description

Severity of AEs were defined as per The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table) Version 2.0, November 2014. Severity grades for AEs were as Grade 1 (mild), Grade 2 (moderate), Grade 3 (severe), Grade 4 (Potentially life-threatening) and Grade 5 were all deaths related to an AE.

End point type

Secondary

End point timeframe

Up to Week 48

End point values	CAB LA+RPV LA (Q4W)	Current ART
Number of subjects analysed	308 ^[23]	308 ^[24]
Units: Participants
Grade 1	101	115
Grade 2	158	81
Grade 3	27	19
Grade 4	8	4
Grade 5	0	1

Notes
[23] - Safety Population
[24] - Safety Population

No statistical analyses for this end point

Secondary: Absolute values for hematology parameters over time including Week 48: basophil, eosinophils, leukocytes, lymphocytes, neutrophils, monocytes, and platelets

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End point title

Absolute values for hematology parameters over time including Week 48: basophil, eosinophils, leukocytes, lymphocytes, neutrophils, monocytes, and platelets

End point description

Blood samples were collected for the analysis of hematology parameters including basophil, eosinophils, leukocytes, lymphocytes, neutrophils, monocytes, and platelets at indicated time points. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).

End point type

Secondary

End point timeframe

Baseline (Day 1) and at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44 and 48

End point values	CAB LA+RPV LA (Q4W)	Current ART
Number of subjects analysed	308 ^[25]	308 ^[26]
Units: 10^9 cells per liter
arithmetic mean (standard deviation)
Basophils, Baseline, n=308, 307	0.021 ± 0.0147	0.021 ± 0.0148
Basophils, Week 4, n=299, 291	0.024 ± 0.0153	0.023 ± 0.0161
Basophils, Week 8, n=216, 294	0.023 ± 0.0188	0.022 ± 0.0155
Basophils, Week 12, n=293, 290	0.022 ± 0.0154	0.022 ± 0.0157
Basophils, Week 16, n=274, 292	0.022 ± 0.0147	0.022 ± 0.0140
Basophils, Week 20, n=273, 292	0.023 ± 0.0182	0.024 ± 0.0195
Basophils, Week 24, n=277, 292	0.023 ± 0.0139	0.024 ± 0.0133
Basophils, Week 28, n=266, 295	0.024 ± 0.0150	0.023 ± 0.0138
Basophils, Week 32, n=262, 283	0.025 ± 0.0171	0.024 ± 0.0159
Basophils, Week 36, n=260, 282	0.029 ± 0.0211	0.028 ± 0.0190
Basophils, Week 40, n=258, 280	0.035 ± 0.0266	0.031 ± 0.0206
Basophils, Week 44, n=258, 268	0.037 ± 0.0275	0.033 ± 0.0222
Basophils, Week 48, n=246, 274	0.040 ± 0.0253	0.039 ± 0.0249
Eosinophils, Baseline, n=308, 307	0.142 ± 0.1409	0.140 ± 0.1538
Eosinophils, Week 4, n=299, 291	0.168 ± 0.1587	0.145 ± 0.1422
Eosinophils, Week 8, n=216, 294	0.154 ± 0.1379	0.131 ± 0.1333
Eosinophils, Week 12, n=293, 290	0.142 ± 0.1172	0.132 ± 0.1471
Eosinophils, Week 16, n=274, 292	0.153 ± 0.1395	0.131 ± 0.1584
Eosinophils, Week 20, n=273, 292	0.152 ± 0.1480	0.116 ± 0.1094
Eosinophils, Week 24, n=277, 292	0.143 ± 0.1323	0.121 ± 0.1337
Eosinophils, Week 28, n=266, 295	0.144 ± 0.1266	0.129 ± 0.1320
Eosinophils, Week 32, n=262, 283	0.170 ± 0.1643	0.131 ± 0.1319
Eosinophils, Week 36, n=260, 282	0.150 ± 0.1403	0.132 ± 0.1162
Eosinophils, Week 40, n=258, 280	0.161 ± 0.1206	0.132 ± 0.1124
Eosinophils, Week 44, n=258, 268	0.175 ± 0.1471	0.136 ± 0.1126
Eosinophils, Week 48, n=246, 274	0.174 ± 0.1412	0.140 ± 0.1265
Leukocytes, Baseline, n=308, 307	5.87 ± 1.928	5.65 ± 1.897
Leukocytes, Week 4, n=300, 298	6.43 ± 2.154	5.81 ± 1.733
Leukocytes, Week 8, n=217, 301	6.14 ± 1.875	5.64 ± 1.663
Leukocytes, Week 12, n=294, 293	6.24 ± 1.876	5.77 ± 1.751
Leukocytes, Week 16, n=279, 295	6.27 ± 1.920	5.82 ± 1.756
Leukocytes, Week 20, n=276, 298	6.27 ± 1.947	5.70 ± 1.721
Leukocytes, Week 24, n=279, 294	6.18 ± 1.931	5.78 ± 1.756
Leukocytes, Week 28, n=268, 297	6.08 ± 1.949	5.73 ± 1.637
Leukocytes, Week 32, n=267, 288	6.30 ± 1.914	5.73 ± 1.666
Leukocytes, Week 36, n=264, 285	6.14 ± 1.831	5.80 ± 1.968
Leukocytes, Week 40, n=264, 286	6.24 ± 2.046	5.74 ± 1.713
Leukocytes, Week 44, n=269, 279	6.15 ± 1.884	5.66 ± 1.745
Leukocytes, Week 48, n=252, 282	6.01 ± 1.943	5.62 ± 1.679
Lymphocytes, Baseline, n=308, 307	1.943 ± 0.6073	1.940 ± 0.6880
Lymphocytes, Week 4, n=299, 291	2.127 ± 0.6942	2.059 ± 0.6929
Lymphocytes, Week 8, n=216, 294	1.995 ± 0.6347	1.975 ± 0.6549
Lymphocytes, Week 12, n=293, 290	1.984 ± 0.6428	2.026 ± 0.6996
Lymphocytes, Week 16, n=274, 292	2.057 ± 0.6840	2.029 ± 0.6584
Lymphocytes, Week 20, n=273, 292	2.035 ± 0.6140	2.030 ± 0.6906
Lymphocytes, Week 24, n=277, 292	2.016 ± 0.6523	1.980 ± 0.6047
Lymphocytes, Week 28, n=266, 295	2.049 ± 0.6960	2.016 ± 0.6476
Lymphocytes, Week 32, n=262, 283	2.020 ± 0.6157	2.007 ± 0.6511
Lymphocytes, Week 36, n=260, 282	1.960 ± 0.6009	1.984 ± 0.6444
Lymphocytes, Week 40, n=258, 280	1.994 ± 0.6149	1.957 ± 0.6305
Lymphocytes, Week 44, n=258, 268	2.016 ± 0.6457	1.970 ± 0.6219
Lymphocytes, Week 48, n=246, 274	1.900 ± 0.5725	1.915 ± 0.6204
Neutrophils, Baseline, n=308, 307	3.437 ± 1.6106	3.209 ± 1.5748
Neutrophils, Week 4, n=299, 291	3.708 ± 1.8763	3.244 ± 1.3931
Neutrophils, Week 8, n=216, 294	3.597 ± 1.6128	3.190 ± 1.3370
Neutrophils, Week 12, n=293, 290	3.724 ± 1.5751	3.268 ± 1.4153
Neutrophils, Week 16, n=274, 292	3.670 ± 1.6777	3.308 ± 1.3870
Neutrophils, Week 20, n=273, 292	3.707 ± 1.6532	3.188 ± 1.3345
Neutrophils, Week 24, n=277, 292	3.613 ± 1.5978	3.289 ± 1.4381
Neutrophils, Week 28, n=266, 295	3.528 ± 1.5464	3.221 ± 1.2962
Neutrophils, Week 32, n=262, 283	3.704 ± 1.6196	3.228 ± 1.2909
Neutrophils, Week 36, n=260, 282	3.629 ± 1.5688	3.314 ± 1.6341
Neutrophils, Week 40, n=258, 280	3.688 ± 1.7685	3.280 ± 1.4190
Neutrophils, Week 44, n=258, 268	3.571 ± 1.5425	3.169 ± 1.4140
Neutrophils, Week 48, n=246, 274	3.450 ± 1.5649	3.172 ± 1.3627
Monocytes, Baseline, n=308, 307	0.353 ± 0.1745	0.339 ± 0.1596
Monocytes, Week 4, n=299, 291	0.404 ± 0.1951	0.367 ± 0.1694
Monocytes, Week 8, n=216, 294	0.369 ± 0.1628	0.358 ± 0.1875
Monocytes, Week 12, n=293, 290	0.375 ± 0.1563	0.342 ± 0.1693
Monocytes, Week 16, n=274, 292	0.364 ± 0.1537	0.345 ± 0.1645
Monocytes, Week 20, n=273, 292	0.356 ± 0.1526	0.342 ± 0.1632
Monocytes, Week 24, n=277, 292	0.370 ± 0.1632	0.341 ± 0.1632
Monocytes, Week 28, n=266, 295	0.354 ± 0.1631	0.333 ± 0.1592
Monocytes, Week 32, n=262, 283	0.378 ± 0.1629	0.351 ± 0.1801
Monocytes, Week 36, n=260, 282	0.376 ± 0.1593	0.366 ± 0.1824
Monocytes, Week 40, n=258, 280	0.402 ± 0.1612	0.359 ± 0.1823
Monocytes, Week 44, n=258, 268	0.409 ± 0.1643	0.388 ± 0.1795
Monocytes, Week 48, n=246, 274	0.407 ± 0.1600	0.384 ± 0.1742
Platelets, Baseline, n=308, 308	231.1 ± 56.75	232.9 ± 59.28
Platelets, Week 4, n=300, 298	233.5 ± 55.09	238.1 ± 61.98
Platelets, Week 8, n=216, 298	227.4 ± 47.04	234.0 ± 61.84
Platelets, Week 12, n=294, 290	230.2 ± 57.32	237.8 ± 64.42
Platelets, Week 16, n=279, 294	226.1 ± 56.82	236.4 ± 61.63
Platelets, Week 20, n=274, 297	226.5 ± 58.11	237.7 ± 61.51
Platelets, Week 24, n=279, 292	224.9 ± 53.19	239.8 ± 64.11
Platelets, Week 28, n=268, 295	224.7 ± 54.15	239.0 ± 62.32
Platelets, Week 32, n=267, 289	226.5 ± 50.84	239.3 ± 59.53
Platelets, Week 36, n=267, 284	229.0 ± 53.90	242.9 ± 66.12
Platelets, Week 40, n=263, 288	230.1 ± 53.48	240.8 ± 61.92
Platelets, Week 44, n=270, 286	235.5 ± 55.80	241.4 ± 61.73
Platelets, Week 48, n=253, 281	230.5 ± 54.33	240.2 ± 62.95

Notes
[25] - Safety Population
[26] - Safety Population

No statistical analyses for this end point

Secondary: Absolute values for hematology parameters: erythrocyte mean corpuscular volume

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End point title

Absolute values for hematology parameters: erythrocyte mean corpuscular volume

End point description

Blood samples were collected for the analysis of hematology parameter including erythrocyte mean corpuscular volume at indicated time points. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).

End point type

Secondary

End point timeframe

Baseline (Day 1) and at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44 and 48

End point values	CAB LA+RPV LA (Q4W)	Current ART
Number of subjects analysed	308 ^[27]	308 ^[28]
Units: Femtoliters
arithmetic mean (standard deviation)
Baseline, n=308, 308	95.7 ± 7.97	96.6 ± 9.35
Week 4, n=300, 300	94.6 ± 6.88	96.9 ± 9.31
Week 8, n=218, 301	92.7 ± 5.76	96.8 ± 9.25
Week 12, n=294, 293	91.7 ± 5.69	96.9 ± 9.34
Week 16, n=280, 296	90.6 ± 5.48	96.8 ± 9.64
Week 20, n=276, 298	90.3 ± 5.37	97.0 ± 9.63
Week 24, n=279, 294	90.2 ± 5.44	96.9 ± 9.75
Week 28, n=268, 297	90.2 ± 5.68	97.2 ± 9.77
Week 32, n=268, 291	90.1 ± 5.55	96.7 ± 9.36
Week 36, n=267, 288	89.8 ± 5.64	96.5 ± 9.08
Week 40, n=264, 289	89.9 ± 5.57	96.5 ± 9.05
Week 44, n=273, 286	89.9 ± 5.52	96.2 ± 9.08
Week 48, n=255, 284	89.9 ± 5.58	96.2 ± 9.38

Notes
[27] - Safety Population
[28] - Safety Population

No statistical analyses for this end point

Secondary: Absolute values for hematology parameters: erythrocytes

Top of page

End point title

Absolute values for hematology parameters: erythrocytes

End point description

Blood samples were collected for the analysis of hematology parameters including erythrocytes at indicated time points. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).

End point type

Secondary

End point timeframe

Baseline (Day 1) and at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44 and 48

End point values	CAB LA+RPV LA (Q4W)	Current ART
Number of subjects analysed	308 ^[29]	308 ^[30]
Units: 10^12 cells per liter
arithmetic mean (standard deviation)
Baseline, n=308, 308	4.55 ± 0.563	4.49 ± 0.570
Week 4, n=300, 300	4.59 ± 0.503	4.45 ± 0.567
Week 8, n=218, 301	4.68 ± 0.479	4.49 ± 0.566
Week 12, n=294, 293	4.79 ± 0.464	4.51 ± 0.580
Week 16, n=280, 296	4.84 ± 0.475	4.48 ± 0.549
Week 20, n=276, 298	4.86 ± 0.459	4.48 ± 0.586
Week 24, n=279, 294	4.86 ± 0.471	4.48 ± 0.572
Week 28, n=268, 297	4.85 ± 0.456	4.47 ± 0.565
Week 32, n=268, 291	4.84 ± 0.452	4.48 ± 0.550
Week 36, n=267, 288	4.81 ± 0.462	4.49 ± 0.561
Week 40, n=264, 289	4.84 ± 0.456	4.49 ± 0.572
Week 44, n=273, 286	4.86 ± 0.448	4.49 ± 0.572
Week 48, n=255, 284	4.81 ± 0.448	4.50 ± 0.600

Notes
[29] - Safety Population
[30] - Safety Population

No statistical analyses for this end point

Secondary: Absolute values for hematology parameters: hemoglobin

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End point title

Absolute values for hematology parameters: hemoglobin

End point description

Blood samples were collected for the analysis of hematology parameter including hemoglobin at indicated time points. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).

End point type

Secondary

End point timeframe

Baseline (Day 1) and at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44 and 48

End point values	CAB LA+RPV LA (Q4W)	Current ART
Number of subjects analysed	308 ^[31]	308 ^[32]
Units: Grams per liter
arithmetic mean (standard deviation)
Baseline, n=308, 308	142.2 ± 17.24	141.4 ± 16.29
Week 4, n=300, 300	141.7 ± 16.30	140.5 ± 16.44
Week 8, n=218, 301	141.5 ± 16.08	141.2 ± 16.51
Week 12, n=294, 293	142.4 ± 15.90	141.6 ± 16.62
Week 16, n=280, 296	142.5 ± 16.19	140.5 ± 15.81
Week 20, n=276, 298	142.6 ± 15.52	141.2 ± 16.62
Week 24, n=279, 294	143.3 ± 15.66	141.6 ± 16.18
Week 28, n=268, 297	142.8 ± 16.05	140.9 ± 15.89
Week 32, n=268, 291	143.0 ± 15.42	141.8 ± 15.81
Week 36, n=267, 288	142.7 ± 16.31	142.3 ± 15.72
Week 40, n=264, 289	143.5 ± 15.80	142.4 ± 15.90
Week 44, n=273, 286	143.6 ± 15.66	142.1 ± 16.38
Week 48, n=255, 284	142.7 ± 15.93	142.8 ± 16.34

Notes
[31] - Safety Population
[32] - Safety Population

No statistical analyses for this end point

Secondary: Absolute values for hematology parameters: hematocrit

Top of page

End point title

Absolute values for hematology parameters: hematocrit

End point description

Blood samples were collected for the analysis of hematology parameters including hematocrit at indicated time points. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).

End point type

Secondary

End point timeframe

Baseline (Day 1) and at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44 and 48

End point values	CAB LA+RPV LA (Q4W)	Current ART
Number of subjects analysed	308 ^[33]	308 ^[34]
Units: Proportion of red blood cells in blood
arithmetic mean (standard deviation)
Baseline, n=308, 308	0.4333 ± 0.04804	0.4305 ± 0.04454
Week 4, n=300, 300	0.4325 ± 0.04570	0.4283 ± 0.04548
Week 8, n=218, 301	0.4327 ± 0.04570	0.4310 ± 0.04580
Week 12, n=294, 293	0.4379 ± 0.04483	0.4338 ± 0.04640
Week 16, n=280, 296	0.4369 ± 0.04626	0.4304 ± 0.04418
Week 20, n=276, 298	0.4378 ± 0.04476	0.4312 ± 0.04755
Week 24, n=279, 294	0.4376 ± 0.04589	0.4312 ± 0.04595
Week 28, n=268, 297	0.4364 ± 0.04607	0.4308 ± 0.04555
Week 32, n=268, 291	0.4350 ± 0.04311	0.4299 ± 0.04431
Week 36, n=267, 288	0.4311 ± 0.04462	0.4295 ± 0.04348
Week 40, n=264, 289	0.4342 ± 0.04381	0.4300 ± 0.04449
Week 44, n=273, 286	0.4357 ± 0.04288	0.4282 ± 0.04472
Week 48, n=255, 284	0.4318 ± 0.04438	0.4286 ± 0.04465

Notes
[33] - Safety Population
[34] - Safety Population

No statistical analyses for this end point

Secondary: Change from Baseline for hematology parameters: basophil, eosinophils, leukocytes, lymphocytes, neutrophils, monocytes, and platelets

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End point title

Change from Baseline for hematology parameters: basophil, eosinophils, leukocytes, lymphocytes, neutrophils, monocytes, and platelets

End point description

Blood samples were collected for the analysis of hematology parameters including basophil, eosinophils, leukocytes, lymphocytes, neutrophils, monocytes, and platelets at indicated timepoints. Baseline value is defined as the latest pre-treatment assessment with a non-missing value. Change from Baseline was defined as post-dose visit value minus Baseline value. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).

End point type

Secondary

End point timeframe

Baseline (Day 1) and at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44 and 48

End point values	CAB LA+RPV LA (Q4W)	Current ART
Number of subjects analysed	308 ^[35]	308 ^[36]
Units: 10^9 cells per liters
arithmetic mean (standard deviation)
Basophils, Week 4, n=299, 290	0.003 ± 0.0202	0.003 ± 0.0185
Basophils, Week 8, n=216, 293	0.003 ± 0.0204	0.000 ± 0.0181
Basophils, Week 12, n=293, 289	0.002 ± 0.0205	0.001 ± 0.0197
Basophils, Week 16, n=274, 291	0.001 ± 0.0186	0.001 ± 0.0181
Basophils, Week 20, n=273, 291	0.002 ± 0.0225	0.002 ± 0.0212
Basophils, Week 24, n=277, 291	0.002 ± 0.0169	0.003 ± 0.0167
Basophils, Week 28, n=266, 294	0.003 ± 0.0200	0.002 ± 0.0181
Basophils, Week 32, n=262, 282	0.005 ± 0.0199	0.003 ± 0.0189
Basophils, Week 36, n=260, 281	0.009 ± 0.0231	0.007 ± 0.0217
Basophils, Week 40, n=258, 279	0.014 ± 0.0292	0.011 ± 0.0233
Basophils, Week 44, n=258, 267	0.017 ± 0.0283	0.012 ± 0.0239
Basophils, Week 48, n=246, 273	0.019 ± 0.0273	0.018 ± 0.0263
Eosinophils, Week 4, n=299, 290	0.026 ± 0.1394	0.009 ± 0.1409
Eosinophils, Week 8, n=216, 293	0.015 ± 0.1278	-0.008 ± 0.1319
Eosinophils, Week 12, n=293, 289	-0.003 ± 0.1155	-0.010 ± 0.1533
Eosinophils, Week 16, n=274, 291	0.009 ± 0.1246	-0.011 ± 0.1759
Eosinophils, Week 20, n=273, 291	0.009 ± 0.1410	-0.027 ± 0.1352
Eosinophils, Week 24, n=277, 291	0.002 ± 0.1228	-0.021 ± 0.1490
Eosinophils, Week 28, n=266, 294	-0.002 ± 0.1298	-0.011 ± 0.1387
Eosinophils, Week 32, n=262, 282	0.022 ± 0.1629	-0.012 ± 0.1511
Eosinophils, Week 36, n=260, 281	0.002 ± 0.1413	-0.012 ± 0.1382
Eosinophils, Week 40, n=258, 279	0.019 ± 0.1319	-0.006 ± 0.1283
Eosinophils, Week 44, n=258, 267	0.032 ± 0.1388	-0.004 ± 0.1061
Eosinophils, Week 48, n=246, 273	0.032 ± 0.1321	0.002 ± 0.1253
Leukocytes, Week 4, n=300, 297	0.54 ± 1.599	0.13 ± 1.544
Leukocytes, Week 8, n=217, 300	0.19 ± 1.579	-0.02 ± 1.548
Leukocytes, Week 12, n=294, 292	0.35 ± 1.743	0.10 ± 1.571
Leukocytes, Week 16, n=279, 294	0.34 ± 1.653	0.17 ± 1.558
Leukocytes, Week 20, n=276, 297	0.46 ± 1.565	0.04 ± 1.529
Leukocytes, Week 24, n=279, 293	0.32 ± 1.720	0.10 ± 1.661
Leukocytes, Week 28, n=268, 296	0.25 ± 1.651	0.07 ± 1.471
Leukocytes, Week 32, n=267, 287	0.43 ± 1.602	0.07 ± 1.631
Leukocytes, Week 36, n=264, 284	0.33 ± 1.699	0.13 ± 1.821
Leukocytes, Week 40, n=264, 285	0.35 ± 1.808	0.12 ± 1.675
Leukocytes, Week 44, n=269, 278	0.22 ± 1.581	-0.03 ± 1.561
Leukocytes, Week 48, n=252, 281	0.09 ± 1.646	-0.06 ± 1.538
Lymphocytes, Week 4, n=299, 290	0.174 ± 0.5185	0.128 ± 0.5618
Lymphocytes, Week 8, n=216, 293	0.068 ± 0.5319	0.023 ± 0.5250
Lymphocytes, Week 12, n=293, 289	0.033 ± 0.5073	0.079 ± 0.5844
Lymphocytes, Week 16, n=274, 291	0.114 ± 0.5596	0.095 ± 0.5389
Lymphocytes, Week 20, n=273, 291	0.071 ± 0.5274	0.086 ± 0.5411
Lymphocytes, Week 24, n=277, 291	0.079 ± 0.5408	0.049 ± 0.4863
Lymphocytes, Week 28, n=266, 294	0.101 ± 0.6133	0.069 ± 0.6005
Lymphocytes, Week 32, n=262, 282	0.063 ± 0.5392	0.064 ± 0.5757
Lymphocytes, Week 36, n=260, 281	0.008 ± 0.5333	0.036 ± 0.5525
Lymphocytes, Week 40, n=258, 279	0.020 ± 0.5171	0.035 ± 0.5280
Lymphocytes, Week 44, n=258, 267	0.045 ± 0.5430	0.045 ± 0.5472
Lymphocytes, Week 48, n=246, 273	-0.063 ± 0.5528	-0.035 ± 0.5115
Neutrophils, Week 4, n=299, 290	0.258 ± 1.5445	0.004 ± 1.3601
Neutrophils, Week 8, n=216, 293	0.080 ± 1.4401	-0.031 ± 1.3599
Neutrophils, Week 12, n=293, 289	0.283 ± 1.6227	0.028 ± 1.3884
Neutrophils, Week 16, n=274, 291	0.181 ± 1.5415	0.080 ± 1.4451
Neutrophils, Week 20, n=273, 291	0.341 ± 1.4475	-0.019 ± 1.4228
Neutrophils, Week 24, n=277, 291	0.175 ± 1.5883	0.056 ± 1.5091
Neutrophils, Week 28, n=266, 294	0.129 ± 1.4052	-0.001 ± 1.3377
Neutrophils, Week 32, n=262, 282	0.291 ± 1.6015	0.008 ± 1.4430
Neutrophils, Week 36, n=260, 281	0.289 ± 1.5702	0.077 ± 1.6758
Neutrophils, Week 40, n=258, 279	0.245 ± 1.6621	0.075 ± 1.5336
Neutrophils, Week 44, n=258, 267	0.063 ± 1.4874	-0.105 ± 1.4587
Neutrophils, Week 48, n=246, 273	0.009 ± 1.5413	-0.066 ± 1.3969
Monocytes, Week 4, n=299, 290	0.049 ± 0.1663	0.030 ± 0.1270
Monocytes Week 8, n=216, 293	0.014 ± 0.1433	0.018 ± 0.1591
Monocytes, Week 12, n=293, 289	0.018 ± 0.1553	0.001 ± 0.1367
Monocytes, Week 16, n=274, 291	0.005 ± 0.1588	0.003 ± 0.1403
Monocytes, Week 20, n=273, 291	0.003 ± 0.1527	0.004 ± 0.1328
Monocytes, Week 24, n=277, 291	0.012 ± 0.1484	0.002 ± 0.1331
Monocytes, Week 28, n=266, 294	0.001 ± 0.1548	-0.004 ± 0.1343
Monocytes, Week 32, n=262, 282	0.019 ± 0.1535	0.011 ± 0.1585
Monocytes, Week 36, n=260, 281	0.016 ± 0.1501	0.024 ± 0.1551
Monocytes, Week 40, n=258, 279	0.039 ± 0.1507	0.020 ± 0.1550
Monocytes, Week 44, n=258, 267	0.045 ± 0.1673	0.045 ± 0.1539
Monocytes, Week 48, n=246, 273	0.047 ± 0.1502	0.039 ± 0.1499
Platelets, Week 4, n=300, 298	1.8 ± 38.02	4.3 ± 36.15
Platelets, Week 8, n=216, 298	-5.5 ± 31.98	0.7 ± 35.15
Platelets, Week 12, n=294, 290	-0.8 ± 40.83	5.5 ± 36.76
Platelets, Week 16, n=279, 294	-5.2 ± 40.67	4.3 ± 34.61
Platelets, Week 20, n=274, 297	-3.7 ± 36.87	5.5 ± 38.86
Platelets, Week 24, n=279, 292	-4.7 ± 35.22	6.7 ± 41.78
Platelets, Week 28, n=268, 295	-5.3 ± 35.22	5.4 ± 38.41
Platelets, Week 32, n=267, 289	-2.6 ± 36.51	6.5 ± 35.99
Platelets, Week 36, n=267, 284	-1.2 ± 37.26	9.8 ± 44.52
Platelets, Week 40, n=263, 288	0.0 ± 40.74	9.7 ± 39.91
Platelets, Week 44, n=270, 286	4.5 ± 38.31	9.2 ± 42.82
Platelets, Week 48, n=253, 281	0.0 ± 38.63	10.4 ± 41.75

Notes
[35] - Safety Population
[36] - Safety Population

No statistical analyses for this end point

Secondary: Change from Baseline for hematology parameters: erythrocyte mean corpuscular volume

Top of page

End point title

Change from Baseline for hematology parameters: erythrocyte mean corpuscular volume

End point description

Blood samples were collected for the analysis of hematology parameter including erythrocyte mean corpuscular volume at indicated timepoints. Baseline value is defined as the latest pre-treatment assessment with a non-missing value. Change from Baseline was defined as post-dose visit value minus Baseline value. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).

End point type

Secondary

End point timeframe

Baseline (Day 1) and at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44 and 48

End point values	CAB LA+RPV LA (Q4W)	Current ART
Number of subjects analysed	308 ^[37]	308 ^[38]
Units: Femtoliters
arithmetic mean (standard deviation)
Week 4, n=300, 300	-1.1 ± 2.71	0.2 ± 1.82
Week 8, n=218, 301	-3.0 ± 4.30	0.1 ± 1.76
Week 12, n=294, 293	-3.9 ± 5.23	0.2 ± 2.08
Week 16, n=280, 296	-4.9 ± 5.86	0.2 ± 2.42
Week 20, n=276, 298	-5.3 ± 5.98	0.3 ± 2.88
Week 24, n=279, 294	-5.4 ± 5.97	0.3 ± 3.24
Week 28, n=268, 297	-5.5 ± 6.11	0.4 ± 3.46
Week 32, n=268, 291	-5.5 ± 6.10	0.1 ± 3.47
Week 36, n=267, 288	-5.8 ± 6.24	-0.0 ± 3.69
Week 40, n=264, 289	-5.6 ± 6.21	-0.1 ± 3.62
Week 44, n=273, 286	-5.8 ± 6.33	-0.3 ± 3.68
Week 48, n=255, 284	-5.7 ± 6.76	-0.4 ± 3.57

Notes
[37] - Safety Population
[38] - Safety Population

No statistical analyses for this end point

Secondary: Change from Baseline for hematology parameters: erythrocytes

Top of page

End point title

Change from Baseline for hematology parameters: erythrocytes

End point description

Blood samples were collected for the analysis of hematology parameters including erythrocytes at indicated timepoints. Baseline value is defined as the latest pre-treatment assessment with a non-missing value. Change from Baseline was defined as post-dose visit value minus Baseline value. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).

End point type

Secondary

End point timeframe

Baseline (Day 1) and at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44 and 48

End point values	CAB LA+RPV LA (Q4W)	Current ART
Number of subjects analysed	308 ^[39]	308 ^[40]
Units: 10^12 cells per liter
arithmetic mean (standard deviation)
Week 4, n=300, 300	0.04 ± 0.255	-0.03 ± 0.226
Week 8, n=218, 301	0.14 ± 0.331	-0.01 ± 0.249
Week 12, n=294, 293	0.23 ± 0.374	0.01 ± 0.252
Week 16, n=280, 296	0.28 ± 0.380	-0.01 ± 0.256
Week 20, n=276, 298	0.30 ± 0.408	-0.01 ± 0.273
Week 24, n=279, 294	0.32 ± 0.397	-0.01 ± 0.246
Week 28, n=268, 297	0.28 ± 0.386	-0.01 ± 0.246
Week 32, n=268, 291	0.29 ± 0.393	-0.01 ± 0.261
Week 36, n=267, 288	0.26 ± 0.401	-0.01 ± 0.259
Week 40, n=264, 289	0.27 ± 0.396	-0.01 ± 0.260
Week 44, n=273, 286	0.31 ± 0.391	-0.01 ± 0.264
Week 48, n=255, 284	0.25 ± 0.394	-0.01 ± 0.262

Notes
[39] - Safety Population
[40] - Safety Population

No statistical analyses for this end point

Secondary: Change from Baseline for hematology parameters: hematocrit

Top of page

End point title

Change from Baseline for hematology parameters: hematocrit

End point description

Blood samples were collected for the analysis of hematology parameters including hematocrit at indicated timepoints. Baseline value is defined as the latest pre-treatment assessment with a non-missing value. Change from Baseline was defined as post-dose visit value minus Baseline value. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).

End point type

Secondary

End point timeframe

Baseline (Day 1) and at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44 and 48

End point values	CAB LA+RPV LA (Q4W)	Current ART
Number of subjects analysed	308 ^[41]	308 ^[42]
Units: Proportion of red blood cells in blood
arithmetic mean (standard deviation)
Week 4, n=300, 300	-0.0003 ± 0.02236	-0.0023 ± 0.02194
Week 8, n=218, 301	0.0007 ± 0.02613	-0.0005 ± 0.02330
Week 12, n=294, 293	0.0042 ± 0.02607	0.0020 ± 0.02408
Week 16, n=280, 296	0.0038 ± 0.02509	-0.0007 ± 0.02513
Week 20, n=276, 298	0.0043 ± 0.02742	0.0002 ± 0.02613
Week 24, n=279, 294	0.0052 ± 0.02790	0.0002 ± 0.02576
Week 28, n=268, 297	0.0023 ± 0.02699	0.0002 ± 0.02603
Week 32, n=268, 291	0.0022 ± 0.02872	-0.0011 ± 0.02916
Week 36, n=267, 288	-0.0012 ± 0.02793	-0.0011 ± 0.02797
Week 40, n=264, 289	-0.0001 ± 0.02741	-0.0011 ± 0.02781
Week 44, n=273, 286	0.0031 ± 0.02896	-0.0025 ± 0.02814
Week 48, n=255, 284	-0.0021 ± 0.02717	-0.0031 ± 0.02700

Notes
[41] - Safety Population
[42] - Safety Population

No statistical analyses for this end point

Secondary: Change from Baseline for hematology parameters: hemoglobin

Top of page

End point title

Change from Baseline for hematology parameters: hemoglobin

End point description

Blood samples were collected for the analysis of hematology parameter including hemoglobin at indicated timepoints. Baseline value is defined as the latest pre-treatment assessment with a non-missing value. Change from Baseline was defined as post-dose visit value minus Baseline value. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).

End point type

Secondary

End point timeframe

Baseline (Day 1) and at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44 and 48

End point values	CAB LA+RPV LA (Q4W)	Current ART
Number of subjects analysed	308 ^[43]	308 ^[44]
Units: Grams per liter
arithmetic mean (standard deviation)
Week 4, n=300, 300	-0.4 ± 6.91	-1.0 ± 6.73
Week 8, n=218, 301	-0.4 ± 8.18	-0.6 ± 7.33
Week 12, n=294, 293	0.0 ± 8.14	-0.3 ± 7.52
Week 16, n=280, 296	0.4 ± 8.22	-1.2 ± 7.75
Week 20, n=276, 298	0.3 ± 8.60	-0.5 ± 8.55
Week 24, n=279, 294	1.2 ± 8.78	-0.0 ± 8.46
Week 28, n=268, 297	0.3 ± 8.49	-0.6 ± 8.68
Week 32, n=268, 291	0.9 ± 8.94	0.2 ± 9.45
Week 36, n=267, 288	0.7 ± 9.03	0.8 ± 9.32
Week 40, n=264, 289	0.8 ± 8.96	0.7 ± 9.29
Week 44, n=273, 286	1.7 ± 9.49	0.6 ± 9.53
Week 48, n=255, 284	0.2 ± 9.26	0.9 ± 9.07

Notes
[43] - Safety Population
[44] - Safety Population

No statistical analyses for this end point

Secondary: Absolute values for clinical chemistry parameters over time including Week 48: Alanine aminotransferase (ALT), alkaline phosphatase (ALP), aspartate aminotransferase (AST) and creatinine kinase (CK)

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End point title

Absolute values for clinical chemistry parameters over time including Week 48: Alanine aminotransferase (ALT), alkaline phosphatase (ALP), aspartate aminotransferase (AST) and creatinine kinase (CK)

End point description

Blood samples were collected for the analysis of clinical chemistry parameters including ALT, ALP, AST and CK at indicated time points. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).

End point type

Secondary

End point timeframe

Baseline (Day 1) and at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44 and 48

End point values	CAB LA+RPV LA (Q4W)	Current ART
Number of subjects analysed	308 ^[45]	308 ^[46]
Units: International units per liter
arithmetic mean (standard deviation)
ALT, Baseline (Day 1), n=308, 308	23.8 ± 13.47	22.4 ± 12.90
ALT, Week 4, n=301, 303	24.4 ± 15.60	22.3 ± 11.10
ALT, Week 8, n=229, 303	24.0 ± 16.85	24.0 ± 29.86
ALT, Week 12, n=295, 299	29.0 ± 114.25	22.7 ± 13.48
ALT, Week 16, n=284, 298	23.7 ± 22.32	21.8 ± 11.31
ALT, Week 20, n=277, 302	23.1 ± 22.49	21.2 ± 10.50
ALT, Week 24, n=284, 299	26.3 ± 62.05	21.6 ± 12.64
ALT, Week 28, n=267, 296	21.1 ± 12.13	22.1 ± 14.62
ALT, Week 32, n=275, 294	21.8 ± 12.56	21.8 ± 12.09
ALT, Week 36, n=273, 292	23.2 ± 24.94	22.3 ± 12.17
ALT, Week 40, n=270, 293	24.5 ± 37.39	22.1 ± 12.78
ALT, Week 44, n=275, 293	21.6 ± 13.10	22.1 ± 13.67
ALT, Week 48, n=265, 292	21.8 ± 13.54	21.7 ± 11.08
ALP, Baseline (Day 1), n=308, 308	76.6 ± 28.20	77.5 ± 26.77
ALP, Week 4, n=301, 303	70.4 ± 22.75	75.7 ± 25.58
ALP, Week 8, n=229, 303	68.9 ± 21.98	78.8 ± 32.40
ALP, Week 12, n=295, 299	68.9 ± 24.79	78.6 ± 28.87
ALP, Week 16, n=284, 298	67.9 ± 19.76	77.3 ± 27.21
ALP, Week 20, n=277, 302	67.6 ± 18.72	76.7 ± 25.48
ALP, Week 24, n=284, 299	68.1 ± 19.15	77.5 ± 26.36
ALP, Week 28, n=267, 296	67.6 ± 18.89	77.2 ± 26.72
ALP, Week 32, n=275, 294	66.6 ± 19.14	75.8 ± 25.56
ALP, Week 36, n=273, 292	66.8 ± 20.68	76.4 ± 25.93
ALP, Week 40, n=270, 293	66.2 ± 17.58	76.2 ± 26.08
ALP, Week 44, n=275, 293	66.1 ± 18.34	76.8 ± 25.82
ALP, Week 48, n=265, 292	66.5 ± 18.84	77.1 ± 26.39
AST, Baseline (Day 1), n=308, 308	23.9 ± 11.31	22.5 ± 10.21
AST, Week 4, n=301, 303	23.2 ± 11.77	22.7 ± 10.93
AST, Week 8, n=229, 303	24.3 ± 19.49	22.5 ± 12.31
AST, Week 12, n=295, 299	26.1 ± 64.69	23.2 ± 10.61
AST, Week 16, n=284, 298	24.1 ± 18.20	22.5 ± 8.59
AST, Week 20, n=277, 302	23.5 ± 15.23	22.0 ± 6.83
AST, Week 24, n=284, 298	24.2 ± 22.89	22.5 ± 9.30
AST, Week 28, n=267, 296	22.2 ± 8.72	22.9 ± 9.61
AST, Week 32, n=275, 294	22.8 ± 13.71	23.2 ± 12.32
AST, Week 36, n=273, 292	23.0 ± 11.27	22.6 ± 7.18
AST, Week 40, n=270, 293	23.8 ± 14.96	22.5 ± 7.79
AST, Week 44, n=275, 293	22.9 ± 14.82	22.6 ± 10.26
AST Week 48, n=265, 292	22.9 ± 10.35	23.2 ± 9.30
CK, Baseline (Day 1), n=308, 308	196.6 ± 367.30	160.8 ± 367.57
CK, Week 4, n=301, 303	192.9 ± 437.09	190.6 ± 472.57
CK, Week 8, n=229, 303	275.9 ± 1064.72	145.4 ± 141.19
CK, Week 12, n=295, 299	200.7 ± 484.08	177.0 ± 321.29
CK, Week 16, n=284, 298	253.5 ± 849.45	167.5 ± 286.90
CK, Week 20, n=277, 302	228.4 ± 570.80	144.5 ± 133.32
CK, Week 24, n=284, 299	193.1 ± 444.27	161.2 ± 241.73
CK, Week 28, n=267, 296	168.8 ± 163.54	182.7 ± 420.44
CK, Week 32, n=275, 294	216.5 ± 593.10	195.9 ± 489.99
CK, Week 36, n=273, 292	186.4 ± 325.64	150.7 ± 134.40
CK, Week 40, n=270, 293	235.1 ± 624.03	160.7 ± 179.64
CK, Week 44, n=275, 293	245.5 ± 1189.35	149.9 ± 148.23
CK, Week 48, n=265, 292	198.8 ± 398.14	179.0 ± 331.51

Notes
[45] - Safety Population
[46] - Safety Population

No statistical analyses for this end point

Secondary: Absolute values for clinical chemistry parameter over time including Week 48: Albumin

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End point title

Absolute values for clinical chemistry parameter over time including Week 48: Albumin

End point description

Blood samples were collected for the analysis of clinical chemistry parameter-albumin at indicated time points. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).

End point type

Secondary

End point timeframe

Baseline (Day 1) and at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44 and 48

End point values	CAB LA+RPV LA (Q4W)	Current ART
Number of subjects analysed	308 ^[47]	308 ^[48]
Units: Grams per liter
arithmetic mean (standard deviation)
Baseline (Day 1), n=308, 308	44.2 ± 3.12	44.3 ± 3.19
Week 4, n=301, 303	43.7 ± 2.88	43.8 ± 2.87
Week 8, n=229, 303	43.8 ± 3.06	43.7 ± 3.17
Week 12, n=295, 299	43.6 ± 2.99	43.9 ± 3.12
Week 16, n=284, 298	43.5 ± 2.77	43.5 ± 3.12
Week 20, n=277, 302	43.4 ± 2.72	43.5 ± 3.07
Week 24, n=284, 299	43.4 ± 2.74	43.5 ± 3.02
Week 28, n=267, 296	43.6 ± 2.85	43.3 ± 3.07
Week 32, n=275, 294	43.5 ± 2.83	43.4 ± 3.25
Week 36, n=273, 292	43.3 ± 2.82	43.4 ± 3.07
Week 40, n=270, 293	43.7 ± 2.72	43.4 ± 3.04
Week 44, n=275, 293	43.7 ± 2.78	43.5 ± 3.02
Week 48, n=265, 292	43.8 ± 2.74	44.0 ± 2.92

Notes
[47] - Safety Population
[48] - Safety Population

No statistical analyses for this end point

Secondary: Absolute values for clinical chemistry parameters over time including Week 48: bilirubin, direct bilirubin and creatinine

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End point title

Absolute values for clinical chemistry parameters over time including Week 48: bilirubin, direct bilirubin and creatinine

End point description

Blood samples were collected for the analysis of clinical chemistry parameters including bilirubin, creatinine and direct bilirubin at indicated time points. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).

End point type

Secondary

End point timeframe

Baseline (Day 1) and at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44 and 48

End point values	CAB LA+RPV LA (Q4W)	Current ART
Number of subjects analysed	308 ^[49]	308 ^[50]
Units: Micromoles per liter
arithmetic mean (standard deviation)
Bilirubin, Baseline (Day 1), n=308, 308	9.9 ± 9.71	9.2 ± 6.39
Bilirubin, Week 4, n=301, 303	9.1 ± 3.98	8.9 ± 6.14
Bilirubin, Week 8, n=229, 303	9.3 ± 4.05	9.4 ± 9.06
Bilirubin, Week 12, n=295, 299	9.3 ± 4.45	9.3 ± 6.62
Bilirubin, Week 16, n=284, 298	10.0 ± 10.71	9.1 ± 6.28
Bilirubin, Week 20, n=277, 302	9.7 ± 4.28	9.3 ± 7.56
Bilirubin, Week 24, n=284, 298	9.3 ± 3.90	9.4 ± 8.38
Bilirubin, Week 28, n=267, 296	9.8 ± 3.99	9.1 ± 7.05
Bilirubin, Week 32, n=275, 294	9.8 ± 4.36	9.3 ± 7.05
Bilirubin, Week 36, n=273, 292	9.3 ± 3.79	9.2 ± 7.34
Bilirubin, Week 40, n=270, 293	9.6 ± 4.07	9.5 ± 9.04
Bilirubin, Week 44, n=275, 293	9.6 ± 4.19	9.7 ± 8.49
Bilirubin, Week 48, n=265, 292	9.7 ± 4.24	9.5 ± 6.36
Direct bilirubin, Baseline (Day 1), n=308, 308	2.4 ± 1.35	2.2 ± 1.25
Direct bilirubin, Week 4, n=301, 303	2.3 ± 1.04	2.3 ± 1.27
Direct bilirubin, Week 8, n=229, 303	2.3 ± 1.08	2.4 ± 3.96
Direct bilirubin, Week 12, n=295, 299	2.2 ± 1.03	2.3 ± 1.30
Direct bilirubin, Week 16, n=284, 298	2.5 ± 4.98	2.1 ± 1.08
Direct bilirubin, Week 20, n=277, 302	2.2 ± 0.95	2.0 ± 1.31
Direct bilirubin, Week 24, n=284, 298	2.2 ± 0.99	2.1 ± 1.26
Direct bilirubin, Week 28, n=267, 296	2.1 ± 0.94	2.0 ± 1.28
Direct bilirubin, Week 32, n=275, 294	2.1 ± 1.00	2.0 ± 1.22
Direct bilirubin, Week 36, n=273, 292	2.1 ± 1.11	2.1 ± 1.27
Direct bilirubin, Week 40, n=270, 293	2.1 ± 1.08	2.1 ± 1.37
Direct bilirubin, Week 44, n=275, 293	2.2 ± 0.95	2.2 ± 1.30
Direct bilirubin, Week 48, n=265, 292	2.2 ± 0.92	2.2 ± 1.23
Creatinine, Baseline (Day 1), n=308, 308	79.05 ± 16.380	77.83 ± 16.497
Creatinine, Week 4, n=301, 301	80.17 ± 15.464	79.47 ± 16.284
Creatinine, Week 8, n=229, 303	78.79 ± 16.122	79.22 ± 16.824
Creatinine, Week 12, n=295, 299	78.65 ± 16.534	79.50 ± 17.191
Creatinine, Week 16, n=284, 298	78.72 ± 15.606	79.51 ± 17.171
Creatinine, Week 20, n=277, 302	79.75 ± 15.695	79.62 ± 16.909
Creatinine, Week 24, n=284, 298	80.15 ± 18.478	79.05 ± 16.673
Creatinine, Week 28, n=267, 296	80.42 ± 16.335	79.35 ± 16.574
Creatinine, Week 32, n=275, 294	79.65 ± 15.044	79.69 ± 16.634
Creatinine, Week 36, n=273, 292	79.73 ± 15.994	79.34 ± 16.527
Creatinine, Week 40, n=270, 293	80.28 ± 15.856	79.42 ± 16.856
Creatinine, Week 44, n=275, 293	79.98 ± 15.775	79.16 ± 16.583
Creatinine, Week 48, n=265, 292	80.77 ± 16.456	78.65 ± 16.204

Notes
[49] - Safety Population
[50] - Safety Population

No statistical analyses for this end point

Secondary: Absolute values for clinical chemistry parameters: total carbon-dioxide (CO2), chloride, glucose, phosphate, potassium, sodium and urea over time including Week 48

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End point title

Absolute values for clinical chemistry parameters: total carbon-dioxide (CO2), chloride, glucose, phosphate, potassium, sodium and urea over time including Week 48

End point description

Blood samples were collected for the analysis of clinical chemistry parameters which includes total CO2, chloride, glucose, phosphate, potassium, sodium and urea at indicated time points. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).

End point type

Secondary

End point timeframe

Baseline (Day 1) and at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44 and 48

End point values	CAB LA+RPV LA (Q4W)	Current ART
Number of subjects analysed	308 ^[51]	308 ^[52]
Units: Millimoles per liter
arithmetic mean (standard deviation)
CO2, Baseline (Day 1), n=308, 308	22.7 ± 2.33	22.6 ± 2.24
CO2, Week 4, n=301, 303	23.7 ± 2.49	23.3 ± 2.27
CO2, Week 8, n=229, 303	23.1 ± 2.17	23.2 ± 2.47
CO2, Week 12, n=295, 299	23.2 ± 2.14	23.0 ± 2.36
CO2, Week 16, n=284, 298	22.9 ± 2.16	23.0 ± 2.31
CO2, Week 20, n=277, 302	22.9 ± 2.16	22.9 ± 2.29
CO2, Week 24, n=284, 298	22.9 ± 2.31	22.8 ± 2.41
CO2, Week 28, n=267, 296	22.7 ± 2.42	22.7 ± 2.27
CO2, Week 32, n=275, 294	22.6 ± 2.15	22.8 ± 2.34
CO2, Week 36, n=273, 292	22.8 ± 2.19	23.0 ± 2.26
CO2, Week 40, n=270, 293	23.1 ± 2.27	23.0 ± 2.45
CO2, Week 44, n=275, 293	23.0 ± 2.19	23.2 ± 2.31
CO2, Week 48, n=265, 292	22.7 ± 2.29	22.9 ± 2.29
Chloride, Baseline (Day 1), n=308, 308	103.8 ± 2.03	103.8 ± 2.39
Chloride, Week 4, n=301, 303	104.3 ± 2.13	104.3 ± 2.22
Chloride, Week 8, n=229, 303	104.3 ± 2.26	104.2 ± 2.40
Chloride, Week 12, n=295, 299	104.2 ± 2.27	104.3 ± 2.24
Chloride, Week 16, n=284, 298	104.5 ± 2.21	104.5 ± 2.28
Chloride, Week 20, n=277, 302	104.7 ± 2.41	104.5 ± 2.38
Chloride, Week 24, n=284, 299	104.5 ± 2.36	104.7 ± 2.30
Chloride, Week 28, n=267, 296	104.8 ± 2.19	104.8 ± 2.36
Chloride, Week 32, n=275, 294	104.7 ± 2.50	104.7 ± 2.31
Chloride, Week 36, n=273, 292	104.8 ± 2.18	104.6 ± 2.36
Chloride, Week 40, n=270, 293	104.7 ± 2.22	104.6 ± 2.61
Chloride, Week 44, n=275, 293	104.6 ± 2.10	104.6 ± 2.27
Chloride, Week 48, n=265, 292	104.4 ± 2.38	104.1 ± 2.37
Glucose, Baseline (Day 1), n=301, 299	5.00 ± 0.714	5.17 ± 0.988
Glucose, Week 4, n=216, 226	5.17 ± 0.747	5.42 ± 1.250
Glucose, Week 8, n=153, 218	5.16 ± 0.990	5.35 ± 1.037
Glucose, Week 12, n=206, 221	5.19 ± 0.965	5.35 ± 1.091
Glucose, Week 16, n=209, 216	5.22 ± 1.163	5.36 ± 1.317
Glucose, Week 20, n=194, 221	5.20 ± 0.736	5.37 ± 1.209
Glucose, Week 24, n=215, 229	5.24 ± 0.810	5.35 ± 0.840
Glucose, Week 28, n=190, 226	5.16 ± 0.697	5.36 ± 0.876
Glucose, Week 32, n=194, 219	5.33 ± 1.042	5.45 ± 1.102
Glucose, Week 36, n=191, 220	5.19 ± 0.777	5.40 ± 1.507
Glucose, Week 40, n=195, 218	5.30 ± 0.797	5.44 ± 1.227
Glucose, Week 44, n=193, 213	5.22 ± 0.887	5.44 ± 1.317
Glucose, Week 48, n=242, 277	5.08 ± 0.614	5.22 ± 0.963
Phosphate, Baseline (Day 1), n=308, 308	1.042 ± 0.1771	1.051 ± 0.1722
Phosphate, Week 4, n=301, 303	1.110 ± 0.1793	1.066 ± 0.1773
Phosphate, Week 8, n=229, 303	1.097 ± 0.1944	1.042 ± 0.1843
Phosphate, Week 12, n=295, 299	1.080 ± 0.1872	1.062 ± 0.1922
Phosphate, Week 16, n=284, 298	1.081 ± 0.1796	1.052 ± 0.1724
Phosphate, Week 20, n=277, 302	1.073 ± 0.1746	1.061 ± 0.1873
Phosphate, Week 24, n=284, 299	1.082 ± 0.1788	1.057 ± 0.1849
Phosphate, Week 28, n=267, 296	1.072 ± 0.1714	1.053 ± 0.1741
Phosphate, Week 32, n=275, 294	1.061 ± 0.1730	1.054 ± 0.1761
Phosphate, Week 36, n=273, 292	1.052 ± 0.1700	1.049 ± 0.1798
Phosphate, Week 40, n=270, 293	1.065 ± 0.1789	1.046 ± 0.1763
Phosphate, Week 44, n=275, 293	1.066 ± 0.1798	1.052 ± 0.1902
Phosphate, Week 48, n=265, 292	1.077 ± 0.1816	1.052 ± 0.1834
Potassium, Baseline (Day 1), n=308, 308	4.16 ± 0.281	4.17 ± 0.314
Potassium, Week 4, n=301, 303	4.21 ± 0.307	4.28 ± 0.352
Potassium, Week 8, n=229, 303	4.16 ± 0.296	4.22 ± 0.393
Potassium, Week 12, n=295, 299	4.19 ± 0.330	4.24 ± 0.332
Potassium, Week 16, n=284, 298	4.18 ± 0.316	4.23 ± 0.321
Potassium, Week 20, n=277, 302	4.19 ± 0.311	4.21 ± 0.320
Potassium, Week 24, n=284, 298	4.18 ± 0.287	4.23 ± 0.337
Potassium, Week 28, n=267, 296	4.19 ± 0.346	4.24 ± 0.391
Potassium, Week 32, n=275, 294	4.18 ± 0.368	4.21 ± 0.341
Potassium, Week 36, n=273, 292	4.19 ± 0.326	4.23 ± 0.345
Potassium, Week 40, n=270, 293	4.20 ± 0.301	4.23 ± 0.322
Potassium, Week 44, n=275, 293	4.21 ± 0.323	4.23 ± 0.359
Potassium, Week 48, n=265, 292	4.15 ± 0.271	4.16 ± 0.331
Sodium, Baseline (Day 1), n=308, 308	139.0 ± 1.91	139.0 ± 1.76
Sodium, Week 4, n=301, 303	139.3 ± 1.70	139.1 ± 1.87
Sodium, Week 8, n=229, 303	139.1 ± 1.98	139.0 ± 1.80
Sodium, Week 12, n=295, 299	139.2 ± 1.84	139.2 ± 1.85
Sodium, Week 16, n=284, 298	139.1 ± 1.98	139.1 ± 1.96
Sodium, Week 20, n=277, 302	139.2 ± 1.87	139.3 ± 1.81
Sodium, Week 24, n=284, 299	139.3 ± 1.88	139.3 ± 1.96
Sodium, Week 28, n=267, 296	139.5 ± 1.77	139.2 ± 2.01
Sodium, Week 32, n=275, 294	139.3 ± 1.75	139.5 ± 1.84
Sodium, Week 36, n=273, 292	139.4 ± 1.79	139.5 ± 2.15
Sodium, Week 40, n=270, 293	139.4 ± 1.93	139.5 ± 1.97
Sodium, Week 44, n=275, 293	139.4 ± 1.80	139.5 ± 1.93
Sodium, Week 48, n=265, 292	139.4 ± 1.94	139.4 ± 1.83
Urea, Baseline (Day 1), n=308, 308	5.23 ± 1.546	5.22 ± 1.632
Urea, Week 4, n=301, 303	5.24 ± 1.495	5.28 ± 1.549
Urea, Week 8, n=229, 303	5.32 ± 1.640	5.22 ± 1.529
Urea, Week 12, n=295, 299	5.38 ± 1.612	5.30 ± 1.649
Urea, Week 16, n=284, 298	5.30 ± 1.662	5.41 ± 1.659
Urea, Week 20, n=277, 302	5.37 ± 1.631	5.33 ± 1.662
Urea, Week 24, n=284, 299	5.49 ± 1.749	5.36 ± 1.639
Urea, Week 28, n=267, 296	5.39 ± 1.756	5.24 ± 1.527
Urea, Week 32, n=275, 294	5.44 ± 1.624	5.29 ± 1.599
Urea, Week 36, n=273, 292	5.26 ± 1.664	5.20 ± 1.485
Urea, Week 40, n=270, 293	5.47 ± 1.593	5.30 ± 1.537
Urea, Week 44, n=275, 293	5.37 ± 1.531	5.26 ± 1.524
Urea, Week 48, n=265, 292	5.48 ± 1.648	5.21 ± 1.437

Notes
[51] - Safety Population
[52] - Safety Population

No statistical analyses for this end point

Secondary: Absolute values for clinical chemistry parameter over time including Week 48: Lipase

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End point title

Absolute values for clinical chemistry parameter over time including Week 48: Lipase

End point description

Blood samples were collected for the analysis of clinical chemistry parameter-lipase at indicated time points. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).

End point type

Secondary

End point timeframe

Baseline (Day 1) and at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44 and 48

End point values	CAB LA+RPV LA (Q4W)	Current ART
Number of subjects analysed	308 ^[53]	308 ^[54]
Units: Units per liter
arithmetic mean (standard deviation)
Baseline, n=308, 308	30.5 ± 22.88	30.8 ± 19.12
Week 4, n=301, 303	35.3 ± 52.73	32.3 ± 23.30
Week 8, n=227, 303	30.6 ± 22.70	31.9 ± 20.71
Week 12, n=294, 297	33.2 ± 27.92	30.0 ± 18.06
Week 16, n=285, 299	33.8 ± 30.49	33.9 ± 34.69
Week 20, n=278, 302	31.0 ± 21.73	31.6 ± 28.88
Week 24, n=283, 299	33.1 ± 24.09	33.8 ± 29.69
Week 28, n=267, 297	32.9 ± 27.42	33.1 ± 19.69
Week 32, n=274, 294	35.7 ± 60.63	33.8 ± 21.64
Week 36, n=273, 292	36.2 ± 51.58	31.6 ± 18.46
Week 40, n=269, 293	35.7 ± 36.06	31.4 ± 15.80
Week 44, n=274, 293	33.3 ± 26.29	33.3 ± 20.44
Week 48, n=264, 290	34.3 ± 30.97	32.4 ± 20.40

Notes
[53] - Safety Population
[54] - Safety Population

No statistical analyses for this end point

Secondary: Absolute values for clinical chemistry parameter over time including Week 48: Creatinine clearance

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End point title

Absolute values for clinical chemistry parameter over time including Week 48: Creatinine clearance

End point description

Blood samples were collected for the analysis of clinical chemistry parameter-creatinine clearance at indicated timepoints. Glomerular filtration rate (GFR) was estimated by the central laboratory using the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI). Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).

End point type

Secondary

End point timeframe

Baseline (Day 1) and at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44 and 48

End point values	CAB LA+RPV LA (Q4W)	Current ART
Number of subjects analysed	308 ^[55]	308 ^[56]
Units: Milliliter per minute per 1.73meter^2
arithmetic mean (standard deviation)
Baseline, n=308, 308	100.5 ± 18.30	101.1 ± 17.72
Week 4, n=301, 301	98.7 ± 17.26	98.9 ± 17.93
Week 8, n=227, 303	100.1 ± 17.19	99.5 ± 17.59
Week 12, n=295, 297	100.9 ± 17.72	99.2 ± 18.34
Week 16, n=284, 297	100.5 ± 17.26	99.0 ± 18.32
Week 20, n=277, 302	99.4 ± 17.37	98.7 ± 17.73
Week 24, n=283, 298	98.9 ± 17.04	98.9 ± 17.44
Week 28, n=267, 296	98.5 ± 17.66	99.0 ± 17.33
Week 32, n=274, 294	99.1 ± 16.89	98.4 ± 17.54
Week 36, n=273, 292	99.0 ± 17.19	98.6 ± 16.85
Week 40, n=268, 293	98.5 ± 17.32	98.5 ± 17.37
Week 44, n=274, 293	98.2 ± 16.96	99.0 ± 17.39
Week 48, n=264, 291	97.6 ± 16.97	99.3 ± 17.09

Notes
[55] - Safety Population
[56] - Safety Population

No statistical analyses for this end point

Secondary: Number of participants with abnormal urinalysis parameters over time including Week 48

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End point title

Number of participants with abnormal urinalysis parameters over time including Week 48

End point description

The dipstick test gives results in a semi-quantitative manner and results for urinalysis parameters (ketones, glucose, bilirubin, occult blood, nitrite and blood protein) can be read as positive, trace, 1+, 2+, 3+ and 4+ indicating proportional concentrations in the urine sample. The urine parameters were graded according to Division of AIDS (DAIDS) scale where Grade 1 indicates mild (trace to 1+), Grade 2 indicates moderate (2+) and Grade 3 indicates severe (3+ or higher). Only participants with abnormal findings for urinalysis at any visit has been presented. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).

End point type

Secondary

End point timeframe

Baseline (Day 1) and at Weeks 4, 24 and 48.

End point values	CAB LA+RPV LA (Q4W)	Current ART
Number of subjects analysed	308 ^[57]	308 ^[58]
Units: Participants
Urine bilirubin,Baseline (Day 1),Trace, n=303, 301	0	0
Urine bilirubin, Baseline (Day 1), 1+, n=303, 301	6	7
Urine bilirubin, Baseline (Day 1), 2+, n=303, 301	0	0
Urine bilirubin, Baseline (Day 1), 3+, n=303, 301	0	0
Urine glucose, Baseline (Day 1), Trace, n=303, 301	1	1
Urine glucose, Baseline (Day 1), 1+, n=303, 301	0	1
Urine glucose, Baseline (Day 1), 2+, n=303, 301	0	0
Urine glucose, Baseline (Day 1), 3+, n=303, 301	0	1
Urine ketones, Baseline (Day 1), Trace, n=303, 301	16	17
Urine ketones, Baseline (Day 1), 1+, n=303, 301	4	0
Urine ketones, Baseline (Day 1), 2+, n=303, 301	2	1
Urine ketones, Baseline (Day 1), 3+, n=303, 301	0	0
Urine leukocyte esterase,Baseline,Trace,n=303,301	25	18
Urine leukocyte esterase, Baseline, 1+, n=303, 301	14	16
Urine leukocyte esterase, Baseline, 2+, n=303, 301	14	8
Urine leukocyte esterase, Baseline, 3+, n=303, 301	5	5
Urine nitrite, Baseline, positive, n=303, 301	11	11
Urine occult blood, Baseline, Trace, n=303, 301	19	12
Urine occult blood, Baseline, 1+, n=303, 301	8	9
Urine occult blood, Baseline, 2+, n=303, 301	7	5
Urine occult blood, Baseline, 3+, n=303, 301	5	3
Urine protein, Baseline, Trace, n=303, 301	14	20
Urine protein, Baseline, 1+, n=303, 301	6	12
Urine protein, Baseline, 2+, n=303, 301	0	1
Urine protein, Baseline, 3+, n=303, 301	0	0
Urine protein, Baseline, 4+, n=303, 301	0	0
Urine bilirubin, Week 4, Trace, n=303, 302	0	0
Urine bilirubin, Week 4, 1+, n=303, 302	9	5
Urine bilirubin, Week 4, 2+, n=303, 302	0	0
Urine bilirubin, Week 4, 3+, n=303, 302	0	0
Urine glucose, Week 4, Trace, n=303, 302	3	2
Urine glucose, Week 4, 1+, n=303, 302	1	2
Urine glucose, Week 4, 2+, n=303, 302	2	0
Urine glucose, Week 4, 3+, n=303, 302	0	1
Urine ketones, Week 4, Trace, n=303, 302	9	15
Urine ketones, Week 4, 1+, n=303, 302	0	2
Urine ketones, Week 4, 2+, n=303, 302	1	1
Urine ketones, Week 4, 3+, n=303, 302	0	0
Urine leukocyte esterase, Week 4, Trace,n=303, 302	25	29
Urine leukocyte esterase, Week 4, 1+, n=303, 302	14	15
Urine leukocyte esterase, Week 4, 2+, n=303, 302	14	9
Urine leukocyte esterase, Week 4, 3+, n=303, 302	3	4
Urine nitrite, Week 4, positive, n=303, 302	10	12
Urine occult blood, Week 4, Trace, n=303, 302	15	18
Urine occult blood, Week 4, 1+, n=303, 302	9	10
Urine occult blood, Week 4, 2+, n=303, 302	5	5
Urine occult blood, Week 4, 3+, n=303, 302	4	3
Urine protein, Week 4, Trace, n=303, 302	10	13
Urine protein, Week 4, 1+, n=303, 302	8	7
Urine protein, Week 4, 2+, n=303, 302	2	4
Urine protein, Week 4, 3+, n=303, 302	0	0
Urine protein, Week 4, 4+, n=303, 302	0	0
Urine bilirubin, Week 24, Trace, n=279, 298	0	0
Urine bilirubin, Week 24, 1+, n=279, 298	10	13
Urine bilirubin, Week 24, 2+, n=279, 298	0	0
Urine bilirubin, Week 24, 3+, n=279, 298	0	0
Urine glucose, Week 24, Trace, n=279, 298	0	1
Urine glucose, Week 24, 1+, n=279, 298	2	0
Urine glucose, Week 24, 2+, n=279, 298	0	1
Urine glucose, Week 24, 3+, n=279, 298	1	1
Urine ketones, Week 24, Trace, n=279, 298	16	13
Urine ketones, Week 24, 1+, n=279, 298	1	1
Urine ketones, Week 24, 2+, n=279, 298	0	0
Urine ketones, Week 24, 3+, n=279, 298	0	0
Urine leukocyte esterase,Week 24, Trace, n=279,298	22	17
Urine leukocyte esterase, Week 24, 1+, n=279, 298	14	14
Urine leukocyte esterase, Week 24, 2+, n=279, 298	6	14
Urine leukocyte esterase, Week 24, 3+, n=279, 298	3	7
Urine nitrite, Week 24, positive, n=279, 298	9	10
Urine occult blood, Week 24, Trace, n=279, 298	13	10
Urine occult blood, Week 24, 1+, n=279, 298	5	6
Urine occult blood, Week 24, 2+, n=279, 298	6	4
Urine occult blood, Week 24, 3+, n=279, 298	0	6
Urine protein, Week 24, Trace, n=279, 298	10	21
Urine protein, Week 24, 1+, n=279, 298	4	12
Urine protein, Week 24, 2+, n=279, 298	1	3
Urine protein, Week 24, 3+, n=279, 298	0	0
Urine protein, Week 24, 4+, n=279, 298	0	0
Urine bilirubin, Week 48, Trace, n=279, 290	0	0
Urine bilirubin, Week 48, 1+, n=279, 290	9	8
Urine bilirubin, Week 48, 2+, n=279, 290	1	0
Urine bilirubin, Week 48, 3+, n=279, 290	0	0
Urine glucose, Week 48, Trace, n=279, 290	0	1
Urine glucose, Week 48, 1+, n=279, 290	0	2
Urine glucose, Week 48, 2+, n=279, 290	1	0
Urine glucose, Week 48, 3+, n=279, 290	0	2
Urine ketones, Week 48, Trace, n=279, 290	13	9
Urine ketones, Week 48, 1+, n=279, 290	0	0
Urine ketones, Week 48, 2+, n=279, 290	0	0
Urine ketones, Week 48, 3+, n=279, 290	0	0
Urine leukocyte esterase, Week 48, Trace,n=279,290	24	27
Urine leukocyte esterase, Week 48, 1+, n=279, 290	13	15
Urine leukocyte esterase, Week 48, 2+, n=279, 290	7	7
Urine leukocyte esterase, Week 48, 3+, n=279, 290	5	6
Urine nitrite, Week 48, positive, n=279, 290	10	6
Urine occult blood, Week 48, Trace, n=279, 290	11	12
Urine occult blood, Week 48, 1+, n=279, 290	5	5
Urine occult blood, Week 48, 2+, n=279, 290	4	4
Urine occult blood, Week 48, 3+, n=279, 290	6	0
Urine protein, Week 48, Trace, n=279, 290	10	15
Urine protein, Week 48, 1+, n=279, 290	4	6
Urine protein, Week 48, 2+, n=279, 290	3	3
Urine protein, Week 48, 3+, n=279, 290	0	0
Urine protein, Week 48, 4+, n=279, 290	0	1

Notes
[57] - Safety Population
[58] - Safety Population

No statistical analyses for this end point

Secondary: Number of participants with urine potential of hydrogen (pH) over time including Week 48

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End point title

Number of participants with urine potential of hydrogen (pH) over time including Week 48

End point description

End point type

Secondary

End point timeframe

Baseline (Day 1) and at Weeks 4, 24 and 48

End point values	CAB LA+RPV LA (Q4W)	Current ART
Number of subjects analysed	308 ^[59]	308 ^[60]
Units: Participants
Baseline, pH=5, n=303, 301	44	42
Baseline, pH=5.5, n=303, 301	78	80
Baseline, pH=6, n=303, 301	85	72
Baseline, pH=6.5, n=303, 301	47	45
Baseline, pH=7, n=303, 301	32	34
Baseline, pH=7.5, n=303, 301	12	19
Baseline, pH=8, n=303, 301	3	7
Baseline, pH=8.5, n=303, 301	0	1
Baseline, pH>9.0, n=303, 301	2	1
Week 4, pH=5, n=303, 302	41	53
Week 4, pH=5.5, n=303, 302	78	93
Week 4, pH=6, n=303, 302	73	67
Week 4, pH=6.5, n=303, 302	49	41
Week 4, pH=7, n=303, 302	38	28
Week 4, pH=7.5, n=303, 302	12	14
Week 4, pH=8, n=303, 302	8	3
Week 4, pH=8.5, n=303, 302	3	2
Week 4, pH>9.0, n=303, 302	1	1
Week 24, pH=5, n=279, 298	23	26
Week 24, pH=5.5, n=279, 298	85	96
Week 24, pH=6, n=279, 298	66	67
Week 24, pH=6.5, n=279, 298	44	52
Week 24, pH=7, n=279, 298	32	31
Week 24, pH=7.5, n=279, 298	16	15
Week 24, pH=8, n=279, 298	7	8
Week 24, pH=8.5, n=279, 298	2	2
Week 24, pH>9.0, n=279, 298	4	1
Week 48, pH=5, n=279, 290	45	43
Week 48, pH=5.5, n=279, 290	69	83
Week 48, pH=6, n=279, 290	61	58
Week 48, pH=6.5, n=279, 290	47	48
Week 48, pH=7, n=279, 290	31	30
Week 48, pH=7.5, n=279, 290	17	17
Week 48, pH=8, n=279, 290	6	5
Week 48, pH=8.5, n=279, 290	0	4
Week 48, pH>9.0, n=279, 290	3	2

Notes
[59] - Safety Population
[60] - Safety Population

No statistical analyses for this end point

Secondary: Change from Baseline in clinical chemistry parameters over time including Week 48: ALT, ALP, AST and CK

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End point title

Change from Baseline in clinical chemistry parameters over time including Week 48: ALT, ALP, AST and CK

End point description

Blood samples were collected for the analysis of clinical chemistry parameters including ALT, ALP, AST and CK. Baseline values is defined as the latest pre-treatment assessment with a non-missing value. Change from Baseline value is calculated as the value at the post-dose visit minus the Baseline value. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).

End point type

Secondary

End point timeframe

Baseline (Day 1) and at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44 and 48

End point values	CAB LA+RPV LA (Q4W)	Current ART
Number of subjects analysed	308 ^[61]	308 ^[62]
Units: International units per liter
arithmetic mean (standard deviation)
ALT, Week 4, n=301, 303	0.8 ± 13.98	0.1 ± 9.65
ALT, Week 8, n=229, 303	0.7 ± 15.35	1.6 ± 29.98
ALT, Week 12, n=295, 299	5.2 ± 113.34	0.4 ± 11.60
ALT, Week 16, n=284, 298	-0.1 ± 21.80	-0.6 ± 10.14
ALT, Week 20, n=277, 302	-0.8 ± 22.62	-1.1 ± 10.86
ALT, Week 24, n=284, 299	2.2 ± 61.65	-0.6 ± 10.57
ALT, Week 28, n=267, 296	-2.7 ± 11.14	-0.2 ± 12.52
ALT, Week 32, n=275, 294	-1.9 ± 14.44	-0.5 ± 11.49
ALT, Week 36, n=273, 292	-0.8 ± 23.51	0.1 ± 10.95
ALT, Week 40, n=270, 293	0.6 ± 36.29	-0.2 ± 11.82
ALT, Week 44, n=275, 293	-2.2 ± 13.97	-0.2 ± 12.37
ALT, Week 48, n=265, 292	-1.9 ± 13.43	-0.6 ± 10.50
ALP, Week 4, n=301, 303	-6.0 ± 12.74	-2.2 ± 8.85
ALP, Week 8, n=229, 303	-6.7 ± 16.59	1.1 ± 20.99
ALP, Week 12, n=295, 299	-8.0 ± 20.87	0.9 ± 14.45
ALP, Week 16, n=284, 298	-9.7 ± 19.47	-0.5 ± 10.35
ALP, Week 20, n=277, 302	-9.2 ± 19.05	-1.0 ± 11.65
ALP, Week 24, n=284, 299	-9.0 ± 19.02	-0.1 ± 10.67
ALP, Week 28, n=267, 296	-10.1 ± 19.08	-0.2 ± 11.44
ALP, Week 32, n=275, 294	-9.9 ± 19.10	-1.7 ± 11.29
ALP, Week 36, n=273, 292	-10.5 ± 20.41	-1.1 ± 11.44
ALP, Week 40, n=270, 293	-10.4 ± 20.71	-1.1 ± 11.34
ALP, Week 44, n=275, 293	-11.4 ± 20.64	-0.7 ± 12.02
ALP, Week 48, n=265, 292	-10.9 ± 23.27	-0.3 ± 12.51
AST, Week 4, n=301, 303	-0.3 ± 12.52	0.2 ± 10.02
AST, Week 8, n=229, 303	1.2 ± 19.73	-0.1 ± 13.68
AST, Week 12, n=295, 299	2.3 ± 65.03	0.6 ± 8.82
AST, Week 16, n=284, 298	0.1 ± 18.49	-0.1 ± 9.71
AST, Week 20, n=277, 302	-0.5 ± 17.02	-0.6 ± 9.80
AST, Week 24, n=284, 298	0.1 ± 24.12	0.0 ± 9.57
AST, Week 28, n=267, 296	-1.4 ± 8.77	0.3 ± 11.19
AST, Week 32, n=275, 294	-1.2 ± 16.08	0.6 ± 13.40
AST, Week 36, n=273, 292	-1.2 ± 12.95	0.1 ± 9.61
AST, Week 40, n=270, 293	-0.2 ± 17.27	0.0 ± 10.64
AST, Week 44, n=275, 293	-1.1 ± 16.51	0.1 ± 11.09
AST Week 48, n=265, 292	-1.0 ± 12.79	0.7 ± 10.75
CK, Week 4, n=301, 303	-0.1 ± 548.15	30.8 ± 435.12
CK, Week 8, n=229, 303	98.2 ± 1076.99	-16.5 ± 344.96
CK, Week 12, n=295, 299	6.0 ± 585.45	14.9 ± 288.85
CK, Week 16, n=284, 298	54.2 ± 882.23	5.8 ± 411.52
CK, Week 20, n=277, 302	31.2 ± 653.11	-16.7 ± 363.30
CK, Week 24, n=284, 299	-9.2 ± 538.95	-0.7 ± 353.99
CK, Week 28, n=267, 296	-1.9 ± 213.98	20.8 ± 538.83
CK, Week 32, n=275, 294	13.3 ± 699.60	34.0 ± 597.29
CK, Week 36, n=273, 292	-18.2 ± 476.64	-10.8 ± 358.72
CK, Week 40, n=270, 293	39.7 ± 704.18	-0.3 ± 373.96
CK, Week 44, n=275, 293	47.4 ± 1185.55	-10.9 ± 350.64
CK, Week 48, n=265, 292	-0.6 ± 528.71	18.1 ± 463.49

Notes
[61] - Safety Population
[62] - Safety Population

No statistical analyses for this end point

Secondary: Change from Baseline values for clinical chemistry parameter over time including Week 48: Albumin

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End point title

Change from Baseline values for clinical chemistry parameter over time including Week 48: Albumin

End point description

Blood samples were collected for the analysis of clinical chemistry parameter-albumin. Baseline value is defined as the latest pre-treatment assessment with a non-missing value. Change from Baseline value is calculated as the value at the post-dose visit minus the Baseline value. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).

End point type

Secondary

End point timeframe

Baseline (Day 1) and at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44 and 48

End point values	CAB LA+RPV LA (Q4W)	Current ART
Number of subjects analysed	308 ^[63]	308 ^[64]
Units: Grams per liter
arithmetic mean (standard deviation)
Week 4, n=301, 303	-0.5 ± 2.60	-0.5 ± 2.49
Week 8, n=229, 303	-0.3 ± 2.76	-0.7 ± 2.70
Week 12, n=295, 299	-0.6 ± 2.72	-0.4 ± 2.63
Week 16, n=284, 298	-0.6 ± 2.78	-0.8 ± 2.70
Week 20, n=277, 302	-0.8 ± 2.78	-0.8 ± 2.56
Week 24, n=284, 299	-0.7 ± 2.69	-0.8 ± 2.59
Week 28, n=267, 296	-0.7 ± 2.60	-1.0 ± 2.47
Week 32, n=275, 294	-0.6 ± 2.78	-1.0 ± 2.56
Week 36, n=273, 292	-0.9 ± 2.71	-0.9 ± 2.65
Week 40, n=270, 293	-0.5 ± 2.53	-1.0 ± 2.61
Week 44, n=275, 293	-0.4 ± 2.58	-0.8 ± 2.47
Week 48, n=265, 292	-0.4 ± 2.64	-0.4 ± 2.55

Notes
[63] - Safety Population
[64] - Safety Population

No statistical analyses for this end point

Secondary: Change from Baseline values for clinical chemistry parameters over time including Week 48: Bilirubin, direct bilirubin and creatinine

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End point title

Change from Baseline values for clinical chemistry parameters over time including Week 48: Bilirubin, direct bilirubin and creatinine

End point description

Blood samples were collected for the analysis of clinical chemistry parameters including bilirubin, creatinine and direct bilirubin. Baseline value is defined as the latest pre-treatment assessment with a non-missing value. Change from Baseline value is calculated as the value at the post-dose visit minus the Baseline value. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).

End point type

Secondary

End point timeframe

Baseline (Day 1) and at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44 and 48

End point values	CAB LA+RPV LA (Q4W)	Current ART
Number of subjects analysed	308 ^[65]	308 ^[66]
Units: Micromoles per liter
arithmetic mean (standard deviation)
Bilirubin, Week 4, n=301, 303	-0.8 ± 9.87	-0.3 ± 4.17
Bilirubin, Week 8, n=229, 303	-0.1 ± 6.92	0.1 ± 7.66
Bilirubin, Week 12, n=295, 299	-0.6 ± 10.23	0.1 ± 4.56
Bilirubin, Week 16, n=284, 298	0.2 ± 14.00	-0.2 ± 4.12
Bilirubin, Week 20, n=277, 302	-0.2 ± 10.04	0.0 ± 6.10
Bilirubin, Week 24, n=284, 298	-0.6 ± 9.90	0.2 ± 5.90
Bilirubin, Week 28, n=267, 296	0.0 ± 10.46	-0.1 ± 4.76
Bilirubin, Week 32, n=275, 294	-0.1 ± 10.36	0.0 ± 4.94
Bilirubin, Week 36, n=273, 292	-0.6 ± 10.39	0.1 ± 4.55
Bilirubin, Week 40, n=270, 293	-0.3 ± 10.61	0.2 ± 6.28
Bilirubin, Week 44, n=275, 293	-0.4 ± 10.11	0.4 ± 5.24
Bilirubin, Week 48, n=265, 292	-0.3 ± 10.57	0.2 ± 3.91
Direct bilirubin, Week 4, n=301, 303	-0.1 ± 1.48	0.1 ± 1.20
Direct bilirubin, Week 8, n=229, 303	-0.1 ± 1.42	0.2 ± 3.96
Direct bilirubin, Week 12, n=295, 299	-0.2 ± 1.61	0.1 ± 1.21
Direct bilirubin, Week 16, n=284, 298	0.1 ± 5.02	-0.1 ± 1.12
Direct bilirubin, Week 20, n=277, 302	-0.3 ± 1.52	-0.2 ± 1.29
Direct bilirubin, Week 24, n=284, 298	-0.2 ± 1.55	-0.1 ± 1.24
Direct bilirubin, Week 28, n=267, 296	-0.3 ± 1.55	-0.2 ± 1.29
Direct bilirubin, Week 32, n=275, 294	-0.3 ± 1.61	-0.2 ± 1.24
Direct bilirubin, Week 36, n=273, 292	-0.3 ± 1.70	-0.1 ± 1.20
Direct bilirubin, Week 40, n=270, 293	-0.3 ± 1.68	-0.2 ± 1.18
Direct bilirubin, Week 44, n=275, 293	-0.2 ± 1.55	-0.1 ± 1.19
Direct bilirubin, Week 48, n=265, 292	-0.2 ± 1.54	0.0 ± 1.23
Creatinine, Week 4, n=301, 301	1.15 ± 8.205	1.80 ± 8.022
Creatinine, Week 8, n=229, 303	-0.66 ± 9.042	1.23 ± 7.560
Creatinine, Week 12, n=295, 299	-0.38 ± 9.380	1.71 ± 7.638
Creatinine, Week 16, n=284, 298	-0.60 ± 9.225	1.62 ± 8.169
Creatinine, Week 20, n=277, 302	0.53 ± 9.390	1.80 ± 8.454
Creatinine, Week 24, n=284, 298	0.90 ± 12.494	1.36 ± 8.038
Creatinine, Week 28, n=267, 296	1.14 ± 10.998	1.59 ± 8.303
Creatinine, Week 32, n=275, 294	0.33 ± 10.102	1.95 ± 8.331
Creatinine, Week 36, n=273, 292	0.34 ± 10.585	1.62 ± 7.891
Creatinine, Week 40, n=270, 293	0.88 ± 9.986	1.64 ± 8.318
Creatinine, Week 44, n=275, 293	1.03 ± 11.253	1.40 ± 8.008
Creatinine, Week 48, n=265, 292	1.59 ± 11.253	0.82 ± 7.846

Notes
[65] - Safety Population
[66] - Safety Population

No statistical analyses for this end point

Secondary: Change from Baseline values for clinical chemistry parameters over time including Week 48

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End point title

Change from Baseline values for clinical chemistry parameters over time including Week 48

End point description

Blood samples were collected for the analysis of clinical chemistry parameters which includes total CO2, chloride, glucose, phosphate, potassium, sodium and urea. Baseline value is defined as the latest pre-treatment assessment with a non-missing value. Change from Baseline value is calculated as the value at the post-dose visit minus the Baseline value. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).

End point type

Secondary

End point timeframe

Baseline (Day 1) and at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44 and 48

End point values	CAB LA+RPV LA (Q4W)	Current ART
Number of subjects analysed	308 ^[67]	308 ^[68]
Units: Millimoles per liter
arithmetic mean (standard deviation)
CO2, Week 4, n=301, 303	1.0 ± 2.53	0.7 ± 2.21
CO2, Week 8, n=229, 303	0.4 ± 2.31	0.6 ± 2.52
CO2, Week 12, n=295, 299	0.5 ± 2.42	0.3 ± 2.39
CO2, Week 16, n=284, 298	0.3 ± 2.42	0.5 ± 2.41
CO2, Week 20, n=277, 302	0.2 ± 2.26	0.3 ± 2.31
CO2, Week 24, n=284, 298	0.2 ± 2.46	0.2 ± 2.44
CO2, Week 28, n=267, 296	0.1 ± 2.47	0.1 ± 2.39
CO2, Week 32, n=275, 294	0.0 ± 2.37	0.2 ± 2.31
CO2, Week 36, n=273, 292	0.2 ± 2.37	0.3 ± 2.39
CO2, Week 40, n=270, 293	0.5 ± 2.49	0.4 ± 2.29
CO2, Week 44, n=275, 293	0.5 ± 2.34	0.5 ± 2.19
CO2, Week 48, n=265, 292	0.1 ± 2.41	0.2 ± 2.31
Chloride, Week 4, n=301, 303	0.4 ± 2.05	0.5 ± 2.13
Chloride, Week 8, n=229, 303	0.3 ± 2.12	0.5 ± 2.19
Chloride, Week 12, n=295, 299	0.4 ± 2.30	0.5 ± 2.25
Chloride, Week 16, n=284, 298	0.6 ± 2.41	0.8 ± 2.25
Chloride, Week 20, n=277, 302	0.8 ± 2.32	0.8 ± 2.38
Chloride, Week 24, n=284, 299	0.6 ± 2.48	0.9 ± 2.26
Chloride, Week 28, n=267, 296	0.9 ± 2.21	1.0 ± 2.55
Chloride, Week 32, n=275, 294	0.8 ± 2.41	0.9 ± 2.33
Chloride, Week 36, n=273, 292	0.9 ± 2.18	0.9 ± 2.48
Chloride, Week 40, n=270, 293	0.8 ± 2.24	0.8 ± 2.76
Chloride, Week 44, n=275, 293	0.7 ± 2.20	0.8 ± 2.28
Chloride, Week 48, n=265, 292	0.5 ± 2.36	0.3 ± 2.38
Glucose, Week 4, n=218, 226	0.17 ± 0.721	0.21 ± 0.900
Glucose, Week 8, n=151, 213	0.22 ± 0.841	0.22 ± 0.832
Glucose, Week 12, n=204, 216	0.19 ± 0.855	0.19 ± 0.974
Glucose, Week 16, n=207, 211	0.23 ± 1.050	0.27 ± 1.084
Glucose, Week 20, n=192, 216	0.19 ± 0.712	0.19 ± 0.961
Glucose, Week 24, n=212, 224	0.23 ± 0.710	0.16 ± 0.881
Glucose, Week 28, n=188, 225	0.17 ± 0.793	0.28 ± 0.903
Glucose, Week 32, n=192, 213	0.35 ± 0.956	0.27 ± 0.939
Glucose, Week 36, n=190, 215	0.18 ± 0.803	0.26 ± 1.070
Glucose, Week 40, n=193, 213	0.27 ± 0.833	0.25 ± 0.891
Glucose, Week 44, n=193, 213	0.23 ± 0.895	0.27 ± 0.898
Glucose, Week 48, n=238, 274	0.04 ± 0.693	0.02 ± 0.924
Phosphate, Week 4, n=301, 303	0.066 ± 0.1666	0.015 ± 0.1595
Phosphate, Week 8, n=229, 303	0.062 ± 0.1862	-0.006 ± 0.1609
Phosphate, Week 12, n=295, 299	0.041 ± 0.1978	0.013 ± 0.1742
Phosphate, Week 16, n=284, 298	0.041 ± 0.2012	0.003 ± 0.1640
Phosphate, Week 20, n=277, 302	0.035 ± 0.1871	0.010 ± 0.1839
Phosphate, Week 24, n=284, 299	0.042 ± 0.1963	0.006 ± 0.1845
Phosphate, Week 28, n=267, 296	0.037 ± 0.1822	0.004 ± 0.1823
Phosphate, Week 32, n=275, 294	0.021 ± 0.1980	0.005 ± 0.1886
Phosphate, Week 36, n=273, 292	0.011 ± 0.1846	-0.002 ± 0.1855
Phosphate, Week 40, n=270, 293	0.024 ± 0.2035	-0.004 ± 0.1736
Phosphate, Week 44, n=275, 293	0.027 ± 0.1982	0.004 ± 0.1811
Phosphate, Week 48, n=265, 292	0.034 ± 0.2007	0.003 ± 0.1741
Potassium, Week 4, n=301, 303	0.05 ± 0.342	0.11 ± 0.375
Potassium, Week 8, n=229, 303	0.01 ± 0.311	0.06 ± 0.393
Potassium, Week 12, n=295, 299	0.04 ± 0.341	0.08 ± 0.356
Potassium, Week 16, n=284, 298	0.01 ± 0.341	0.06 ± 0.340
Potassium, Week 20, n=277, 302	0.04 ± 0.345	0.05 ± 0.359
Potassium, Week 24, n=284, 298	0.03 ± 0.325	0.07 ± 0.337
Potassium, Week 28, n=267, 296	0.04 ± 0.380	0.07 ± 0.389
Potassium, Week 32, n=275, 294	0.02 ± 0.390	0.05 ± 0.347
Potassium, Week 36, n=273, 292	0.03 ± 0.356	0.07 ± 0.359
Potassium, Week 40, n=270, 293	0.04 ± 0.344	0.07 ± 0.350
Potassium, Week 44, n=275, 293	0.06 ± 0.344	0.07 ± 0.372
Potassium, Week 48, n=265, 292	-0.02 ± 0.299	0.00 ± 0.332
Sodium, Week 4, n=301, 303	0.3 ± 1.84	0.1 ± 1.99
Sodium, Week 8, n=229, 303	0.2 ± 1.99	-0.1 ± 1.92
Sodium, Week 12, n=295, 299	0.2 ± 2.07	0.2 ± 1.91
Sodium, Week 16, n=284, 298	0.1 ± 2.18	0.1 ± 2.06
Sodium, Week 20, n=277, 302	0.3 ± 2.10	0.3 ± 1.95
Sodium, Week 24, n=284, 299	0.3 ± 2.07	0.2 ± 1.95
Sodium, Week 28, n=267, 296	0.5 ± 2.11	0.2 ± 2.24
Sodium, Week 32, n=275, 294	0.3 ± 2.05	0.4 ± 1.89
Sodium, Week 36, n=273, 292	0.5 ± 2.01	0.5 ± 2.19
Sodium, Week 40, n=270, 293	0.4 ± 2.02	0.5 ± 2.07
Sodium, Week 44, n=275, 293	0.5 ± 2.03	0.5 ± 2.05
Sodium, Week 48, n=265, 292	0.4 ± 2.20	0.3 ± 1.95
Urea, Week 4, n=301, 303	0.01 ± 1.369	0.08 ± 1.334
Urea, Week 8, n=229, 303	0.07 ± 1.453	0.00 ± 1.363
Urea, Week 12, n=295, 299	0.15 ± 1.409	0.09 ± 1.381
Urea, Week 16, n=284, 298	0.08 ± 1.387	0.19 ± 1.496
Urea, Week 20, n=277, 302	0.15 ± 1.399	0.11 ± 1.461
Urea, Week 24, n=284, 299	0.25 ± 1.420	0.15 ± 1.311
Urea, Week 28, n=267, 296	0.15 ± 1.524	0.00 ± 1.439
Urea, Week 32, n=275, 294	0.20 ± 1.511	0.06 ± 1.415
Urea, Week 36, n=273, 292	0.06 ± 1.420	-0.02 ± 1.386
Urea, Week 40, n=270, 293	0.19 ± 1.400	0.09 ± 1.452
Urea, Week 44, n=275, 293	0.13 ± 1.426	0.02 ± 1.467
Urea, Week 48, n=265, 292	0.24 ± 1.465	-0.01 ± 1.312

Notes
[67] - Safety Population
[68] - Safety Population

No statistical analyses for this end point

Secondary: Change from Baseline values for fasting lipid panel over time including Week 48

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End point title

Change from Baseline values for fasting lipid panel over time including Week 48

End point description

Blood samples were collected for the analysis of fasting lipid parameters- total cholesterol, HDL cholesterol, LDL cholesterol and triglycerides. Baseline value is defined as the latest pre-treatment assessment with a non-missing value. Change from Baseline value is calculated as the value at the post-dose visit minus the Baseline value. Only those participants with data available at specified data points were analyzed(represented by n=X in category titles)

End point type

Secondary

End point timeframe

Baseline (Day 1) and at Week 48

End point values	CAB LA+RPV LA (Q4W)	Current ART
Number of subjects analysed	308 ^[69]	308 ^[70]
Units: Millimoles per liter
arithmetic mean (standard deviation)
Total cholesterol, Week 48, n=231, 242	0.08 ± 0.688	-0.04 ± 0.665
HDL cholesterol, Week 48, n=231, 242	0.040 ± 0.2702	0.002 ± 0.2682
LDL cholesterol, Week 48, n=224, 238	0.098 ± 0.6105	-0.017 ± 0.5314
Triglycerides, Week 48, n=231, 242	-0.159 ± 0.8670	-0.033 ± 0.7844

Notes
[69] - Safety Population
[70] - Safety Population

No statistical analyses for this end point

Secondary: Change from Baseline values for clinical chemistry parameter over time including Week 48: Lipase

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End point title

Change from Baseline values for clinical chemistry parameter over time including Week 48: Lipase

End point description

Blood samples were collected for the analysis of clinical chemistry parameter-lipase. Baseline value is defined as the latest pre-treatment assessment with a non-missing value. Change from Baseline value is calculated as the value at the post-dose visit minus the Baseline value. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).

End point type

Secondary

End point timeframe

Baseline (Day 1) and at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44 and 48

End point values	CAB LA+RPV LA (Q4W)	Current ART
Number of subjects analysed	308 ^[71]	308 ^[72]
Units: Units per liter
arithmetic mean (standard deviation)
Week 4, n=301, 303	5.2 ± 41.42	1.5 ± 23.88
Week 8, n=227, 303	1.2 ± 19.31	1.0 ± 17.96
Week 12, n=294, 297	2.7 ± 25.12	-0.8 ± 18.59
Week 16, n=285, 299	2.6 ± 24.79	3.5 ± 31.03
Week 20, n=278, 302	0.9 ± 15.65	0.8 ± 28.95
Week 24, n=283, 299	2.1 ± 20.79	3.0 ± 23.85
Week 28, n=267, 297	2.2 ± 24.93	2.3 ± 18.96
Week 32, n=274, 294	5.2 ± 57.44	3.1 ± 21.31
Week 36, n=273, 292	5.1 ± 49.92	0.7 ± 17.39
Week 40, n=269, 293	5.1 ± 33.58	0.5 ± 17.60
Week 44, n=274, 293	2.0 ± 22.57	2.3 ± 21.13
Week 48, n=264, 290	3.0 ± 28.26	1.5 ± 19.00

Notes
[71] - Safety Population
[72] - Safety Population

No statistical analyses for this end point

Secondary: Change from Baseline values for clinical chemistry parameter over time including Week 48: Creatinine clearance

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End point title

Change from Baseline values for clinical chemistry parameter over time including Week 48: Creatinine clearance

End point description

Blood samples were collected for the analysis of clinical chemistry parameter-creatinine clearance. GFR was estimated by the central laboratory using the CKD-EPI. Baseline value is defined as the latest pre-treatment assessment with a non-missing value. Change from Baseline value is calculated as the value at the post-dose visit minus the Baseline value. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).

End point type

Secondary

End point timeframe

Baseline (Day 1) and at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44 and 48

End point values	CAB LA+RPV LA (Q4W)	Current ART
Number of subjects analysed	308 ^[73]	308 ^[74]
Units: Milliliters per minute per 1.73meter^2
arithmetic mean (standard deviation)
Week 4, n=301, 301	-1.8 ± 9.51	-2.3 ± 9.18
Week 8, n=227, 303	0.4 ± 9.88	-1.5 ± 8.06
Week 12, n=295, 297	0.3 ± 10.28	-1.9 ± 8.02
Week 16, n=284, 297	0.4 ± 10.63	-1.9 ± 8.69
Week 20, n=277, 302	-1.0 ± 10.37	-2.4 ± 8.55
Week 24, n=283, 298	-1.0 ± 10.52	-2.3 ± 8.76
Week 28, n=267, 296	-1.8 ± 11.47	-2.4 ± 8.93
Week 32, n=274, 294	-1.2 ± 11.11	-3.0 ± 8.94
Week 36, n=273, 292	-1.2 ± 11.26	-2.6 ± 8.52
Week 40, n=268, 293	-1.7 ± 10.70	-2.7 ± 9.10
Week 44, n=274, 293	-2.1 ± 10.45	-2.3 ± 8.74
Week 48, n=264, 291	-2.5 ± 11.80	-1.9 ± 8.50

Notes
[73] - Safety Population
[74] - Safety Population

No statistical analyses for this end point

Secondary: Change from Baseline values in urine albumin/creatinine ratio and urine protein/creatinine ratio over time including Week 48

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End point title

Change from Baseline values in urine albumin/creatinine ratio and urine protein/creatinine ratio over time including Week 48

End point description

Urine biomarker samples were collected for the analysis of urine albumin/creatinine ratio and urine protein/creatinine ratio.Baseline value is defined as the latest pre-treatment assessment with a non-missing value. Change from Baseline value is calculated as the value at the post-dose visit minus the Baseline value. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).

End point type

Secondary

End point timeframe

Baseline (Day 1) and at Weeks 4, 24 and 48

End point values	CAB LA+RPV LA (Q4W)	Current ART
Number of subjects analysed	308 ^[75]	308 ^[76]
Units: Grams per mole
arithmetic mean (standard deviation)
Urine albumin/creatinine ratio, Week 4,n=210, 221	0.32 ± 3.948	0.06 ± 6.383
Urine albumin/creatinine ratio, Week 24,n=198, 208	-0.08 ± 3.360	-0.11 ± 8.552
Urine albumin/creatinine ratio, Week 48,n=191, 197	0.15 ± 6.049	-0.14 ± 5.286
Urine protein/creatinine, Week 4, n=234, 236	-0.66 ± 11.803	1.85 ± 31.997
Urine protein/creatinine, Week 24, n=208, 232	-2.49 ± 8.028	1.67 ± 20.505
Urine protein/creatinine, Week 48, n=206, 225	-1.72 ± 9.551	6.70 ± 112.353

Notes
[75] - Safety Population
[76] - Safety Population

No statistical analyses for this end point

Secondary: Change from Baseline values in urine creatinine over time including Week 48

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End point title

Change from Baseline values in urine creatinine over time including Week 48

End point description

Urine biomarker samples were collected for the analysis of urine creatinine. Baseline value is defined as the latest pre-treatment assessment with a non-missing value. Change from Baseline value is calculated as the value at the post-dose visit minus the Baseline value. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).

End point type

Secondary

End point timeframe

Baseline (Day 1) and at Weeks 4, 24 and 48

End point values	CAB LA+RPV LA (Q4W)	Current ART
Number of subjects analysed	308 ^[77]	308 ^[78]
Units: Micromoles per liter
arithmetic mean (standard deviation)
Week 4, n=304, 302	-543.9 ± 8693.94	-305.5 ± 8787.62
Week 24, n=282, 297	-341.8 ± 9286.26	-270.4 ± 8437.76
Week 48, n=282, 291	-342.9 ± 8965.01	-521.6 ± 7873.28

Notes
[77] - Safety Population
[78] - Safety Population

No statistical analyses for this end point

Secondary: Change from Baseline values in urine phosphate over time including Week 48

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End point title

Change from Baseline values in urine phosphate over time including Week 48

End point description

Urine biomarker samples were collected for the analysis of urine phosphate. Baseline value is defined as the latest pre-treatment assessment with a non-missing value. Change from Baseline value is calculated as the value at the post-dose visit minus the Baseline value. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).

End point type

Secondary

End point timeframe

Baseline (Day 1) and at Weeks 4, 24 and 48

End point values	CAB LA+RPV LA (Q4W)	Current ART
Number of subjects analysed	308 ^[79]	308 ^[80]
Units: Millimoles per liter
arithmetic mean (standard deviation)
Week 4, n=302, 300	-0.460 ± 15.2707	1.483 ± 15.0378
Week 24, n=281, 294	0.286 ± 16.1887	0.640 ± 14.4201
Week 48, n=280, 291	-0.369 ± 14.2441	1.254 ± 15.6532

Notes
[79] - Safety Population
[80] - Safety Population

No statistical analyses for this end point

Secondary: Change from Baseline values in urine retinol binding protein over time including Week 48

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End point title

Change from Baseline values in urine retinol binding protein over time including Week 48

End point description

Urine biomarker samples were collected for the analysis of urine retinol binding protein. Baseline value is defined as the latest pre-treatment assessment with a non-missing value. Change from Baseline value is calculated as the value at the post-dose visit minus the Baseline value. Only those participants with data available at the specified data points were analyzed.

End point type

Secondary

End point timeframe

Baseline (Day 1) and at Week 48

End point values	CAB LA+RPV LA (Q4W)	Current ART
Number of subjects analysed	275 ^[81]	284 ^[82]
Units: Nanomoles per liter
arithmetic mean (standard deviation)	-1.8913 ± 14.10125	1.4289 ± 15.70559

Notes
[81] - Safety Population
[82] - Safety Population

No statistical analyses for this end point

Secondary: Change from Baseline values in urine specific gravity over time including Week 48

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End point title

Change from Baseline values in urine specific gravity over time including Week 48

End point description

Urine biomarker samples were collected for the analysis of urine specific gravity. Urine specific gravity is a measure of the concentration of solutes in the urine and provides information on the kidney’s ability to concentrate urine. The dipstick test gives results in a semi-quantitative manner. Baseline value is defined as the latest pre-treatment assessment with a non-missing value. Change from Baseline value is calculated as the value at the post-dose visit minus the Baseline value. The urine specific gravity was measured as the ratio of urine density compared with water density. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).

End point type

Secondary

End point timeframe

Baseline (Day 1) and at Weeks 4, 24 and 48

End point values	CAB LA+RPV LA (Q4W)	Current ART
Number of subjects analysed	308 ^[83]	308 ^[84]
Units: Ratio of urine density to water density
arithmetic mean (standard deviation)
Week 4, n=298, 295	-0.0009 ± 0.00800	-0.0000 ± 0.00785
Week 24, n=274, 291	-0.0008 ± 0.00784	-0.0000 ± 0.00770
Week 48, n=274, 283	-0.0009 ± 0.00772	-0.0002 ± 0.00768

Notes
[83] - Safety Population
[84] - Safety Population

No statistical analyses for this end point

Secondary: Change from Baseline values in urine pH over time including Week 48

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End point title

Change from Baseline values in urine pH over time including Week 48

End point description

Urine samples were collected for analysis of urine pH. pH is calculated on a scale of 0 to 14, values on the scale refer to the degree of alkalinity or acidity. A pH of 7 is neutral. A pH of less than 7 is acidic and a pH of greater than 7 is basic. Normal urine has a slightly acidic pH (5.0-6.0). The dipstick test gives results in a semi-quantitative manner. Baseline value is defined as the latest pre-treatment assessment with a non-missing value. Change from Baseline value is calculated as the value at the post-dose visit minus the Baseline value. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).

End point type

Secondary

End point timeframe

Baseline (Day 1) and at Weeks 4, 24 and 48

End point values	CAB LA+RPV LA (Q4W)	Current ART
Number of subjects analysed	308 ^[85]	308 ^[86]
Units: pH
arithmetic mean (standard deviation)
Week 4, n=298, 295	0.08 ± 0.886	-0.13 ± 0.935
Week 24, n=274, 291	0.18 ± 1.021	0.01 ± 0.870
Week 48, n=274, 283	0.09 ± 1.036	-0.02 ± 0.951

Notes
[85] - Safety population
[86] - Safety Population

No statistical analyses for this end point

Secondary: Number of participants who discontinued or withdrawn due to AEs over time including Week 48

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End point title

Number of participants who discontinued or withdrawn due to AEs over time including Week 48

End point description

An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment.

End point type

Secondary

End point timeframe

Up to Week 48

End point values	CAB LA+RPV LA (Q4W)	Current ART
Number of subjects analysed	308 ^[87]	308 ^[88]
Units: Participants	13	5

Notes
[87] - Safety Population
[88] - Safety Population

No statistical analyses for this end point

Secondary: Percentage change from Baseline in fasting lipids overtime including Week 48

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End point title

Percentage change from Baseline in fasting lipids overtime including Week 48

End point description

Blood samples were collected at Baseline and at Week 48 to assess fasting lipids which included total cholesterol, HDL cholesterol, LDL cholesterol and triglycerides. Baseline value is defined as the latest pre-treatment assessment with a non-missing value. Percentage change from Baseline is calculated as: value at Week 48 minus Baseline value divided by Baseline value multiplied by 100. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).

End point type

Secondary

End point timeframe

Baseline (Day 1) and at Week 48

End point values	CAB LA+RPV LA (Q4W)	Current ART
Number of subjects analysed	308 ^[89]	308 ^[90]
Units: Percent change
arithmetic mean (standard deviation)
Cholesterol, Week 48, Overall, n=231, 242	3.25 ± 15.563	0.13 ± 13.379
HDL cholesterol, Week 48, Overall, n=231, 242	5.059 ± 20.5368	2.132 ± 18.0473
LDL cholesterol, Week 48, Overall, n=224, 238	6.762 ± 31.7209	1.029 ± 19.4719
Triglycerides, Week 48, Overall, n=231, 242	0.708 ± 43.5160	8.203 ± 51.7632

Notes
[89] - Safety Population
[90] - Safety Population

No statistical analyses for this end point

Secondary: Number of participants with phenotypic resistance through Week 48

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End point title

Number of participants with phenotypic resistance through Week 48

End point description

The CVF population comprised of ITT-E population meeting CVF criteria.Phenotypic Resistancedatafordrugs:CAB,dolutegravir(DTG),elvitegravir(EVG),raltegravir(RAL),delavirdine(DLV),efavirenz(EFV),etravirine(ETR),nevirapine(NVP),RPV,lamivudine(3TC),abacavir(ABC),emtricitabine(FTC),tenofovir(TDF),zidovudine(ZDV),stavudine(d4T),didanosine(ddI),atazanavir(ATV),darunavir(DRV),fosamprenavir(FPV),indinavir(IDV),lopinavir(LPV),nelfinavir(NFV),rito-navir(RTV),saquinavir(SQV) and tipranavir(TPV) in participants meeting CVF criteria is presented.Phenotypic resistance,partiallysensitive, and Sensitive were based on fold change(FC) value fromMonogram:resistance(FC>clinical higher cutoff/biologic cutoff),partially sensitive(FC<=clinical higher cutoff and >clinical lower cutoff),sensitive(FC<=clinical lower cutoff/biologic cutoff).Only those participants with data available at specified data points were analyzed(represented by n=X in category titles)

End point type

Secondary

End point timeframe

At the time of CVF

End point values	CAB LA+RPV LA (Q4W)	Current ART
Number of subjects analysed	3 ^[91]	4 ^[92]
Units: Participants
INI, CAB, resistant, n=3, 4	1	0
INI, CAB, sensitive, n=3, 4	2	4
INI, DTG, resistant, n=3, 4	0	0
INI, DTG, partially sensitive, n=3, 4	0	0
INI, DTG, sensitive, n=3, 4	3	4
INI, EVG, resistant, n=3, 4	1	0
INI, EVG, sensitive, n=3, 4	2	4
INI, RAL, resistant, n=3, 4	1	0
INI, RAL, sensitive, n=3, 4	2	4
NNRTI, DLV, resistant, n=3, 3	2	0
NNRTI, DLV, sensitive, n=3, 3	1	3
NNRTI, EFV, resistant, n=3, 3	2	0
NNRTI, EFV, sensitive, n=3, 3	1	3
NNRTI, ETR, resistant, n=3, 3	0	0
NNRTI, ETR, partially sensitive, n=3, 3	2	0
NNRTI, ETR, sensitive, n=3, 3	1	3
NNRTI, NVP, resistant, n=3, 3	2	0
NNRTI, NVP, sensitive, n=3, 3	1	3
NNRTI, RPV, resistant, n=3, 3	3	0
NNRTI, RPV, sensitive, n=3, 3	0	3
NRTI, 3TC, resistant, n=3, 3	0	1
NRTI, 3TC, sensitive, n=3, 3	3	2
NRTI, ABC, resistant, n=3, 3	0	0
NRTI, ABC, partially sensitive, n=3, 3	0	0
NRTI, ABC, sensitive, n=3, 3	3	3
NRTI, FTC, resistant, n=3, 3	0	1
NRTI, FTC, sensitive, n=3, 3	3	2
NRTI, TDF, resistant, n=3, 3	0	0
NRTI, TDF, partially sensitive, n=3, 3	0	0
NRTI, TDF, sensitive, n=3, 3	3	3
NRTI, ZDV, resistant, n=3, 3	1	0
NRTI, ZDV, sensitive, n=3, 3	2	3
NRTI, d4T, resistant, n=3, 3	0	0
NRTI, d4T, sensitive, n=3, 3	3	3
NRTI, ddI, resistant, n=3, 3	0	0
NRTI, ddI, partially sensitive, n=3, 3	0	0
NRTI, ddI, sensitive, n=3, 3	3	3
PI, ATV, resistant, n=3, 3	0	0
PI, ATV, sensitive, n=3, 3	3	3
PI, DRV, resistant, n=3, 3	0	0
PI, DRV, partially sensitive, n=3, 3	0	0
PI, DRV, sensitive, n=3, 3	3	3
PI, FPV, resistant, n=3, 3	0	0
PI, FPV, partially sensitive, n=3, 3	0	0
PI, FPV, sensitive, n=3, 3	3	3
PI, IDV, resistant, n=3, 3	0	0
PI, IDV, sensitive, n=3, 3	3	3
PI, LPV, resistant, n=3, 3	0	0
PI, LPV, partially sensitive, n=3, 3	0	0
PI, LPV, sensitive, n=3, 3	3	3
PI, NFV, resistant, n=3, 3	0	0
PI, NFV, sensitive, n=3, 3	3	3
PI, RTV, resistant, n=3, 3	0	0
PI, RTV, sensitive, n=3, 3	3	3
PI, SQV, resistant, n=3, 3	0	0
PI, SQV, partially sensitive, n=3, 3	0	0
PI, SQV, sensitive, n=3, 3	3	3
PI, TPV, resistant, n=3, 3	0	0
PI, TPV, partially sensitive, n=3, 3	0	0
PI, TPV, sensitive, n=3, 3	3	3

Notes
[91] - CVF Population
[92] - CVF Population

No statistical analyses for this end point

Secondary: Number of participants with genotypic resistance through Week 48

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End point title

Number of participants with genotypic resistance through Week 48

End point description

Plasma samples were collected and analyzed from participants who met confirmed virologic withdrawal criteria. Genotypic Resistance data for the following drugs: DTG, EVG, RAL, DLV, EFV, ETR, NVP, RPV, 3TC, ABC, FTC, TDF, ZDV, d4T, ddI, ATV, DRV, FPV, IDV, LPV, NFV, RTV, SQV and TPV in participants meeting CVF criteria has been presented. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).

End point type

Secondary

End point timeframe

At the time of CVF

End point values	CAB LA+RPV LA (Q4W)	Current ART
Number of subjects analysed	3 ^[93]	4 ^[94]
Units: Participants
INI, DTG, resistant	0	0
INI, DTG, resistance possible	0	0
INI, DTG, sensitive	3	4
INI, EVG, resistant	1	0
INI, EVG, resistance possible	0	0
INI, EVG, sensitive	2	4
INI, RAL, resistant	1	0
INI, RAL, resistance possible	0	0
INI, RAL, sensitive	2	4
NNRTI, DLV, resistant	0	0
NNRTI, DLV, resistance possible	0	0
NNRTI, DLV, sensitive	3	4
NNRTI, EFV, resistant	1	1
NNRTI, EFV, resistance possible	0	0
NNRTI, EFV, sensitive	2	3
NNRTI, ETR, resistant	0	0
NNRTI, ETR, resistance possible	2	0
NNRTI, ETR, sensitive	1	4
NNRTI, NVP, resistant	1	1
NNRTI, NVP, resistance possible	0	0
NNRTI, NVP, sensitive	2	3
NNRTI, RPV, resistant	3	1
NNRTI, RPV, resistance possible	0	0
NNRTI, RPV, sensitive	0	3
NRTI, 3TC, resistant	0	2
NNRTI, 3TC, resistance possible	0	0
NRTI, 3TC, sensitive	3	2
NRTI, ABC, resistant	0	0
NRTI, ABC, resistance possible	0	0
NRTI, ABC, sensitive	3	4
NRTI, FTC, resistant	0	2
NRTI, FTC, resistance possible	0	0
NRTI, FTC, sensitive	3	2
NRTI, TDF, resistant	0	0
NRTI, TDF, resistance possible	0	0
NRTI, TDF, sensitive	3	4
NRTI, ZDV, resistant	0	0
NRTI, ZDV, resistance possible	0	0
NRTI, ZDV, sensitive	3	4
NRTI, d4T, resistant	0	0
NRTI, d4T, resistance possible	0	0
NRTI, d4T, sensitive	3	4
NRTI, ddI, resistant	0	0
NRTI, ddI, resistance possible	0	2
NRTI, ddI, sensitive	3	2
PI, ATV, resistant	1	0
PI, ATV, resistance possible	0	0
PI, ATV, sensitive	2	4
PI, ATV/r, resistant	0	0
PI, ATV/r, resistance possible	1	0
PI, ATV/r, sensitive	2	4
PI, DRV/r, resistant	0	0
PI, DRV/r, resistance possible	0	0
PI, DRV/r, sensitive	3	4
PI, FPV/r, resistant	0	0
PI, FPV/r, resistance possible	0	0
PI, FPV/r, sensitive	3	4
PI, IDV/r, resistant	0	0
PI, IDV/r, resistance possible	0	0
PI, IDV/r, sensitive	3	4
PI, LPV/r, resistant	0	0
PI, LPV/r, resistance possible	0	0
PI, LPV/r, sensitive	3	4
PI, NFV, resistant	1	0
PI, NFV, resistance possible	0	0
PI, NFV, sensitive	2	4
PI, RTV, resistant	0	0
PI, RTV, resistance possible	0	0
PI, RTV, sensitive	3	4
PI, SQV/r, resistant	0	0
PI, SQV/r, resistance possible	0	0
PI, SQV/r, sensitive	3	4
PI, TPV/r, resistant	0	0
PI, TPV/r, resistance possible	0	0
PI, TPV/r, sensitive	3	4

Notes
[93] - CVF Population
[94] - CVF Population

No statistical analyses for this end point

Secondary: Number of participants with AEs by using Baseline third agent treatment class overtime including Week 48

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End point title

Number of participants with AEs by using Baseline third agent treatment class overtime including Week 48

End point description

An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment.Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).

End point type

Secondary

End point timeframe

Up to Week 48

End point values	CAB LA+RPV LA (Q4W)	Current ART
Number of subjects analysed	308 ^[95]	308 ^[96]
Units: Participants
Any AE, INI, n=102, 99	99	68
Any AE, NNRTI, n=155, 155	148	116
Any AE, PI, n=51, 54	47	36

Notes
[95] - Safety Population
[96] - Safety Population

No statistical analyses for this end point

Secondary: Absolute values for clinical chemistry parameters using baseline third agent treatment class overtime including Week 48: ALT, ALP, AST and CK

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End point title

Absolute values for clinical chemistry parameters using baseline third agent treatment class overtime including Week 48: ALT, ALP, AST and CK

End point description

Blood samples were collected for the analysis of clinical chemistry parameters to assess the impact of Baseline third agent treatment class (PI, NNRTI and INI). Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).

End point type

Secondary

End point timeframe

Baseline (Day 1) and at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44 and 48

End point values	CAB LA+RPV LA (Q4W)	Current ART
Number of subjects analysed	308 ^[97]	308 ^[98]
Units: International units per liter
arithmetic mean (standard deviation)
PI, ALT, Baseline, n=51, 54	19.3 ± 11.23	18.7 ± 9.13
PI, ALT, Week 4, n=51, 53	28.7 ± 20.12	19.8 ± 12.29
PI, ALT, Week 8, n=34, 53	25.8 ± 19.28	19.6 ± 10.43
PI, ALT, Week 12, n=50, 52	24.7 ± 17.09	20.1 ± 14.19
PI, ALT, Week 16, n=48, 53	26.3 ± 19.89	20.0 ± 12.04
PI, ALT, Week 20, n=46, 53	24.9 ± 18.46	19.0 ± 9.52
PI, ALT, Week 24, n=47, 53	24.1 ± 13.75	19.1 ± 10.02
PI, ALT, Week 28, n=42, 53	22.0 ± 12.42	19.4 ± 10.45
PI, ALT, Week 32, n=45, 51	22.7 ± 15.18	18.8 ± 8.18
PI, ALT, Week 36, n=44, 50	22.3 ± 15.09	20.7 ± 13.18
PI, ALT, Week 40, n=42, 51	24.9 ± 19.63	19.5 ± 13.46
PI, ALT, Week 44, n=47, 51	23.2 ± 17.05	19.3 ± 14.23
PI, ALT, Week 48, n=43, 50	22.5 ± 13.28	19.0 ± 8.52
INI, ALT, Baseline, n=102, 99	24.8 ± 15.23	21.2 ± 10.93
INI, ALT, Week 4, n=99, 97	26.5 ± 18.35	21.7 ± 10.09
INI, ALT, Week 8, n=73, 98	28.4 ± 22.77	26.8 ± 49.37
INI, ALT, Week 12, n=99, 95	23.8 ± 14.21	22.9 ± 16.05
INI, ALT, Week 16, n=93, 96	23.2 ± 13.62	21.2 ± 11.24
INI, ALT, Week 20, n=93, 97	23.0 ± 15.29	20.7 ± 9.83
INI, ALT, Week 24, n=94, 95	25.7 ± 20.09	21.0 ± 13.40
INI, ALT, Week 28, n=89, 93	21.5 ± 13.06	20.9 ± 14.10
INI, ALT, Week 32, n=93, 95	22.5 ± 10.95	21.1 ± 12.32
INI, ALT, Week 36, n=94, 95	26.5 ± 38.41	20.5 ± 9.38
INI, ALT, Week 40, n=90, 95	30.2 ± 61.80	20.6 ± 9.20
INI, ALT, Week 44, n=91, 94	23.2 ± 15.03	20.7 ± 10.01
INI, ALT, Week 48, n=91, 95	24.4 ± 17.58	20.3 ± 9.79
NNRTI, ALT, Baseline, n=155, 155	24.6 ± 12.67	24.4 ± 14.74
NNRTI, ALT, Week 4, n=151, 153	21.6 ± 10.72	23.7 ± 11.16
NNRTI, ALT, Week 8, n=122, 152	20.8 ± 10.13	23.7 ± 12.94
NNRTI, ALT, Week 12, n=146, 152	33.9 ± 161.81	23.6 ± 11.27
NNRTI, ALT, Week 16, n=143, 149	23.2 ± 27.18	22.8 ± 11.06
NNRTI, ALT, Week 20, n=138, 152	22.6 ± 27.36	22.3 ± 11.15
NNRTI, ALT, Week 24, n=143, 151	27.4 ± 85.70	22.9 ± 12.88
NNRTI, ALT, Week 28, n=136, 150	20.6 ± 11.45	23.8 ± 16.00
NNRTI, ALT, Week 32, n=137, 148	21.1 ± 12.69	23.4 ± 12.86
NNRTI, ALT, Week 36, n=135, 147	21.2 ± 12.38	24.1 ± 13.19
NNRTI, ALT, Week 40, n=138, 147	20.8 ± 10.63	23.9 ± 14.24
NNRTI, ALT, Week 44, n=137, 148	20.0 ± 9.61	23.9 ± 15.22
NNRTI, ALT, Week 48, n=131, 147	19.8 ± 9.62	23.5 ± 12.32
PI, ALP, Baseline, n=51, 54	73.8 ± 24.90	70.2 ± 19.56
PI, ALP, Week 4, n=51, 53	70.4 ± 20.03	67.7 ± 19.24
PI, ALP, Week 8, n=34, 53	72.4 ± 34.86	70.9 ± 23.18
PI, ALP, Week 12, n=50, 52	68.2 ± 17.49	71.6 ± 23.60
PI, ALP, Week 16, n=48, 53	66.9 ± 15.70	71.2 ± 21.50
PI, ALP, Week 20, n=46, 53	67.7 ± 16.36	70.8 ± 20.96
PI, ALP, Week 24, n=47, 53	67.6 ± 16.14	70.3 ± 19.23
PI, ALP, Week 28, n=42, 53	67.3 ± 17.71	73.7 ± 21.89
PI, ALP, Week 32, n=45, 51	63.8 ± 16.09	69.8 ± 21.44
PI, ALP, Week 36, n=44, 50	64.3 ± 16.50	71.7 ± 23.57
PI, ALP, Week 40, n=42, 51	65.5 ± 13.63	68.5 ± 19.55
PI, ALP, Week 44, n=47, 51	63.0 ± 15.76	69.1 ± 20.67
PI, ALP, Week 48, n=43, 50	63.6 ± 14.22	69.9 ± 18.94
INI, ALP, Baseline, n=102, 99	66.3 ± 17.31	64.9 ± 19.05
INI, ALP, Week 4, n=99, 97	65.9 ± 17.25	64.4 ± 18.77
INI, ALP, Week 8, n=73, 98	64.0 ± 16.21	69.7 ± 38.92
INI, ALP, Week 12, n=99, 95	64.7 ± 16.33	67.7 ± 27.73
INI, ALP, Week 16, n=93, 96	65.3 ± 17.01	64.4 ± 20.89
INI, ALP, Week 20, n=93, 97	64.9 ± 16.80	64.2 ± 19.58
INI, ALP, Week 24, n=94, 95	65.0 ± 17.08	64.4 ± 19.46
INI, ALP, Week 28, n=89, 93	65.0 ± 15.81	63.3 ± 18.76
INI, ALP, Week 32, n=93, 95	64.4 ± 16.12	62.3 ± 17.96
INI, ALP, Week 36, n=94, 95	64.3 ± 18.15	62.2 ± 18.12
INI, ALP, Week 40, n=90, 95	65.1 ± 17.07	62.2 ± 18.22
INI, ALP, Week 44, n=91, 94	64.0 ± 16.71	64.1 ± 19.31
INI, ALP, Week 48, n=91, 95	65.1 ± 15.98	63.0 ± 18.76
NNRTI, ALP, Baseline, n=155, 155	84.4 ± 32.47	88.1 ± 28.83
NNRTI, ALP, Week 4, n=151, 153	73.4 ± 26.16	85.6 ± 27.39
NNRTI, ALP, Week 8, n=122, 152	70.9 ± 20.00	87.4 ± 28.15
NNRTI, ALP, Week 12, n=146, 152	72.0 ± 30.68	87.8 ± 28.30
NNRTI, ALP, Week 16, n=143, 149	69.9 ± 22.37	87.7 ± 28.55
NNRTI, ALP, Week 20, n=138, 152	69.3 ± 20.51	86.7 ± 26.18
NNRTI, ALP, Week 24, n=143, 151	70.2 ± 21.08	88.3 ± 27.77
NNRTI, ALP, Week 28, n=136, 150	69.3 ± 20.91	87.0 ± 28.40
NNRTI, ALP, Week 32, n=137, 148	69.1 ± 21.60	86.5 ± 26.32
NNRTI, ALP, Week 36, n=135, 147	69.3 ± 23.22	87.1 ± 26.24
NNRTI, ALP, Week 40, n=138, 147	67.1 ± 18.98	87.8 ± 27.07
NNRTI, ALP, Week 44, n=137, 148	68.4 ± 19.94	87.5 ± 26.53
NNRTI, ALP, Week 48, n=131, 147	68.5 ± 21.69	88.6 ± 27.61
PI, AST, Baseline, n=51, 54	19.7 ± 6.97	20.1 ± 5.66
PI, AST, Week 4, n=51, 53	23.5 ± 9.76	22.5 ± 17.53
PI, AST, Week 8, n=34, 53	23.4 ± 11.04	20.0 ± 5.24
PI, AST, Week 12, n=50, 52	22.5 ± 11.60	21.8 ± 9.63
PI, AST, Week 16, n=48, 53	23.7 ± 15.77	22.0 ± 10.39
PI, AST, Week 20, n=46, 53	24.1 ± 20.53	20.6 ± 6.35
PI, AST, Week 24, n=47, 53	21.5 ± 7.02	21.7 ± 11.65
PI, AST, Week 28, n=42, 53	22.9 ± 9.20	22.0 ± 8.47
PI, AST, Week 32, n=45, 51	23.0 ± 13.51	20.3 ± 5.57
PI, AST, Week 36, n=44, 50	21.5 ± 7.88	21.8 ± 7.04
PI, AST, Week 40, n=42, 51	25.1 ± 23.51	20.5 ± 7.55
PI, AST, Week 44, n=47, 51	21.6 ± 8.80	21.4 ± 13.16
PI, AST, Week 48, n=43, 50	21.6 ± 7.59	22.2 ± 8.85
INI, AST, Baseline, n=102, 99	24.5 ± 13.03	22.2 ± 13.13
INI, AST, Week 4, n=99, 97	24.5 ± 13.22	22.0 ± 10.41
INI, AST, Week 8, n=73, 98	26.8 ± 25.34	23.6 ± 19.30
INI, AST, Week 12, n=99, 95	23.2 ± 10.47	23.2 ± 13.10
INI, AST, Week 16, n=93, 96	22.5 ± 8.78	22.5 ± 9.96
INI, AST, Week 20, n=93, 97	22.8 ± 10.11	21.4 ± 6.12
INI, AST, Week 24, n=94, 95	24.4 ± 12.42	22.0 ± 9.44
INI, AST, Week 28, n=89, 93	21.3 ± 7.14	21.6 ± 8.49
INI, AST, Week 32, n=93, 95	22.2 ± 7.77	21.6 ± 7.87
INI, AST, Week 36, n=94, 95	23.9 ± 15.06	21.1 ± 5.43
INI, AST, Week 40, n=90, 95	25.4 ± 18.01	21.8 ± 7.30
INI, AST, Week 44, n=91, 94	25.6 ± 23.29	21.4 ± 6.51
INI, AST, Week 48, n=91, 95	24.9 ± 13.88	22.4 ± 9.70
NNRTI, AST, Baseline, n=155, 155	24.8 ± 10.99	23.6 ± 9.16
NNRTI, AST, Week 4, n=151, 153	22.2 ± 11.35	23.2 ± 7.95
NNRTI, AST, Week 8, n=122, 152	23.0 ± 17.16	22.8 ± 7.19
NNRTI, AST, Week 12, n=146, 152	29.4 ± 91.34	23.6 ± 9.12
NNRTI, AST, Week 16, n=143, 149	25.3 ± 22.91	22.6 ± 6.80
NNRTI, AST, Week 20, n=138, 152	23.8 ± 16.12	22.9 ± 7.33
NNRTI, AST, Week 24, n=143, 150	25.1 ± 30.40	23.1 ± 8.25
NNRTI, AST, Week 28, n=136, 150	22.6 ± 9.49	24.0 ± 10.53
NNRTI, AST, Week 32, n=137, 148	23.2 ± 16.69	25.1 ± 15.63
NNRTI, AST, Week 36, n=135, 147	22.8 ± 8.90	23.9 ± 7.99
NNRTI, AST, Week 40, n=138, 147	22.3 ± 7.66	23.7 ± 8.01
NNRTI, AST, Week 44, n=137, 148	21.7 ± 7.11	23.8 ± 10.98
NNRTI, AST, Week 48, n=131, 147	22.0 ± 7.86	24.2 ± 9.16
PI, CK, Baseline, n=51, 54	121.3 ± 173.52	111.8 ± 66.03
PI, CK, Week 4, n=51, 53	130.0 ± 94.61	244.2 ± 908.06
PI, CK, Week 8, n=34, 53	157.7 ± 174.37	134.2 ± 179.01
PI, CK, Week 12, n=50, 52	124.2 ± 71.36	168.8 ± 406.86
PI, CK, Week 16, n=48, 53	142.3 ± 197.96	127.0 ± 82.59
PI, CK, Week 20, n=46, 53	227.9 ± 689.65	117.5 ± 76.83
PI, CK, Week 24, n=47, 53	120.8 ± 72.63	128.9 ± 85.38
PI, CK, Week 28, n=42, 53	185.9 ± 237.49	124.2 ± 96.15
PI, CK, Week 32, n=45, 51	282.5 ± 959.49	110.1 ± 58.84
PI, CK, Week 36, n=44, 50	115.5 ± 81.36	130.9 ± 95.59
PI, CK, Week 40, n=42, 51	319.4 ± 1169.15	109.9 ± 53.99
PI, CK, Week 44, n=47, 51	117.2 ± 74.25	114.4 ± 62.44
PI, CK, Week 48, n=43, 50	123.5 ± 90.77	183.1 ± 485.07
INI, CK, Baseline, n=102, 99	257.9 ± 565.99	214.3 ± 627.94
INI, CK, Week 4, n=99, 97	225.9 ± 484.50	193.6 ± 415.15
INI, CK, Week 8, n=73, 98	306.8 ± 791.76	158.0 ± 164.72
INI, CK, Week 12, n=99, 95	242.5 ± 649.06	195.3 ± 383.74
INI, CK, Week 16, n=93, 96	198.6 ± 335.16	216.4 ± 422.21
INI, CK, Week 20, n=93, 97	200.9 ± 301.61	158.8 ± 156.94
INI, CK, Week 24, n=94, 95	202.1 ± 276.49	178.8 ± 356.60
INI, CK, Week 28, n=89, 93	151.1 ± 128.42	192.6 ± 463.71
INI, CK, Week 32, n=93, 95	182.2 ± 202.28	175.1 ± 256.84
INI, CK, Week 36, n=94, 95	190.7 ± 268.67	153.8 ± 151.29
INI, CK, Week 40, n=90, 95	286.9 ± 705.76	178.2 ± 200.25
INI, CK, Week 44, n=91, 94	457.7 ± 2054.68	153.6 ± 139.48
INI, CK, Week 48, n=91, 95	278.9 ± 651.96	188.7 ± 339.93
NNRTI, CK, Baseline, n=155, 155	180.9 ± 210.84	143.8 ± 118.05
NNRTI, CK, Week 4, n=151, 153	192.5 ± 472.95	170.1 ± 226.58
NNRTI, CK, Week 8, n=122, 152	290.4 ± 1322.89	141.1 ± 106.01
NNRTI, CK, Week 12, n=146, 152	198.5 ± 430.65	168.5 ± 236.30
NNRTI, CK, Week 16, n=143, 149	326.5 ± 1157.93	150.4 ± 214.31
NNRTI, CK, Week 20, n=138, 152	247.2 ± 661.97	144.9 ± 131.72
NNRTI, CK, Week 24, n=143, 151	210.9 ± 582.66	161.5 ± 182.51
NNRTI, CK, Week 28, n=136, 150	175.0 ± 156.46	197.3 ± 460.97
NNRTI, CK, Week 32, n=137, 148	218.0 ± 617.20	238.8 ± 656.12
NNRTI, CK, Week 36, n=135, 147	206.4 ± 401.19	155.5 ± 134.30
NNRTI, CK, Week 40, n=138, 147	175.6 ± 156.39	166.9 ± 191.28
NNRTI, CK, Week 44, n=137, 148	148.6 ± 94.67	159.7 ± 171.66
NNRTI, CK, Week 48, n=131, 147	167.8 ± 132.83	171.3 ± 256.04

Notes
[97] - Safety Population
[98] - Safety Population

No statistical analyses for this end point

Secondary: Absolute values for clinical chemistry parameters using baseline third agent treatment class overtime including Week 48: Albumin

Top of page

End point title

Absolute values for clinical chemistry parameters using baseline third agent treatment class overtime including Week 48: Albumin

End point description

Blood samples were collected for the analysis of clinical chemistry parameter: albumin to assess the impact of Baseline third agent treatment class (PI, NNRTI and INI). . Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).

End point type

Secondary

End point timeframe

Baseline (Day 1) and at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44 and 48

End point values	CAB LA+RPV LA (Q4W)	Current ART
Number of subjects analysed	308 ^[99]	308 ^[100]
Units: Grams per Liter
arithmetic mean (standard deviation)
PI, Baseline, n=51, 54	43.9 ± 3.22	44.2 ± 3.36
PI, Week 4, n=51, 53	44.1 ± 2.90	43.9 ± 2.92
PI, Week 8, n=34, 53	44.6 ± 3.36	44.1 ± 3.32
PI, Week 12, n=50, 52	43.7 ± 3.25	43.8 ± 3.56
PI, Week 16, n=48, 53	43.8 ± 3.19	43.4 ± 3.36
PI, Week 20, n=46, 53	43.6 ± 2.70	43.3 ± 3.57
PI, Week 24, n=47, 53	43.5 ± 2.80	43.3 ± 3.09
PI, Week 28, n=42, 53	43.5 ± 2.74	42.8 ± 3.43
PI, Week 32, n=45, 51	43.2 ± 2.85	43.7 ± 3.31
PI, Week 36, n=44, 50	43.5 ± 2.87	43.4 ± 3.02
PI, Week 40, n=42, 51	44.2 ± 2.64	43.9 ± 3.11
PI, Week 44, n=47, 51	43.6 ± 2.58	43.9 ± 3.03
PI, Week 48, n=43, 50	43.9 ± 2.97	44.5 ± 2.44
INI, Baseline, n=102, 99	44.3 ± 3.08	44.9 ± 3.21
INI, Week 4, n=99, 97	43.9 ± 2.91	43.8 ± 2.57
INI, Week 8, n=73, 98	43.7 ± 3.07	43.9 ± 3.10
INI, Week 12, n=99, 95	44.1 ± 3.01	44.3 ± 2.62
INI, Week 16, n=93, 96	43.9 ± 2.77	43.7 ± 2.76
INI, Week 20, n=93, 97	43.6 ± 2.70	44.1 ± 2.87
INI, Week 24, n=94, 95	43.4 ± 3.03	43.9 ± 3.00
INI, Week 28, n=89, 93	44.0 ± 2.97	43.9 ± 2.87
INI, Week 32, n=93, 95	44.1 ± 2.87	43.7 ± 2.89
INI, Week 36, n=94, 95	43.6 ± 2.74	43.7 ± 2.60
INI, Week 40, n=90, 95	44.1 ± 2.79	43.6 ± 2.70
INI, Week 44, n=91, 94	43.6 ± 2.96	43.8 ± 2.83
INI, Week 48, n=91, 95	44.3 ± 2.58	44.3 ± 2.73
NNRTI, Baseline, n=155, 155	44.1 ± 3.11	44.0 ± 3.10
NNRTI, Week 4, n=151, 153	43.4 ± 2.83	43.7 ± 3.04
NNRTI, Week 8, n=122, 152	43.6 ± 2.96	43.4 ± 3.16
NNRTI, Week 12, n=146, 152	43.3 ± 2.86	43.7 ± 3.25
NNRTI, Week 16, n=143, 149	43.3 ± 2.61	43.3 ± 3.27
NNRTI, Week 20, n=138, 152	43.1 ± 2.75	43.2 ± 2.98
NNRTI, Week 24, n=143, 151	43.4 ± 2.54	43.4 ± 3.01
NNRTI, Week 28, n=136, 150	43.3 ± 2.78	43.2 ± 3.03
NNRTI, Week 32, n=137, 148	43.2 ± 2.74	43.1 ± 3.43
NNRTI, Week 36, n=135, 147	43.0 ± 2.86	43.3 ± 3.37
NNRTI, Week 40, n=138, 147	43.3 ± 2.66	43.1 ± 3.20
NNRTI, Week 44, n=137, 148	43.7 ± 2.74	43.2 ± 3.13
NNRTI, Week 48, n=131, 147	43.4 ± 2.73	43.6 ± 3.14

Notes
[99] - Safety Population
[100] - Safety Population

No statistical analyses for this end point

Secondary: Absolute values for clinical chemistry parameters using baseline third agent treatment class overtime including Week 48: Bilirubin, direct bilirubin and creatinine

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End point title

Absolute values for clinical chemistry parameters using baseline third agent treatment class overtime including Week 48: Bilirubin, direct bilirubin and creatinine

End point description

Blood samples were collected for the analysis of clinical chemistry parameter: bilirubin, direct bilirubin and creatinine to assess the impact of Baseline third agent treatment class (PI, NNRTI and INI). Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).

End point type

Secondary

End point timeframe

Baseline (Day 1) and at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44 and 48

End point values	CAB LA+RPV LA (Q4W)	Current ART
Number of subjects analysed	308 ^[101]	308 ^[102]
Units: Micromoles per liter
arithmetic mean (standard deviation)
PI, Bilirubin, Baseline, n=51, 54	18.3 ± 20.54	13.9 ± 11.07
PI, Bilirubin, Week 4, n=51, 53	9.3 ± 3.81	14.4 ± 10.37
PI, Bilirubin, Week 8, n=34, 53	8.9 ± 3.45	14.2 ± 10.79
PI, Bilirubin, Week 12, n=50, 52	8.1 ± 3.44	15.6 ± 11.70
PI, Bilirubin, Week 16, n=48, 53	8.7 ± 3.95	14.7 ± 10.78
PI, Bilirubin, Week 20, n=46, 53	9.3 ± 3.60	15.6 ± 14.96
PI, Bilirubin, Week 24, n=47, 53	9.5 ± 3.42	16.8 ± 16.15
PI, Bilirubin, Week 28, n=42, 53	9.4 ± 4.29	15.0 ± 12.75
PI, Bilirubin, Week 32, n=45, 51	9.7 ± 3.66	17.1 ± 12.45
PI, Bilirubin, Week 36, n=44, 50	8.3 ± 3.17	16.0 ± 14.09
PI, Bilirubin, Week 40, n=42, 51	9.2 ± 3.51	17.9 ± 18.08
PI, Bilirubin, Week 44, n=47, 51	9.5 ± 3.41	18.1 ± 16.62
PI, Bilirubin, Week 48, n=43, 50	9.3 ± 3.77	16.7 ± 10.73
INI, Bilirubin, Baseline, n=102, 99	9.4 ± 3.94	9.7 ± 5.07
INI, Bilirubin, Week 4, n=99, 97	9.5 ± 3.88	9.0 ± 4.77
INI, Bilirubin, Week 8, n=73, 98	10.1 ± 4.29	10.7 ± 12.28
INI, Bilirubin, Week 12, n=99, 95	9.9 ± 4.50	9.2 ± 3.91
INI, Bilirubin, Week 16, n=93, 96	9.8 ± 4.29	9.6 ± 3.80
INI, Bilirubin, Week 20, n=93, 97	10.1 ± 4.05	9.3 ± 3.60
INI, Bilirubin, Week 24, n=94, 94	9.4 ± 4.11	9.1 ± 3.81
INI, Bilirubin, Week 28, n=89, 93	10.3 ± 3.53	9.5 ± 4.67
INI, Bilirubin, Week 32, n=93, 95	9.9 ± 4.42	8.8 ± 3.32
INI, Bilirubin, Week 36, n=94, 95	9.8 ± 4.09	9.1 ± 3.76
INI, Bilirubin, Week 40, n=90, 95	9.9 ± 4.12	8.9 ± 3.63
INI, Bilirubin, Week 44, n=91, 94	10.1 ± 4.75	9.0 ± 3.40
INI, Bilirubin, Week 48, n=91, 95	10.3 ± 4.37	8.9 ± 3.76
NNRTI, Bilirubin, Baseline, n=155, 155	7.4 ± 3.30	7.2 ± 3.30
NNRTI, Bilirubin, Week 4, n=151, 153	8.7 ± 4.10	6.9 ± 2.98
NNRTI, Bilirubin, Week 8, n=122, 152	8.9 ± 4.01	6.8 ± 3.40
NNRTI, Bilirubin, Week 12, n=146, 152	9.3 ± 4.66	7.1 ± 3.50
NNRTI, Bilirubin, Week 16, n=143, 149	10.5 ± 14.51	6.8 ± 3.52
NNRTI, Bilirubin, Week 20, n=138, 152	9.6 ± 4.63	7.1 ± 3.15
NNRTI, Bilirubin, Week 24, n=143, 151	9.1 ± 3.93	6.9 ± 3.75
NNRTI, Bilirubin, Week 28, n=136, 150	9.7 ± 4.17	6.9 ± 3.29
NNRTI, Bilirubin, Week 32, n=137, 148	9.7 ± 4.55	6.9 ± 3.52
NNRTI, Bilirubin, Week 36, n=135, 147	9.3 ± 3.72	7.0 ± 3.33
NNRTI, Bilirubin, Week 40, n=138, 147	9.6 ± 4.21	7.0 ± 3.43
NNRTI, Bilirubin, Week 44, n=137, 148	9.4 ± 4.03	7.1 ± 3.25
NNRTI, Bilirubin, Week 48, n=131, 147	9.4 ± 4.28	7.3 ± 3.19
PI, Direct bilirubin, Baseline, n=51, 54	3.6 ± 2.13	2.9 ± 1.68
PI, Direct bilirubin, Week 4, n=51, 53	2.4 ± 1.20	3.3 ± 1.67
PI, Direct bilirubin, Week 8, n=34, 53	2.3 ± 1.12	2.8 ± 1.68
PI, Direct bilirubin, Week 12, n=50, 52	1.9 ± 0.80	3.2 ± 1.95
PI, direct bilirubin, Week 16, n=48, 53	2.0 ± 0.87	2.9 ± 1.45
PI, Direct bilirubin, Week 20, n=46, 53	2.2 ± 0.79	2.9 ± 2.17
PI, Direct bilirubin, Week 24, n=47, 53	2.2 ± 0.75	3.1 ± 2.02
PI, Direct bilirubin, Week 28, n=42, 53	2.1 ± 1.08	2.7 ± 1.84
PI, Direct bilirubin, Week 32, n=45, 51	2.2 ± 0.88	3.1 ± 1.84
PI, Direct bilirubin, Week 36, n=44, 50	1.9 ± 0.80	3.1 ± 1.95
PI, Direct bilirubin, Week 40, n=42, 51	2.0 ± 0.77	3.2 ± 2.05
PI, Direct bilirubin, Week 44, n=47, 51	2.1 ± 0.83	3.3 ± 1.99
PI, Direct bilirubin, Week 48, n=43, 50	2.3 ± 0.93	3.2 ± 1.71
INI, Direct bilirubin, Baseline, n=102, 99	2.4 ± 0.96	2.3 ± 1.16
INI, Direct bilirubin, Week 4, n=99, 97	2.4 ± 0.90	2.3 ± 1.18
INI, Direct bilirubin, Week 8, n=73, 98	2.4 ± 1.02	3.0 ± 6.70
INI, Direct bilirubin, Week 12, n=99, 95	2.3 ± 0.98	2.3 ± 1.06
INI, Direct bilirubin, Week 16, n=93, 96	2.3 ± 1.03	2.1 ± 0.87
INI, Direct bilirubin, Week 20, n=93, 97	2.2 ± 0.85	2.1 ± 0.89
INI, Direct bilirubin, Week 24, n=94, 94	2.2 ± 1.02	2.0 ± 0.78
INI, Direct bilirubin, Week 28, n=89, 93	2.2 ± 0.74	2.1 ± 1.12
INI, Direct bilirubin, Week 32, n=93, 95	2.2 ± 0.94	1.9 ± 0.77
INI, Direct bilirubin, Week 36, n=94, 95	2.2 ± 1.25	2.0 ± 0.97
INI, Direct bilirubin, Week 40, n=90, 95	2.2 ± 1.06	2.0 ± 1.11
INI, Direct bilirubin. Week 44, n=91, 94	2.3 ± 0.99	2.1 ± 0.95
INI, Direct bilirubin, Week 48, n=91, 95	2.3 ± 0.82	2.2 ± 1.00
NNRTI, Direct bilirubin, Baseline, n=155, 155	2.1 ± 1.00	1.9 ± 1.00
NNRTI, Direct bilirubin, Week 4, n=151, 153	2.2 ± 1.06	2.0 ± 0.96
NNRTI, Direct bilirubin, Week 8, n=122, 152	2.2 ± 1.10	1.9 ± 0.97
NNRTI, Direct bilirubin, Week 12, n=146, 152	2.2 ± 1.12	1.9 ± 0.98
NNRTI, Direct bilirubin, Week 16, n=143, 149	2.7 ± 6.95	1.9 ± 0.90
NNRTI, Direct bilirubin, Week 20, n=138, 152	2.2 ± 1.07	1.7 ± 0.97
NNRTI, Week 24, Direct bilirubin, n=143, 151	2.1 ± 1.04	1.8 ± 0.95
NNRTI, Direct bilirubin, Week 28, n=136, 150	2.1 ± 1.01	1.7 ± 1.01
NNRTI, Direct bilirubin, Week 32, n=137, 148	2.1 ± 1.08	1.7 ± 0.94
NNRTI, Direct bilirubin, Week 36, n=135, 147	2.1 ± 1.10	1.7 ± 0.94
NNRTI, Direct bilirubin, Week 40, n=138, 147	2.1 ± 1.18	1.7 ± 1.00
NNRTI, Direct bilirubin, Week 44, n=137, 148	2.1 ± 0.96	1.8 ± 0.91
NNRTI, Direct bilirubin, Week 48, n=131, 147	2.2 ± 0.98	1.9 ± 0.96
PI, Creatinine, Baseline, n=51, 54	71.41 ± 12.315	70.20 ± 13.391
PI, Creatinine, Week 4, n=51, 53	72.87 ± 11.632	72.53 ± 14.574
PI, Creatinine, Week 8, n=34, 53	71.66 ± 13.012	71.54 ± 14.362
PI, Creatinine, Week 12, n=50, 52	70.05 ± 11.609	73.22 ± 14.968
PI, Creatinine, Week 16, n=48, 53	71.05 ± 11.778	73.25 ± 15.740
PI, Creatinine, Week 20, n=46, 53	73.40 ± 12.191	75.37 ± 15.799
PI, Creatinine, Week 24, n=47, 53	72.75 ± 11.654	72.84 ± 14.549
PI, Creatinine, Week 28, n=42, 53	75.18 ± 13.118	73.42 ± 14.738
PI, Creatinine, Week 32, n=45, 51	74.59 ± 13.730	73.93 ± 15.399
PI, Creatinine, Week 36, n=44, 50	74.41 ± 12.217	72.37 ± 14.570
PI, Creatinine, Week 40, n=42, 51	74.31 ± 11.749	73.73 ± 15.726
PI, Creatinine, Week 44, n=47, 51	75.38 ± 13.405	73.00 ± 14.885
PI, Creatinine, Week 48, n=43, 50	76.95 ± 13.021	72.21 ± 15.031
INI, Creatinine, Baseline, n=102, 99	88.16 ± 16.835	86.34 ± 17.320
INI, Creatinine, Week 4, n=99, 95	86.39 ± 14.472	87.66 ± 16.208
INI, Creatinine, Week 8, n=73, 98	85.52 ± 15.851	88.11 ± 17.308
INI, Creatinine, Week 12, n=99, 95	85.53 ± 17.539	89.36 ± 17.923
INI, Creatinine, Week 16, n=93, 96	84.99 ± 15.429	86.85 ± 17.320
INI, Creatinine, Week 20, n=93, 97	85.01 ± 14.695	87.06 ± 16.987
INI, Creatinine, Week 24, n=94, 94	84.21 ± 15.039	87.02 ± 16.777
INI, Creatinine, Week 28, n=89, 93	84.84 ± 15.670	87.41 ± 17.065
INI, Creatinine, Week 32, n=93, 95	85.42 ± 15.349	86.91 ± 15.628
INI, Creatinine, Week 36, n=94, 95	84.49 ± 15.189	87.20 ± 15.835
INI, Creatinine, Week 40, n=90, 95	85.92 ± 14.651	87.70 ± 17.119
INI, Creatinine, Week 44, n=91, 94	84.66 ± 15.701	87.08 ± 16.694
INI, Creatinine, Week 48, n=91, 95	85.27 ± 15.683	86.64 ± 15.958
NNRTI, Creatinine, Baseline, n=155, 155	75.57 ± 14.604	75.06 ± 14.671
NNRTI, Creatinine, Week 4, n=151, 153	78.57 ± 15.814	76.79 ± 14.908
NNRTI, Creatinine, Week 8, n=122, 152	76.75 ± 15.759	76.17 ± 14.876
NNRTI, Creatinine, Week 12, n=146, 152	76.93 ± 15.495	75.50 ± 14.723
NNRTI, Creatinine, Week 16, n=143, 149	77.22 ± 15.406	77.00 ± 16.025
NNRTI, Creatinine, Week 20, n=138, 152	78.32 ± 16.372	76.36 ± 15.744
NNRTI, Creatinine, Week 24, n=143, 151	79.92 ± 21.430	76.26 ± 15.534
NNRTI, Creatinine, Week 28, n=136, 150	79.13 ± 17.039	76.45 ± 15.060
NNRTI, Creatinine, Week 32, n=137, 148	77.40 ± 14.117	77.05 ± 16.200
NNRTI, Creatinine, Week 36, n=135, 147	78.15 ± 16.839	76.64 ± 15.734
NNRTI, Creatinine, Week 40, n=138, 147	78.42 ± 16.662	76.04 ± 15.083
NNRTI, Creatinine, Week 44, n=137, 148	78.45 ± 15.909	76.25 ± 15.257
NNRTI, Creatinine, Week 48, n=131, 147	78.91 ± 17.389	75.67 ± 14.794

Notes
[101] - Safety Population
[102] - Safety Population

No statistical analyses for this end point

Secondary: Absolute values for clinical chemistry parameters using baseline third agent treatment class overtime including Week 48: Creatinine clearance

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End point title

Absolute values for clinical chemistry parameters using baseline third agent treatment class overtime including Week 48: Creatinine clearance

End point description

End point type

Secondary

End point timeframe

Baseline (Day 1) and at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44 and 48

End point values	CAB LA+RPV LA (Q4W)	Current ART
Number of subjects analysed	308 ^[103]	308 ^[104]
Units: Milliliters per minute per 1.73meter^2
arithmetic mean (standard deviation)
PI, Baseline, n=51, 54	105.2 ± 15.67	104.9 ± 15.22
PI, Week 4, n=51, 53	103.0 ± 15.59	102.1 ± 15.68
PI, Week 8, n=34, 53	104.3 ± 14.52	103.5 ± 15.61
PI, Week 12, n=50, 52	107.1 ± 14.95	101.1 ± 15.94
PI, Week 16, n=48, 53	105.4 ± 15.88	101.8 ± 15.99
PI, Week 20, n=46, 53	102.9 ± 17.17	99.8 ± 16.53
PI, Week 24, n=47, 53	103.3 ± 14.64	101.0 ± 15.54
PI, Week 28, n=42, 53	100.6 ± 16.62	100.8 ± 14.58
PI, Week 32, n=45, 51	101.0 ± 17.38	100.4 ± 16.04
PI, Week 36, n=44, 50	100.7 ± 16.68	101.7 ± 14.42
PI, Week 40, n=42, 51	100.2 ± 14.54	100.3 ± 15.51
PI, Week 44, n=47, 51	99.8 ± 18.00	101.0 ± 15.31
PI, Week 48, n=43, 50	98.8 ± 17.31	102.2 ± 15.45
INI, Baseline, n=102, 99	92.3 ± 17.62	94.9 ± 18.82
INI, Week 4, n=99, 95	93.4 ± 15.07	93.1 ± 18.22
INI, Week 8, n=72, 98	94.4 ± 17.05	93.0 ± 18.12
INI, Week 12, n=99, 93	94.5 ± 16.82	91.6 ± 18.81
INI, Week 16, n=93, 96	94.9 ± 16.02	94.4 ± 18.30
INI, Week 20, n=93, 97	95.3 ± 15.97	93.3 ± 17.48
INI, Week 24, n=94, 94	95.6 ± 15.88	93.1 ± 17.21
INI, Week 28, n=89, 93	95.4 ± 17.00	93.6 ± 17.89
INI, Week 32, n=92, 95	94.8 ± 17.16	93.1 ± 16.94
INI, Week 36, n=94, 95	95.6 ± 15.81	92.7 ± 15.65
INI, Week 40, n=89, 95	94.8 ± 16.32	92.9 ± 18.15
INI, Week 44, n=91, 94	94.8 ± 15.64	93.4 ± 17.94
INI, Week 48, n=90, 94	95.4 ± 16.20	93.5 ± 17.00
NNRTI, Baseline, n=155, 155	104.4 ± 17.78	103.7 ± 16.85
NNRTI, Week 4, n=151, 153	100.8 ± 18.35	101.5 ± 17.72
NNRTI, Week 8, n=121, 152	102.3 ± 17.23	102.2 ± 16.85
NNRTI, Week 12, n=146, 152	103.1 ± 18.02	103.2 ± 17.47
NNRTI, Week 16, n=143, 148	102.5 ± 17.66	101.0 ± 18.66
NNRTI, Week 20, n=138, 152	101.0 ± 17.94	101.8 ± 17.61
NNRTI, Week 24, n=142, 151	99.6 ± 18.18	101.7 ± 17.43
NNRTI, Week 28, n=136, 150	99.9 ± 18.23	101.7 ± 17.20
NNRTI, Week 32, n=137, 148	101.3 ± 16.10	101.0 ± 17.79
NNRTI, Week 36, n=135, 147	100.8 ± 18.02	101.4 ± 17.46
NNRTI, Week 40, n=137, 147	100.5 ± 18.40	101.6 ± 16.68
NNRTI, Week 44, n=136, 148	99.9 ± 17.23	101.8 ± 16.96
NNRTI, Week 48, n=131, 147	98.7 ± 17.35	102.1 ± 16.83

Notes
[103] - Safety Population
[104] - Safety Population

No statistical analyses for this end point

Secondary: Absolute values for clinical chemistry parameters using baseline third agent treatment class overtime including Week 48: Lipase

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End point title

Absolute values for clinical chemistry parameters using baseline third agent treatment class overtime including Week 48: Lipase

End point description

Blood samples were collected for the analysis of clinical chemistry parameter: lipase to assess the impact of Baseline third agent treatment class (PI, NNRTI and INI). Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).

End point type

Secondary

End point timeframe

Baseline (Day 1) and at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44 and 48

End point values	CAB LA+RPV LA (Q4W)	Current ART
Number of subjects analysed	308 ^[105]	308 ^[106]
Units: Units per liter
arithmetic mean (standard deviation)
PI, Baseline, n=51, 54	27.6 ± 21.69	33.0 ± 22.44
PI, Week 4, n=51, 53	25.5 ± 14.41	34.4 ± 20.77
PI, Week 8, n=34, 53	23.4 ± 10.96	35.7 ± 28.85
PI, Week 12, n=49, 52	26.4 ± 12.00	31.2 ± 15.31
PI, Week 16, n=47, 53	28.1 ± 13.01	34.6 ± 18.14
PI, Week 20, n=46, 53	25.8 ± 11.37	32.7 ± 16.37
PI, Week 24, n=47, 53	25.8 ± 11.74	30.5 ± 15.48
PI, Week 28, n=42, 53	26.4 ± 10.86	33.4 ± 15.92
PI, Week 32, n=45, 51	26.9 ± 12.18	36.2 ± 24.23
PI, Week 36, n=44, 50	27.1 ± 13.69	32.7 ± 17.14
PI, Week 40, n=42, 51	30.5 ± 19.78	32.0 ± 15.16
PI, Week 44, n=47, 51	27.1 ± 10.70	35.2 ± 18.59
PI, Week 48, n=43, 50	26.3 ± 12.02	32.7 ± 15.62
INI, Baseline, n=102, 99	29.3 ± 20.90	28.2 ± 16.64
INI, Week 4, n=99, 97	36.8 ± 43.46	32.1 ± 31.31
INI, Week 8, n=72, 98	28.8 ± 16.80	27.7 ± 12.72
INI, Week 12, n=99, 93	33.1 ± 20.98	29.8 ± 23.81
INI, Week 16, n=93, 97	34.4 ± 33.09	28.9 ± 14.77
INI, Week 20, n=94, 97	32.0 ± 28.19	29.1 ± 16.34
INI, Week 24, n=94, 95	32.0 ± 19.15	30.1 ± 21.56
INI, Week 28, n=89, 94	35.1 ± 38.32	32.8 ± 24.85
INI, Week 32, n=92, 95	32.6 ± 23.00	32.7 ± 21.75
INI, Week 36, n=94, 95	35.0 ± 32.32	27.6 ± 12.20
INI, Week 40, n=89, 95	33.8 ± 20.14	29.6 ± 14.21
INI, Week 44, n=91, 94	34.6 ± 34.66	32.8 ± 22.45
INI, Week 48, n=90, 94	35.1 ± 36.88	31.6 ± 23.18
NNRTI, Baseline, n=155, 155	32.1 ± 24.46	31.8 ± 19.30
NNRTI, Week 4, n=151, 153	37.6 ± 64.95	31.7 ± 17.60
NNRTI, Week 8, n=121, 152	33.8 ± 27.26	33.4 ± 21.17
NNRTI, Week 12, n=146, 152	35.6 ± 34.76	29.7 ± 14.64
NNRTI, Week 16, n=145, 149	35.3 ± 32.66	36.8 ± 46.27
NNRTI, Week 20, n=138, 152	32.0 ± 19.03	32.9 ± 37.34
NNRTI, Week 24, n=142, 151	36.2 ± 29.08	37.2 ± 36.77
NNRTI, Week 28, n=136, 150	33.4 ± 21.71	33.1 ± 17.20
NNRTI, Week 32, n=137, 148	40.6 ± 83.20	33.6 ± 20.70
NNRTI, Week 36, n=135, 147	39.9 ± 67.63	33.9 ± 21.66
NNRTI, Week 40, n=138, 147	38.6 ± 46.34	32.3 ± 16.96
NNRTI, Week 44, n=136, 148	34.5 ± 23.27	32.9 ± 19.81
NNRTI, Week 48, n=131, 146	36.3 ± 30.60	32.8 ± 20.04

Notes
[105] - Safety Population
[106] - Safety Population

No statistical analyses for this end point

Secondary: Absolute values for clinical chemistry parameters using baseline third agent treatment class overtime including Week 48

Top of page

End point title

Absolute values for clinical chemistry parameters using baseline third agent treatment class overtime including Week 48

End point description

Blood samples were collected for the analysis of clinical chemistry parameters: CO2, chloride, glucose, phosphate, potassium, sodium and urea to assess the impact of Baseline third agent treatment class (PI, NNRTI and INI). Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).

End point type

Secondary

End point timeframe

Baseline (Day 1) and at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44 and 48

End point values	CAB LA+RPV LA (Q4W)	Current ART
Number of subjects analysed	308 ^[107]	308 ^[108]
Units: Millimoles per liter
arithmetic mean (standard deviation)
PI, CO2, Baseline, n=51, 54	22.3 ± 2.53	22.7 ± 2.17
PI, CO2, Week 4, n=51, 53	23.6 ± 2.37	23.4 ± 2.28
PI, CO2, Week 8, n=34, 53	23.0 ± 1.95	23.0 ± 2.53
PI, CO2, Week 12, n=50, 52	22.9 ± 2.14	22.9 ± 2.41
PI, CO2, Week 16, n=48, 53	23.0 ± 2.07	22.9 ± 2.32
PI, CO2, Week 20, n=46, 53	23.1 ± 2.04	22.7 ± 2.59
PI, CO2, Week 24, n=47, 53	22.7 ± 1.95	22.8 ± 2.62
PI, CO2, Week 28, n=42, 53	22.7 ± 2.31	22.5 ± 2.48
PI, CO2, Week 32, n=45, 51	22.6 ± 2.22	22.6 ± 2.84
PI, CO2, Week 36, n=44, 50	22.6 ± 2.21	22.4 ± 2.36
PI, CO2, Week 40, n=42, 51	22.8 ± 2.24	23.1 ± 2.37
PI, CO2, Week 44, n=47, 51	22.9 ± 1.94	23.1 ± 2.37
PI, CO2, Week 48, n=43, 50	23.0 ± 2.01	22.7 ± 2.19
INI, CO2, Baseline, n=102, 99	22.8 ± 2.09	22.9 ± 2.08
INI, CO2, Week 4, n=99, 97	23.7 ± 2.36	23.7 ± 2.28
INI, CO2, Week 8, n=73, 98	23.0 ± 2.10	23.6 ± 2.20
INI, CO2, Week 12, n=99, 95	23.2 ± 2.07	23.3 ± 2.26
INI, CO2, Week 16, n=93, 96	22.8 ± 2.10	23.5 ± 2.39
INI, CO2, Week 20, n=93, 97	22.8 ± 2.11	23.6 ± 2.14
INI, CO2, Week 24, n=94, 95	22.8 ± 2.22	23.1 ± 2.21
INI, CO2, Week 28, n=89, 93	22.5 ± 2.21	23.1 ± 2.14
INI, CO2, Week 32, n=93, 95	22.8 ± 2.17	23.0 ± 2.09
INI, CO2, Week 36, n=94, 95	22.8 ± 1.90	23.5 ± 2.12
INI, CO2, Week 40, n=90, 95	23.1 ± 2.07	23.2 ± 2.09
INI, CO2, Week 44, n=91, 94	23.1 ± 2.08	23.7 ± 2.11
INI, CO2, Week 48, n=91, 95	22.9 ± 1.97	23.3 ± 2.32
NNRTI, CO2, Baseline, n=155, 155	22.7 ± 2.41	22.3 ± 2.35
NNRTI, CO2, Week 4, n=151, 153	23.7 ± 2.63	23.0 ± 2.24
NNRTI, CO2, Week 8, n=122, 152	23.2 ± 2.28	23.1 ± 2.61
NNRTI, CO2, Week 12, n=146, 152	23.2 ± 2.18	22.8 ± 2.39
NNRTI, CO2, Week 16, n=143, 149	23.0 ± 2.24	22.8 ± 2.23
NNRTI, CO2, Week 20, n=138, 152	22.9 ± 2.24	22.5 ± 2.20
NNRTI, CO2, Week 24, n=143, 150	23.0 ± 2.49	22.7 ± 2.45
NNRTI, CO2, Week 28, n=136, 150	22.8 ± 2.58	22.6 ± 2.27
NNRTI, CO2, Week 32, n=137, 148	22.5 ± 2.11	22.7 ± 2.29
NNRTI, CO2, Week 36, n=135, 147	22.8 ± 2.38	22.8 ± 2.27
NNRTI, CO2, Week 40, n=138, 147	23.1 ± 2.40	22.8 ± 2.68
NNRTI, CO2, Week 44, n=137, 148	23.0 ± 2.35	22.8 ± 2.38
NNRTI, CO2, Week 48, n=131, 147	22.5 ± 2.55	22.6 ± 2.29
PI, Chloride, Baseline, n=51, 54	104.0 ± 1.46	103.5 ± 2.61
PI, Chloride, Week 4, n=51, 53	104.5 ± 1.80	104.0 ± 2.10
PI, Chloride, Week 8, n=34, 53	104.4 ± 2.35	104.2 ± 2.28
PI, Chloride, Week 12, n=50, 52	104.4 ± 2.02	104.3 ± 2.13
PI, Chloride, Week 16, n=48, 53	104.4 ± 2.08	104.5 ± 2.10
PI, Chloride, Week 20, n=46, 53	104.8 ± 1.98	104.2 ± 1.97
PI, Chloride, Week 24, n=47, 53	105.1 ± 1.85	104.7 ± 2.02
PI, Chloride, Week 28, n=42, 53	105.3 ± 1.88	104.6 ± 2.47
PI, Chloride, Week 32, n=45, 51	105.0 ± 2.32	104.4 ± 1.92
PI, Chloride, Week 36, n=44, 50	105.0 ± 2.17	104.4 ± 2.27
PI, Chloride, Week 40, n=42, 51	105.2 ± 2.27	104.5 ± 2.31
PI, Chloride, Week 44, n=47, 51	105.1 ± 1.84	104.5 ± 1.88
PI, Chloride, Week 48, n=43, 50	104.4 ± 1.72	104.3 ± 1.88
INI, Chloride, Baseline, n=102, 99	103.6 ± 2.03	103.5 ± 2.26
INI, Chloride, Week 4, n=99, 97	104.0 ± 2.17	104.0 ± 2.15
INI, Chloride, Week 8, n=73, 98	104.1 ± 2.16	103.5 ± 2.58
INI, Chloride, Week 12, n=99, 95	104.1 ± 2.31	104.0 ± 2.32
INI, Chloride, Week 16, n=93, 96	104.7 ± 2.05	104.2 ± 2.26
INI, Chloride, Week 20, n=93, 97	104.8 ± 2.39	103.8 ± 2.36
INI, Chloride, Week 24, n=94, 95	104.3 ± 2.30	104.1 ± 2.50
INI, Chloride, Week 28, n=89, 93	104.7 ± 1.92	104.0 ± 2.16
INI, Chloride, Week 32, n=93, 95	104.5 ± 2.33	104.2 ± 2.47
INI, Chloride, Week 36, n=94, 95	104.6 ± 2.04	104.1 ± 2.40
INI, Chloride, Week 40, n=90, 95	104.4 ± 1.94	103.9 ± 2.48
INI, Chloride, Week 44, n=91, 94	104.5 ± 2.12	104.0 ± 2.27
INI, Chloride, Week 48, n=91, 95	104.2 ± 2.43	103.2 ± 2.26
NNRTI, Chloride, Baseline, n=155, 155	103.9 ± 2.18	104.0 ± 2.37
NNRTI, Chloride, Week 4, n=151, 153	104.3 ± 2.21	104.6 ± 2.29
NNRTI, Chloride, Week 8, n=122, 152	104.4 ± 2.31	104.7 ± 2.22
NNRTI, Chloride, Week 12, n=146, 152	104.3 ± 2.33	104.5 ± 2.23
NNRTI, Chloride, Week 16, n=143, 149	104.4 ± 2.37	104.8 ± 2.34
NNRTI, Chloride, Week 20, n=138, 152	104.6 ± 2.55	105.1 ± 2.38
NNRTI, Chloride, Week 24, n=143, 151	104.4 ± 2.52	105.1 ± 2.18
NNRTI, Chloride, Week 28, n=136, 150	104.7 ± 2.41	105.3 ± 2.31
NNRTI, Chloride, Week 32, n=137, 148	104.7 ± 2.68	105.1 ± 2.26
NNRTI, Chloride, Week 36, n=135, 147	105.0 ± 2.28	105.1 ± 2.30
NNRTI, Chloride, Week 40, n=138, 147	104.7 ± 2.36	105.0 ± 2.70
NNRTI, Chloride, Week 44, n=137, 148	104.6 ± 2.17	105.0 ± 2.32
NNRTI, Chloride, Week 48, n=131, 147	104.6 ± 2.54	104.5 ± 2.46
PI, Glucose, Baseline, n=51, 53	5.11 ± 0.878	5.03 ± 0.505
PI, Glucose, Week 4, n=43, 43	5.06 ± 0.481	5.29 ± 0.452
PI, Glucose, Week 8, n=25, 41	5.11 ± 0.456	5.18 ± 0.462
PI, Glucose, Week 12, n=40, 43	5.21 ± 0.533	5.25 ± 0.535
PI, Glucose, Week 16, n=39, 44	5.24 ± 0.800	5.26 ± 0.614
PI, Glucose, Week 20, n=35, 42	5.11 ± 0.580	5.29 ± 0.718
PI, Glucose, Week 24, n=38, 43	5.31 ± 0.526	5.29 ± 0.747
PI, Glucose, Week 28, n=32, 43	5.16 ± 0.651	5.12 ± 0.512
PI, Glucose, Week 32, n=36, 42	5.37 ± 0.700	5.31 ± 0.643
PI, Glucose, Week 36, n=35, 42	5.13 ± 0.525	5.23 ± 0.513
PI, Glucose, Week 40, n=34, 41	5.31 ± 0.464	5.17 ± 0.555
PI, Glucose, Week 44, n=40, 40	5.13 ± 0.681	5.20 ± 0.408
PI, Glucose, Week 48, n=39, 48	5.16 ± 0.647	5.18 ± 0.661
INI, Glucose, Baseline, n=98, 96	5.06 ± 0.638	5.25 ± 0.801
INI, Glucose, Week 4, n=55, 54	5.39 ± 0.771	5.37 ± 1.043
INI, Glucose, Week 8, n=36, 58	5.16 ± 0.584	5.49 ± 1.307
INI, Glucose, Week 12, n=53, 56	5.50 ± 1.317	5.51 ± 1.414
INI, Glucose, Week 16, n=54, 53	5.41 ± 1.727	5.25 ± 0.624
INI, Glucose, Week 20, n=52, 58	5.36 ± 0.674	5.21 ± 0.793
INI, Glucose, Week 24, n=61, 62	5.34 ± 0.660	5.36 ± 0.753
INI, Glucose, Week 28, n=53, 63	5.32 ± 0.817	5.45 ± 0.940
INI, Glucose, Week 32, n=54, 56	5.57 ± 1.260	5.52 ± 0.839
INI, Glucose, Week 36, n=53, 58	5.46 ± 0.697	5.34 ± 1.142
INI, Glucose, Week 40, n=59, 63	5.53 ± 0.931	5.46 ± 0.765
INI, Glucose, Week 44, n=54, 57	5.40 ± 1.020	5.43 ± 0.637
INI, Glucose, Week 48, n=84, 91	5.16 ± 0.549	5.24 ± 0.752
NNRTI, Glucose, Baseline, n=152, 150	4.93 ± 0.697	5.17 ± 1.201
NNRTI, Glucose, Week 4, n=118, 129	5.11 ± 0.798	5.48 ± 1.490
NNRTI, Glucose, Week 8, n=92, 119	5.17 ± 1.204	5.35 ± 1.030
NNRTI, Glucose, Week 12, n=113, 122	5.04 ± 0.856	5.30 ± 1.067
NNRTI, Glucose, Week 16, n=116, 119	5.12 ± 0.914	5.45 ± 1.683
NNRTI, Glucose, Week 20, n=107, 121	5.16 ± 0.802	5.48 ± 1.476
NNRTI, Glucose, Week 24, n=116, 124	5.16 ± 0.944	5.36 ± 0.914
NNRTI, Glucose, Week 28, n=105, 120	5.08 ± 0.635	5.40 ± 0.934
NNRTI, Glucose, Week 32, n=104, 121	5.18 ± 1.000	5.47 ± 1.316
NNRTI, Glucose, Week 36, n=103, 120	5.07 ± 0.856	5.49 ± 1.857
NNRTI, Glucose, Week 40, n=102, 114	5.16 ± 0.776	5.53 ± 1.558
NNRTI, Glucose, Week 44, n=99, 116	5.15 ± 0.877	5.53 ± 1.708
NNRTI, Glucose, Week 48, n=119, 138	5.01 ± 0.640	5.23 ± 1.160
PI, Phosphate, Baseline, n=51, 54	1.048 ± 0.1523	1.060 ± 0.1719
PI, Phosphate, Week 4, n=51, 53	1.116 ± 0.1648	1.069 ± 0.1647
PI, Phosphate, Week 8, n=34, 53	1.119 ± 0.1891	1.041 ± 0.1664
PI, Phosphate, Week 12, n=50, 52	1.073 ± 0.1788	1.064 ± 0.1872
PI, Phosphate, Week 16, n=48, 53	1.111 ± 0.2006	1.051 ± 0.1849
PI, Phosphate, Week 20, n=46, 53	1.119 ± 0.1689	1.076 ± 0.2187
PI, Phosphate, Week 24, n=47, 53	1.086 ± 0.1647	1.077 ± 0.1631
PI, Phosphate, Week 28, n=42, 53	1.085 ± 0.1803	1.076 ± 0.1970
PI, Phosphate, Week 32, n=45, 51	1.109 ± 0.1869	1.081 ± 0.1769
PI, Phosphate, Week 36, n=44, 50	1.084 ± 0.1659	1.058 ± 0.1830
PI, Phosphate, Week 40, n=42, 51	1.067 ± 0.2020	1.053 ± 0.1932
PI, Phosphate, Week 44, n=47, 51	1.084 ± 0.1785	1.063 ± 0.2227
PI, Phosphate, Week 48, n=43, 50	1.095 ± 0.1636	1.070 ± 0.1804
INI, Phosphate, Baseline, n=102, 99	1.045 ± 0.1687	1.063 ± 0.1700
INI, Phosphate, Week 4, n=99, 97	1.080 ± 0.1725	1.082 ± 0.1857
INI, Phosphate, Week 8, n=73, 98	1.086 ± 0.1901	1.071 ± 0.2001
INI, Phosphate, Week 12, n=99, 95	1.068 ± 0.1970	1.078 ± 0.1823
INI, Phosphate, Week 16, n=93, 96	1.063 ± 0.1623	1.061 ± 0.1702
INI, Phosphate, Week 20, n=93, 97	1.046 ± 0.1717	1.091 ± 0.1757
INI, Phosphate, Week 24, n=94, 95	1.066 ± 0.1661	1.052 ± 0.1921
INI, Phosphate, Week 28, n=89, 93	1.060 ± 0.1602	1.065 ± 0.1835
INI, Phosphate, Week 32, n=93, 95	1.045 ± 0.1649	1.045 ± 0.1569
INI, Phosphate, Week 36, n=94, 95	1.032 ± 0.1572	1.059 ± 0.1800
INI, Phosphate, Week 40, n=90, 95	1.054 ± 0.1838	1.062 ± 0.1731
INI, Phosphate, Week 44, n=91, 94	1.043 ± 0.1805	1.066 ± 0.2029
INI, Phosphate, Week 48, n=91, 95	1.072 ± 0.1721	1.066 ± 0.1918
NNRTI, Phosphate, Baseline, n=155, 155	1.038 ± 0.1905	1.040 ± 0.1741
NNRTI, Phosphate, Week 4, n=151, 153	1.128 ± 0.1867	1.056 ± 0.1764
NNRTI, Phosphate, Week 8, n=122, 152	1.097 ± 0.1994	1.024 ± 0.1784
NNRTI, Phosphate, Week 12, n=146, 152	1.091 ± 0.1838	1.051 ± 0.2002
NNRTI, Phosphate, Week 16, n=143, 149	1.082 ± 0.1827	1.046 ± 0.1700
NNRTI, Phosphate, Week 20, n=138, 152	1.076 ± 0.1763	1.037 ± 0.1806
NNRTI, Phosphate, Week 24, n=143, 151	1.091 ± 0.1914	1.052 ± 0.1882
NNRTI, Phosphate, Week 28, n=136, 150	1.076 ± 0.1764	1.038 ± 0.1585
NNRTI, Phosphate, Week 32, n=137, 148	1.057 ± 0.1722	1.050 ± 0.1874
NNRTI, Phosphate, Week 36, n=135, 147	1.055 ± 0.1790	1.039 ± 0.1793
NNRTI, Phosphate, Week 40, n=138, 147	1.071 ± 0.1689	1.033 ± 0.1724
NNRTI, Phosphate, Week 44, n=137, 148	1.076 ± 0.1795	1.040 ± 0.1693
NNRTI, Phosphate, Week 48, n=131, 147	1.075 ± 0.1941	1.037 ± 0.1789
PI, Potassium, Baseline, n=51, 54	4.13 ± 0.288	4.10 ± 0.308
PI, Potassium, Week 4, n=51, 53	4.25 ± 0.355	4.31 ± 0.395
PI, Potassium, Week 8, n=34, 53	4.18 ± 0.283	4.19 ± 0.331
PI, Potassium, Week 12, n=50, 52	4.25 ± 0.335	4.31 ± 0.364
PI, Potassium, Week 16, n=48, 53	4.16 ± 0.322	4.30 ± 0.359
PI, Potassium, Week 20, n=46, 53	4.18 ± 0.291	4.29 ± 0.314
PI, Potassium, Week 24, n=47, 53	4.15 ± 0.335	4.30 ± 0.379
PI, Potassium, Week 28, n=42, 53	4.21 ± 0.342	4.26 ± 0.348
PI, Potassium, Week 32, n=45, 51	4.15 ± 0.326	4.31 ± 0.367
PI, Potassium, Week 36, n=44, 50	4.25 ± 0.345	4.26 ± 0.378
PI, Potassium, Week 40, n=42, 51	4.23 ± 0.293	4.26 ± 0.363
PI, Potassium, Week 44, n=47, 51	4.24 ± 0.348	4.32 ± 0.375
PI, Potassium, Week 48, n=43, 50	4.15 ± 0.292	4.12 ± 0.320
INI, Potassium, Baseline, n=102, 99	4.17 ± 0.245	4.18 ± 0.289
INI, Potassium, Week 4, n=99, 97	4.20 ± 0.311	4.26 ± 0.359
INI, Potassium, Week 8, n=73, 98	4.14 ± 0.306	4.24 ± 0.462
INI, Potassium, Week 12, n=99, 95	4.19 ± 0.340	4.18 ± 0.291
INI, Potassium, Week 16, n=93, 96	4.15 ± 0.317	4.19 ± 0.297
INI, Potassium, Week 20, n=93, 97	4.20 ± 0.299	4.18 ± 0.289
INI, Potassium, Week 24, n=94, 95	4.19 ± 0.304	4.21 ± 0.304
INI, Potassium,Week 28, n=89, 93	4.19 ± 0.412	4.22 ± 0.341
INI, Potassium, Week 32, n=93, 95	4.20 ± 0.358	4.19 ± 0.307
INI, Potassium, Week 36, n=94, 95	4.19 ± 0.365	4.23 ± 0.332
INI, Potassium, Week 40, n=90, 95	4.18 ± 0.332	4.19 ± 0.297
INI, Potassium, Week 44, n=91, 94	4.18 ± 0.309	4.17 ± 0.314
INI, Potassium, Week 48, n=91, 95	4.15 ± 0.266	4.16 ± 0.305
NNRTI, Potassium, Baseline, n=155, 155	4.16 ± 0.302	4.18 ± 0.331
NNRTI, Potassium, Week 4, n=151, 153	4.21 ± 0.287	4.28 ± 0.333
NNRTI, Potassium, Week 8, n=122, 152	4.17 ± 0.295	4.23 ± 0.366
NNRTI, Potassium, Week 12, n=146, 152	4.18 ± 0.322	4.26 ± 0.341
NNRTI, Potassium, Week 16, n=143, 149	4.20 ± 0.313	4.23 ± 0.320
NNRTI, Potassium,Week 20, n=138, 152	4.20 ± 0.326	4.21 ± 0.337
NNRTI, Potassium, Week 24, n=143, 150	4.19 ± 0.259	4.22 ± 0.341
NNRTI, Potassium, Week 28, n=136, 150	4.18 ± 0.301	4.25 ± 0.434
NNRTI, Potassium, Week 32, n=137, 148	4.17 ± 0.388	4.20 ± 0.349
NNRTI, Potassium, Week 36, n=135, 147	4.17 ± 0.289	4.22 ± 0.343
NNRTI, Potassium, Week 40, n=138, 147	4.20 ± 0.283	4.26 ± 0.321
NNRTI, Potassium, Week 44, n=137, 148	4.23 ± 0.324	4.24 ± 0.374
NNRTI, Potassium, Week 48, n=131, 147	4.14 ± 0.271	4.17 ± 0.352
PI, Sodium, Baseline, n=51, 54	138.9 ± 2.15	138.7 ± 2.10
PI, Sodium, Week 4, n=51, 53	139.3 ± 1.64	139.0 ± 2.08
PI, Sodium, Week 8, n=34, 53	139.6 ± 2.10	139.0 ± 1.95
PI, Sodium, Week 12, n=50, 52	139.3 ± 1.76	139.4 ± 2.03
PI, Sodium, Week 16, n=48, 53	139.4 ± 2.18	139.0 ± 1.75
PI, Sodium, Week 20, n=46, 53	139.6 ± 1.71	139.1 ± 1.97
PI, Sodium, Week 24, n=47, 53	139.4 ± 2.08	139.1 ± 2.07
PI, Sodium, Week 28, n=42, 53	140.3 ± 1.59	139.5 ± 2.49
PI, Sodium, Week 32, n=45, 51	139.4 ± 2.14	139.3 ± 2.28
PI, Sodium, Week 36, n=44, 50	139.7 ± 1.63	139.4 ± 2.32
PI, Sodium, Week 40, n=42, 51	139.8 ± 1.94	139.4 ± 1.93
PI, Sodium, Week 44, n=47, 51	139.7 ± 1.78	139.4 ± 2.09
PI, Sodium, Week 48, n=43, 50	139.8 ± 1.86	139.6 ± 1.90
INI, Sodium, Baseline, n=102, 99	138.8 ± 1.62	139.0 ± 1.67
INI, Sodium, Week 4, n=99, 97	139.2 ± 1.58	139.1 ± 1.72
INI, Sodium, Week 8, n=73, 98	138.8 ± 2.00	138.8 ± 1.79
INI, Sodium, Week 12, n=99, 95	139.1 ± 1.97	139.0 ± 1.88
INI, Sodium, Week 16, n=93, 96	139.1 ± 1.87	139.4 ± 1.89
INI, Sodium, Week 20, n=93, 97	139.4 ± 1.92	139.2 ± 1.67
INI, Sodium, Week 24, n=94, 95	139.3 ± 1.86	139.1 ± 1.91
INI, Sodium, Week 28, n=89, 93	139.4 ± 1.65	138.8 ± 1.67
INI, Sodium, Week 32, n=93, 95	139.4 ± 1.63	139.2 ± 1.68
INI, Sodium, Week 36, n=94, 95	139.2 ± 1.84	139.4 ± 1.99
INI, Sodium, Week 40, n=90, 95	139.3 ± 2.01	139.3 ± 1.83
INI, Sodium, Week 44, n=91, 94	139.3 ± 1.67	139.4 ± 1.88
INI, Sodium, Week 48, n=91, 95	139.3 ± 1.98	139.0 ± 1.76
NNRTI, Sodium, Baseline, n=155, 155	139.1 ± 2.00	139.2 ± 1.68
NNRTI, Sodium, Week 4, n=151, 153	139.4 ± 1.79	139.2 ± 1.90
NNRTI, Sodium, Week 8, n=122, 152	139.1 ± 1.91	139.2 ± 1.76
NNRTI, Sodium, Week 12, n=146, 152	139.2 ± 1.78	139.2 ± 1.77
NNRTI, Sodium, Week 16, n=143, 149	139.0 ± 1.99	139.0 ± 2.06
NNRTI, Sodium, Week 20, n=138, 152	139.0 ± 1.87	139.5 ± 1.83
NNRTI, Sodium, Week 24, n=143, 151	139.2 ± 1.83	139.4 ± 1.94
NNRTI, Sodium, Week 28, n=136, 150	139.3 ± 1.84	139.4 ± 1.99
NNRTI, Sodium, Week 32, n=137, 148	139.2 ± 1.68	139.7 ± 1.75
NNRTI, Sodium, Week 36, n=135, 147	139.4 ± 1.80	139.7 ± 2.19
NNRTI, Sodium, Week 40, n=138, 147	139.4 ± 1.87	139.7 ± 2.06
NNRTI, Sodium, Week 44, n=137, 148	139.5 ± 1.88	139.7 ± 1.92
NNRTI, Sodium, Week 48, n=131, 147	139.4 ± 1.93	139.5 ± 1.82
PI, Urea, Baseline, n=51, 54	4.97 ± 1.409	4.89 ± 1.316
PI, Urea, Week 4, n=51, 53	4.99 ± 1.210	4.91 ± 1.455
PI, Urea, Week 8, n=34, 53	5.10 ± 1.353	4.88 ± 1.447
PI, Urea, Week 12, n=50, 52	5.03 ± 1.368	4.85 ± 1.480
PI, Urea, Week 16, n=48, 53	5.20 ± 1.295	5.09 ± 1.754
PI, Urea, Week 20, n=46, 53	5.18 ± 1.216	5.07 ± 1.535
PI, Urea, Week 24, n=47, 53	5.44 ± 1.587	5.00 ± 1.414
PI, Urea, Week 28, n=42, 53	5.21 ± 1.358	4.90 ± 1.530
PI, Urea, Week 32, n=45, 51	5.13 ± 1.135	5.09 ± 1.482
PI, Urea, Week 36, n=44, 50	4.99 ± 1.310	4.78 ± 1.411
PI, Urea, Week 40, n=42, 51	5.35 ± 1.227	5.30 ± 1.758
PI, Urea, Week 44, n=47, 51	5.38 ± 1.483	5.10 ± 1.517
PI, Urea, Week 48, n=43, 50	5.22 ± 1.469	5.11 ± 1.489
INI, Urea, Baseline, n=102, 99	5.76 ± 1.528	5.61 ± 1.894
INI, Urea, Week 4, n=99, 97	5.63 ± 1.471	5.77 ± 1.676
INI, Urea, Week 8, n=73, 98	5.80 ± 1.617	5.60 ± 1.607
INI, Urea, Week 12, n=99, 95	5.81 ± 1.536	5.83 ± 1.724
INI, Urea, Week 16, n=93, 96	5.76 ± 1.577	5.70 ± 1.574
INI, Urea, Week 20, n=93, 97	5.75 ± 1.640	5.76 ± 1.580
INI, Urea, Week 24, n=94, 95	5.84 ± 1.578	5.72 ± 1.774
INI, Urea, Week 28, n=89, 93	5.76 ± 1.593	5.65 ± 1.435
INI, Urea, Week 32, n=93, 95	5.67 ± 1.537	5.63 ± 1.477
INI, Urea, Week 36, n=94, 95	5.67 ± 1.670	5.53 ± 1.456
INI, Urea, Week 40, n=90, 95	5.81 ± 1.669	5.66 ± 1.593
INI, Urea, Week 44, n=91, 94	5.59 ± 1.607	5.46 ± 1.368
INI, Urea, Week 48, n=91, 95	5.83 ± 1.654	5.50 ± 1.468
NNRTI, Urea, Baseline, n=155, 155	4.96 ± 1.519	5.10 ± 1.510
NNRTI, Urea, Week 4, n=151, 153	5.08 ± 1.556	5.09 ± 1.426
NNRTI, Urea, Week 8, n=122, 152	5.09 ± 1.675	5.10 ± 1.465
NNRTI, Urea, Week 12, n=146, 152	5.20 ± 1.684	5.13 ± 1.583
NNRTI, Urea, Week 16, n=143, 149	5.03 ± 1.768	5.34 ± 1.660
NNRTI, Urea, Week 20, n=138, 152	5.18 ± 1.709	5.15 ± 1.713
NNRTI, Urea, Week 24, n=143, 151	5.29 ± 1.878	5.26 ± 1.591
NNRTI, Urea, Week 28, n=136, 150	5.20 ± 1.931	5.10 ± 1.537
NNRTI, Urea, Week 32, n=137, 148	5.38 ± 1.796	5.14 ± 1.687
NNRTI, Urea, Week 36, n=135, 147	5.07 ± 1.719	5.13 ± 1.493
NNRTI, Urea, Week 40, n=138, 147	5.30 ± 1.616	5.07 ± 1.377
NNRTI, Urea, Week 44, n=137, 148	5.23 ± 1.489	5.18 ± 1.613
NNRTI, Urea, Week 48, n=131, 147	5.32 ± 1.671	5.06 ± 1.380

Notes
[107] - Safety Population
[108] - Safety Population

No statistical analyses for this end point

Secondary: Absolute values for fasting lipid panel using baseline third agent treatment class overtime including Week 48

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End point title

Absolute values for fasting lipid panel using baseline third agent treatment class overtime including Week 48

End point description

Blood samples were collected for the analysis of fasting lipid panel: triglycerides, total cholesterol, HDL cholesterol and LDL cholesterol to assess the impact of Baseline third agent treatment class (PI, NNRTI and INI).Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).

End point type

Secondary

End point timeframe

Baseline (Day 1) and at Week 48

End point values	CAB LA+RPV LA (Q4W)	Current ART
Number of subjects analysed	308 ^[109]	308 ^[110]
Units: Millimoles per liter
arithmetic mean (standard deviation)
PI, Triglycerides, Baseline, n=46, 50	1.951 ± 1.8801	1.894 ± 1.4058
PI, Triglycerides, Week 48, n=40, 45	1.309 ± 0.7647	1.772 ± 1.1828
INI, Triglycerides, Baseline, n=82, 84	1.470 ± 1.0152	1.426 ± 0.8720
INI, Triglycerides, Week 48, n=72, 77	1.405 ± 0.9068	1.307 ± 0.7427
NNRTI, Triglycerides, Baseline, n=136, 140	1.322 ± 0.7986	1.506 ± 1.4388
NNRTI, Triglycerides, Week 48, n=119, 120	1.305 ± 0.8771	1.316 ± 0.7914
PI, Cholesterol, Baseline, n=46, 50	4.98 ± 0.960	5.14 ± 1.152
PI, Cholesterol, Week 48, n=40, 45	5.07 ± 0.775	5.16 ± 1.130
INI, Cholesterol, Baseline, n=82, 84	4.81 ± 1.077	5.01 ± 1.080
INI, Cholesterol, Week 48, n=72, 77	4.90 ± 0.881	4.87 ± 0.997
NNRTI, Cholesterol, Baseline, n=136, 140	4.87 ± 0.958	4.98 ± 1.007
NNRTI, Cholesterol, Week 48, n=119, 120	4.93 ± 0.904	4.91 ± 1.007
PI, HDL cholesterol, Baseline, n=46, 50	1.389 ± 0.4943	1.537 ± 0.6096
PI, HDL cholesterol, Week 48, n=40, 45	1.505 ± 0.5459	1.550 ± 0.5950
INI, HDL cholesterol, Baseline, n=82, 84	1.257 ± 0.3450	1.383 ± 0.3890
INI, HDL cholesterol, Week 48, n=72, 77	1.288 ± 0.3664	1.323 ± 0.3588
NNRTI, HDL cholesterol, Baseline, n=136, 140	1.449 ± 0.4756	1.405 ± 0.4401
NNRTI, HDL cholesterol, Week 48, n=119, 120	1.442 ± 0.4413	1.471 ± 0.4226
PI, LDL cholesterol, Baseline, n=43, 48	2.734 ± 0.7891	2.743 ± 0.7948
PI, LDL cholesterol, Week 48, n=37, 43	2.944 ± 0.7175	2.784 ± 0.8477
INI, LDL cholesterol, Basline, n=81, 83	2.881 ± 0.9196	2.946 ± 0.8614
INI, LDL cholesterol, Week 48, n=71, 76	2.975 ± 0.8787	2.939 ± 0.8591
NNRTI, LDL cholesterol, Baseline, n=134, 137	2.834 ± 0.8442	2.901 ± 0.8714
NNRTI, LDL cholesterol, Week 48, n=116, 119	2.900 ± 0.8415	2.834 ± 0.8763

Notes
[109] - Safety Population
[110] - Safety Population

No statistical analyses for this end point

Secondary: Number of participants discontinued or withdrawn due to AEs when Baseline third agent treatment class was used over time including Week 48

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End point title

Number of participants discontinued or withdrawn due to AEs when Baseline third agent treatment class was used over time including Week 48

End point description

An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment.

End point type

Secondary

End point timeframe

Up to Week 48

End point values	CAB LA+RPV LA (Q4W)	Current ART
Number of subjects analysed	308 ^[111]	308 ^[112]
Units: Participants
PI	2	2
INI	6	0
NNRTI	5	3

Notes
[111] - Safety Population
[112] - Safety Population

No statistical analyses for this end point

Secondary: Plasma trough concentration (Ctrough) for CAB LA evaluable

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End point title

Plasma trough concentration (Ctrough) for CAB LA evaluable

End point description

Blood samples will be collected at indicated time points for pharmacokinetic (PK) analysis of CAB LA. PK population includes all participants who received CAB and / or RPV and underwent PK sampling during the study, and provided CAB and /or RPV plasma concentration data. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).

End point type

Secondary

End point timeframe

Pre-dose at Weeks 8, 12, 16, 20, 24, 28, 32, 36, 40, 44 and 48

End point values	CAB LA
Number of subjects analysed	308 ^[113]
Units: Micrograms per milliliter
geometric mean (confidence interval 95%)
Pre-dose, Week 8, n=252	1.2277 (1.1293 to 1.3346)
Pre-dose, Week 12, n=261	1.6925 (1.6005 to 1.7897)
Pre-dose, Week 16, n=248	1.9533 (1.8492 to 2.0632)
Pre-dose, Week 20, n=233	2.1036 (1.9924 to 2.2209)
Pre-dose, Week 24, n=234	2.2537 (2.1177 to 2.3984)
Pre-dose, Week 28, n=232	2.4300 (2.3093 to 2.5569)
Pre-dose, Week 32, n=219	2.4483 (2.3321 to 2.5703)
Pre-dose, Week 36, n=209	2.4681 (2.3377 to 2.6057)
Pre-dose, Week 40, n=209	2.5126 (2.3477 to 2.6890)
Pre-dose, Week 44, n=221	2.7748 (2.6323 to 2.9250)
Pre-dose, Week 48, n=217	2.8378 (2.6763 to 3.0090)

Notes
[113] - PK Population

No statistical analyses for this end point

Secondary: Ctrough for RPV LA evaluable

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End point title

Ctrough for RPV LA evaluable

End point description

Blood samples will be collected at indicated time points for PK analysis of RPV LA. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).

End point type

Secondary

End point timeframe

Pre-dose at Weeks 8, 12, 16, 20, 24, 28, 32, 36, 40, 44 and 48

End point values	RPV LA
Number of subjects analysed	308 ^[114]
Units: Nanograms per milliliter
geometric mean (confidence interval 95%)
Pre-dose, Week 8, n=251	38.58 (35.96 to 41.39)
Pre-dose, Week 12, n=261	47.00 (44.50 to 49.64)
Pre-dose, Week 16, n=247	53.87 (50.92 to 56.98)
Pre-dose, Week 20, n=233	54.14 (51.13 to 57.34)
Pre-dose, Week 24, n=231	61.26 (57.80 to 64.93)
Pre-dose, Week 28, n=232	66.53 (62.87 to 70.40)
Pre-dose, Week 32, n=218	70.93 (66.97 to 75.11)
Pre-dose, Week 36, n=209	73.00 (68.54 to 77.75)
Pre-dose, Week 40, n=208	76.24 (71.71 to 81.07)
Pre-dose, Week 44, n=223	83.65 (78.94 to 88.63)
Pre-dose, Week 48, n=216	90.28 (84.92 to 95.98)

Notes
[114] - PK Population

No statistical analyses for this end point

Secondary: Area under the curve (AUC) for CAB LA

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End point title

Area under the curve (AUC) for CAB LA

End point description

AUC values are Bayesian PK parameter estimates obtained from a population PK meta-analysis of the data collected from studies 201585 and 201584 # NCT02938520. Blood samples from the current study 201585 were collected at indicated time points to analyze concentration in plasma for CAB LA. Only those participants with data available at the specified data points were analyzed.

End point type

Secondary

End point timeframe

Pre-dose at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48; 1 Week post-dose at Weeks 5 and 41

End point values	CAB LA
Number of subjects analysed	303 ^[115]
Units: Hours*microgram per milliliter
geometric mean (confidence interval 95%)	2324.29 (2249.850 to 2401.187)

Notes
[115] - PK Population.

No statistical analyses for this end point

Secondary: AUC for RPV LA

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End point title

AUC for RPV LA

End point description

AUC values are Bayesian PK parameter estimates obtained from a population PK meta-analysis of the data collected from studies 201585 and 201584 # NCT02938520. Blood samples from the current study 201585 were collected at indicated time points to analyze concentration in plasma for RPV LA. Only those participants with data available at the specified data points were analyzed.

End point type

Secondary

End point timeframe

Pre-dose at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48; 1 Week post-dose at Weeks 5 and 41

End point values	CAB LA
Number of subjects analysed	303 ^[116]
Units: Hours*nanogram per milliliter
geometric mean (confidence interval 95%)	67119.84 (64426.092 to 69926.208)

Notes
[116] - PK Population.

No statistical analyses for this end point

Secondary: Maximum concentration (Cmax) in plasma for CAB LA evaluable at Week 41

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End point title

Maximum concentration (Cmax) in plasma for CAB LA evaluable at Week 41

End point description

Blood samples will be collected at indicated time points for PK analysis of CAB LA. Only those participants with data available at the specified data points were analyzed.

End point type

Secondary

End point timeframe

Week 41- 1 Week post dose

End point values	CAB LA
Number of subjects analysed	251 ^[117]
Units: Micrograms per milliliter
geometric mean (confidence interval 95%)	3.3862 (3.1804 to 3.6054)

Notes
[117] - PK Population

No statistical analyses for this end point

Secondary: Cmax in plasma for RPV LA evaluable at Week 41

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End point title

Cmax in plasma for RPV LA evaluable at Week 41

End point description

Blood samples will be collected at indicated time points for PK analysis of RPV LA. Only those participants with data available at the specified data points were analyzed.

End point type

Secondary

End point timeframe

Week 41- 1 Week post dose

End point values	RPV LA
Number of subjects analysed	251 ^[118]
Units: Nanograms per milliliter
geometric mean (confidence interval 95%)	110.36 (103.28 to 117.93)

Notes
[118] - PK Population

No statistical analyses for this end point

Secondary: Percentage of participants with a virologic failure using snapshot algorithm by Baseline third agent

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End point title

Percentage of participants with a virologic failure using snapshot algorithm by Baseline third agent

End point description

Percentage of participants with virologic failure endpoint as per FDA snapshot algorithm at Week 48 was assessed based on the non-inferior antiviral activity of switching IM CAB LA+RPV LA every 4 weeks compared to continuation of current ART regimen over 48 weeks in HIV-1 infected ART-experienced participants. The HIV-RNA >=50 copies/mL per snapshot algorithm was determined using a Cochran-Mantel Haenszel test stratified by baseline third agent class: INI, NNRTI, or PI. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).

End point type

Secondary

End point timeframe

Week 48

End point values	CAB LA+RPV LA (Q4W)	Current ART
Number of subjects analysed	308 ^[119]	308 ^[120]
Units: Percentage of participants
number (not applicable)
PI, n=51, 54	2.0	0
INI, n=102, 99	0	2.0
NNRTI, n=155, 155	2.6	0.6

Notes
[119] - ITT-E Population.
[120] - ITT-E Population

No statistical analyses for this end point

Secondary: Percentage of participants with plasma HIV-1 RNA <50copies/mL using snapshot algorithm by Baseline third agent

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End point title

Percentage of participants with plasma HIV-1 RNA <50copies/mL using snapshot algorithm by Baseline third agent

End point description

Percentage of participants with HIV-1 RNA < 50copies/mL endpoint as per FDA snapshot algorithm at Week 48 was assessed based on the non-inferior antiviral activity of switching IM CAB LA+RPV LA every 4 weeks compared to continuation of current ART regimen over 48 weeks in HIV-1 infected ART-experienced participants. The HIV-RNA <50 copies/mL per snapshot algorithm was determined using a Cochran-Mantel Haenszel test stratified by baseline third agent class: INI, NNRTI, or PI. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).

End point type

Secondary

End point timeframe

Week 48

End point values	CAB LA+RPV LA (Q4W)	Current ART
Number of subjects analysed	308 ^[121]	308 ^[122]
Units: Percentage of participants
number (not applicable)
PI, n=51, 54	92	94
INI, n=102, 99	94	96
NNRTI, n=155, 155	92	95

Notes
[121] - ITT-E Population
[122] - ITT-E Population

No statistical analyses for this end point

Secondary: Number of participants with severity of adverse events by Baseline third agents

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End point title

Number of participants with severity of adverse events by Baseline third agents

End point description

Severity of AEs were defined as per The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table). Severity grades for AEs were: Grade 1 (mild), Grade 2 (moderate), Grade 3 (severe), Grade 4 (Potentially life-threatening) and Grade 5 were all deaths related to an AE.

End point type

Secondary

End point timeframe

Up to Week 48

End point values	CAB LA+RPV LA (Q4W)	Current ART
Number of subjects analysed	308 ^[123]	308 ^[124]
Units: Participants
PI, Grade 1	22	20
PI, Grade 2	20	11
PI, Grade 3	4	4
PI, Grade 4	1	0
PI, Grade 5	0	1
INI, Grade 1	40	40
INI, Grade 2	50	23
INI, Grade 3	8	3
INI, Grade 4	1	2
INI, Grade 5	0	0
NNRTI, Grade 1	39	55
NNRTI, Grade 2	88	47
NNRTI, Grade 3	15	12
NNRTI, Grade 4	6	2
NNRTI, Grade 5	0	0

Notes
[123] - Safety Population
[124] - Safety Population

No statistical analyses for this end point

Secondary: Change from Baseline values for clinical chemistry parameters using baseline third agent treatment class overtime including Week 48: ALT, ALP, AST and CK

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End point title

Change from Baseline values for clinical chemistry parameters using baseline third agent treatment class overtime including Week 48: ALT, ALP, AST and CK

End point description

Blood samples were collected for the analysis of clinical chemistry parameters: ALT, ALP, AST and CK to assess the impact of Baseline third agent treatment class (PI, NNRTI and INI). Baseline value is defined as the latest pre-treatment assessment with a non-missing value. Change from Baseline value is calculated as the value at the post-dose visit minus the Baseline value. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).

End point type

Secondary

End point timeframe

Baseline (Day 1) and at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44 and 48

End point values	CAB LA+RPV LA (Q4W)	Current ART
Number of subjects analysed	308 ^[125]	308 ^[126]
Units: International units per liter
arithmetic mean (standard deviation)
PI, ALT, Week 4, n=51, 53	9.4 ± 17.93	1.1 ± 9.99
PI, ALT, Week 8, n=34, 53	7.9 ± 17.19	0.9 ± 7.20
PI, ALT, Week 12, n=50, 52	5.3 ± 17.31	1.4 ± 9.76
PI, ALT, Week 16, n=48, 53	6.5 ± 20.92	1.4 ± 8.75
PI, ALT, Week 20, n=46, 53	4.9 ± 18.06	0.3 ± 7.34
PI, ALT, Week 24, n=47, 53	4.1 ± 14.42	0.5 ± 7.30
PI, ALT, Week 28, n=42, 53	2.6 ± 11.47	0.8 ± 7.46
PI, ALT, Week 32, n=45, 51	3.5 ± 14.88	0.5 ± 7.36
PI, ALT, Week 36, n=44, 50	3.3 ± 13.55	2.0 ± 9.78
PI, ALT, Week 40, n=42, 51	5.4 ± 17.81	1.1 ± 10.52
PI, ALT, Week 44, n=47, 51	4.0 ± 15.83	0.9 ± 11.97
PI, ALT, Week 48, n=43, 50	2.9 ± 10.69	0.5 ± 8.04
INI, ALT, Week 4, n=99, 97	1.7 ± 15.15	0.7 ± 7.20
INI, ALT, Week 8, n=73, 98	3.3 ± 18.20	5.4 ± 50.20
INI, ALT, Week 12, n=99, 95	-1.0 ± 12.48	1.7 ± 10.63
INI, ALT, Week 16, n=93, 96	-1.8 ± 12.27	-0.1 ± 8.58
INI, ALT, Week 20, n=93, 97	-1.9 ± 13.60	-0.5 ± 9.38
INI, ALT, Week 24, n=94, 95	0.6 ± 17.33	0.1 ± 9.95
INI, ALT, Week 28, n=89, 93	-2.4 ± 9.70	-0.4 ± 12.31
INI, ALT, Week 32, n=93, 95	-1.8 ± 12.87	-0.3 ± 7.79
INI, ALT, Week 36, n=94, 95	1.5 ± 35.82	-0.4 ± 8.79
INI, ALT, Week 40, n=90, 95	5.0 ± 59.10	-0.6 ± 9.62
INI, ALT, Week 44, n=91, 94	-1.6 ± 13.90	-0.4 ± 7.91
INI, ALT, Week 48, n=91, 95	-0.2 ± 15.17	-0.8 ± 7.41
NNRTI, ALT, Week 4, n=151, 153	-2.6 ± 9.82	-0.7 ± 10.80
NNRTI, ALT, Week 8, n=122, 152	-2.9 ± 11.62	-0.8 ± 12.06
NNRTI, ALT, Week 12, n=146, 152	9.5 ± 160.61	-0.8 ± 12.66
NNRTI, ALT, Week 16, n=143, 149	-1.3 ± 26.21	-1.6 ± 11.39
NNRTI, ALT, Week 20, n=138, 152	-2.0 ± 28.04	-2.0 ± 12.61
NNRTI, ALT, Week 24, n=143, 151	2.6 ± 85.48	-1.3 ± 11.85
NNRTI, ALT, Week 28, n=136, 150	-4.5 ± 11.46	-0.5 ± 14.03
NNRTI, ALT, Week 32, n=137, 148	-3.8 ± 14.93	-0.9 ± 14.33
NNRTI, ALT, Week 36, n=135, 147	-3.8 ± 12.44	-0.1 ± 12.48
NNRTI, ALT, Week 40, n=138, 147	-3.8 ± 13.48	-0.4 ± 13.47
NNRTI, ALT, Week 44, n=137, 148	-4.7 ± 12.67	-0.4 ± 14.67
NNRTI, ALT, Week 48, n=131, 147	-4.6 ± 12.38	-0.9 ± 12.75
PI, ALP, Week 4, n=51, 53	-3.5 ± 11.63	-2.9 ± 8.07
PI, ALP, Week 8, n=34, 53	-2.1 ± 24.59	0.2 ± 11.37
PI, ALP, Week 12, n=50, 52	-5.7 ± 14.40	0.9 ± 10.22
PI, ALP, Week 16, n=48, 53	-7.3 ± 17.09	0.6 ± 8.68
PI, ALP, Week 20, n=46, 53	-6.8 ± 16.71	0.1 ± 10.70
PI, ALP, Week 24, n=47, 53	-7.5 ± 17.90	-0.4 ± 7.67
PI, ALP, Week 28, n=42, 53	-7.3 ± 17.23	3.0 ± 9.69
PI, ALP, Week 32, n=45, 51	-9.3 ± 16.47	-0.7 ± 8.50
PI, ALP, Week 36, n=44, 50	-10.2 ± 18.52	0.6 ± 13.52
PI, ALP, Week 40, n=42, 51	-8.7 ± 17.37	-1.4 ± 8.79
PI, ALP, Week 44, n=47, 51	-11.5 ± 17.49	-0.9 ± 9.05
PI, ALP, Week 48, n=43, 50	-8.0 ± 16.05	-0.2 ± 9.08
INI, ALP, Week 4, n=99, 97	-0.5 ± 10.59	-0.9 ± 7.92
INI, ALP, Week 8, n=73, 98	-1.8 ± 8.55	4.9 ± 33.17
INI, ALP, Week 12, n=99, 95	-1.6 ± 8.57	3.5 ± 19.97
INI, ALP, Week 16, n=93, 96	-1.7 ± 10.53	-0.2 ± 10.93
INI, ALP, Week 20, n=93, 97	-2.0 ± 10.23	-0.4 ± 7.93
INI, ALP, Week 24, n=94, 95	-1.4 ± 10.23	-0.6 ± 8.25
INI, ALP, Week 28, n=89, 93	-2.1 ± 10.83	-0.8 ± 8.80
INI, ALP, Week 32, n=93, 95	-1.6 ± 11.08	-2.0 ± 8.23
INI, ALP, Week 36, n=94, 95	-2.4 ± 12.03	-2.2 ± 9.41
INI, ALP, Week 40, n=90, 95	-0.9 ± 13.77	-1.9 ± 9.33
INI, ALP, Week 44, n=91, 94	-2.6 ± 13.69	-0.4 ± 11.60
INI, ALP, Week 48, n=91, 95	-1.9 ± 13.29	-1.2 ± 10.26
NNRTI, ALP, Week 4, n=151, 153	-10.4 ± 12.81	-2.7 ± 9.60
NNRTI, ALP, Week 8, n=122, 152	-10.9 ± 16.50	-1.0 ± 10.77
NNRTI, ALP, Week 12, n=146, 152	-13.0 ± 26.62	-0.7 ± 11.04
NNRTI, ALP, Week 16, n=143, 149	-15.7 ± 22.52	-1.0 ± 10.54
NNRTI, ALP, Week 20, n=138, 152	-14.9 ± 22.35	-1.8 ± 13.77
NNRTI, ALP, Week 24, n=143, 151	-14.5 ± 21.88	0.4 ± 12.75
NNRTI, ALP, Week 28, n=136, 150	-16.2 ± 21.66	-1.0 ± 13.18
NNRTI, ALP, Week 32, n=137, 148	-15.8 ± 21.98	-1.8 ± 13.63
NNRTI, ALP, Week 36, n=135, 147	-16.1 ± 23.60	-1.0 ± 11.86
NNRTI, ALP, Week 40, n=138, 147	-17.2 ± 22.83	-0.4 ± 13.19
NNRTI, ALP, Week 44, n=137, 148	-17.3 ± 23.32	-0.8 ± 13.20
NNRTI, ALP, Week 48, n=131, 147	-18.0 ± 27.97	0.2 ± 14.69
PI, AST, Week 4, n=51, 53	3.8 ± 9.18	2.3 ± 16.78
PI, AST, Week 8, n=34, 53	5.1 ± 8.35	-0.1 ± 4.60
PI, AST, Week 12, n=50, 52	2.7 ± 11.49	1.7 ± 7.21
PI, AST, Week 16, n=48, 53	3.9 ± 16.81	1.8 ± 10.69
PI, AST, Week 20, n=46, 53	4.1 ± 20.85	0.5 ± 4.29
PI, AST, Week 24, n=47, 53	1.5 ± 7.76	1.6 ± 9.93
PI, AST, Week 28, n=42, 53	2.9 ± 8.86	1.9 ± 7.45
PI, AST, Week 32, n=45, 51	3.1 ± 14.13	0.6 ± 4.93
PI, AST, Week 36, n=44, 50	1.7 ± 8.04	1.9 ± 6.24
PI, AST, Week 40, n=42, 51	5.7 ± 24.61	0.5 ± 6.05
PI, AST, Week 44, n=47, 51	1.7 ± 9.71	1.4 ± 11.60
PI, AST, Week 48, n=43, 50	1.7 ± 7.09	2.1 ± 8.74
INI, AST, Week 4, n=99, 97	0.0 ± 15.36	-0.1 ± 6.29
INI, AST, Week 8, n=73, 98	3.3 ± 25.01	1.2 ± 21.48
INI, AST, Week 12, n=99, 95	-1.3 ± 14.22	0.8 ± 7.35
INI, AST, Week 16, n=93, 96	-2.1 ± 12.73	0.1 ± 10.96
INI, AST, Week 20, n=93, 97	-1.7 ± 13.77	-0.9 ± 12.67
INI, AST, Week 24, n=94, 95	-0.4 ± 14.88	-0.2 ± 10.40
INI, AST, Week 28, n=89, 93	-1.4 ± 7.74	-0.9 ± 13.48
INI, AST, Week 32, n=93, 95	-2.1 ± 13.06	-0.8 ± 10.01
INI, AST, Week 36, n=94, 95	-0.7 ± 17.34	-1.1 ± 11.70
INI, AST, Week 40, n=90, 95	1.0 ± 20.11	-0.4 ± 13.96
INI, AST, Week 44, n=91, 94	1.0 ± 24.54	-0.7 ± 10.69
INI, AST, Week 48, n=91, 95	0.4 ± 16.57	0.2 ± 11.91
NNRTI, AST, Week 4, n=151, 153	-1.9 ± 11.09	-0.5 ± 8.73
NNRTI, AST, Week 8, n=122, 152	-1.3 ± 18.14	-0.9 ± 8.31
NNRTI, AST, Week 12, n=146, 152	4.7 ± 91.54	0.0 ± 10.08
NNRTI, AST, Week 16, n=143, 149	0.3 ± 21.80	-1.0 ± 8.37
NNRTI, AST, Week 20, n=138, 152	-1.2 ± 17.47	-0.7 ± 9.09
NNRTI, AST, Week 24, n=143, 150	-0.1 ± 31.53	-0.4 ± 8.87
NNRTI, AST, Week 28, n=136, 150	-2.8 ± 9.02	0.4 ± 10.70
NNRTI, AST, Week 32, n=137, 148	-2.0 ± 18.27	1.5 ± 16.84
NNRTI, AST, Week 36, n=135, 147	-2.5 ± 10.33	0.2 ± 9.00
NNRTI, AST, Week 40, n=138, 147	-2.7 ± 11.14	0.1 ± 9.40
NNRTI, AST, Week 44, n=137, 148	-3.4 ± 10.38	0.1 ± 11.20
NNRTI, AST, Week 48, n=131, 147	-2.9 ± 10.87	0.5 ± 10.60
PI, CK, Week 4, n=51, 53	8.6 ± 182.21	133.5 ± 907.82
PI, CK, Week 8, n=34, 53	67.9 ± 176.14	23.5 ± 174.40
PI, CK, Week 12, n=50, 52	3.1 ± 162.71	57.9 ± 406.52
PI, CK, Week 16, n=48, 53	19.4 ± 253.86	16.3 ± 66.34
PI, CK, Week 20, n=46, 53	103.6 ± 696.54	6.8 ± 72.86
PI, CK, Week 24, n=47, 53	-3.0 ± 181.03	18.2 ± 86.69
PI, CK, Week 28, n=42, 53	60.3 ± 299.83	13.5 ± 93.14
PI, CK, Week 32, n=45, 51	157.1 ± 988.65	1.5 ± 64.94
PI, CK, Week 36, n=44, 50	-9.0 ± 191.25	22.3 ± 62.09
PI, CK, Week 40, n=42, 51	193.7 ± 1188.89	0.3 ± 48.24
PI, CK, Week 44, n=47, 51	-6.3 ± 185.69	4.8 ± 62.91
PI, CK, Week 48, n=43, 50	-1.0 ± 158.33	72.9 ± 478.94
INI, CK, Week 4, n=99, 97	-32.7 ± 717.86	-17.9 ± 260.84
INI, CK, Week 8, n=73, 98	95.6 ± 801.75	-58.0 ± 577.11
INI, CK, Week 12, n=99, 95	-16.1 ± 852.44	-23.9 ± 304.61
INI, CK, Week 16, n=93, 96	-59.5 ± 629.54	-1.9 ± 686.38
INI, CK, Week 20, n=93, 97	-55.7 ± 623.92	-58.1 ± 622.84
INI, CK, Week 24, n=94, 95	-63.1 ± 549.02	-40.7 ± 588.24
INI, CK Week 28, n=89, 93	-17.4 ± 224.35	-27.4 ± 759.07
INI, CK, Week 32, n=93, 95	-82.8 ± 587.51	-42.1 ± 637.00
INI, CK, Week 36, n=94, 95	-76.1 ± 602.03	-60.9 ± 603.48
INI, CK, Week 40, n=90, 95	40.3 ± 864.00	-36.2 ± 609.80
INI, CK, Week 44, n=91, 94	199.8 ± 2043.35	-60.2 ± 576.84
INI, CK, Week 48, n=91, 95	20.5 ± 861.55	-25.0 ± 653.03
NNRTI, CK, Week 4, n=151, 153	18.2 ± 502.12	26.0 ± 214.58
NNRTI, CK, Week 8, n=122, 152	108.2 ± 1339.52	-3.6 ± 108.28
NNRTI, CK, Week 12, n=146, 152	21.9 ± 440.81	24.5 ± 222.26
NNRTI, CK, Week 16, n=143, 149	139.9 ± 1121.08	7.0 ± 189.21
NNRTI, CK, Week 20, n=138, 152	65.5 ± 656.11	1.6 ± 114.05
NNRTI, CK, Week 24, n=143, 151	24.1 ± 606.47	17.7 ± 167.38
NNRTI, CK, Week 28, n=136, 150	-10.9 ± 169.29	53.2 ± 462.07
NNRTI, CK, Week 32, n=137, 148	31.3 ± 650.27	94.0 ± 665.17
NNRTI, CK, Week 36, n=135, 147	19.0 ± 440.56	10.3 ± 135.08
NNRTI, CK, Week 40, n=138, 147	-7.7 ± 237.00	22.6 ± 195.23
NNRTI, CK, Week 44, n=137, 148	-35.4 ± 183.15	14.9 ± 173.39
NNRTI, CK, Week 48, n=131, 147	-15.1 ± 212.52	27.3 ± 272.59

Notes
[125] - Safety Population
[126] - Safety Population

No statistical analyses for this end point

Secondary: Change from Baseline values for clinical chemistry parameters using baseline third agent treatment class overtime including Week 48: Albumin

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End point title

Change from Baseline values for clinical chemistry parameters using baseline third agent treatment class overtime including Week 48: Albumin

End point description

Blood samples were collected for the analysis of clinical chemistry parameter: albumin to assess the impact of Baseline third agent treatment class (PI, NNRTI and INI). Baseline value is defined as the latest pre-treatment assessment with a non-missing value. Change from Baseline value is calculated as the value at the post-dose visit minus the Baseline value. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).

End point type

Secondary

End point timeframe

Baseline (Day 1) and at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44 and 48

End point values	CAB LA+RPV LA (Q4W)	Current ART
Number of subjects analysed	308 ^[127]	308 ^[128]
Units: Grams per Liter
arithmetic mean (standard deviation)
PI, Week 4, n=51, 53	0.2 ± 2.21	-0.2 ± 2.41
PI, Week 8, n=34, 53	0.7 ± 2.73	-0.1 ± 2.74
PI, Week 12, n=50, 52	-0.2 ± 2.67	-0.3 ± 2.81
PI, Week 16, n=48, 53	-0.2 ± 2.77	-0.8 ± 2.72
PI, Week 20, n=46, 53	-0.4 ± 2.35	-0.8 ± 2.82
PI, Week 24, n=47, 53	-0.6 ± 2.24	-0.8 ± 2.40
PI, Week 28, n=42, 53	-0.6 ± 2.26	-1.4 ± 2.08
PI, Week 32, n=45, 51	-0.7 ± 2.39	-0.5 ± 2.42
PI, Week 36, n=44, 50	-0.6 ± 2.44	-0.9 ± 2.48
PI, Week 40, n=42, 51	-0.1 ± 2.72	-0.5 ± 2.37
PI, Week 44, n=47, 51	-0.5 ± 2.15	-0.5 ± 2.60
PI, Week 48, n=43, 50	-0.3 ± 2.74	-0.1 ± 2.44
INI, Week 4, n=99, 97	-0.4 ± 2.56	-0.9 ± 2.62
INI, Week 8, n=73, 98	-0.5 ± 2.59	-1.0 ± 2.89
INI, Week 12, n=99, 95	-0.3 ± 2.92	-0.5 ± 2.59
INI, Week 16, n=93, 96	-0.5 ± 2.78	-1.1 ± 2.80
INI, Week 20, n=93, 97	-0.7 ± 2.71	-0.7 ± 2.77
INI, Week 24, n=94, 95	-0.8 ± 2.86	-1.0 ± 2.74
INI, Week 28, n=89, 93	-0.3 ± 2.55	-1.1 ± 2.87
INI, Week 32, n=93, 95	-0.2 ± 2.70	-1.3 ± 2.77
INI, Week 36, n=94, 95	-0.8 ± 2.67	-1.1 ± 2.54
INI, Week 40, n=90, 95	-0.3 ± 2.40	-1.3 ± 2.84
INI, Week 44, n=91, 94	-0.5 ± 2.77	-1.0 ± 2.76
INI, Week 48, n=91, 95	-0.1 ± 2.69	-0.5 ± 2.69
NNRTI, Week 4, n=151, 153	-0.8 ± 2.70	-0.3 ± 2.42
NNRTI, Week 8, n=122, 152	-0.4 ± 2.83	-0.6 ± 2.53
NNRTI, Week 12, n=146, 152	-0.8 ± 2.59	-0.3 ± 2.61
NNRTI, Week 16, n=143, 149	-0.8 ± 2.79	-0.7 ± 2.63
NNRTI, Week 20, n=138, 152	-0.9 ± 2.96	-0.9 ± 2.33
NNRTI, Week 24, n=143, 151	-0.7 ± 2.73	-0.7 ± 2.57
NNRTI, Week 28, n=136, 150	-0.9 ± 2.72	-0.9 ± 2.34
NNRTI, Week 32, n=137, 148	-0.9 ± 2.94	-1.0 ± 2.45
NNRTI, Week 36, n=135, 147	-1.0 ± 2.83	-0.8 ± 2.79
NNRTI, Week 40, n=138, 147	-0.7 ± 2.54	-1.0 ± 2.52
NNRTI, Week 44, n=137, 148	-0.3 ± 2.60	-0.8 ± 2.22
NNRTI, Week 48, n=131, 147	-0.6 ± 2.57	-0.5 ± 2.49

Notes
[127] - Safety Population
[128] - Safety Population

No statistical analyses for this end point

Secondary: Change from Baseline values for clinical chemistry parameters using baseline third agent treatment class overtime including Week 48: Bilirubin, direct bilirubin and creatinine

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End point title

Change from Baseline values for clinical chemistry parameters using baseline third agent treatment class overtime including Week 48: Bilirubin, direct bilirubin and creatinine

End point description

Blood samples were collected for the analysis of clinical chemistry parameter: bilirubin, direct bilirubin and creatinine to assess the impact of Baseline third agent treatment class (PI, NNRTI and INI). Baseline value is defined as the latest pre-treatment assessment with a non-missing value. Change from Baseline value is calculated as the value at the post-dose visit minus the Baseline value. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).

End point type

Secondary

End point timeframe

Baseline (Day 1) and at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44 and 48

End point values	CAB LA+RPV LA (Q4W)	Current ART
Number of subjects analysed	308 ^[129]	308 ^[130]
Units: Micromoles per liter
arithmetic mean (standard deviation)
PI, Bilirubin, Week 4, n=51, 53	-9.0 ± 20.62	0.3 ± 6.95
PI, Bilirubin, Week 8, n=34, 53	-6.6 ± 13.76	0.1 ± 5.76
PI, Bilirubin, Week 12, n=50, 52	-10.2 ± 20.18	1.7 ± 7.11
PI, Bilirubin, Week 16, n=48, 53	-10.0 ± 20.13	0.6 ± 6.42
PI, Bilirubin, Week 20, n=46, 53	-9.2 ± 20.21	1.5 ± 12.45
PI, Bilirubin, Week 24, n=47, 53	-9.6 ± 20.64	2.7 ± 11.87
PI, Bilirubin, Week 28, n=42, 53	-10.0 ± 22.42	0.9 ± 7.70
PI, Bilirubin, Week 32, n=45, 51	-8.9 ± 21.34	2.7 ± 8.64
PI, Bilirubin, Week 36, n=44, 50	-10.5 ± 21.75	2.6 ± 7.35
PI, Bilirubin, Week 40, n=42, 51	-11.0 ± 22.20	3.5 ± 12.74
PI, Bilirubin, Week 44, n=47, 51	-9.6 ± 20.32	3.7 ± 9.10
PI, Bilirubin, Week 48, n=43, 50	-10.7 ± 21.77	2.3 ± 5.23
INI, Bilirubin, Week 4, n=99, 97	0.2 ± 3.92	-0.7 ± 3.93
INI, Bilirubin, Week 8, n=73, 98	0.4 ± 3.96	0.9 ± 12.43
INI, Bilirubin, Week 12, n=99, 95	0.6 ± 4.41	-0.5 ± 4.69
INI, Bilirubin, Week 16, n=93, 96	0.6 ± 4.30	-0.2 ± 4.35
INI, Bilirubin, Week 20, n=93, 97	0.9 ± 4.08	-0.5 ± 4.32
INI, Bilirubin, Week 24, n=94, 94	0.2 ± 3.72	-0.5 ± 3.88
INI, Bilirubin, Week 28, n=89, 93	1.1 ± 3.58	-0.4 ± 4.85
INI, Bilirubin, Week 32, n=93, 95	0.7 ± 4.67	-1.1 ± 4.54
INI, Bilirubin, Week 36, n=94, 95	0.5 ± 4.07	-0.6 ± 4.62
INI, Bilirubin, Week 40, n=90, 95	0.6 ± 4.28	-1.0 ± 4.26
INI, Bilirubin, Week 44, n=91, 94	0.9 ± 4.34	-0.7 ± 4.72
INI, Bilirubin, Week 48, n=91, 95	1.1 ± 3.72	-0.9 ± 3.96
NNRTI, Bilirubin, Week 4, n=151, 153	1.4 ± 3.87	-0.4 ± 2.85
NNRTI, Bilirubin, Week 8, n=122, 152	1.4 ± 3.84	-0.4 ± 2.43
NNRTI, Bilirubin, Week 12, n=146, 152	2.0 ± 4.69	-0.2 ± 3.01
NNRTI, Bilirubin, Week 16, n=143, 149	3.3 ± 14.12	-0.5 ± 2.66
NNRTI, Bilirubin, Week 20, n=138, 152	2.1 ± 4.90	-0.1 ± 2.81
NNRTI, Bilirubin, Week 24, n=143, 151	1.8 ± 3.91	-0.3 ± 2.84
NNRTI, Bilirubin, Week 28, n=136, 150	2.4 ± 4.11	-0.4 ± 3.04
NNRTI, Bilirubin, Week 32, n=137, 148	2.2 ± 4.76	-0.3 ± 2.57
NNRTI, Bilirubin, Week 36, n=135, 147	1.8 ± 4.14	-0.2 ± 2.61
NNRTI, Bilirubin, Week 40, n=138, 147	2.2 ± 4.43	-0.2 ± 2.61
NNRTI, Bilirubin, Week 44, n=137, 148	2.0 ± 4.15	-0.1 ± 2.72
NNRTI, Bilirubin, Week 48, n=131, 147	2.2 ± 4.59	0.1 ± 2.98
PI, Direct bilirubin, Week 4, n=51, 53	-1.2 ± 2.34	0.3 ± 1.40
PI, Direct bilirubin, Week 8, n=34, 53	-0.9 ± 2.16	-0.1 ± 1.44
PI, Direct bilirubin, Week 12, n=50, 52	-1.6 ± 2.16	0.3 ± 1.39
PI, direct bilirubin, Week 16, n=48, 53	-1.7 ± 2.12	0.0 ± 1.30
PI, Direct bilirubin, Week 20, n=46, 53	-1.5 ± 2.27	0.0 ± 1.86
PI, Direct bilirubin, Week 24, n=47, 53	-1.4 ± 2.27	0.2 ± 1.72
PI, Direct bilirubin, Week 28, n=42, 53	-1.6 ± 2.43	-0.3 ± 1.52
PI, Direct bilirubin, Week 32, n=45, 51	-1.4 ± 2.48	0.2 ± 1.74
PI, Direct bilirubin, Week 36, n=44, 50	-1.8 ± 2.29	0.2 ± 1.49
PI, Direct bilirubin, Week 40, n=42, 51	-1.8 ± 2.29	0.2 ± 1.43
PI, Direct bilirubin, Week 44, n=47, 51	-1.5 ± 2.22	0.3 ± 1.52
PI, Direct bilirubin, Week 48, n=43, 50	-1.5 ± 2.35	0.2 ± 1.36
INI, Direct bilirubin, Week 4, n=99, 97	0.0 ± 1.11	0.0 ± 1.19
INI, Direct bilirubin, Week 8, n=73, 98	0.0 ± 1.13	0.7 ± 6.76
INI, Direct bilirubin, Week 12, n=99, 95	0.0 ± 1.14	0.0 ± 1.29
INI, Direct bilirubin, Week 16, n=93, 96	0.0 ± 1.14	-0.3 ± 1.06
INI, Direct bilirubin, Week 20, n=93, 97	-0.2 ± 0.96	-0.2 ± 1.23
INI, Direct bilirubin, Week 24, n=94, 94	-0.1 ± 1.07	-0.3 ± 1.16
INI, Direct bilirubin, Week 28, n=89, 93	-0.1 ± 0.97	-0.2 ± 1.30
INI, Direct bilirubin, Week 32, n=93, 95	-0.2 ± 1.24	-0.4 ± 1.15
INI, Direct bilirubin, Week 36, n=94, 95	-0.2 ± 1.33	-0.3 ± 1.18
INI, Direct bilirubin, Week 40, n=90, 95	-0.1 ± 1.10	-0.4 ± 1.24
INI, Direct bilirubin. Week 44, n=91, 94	0.0 ± 1.14	-0.3 ± 1.11
INI, Direct bilirubin, Week 48, n=91, 95	0.0 ± 1.01	-0.1 ± 1.28
NNRTI, Direct bilirubin, Week 4, n=151, 153	0.1 ± 1.14	0.1 ± 1.12
NNRTI, Direct bilirubin, Week 8, n=122, 152	0.1 ± 1.24	0.0 ± 1.03
NNRTI, Direct bilirubin, Week 12, n=146, 152	0.2 ± 1.38	0.0 ± 1.08
NNRTI, Direct bilirubin, Week 16, n=143, 149	0.7 ± 6.82	-0.1 ± 1.09
NNRTI, Direct bilirubin, Week 20, n=138, 152	0.1 ± 1.32	-0.2 ± 1.08
NNRTI, Direct bilirubin, Week 24, n=143, 151	0.1 ± 1.34	-0.1 ± 1.06
NNRTI, Direct bilirubin, Week 28, n=136, 150	0.1 ± 1.29	-0.2 ± 1.19
NNRTI, Direct bilirubin, Week 32, n=137, 148	0.0 ± 1.31	-0.2 ± 1.06
NNRTI, Direct bilirubin, Week 36, n=135, 147	0.0 ± 1.47	-0.2 ± 1.09
NNRTI, Direct bilirubin, Week 40, n=138, 147	0.0 ± 1.55	-0.2 ± 1.01
NNRTI, Direct bilirubin, Week 44, n=137, 148	0.1 ± 1.28	-0.1 ± 1.08
NNRTI, Direct bilirubin, Week 48, n=131, 147	0.1 ± 1.27	0.0 ± 1.16
PI, Creatinine, Week 4, n=51, 53	1.46 ± 7.726	2.16 ± 6.737
PI, Creatinine, Week 8, n=34, 53	0.87 ± 7.777	1.17 ± 5.605
PI, Creatinine, Week 12, n=50, 52	-1.66 ± 8.971	3.01 ± 5.406
PI, Creatinine, Week 16, n=48, 53	-0.90 ± 8.658	2.88 ± 5.918
PI, Creatinine, Week 20, n=46, 53	1.63 ± 8.709	5.00 ± 9.336
PI, Creatinine, Week 24, n=47, 53	0.48 ± 7.143	2.47 ± 6.821
PI, Creatinine, Week 28, n=42, 53	3.06 ± 9.741	3.05 ± 6.908
PI, Creatinine, Week 32, n=45, 51	2.29 ± 10.124	3.79 ± 6.540
PI, Creatinine, Week 36, n=44, 50	2.20 ± 7.347	2.36 ± 6.291
PI, Creatinine, Week 40, n=42, 51	1.10 ± 9.155	3.46 ± 6.166
PI, Creatinine, Week 44, n=47, 51	3.01 ± 8.981	2.73 ± 6.169
PI, Creatinine, Week 48, n=43, 50	4.41 ± 10.009	1.86 ± 5.575
INI, Creatinine, Week 4, n=99, 95	-1.61 ± 8.848	1.64 ± 10.592
INI, Creatinine, Week 8, n=73, 98	-3.93 ± 10.030	1.56 ± 9.444
INI, Creatinine, Week 12, n=99, 95	-2.47 ± 10.973	3.03 ± 10.203
INI, Creatinine, Week 16, n=93, 96	-3.93 ± 9.000	0.36 ± 8.651
INI, Creatinine, Week 20, n=93, 97	-3.73 ± 9.101	0.86 ± 9.608
INI, Creatinine, Week 24, n=94, 94	-4.25 ± 8.281	0.87 ± 10.493
INI, Creatinine, Week 28, n=89, 93	-3.54 ± 10.713	0.92 ± 10.086
INI, Creatinine, Week 32, n=93, 95	-3.48 ± 10.591	0.86 ± 9.754
INI, Creatinine, Week 36, n=94, 95	-4.31 ± 10.360	1.34 ± 9.369
INI, Creatinine, Week 40, n=90, 95	-3.08 ± 9.913	1.66 ± 10.272
INI, Creatinine, Week 44, n=91, 94	-3.33 ± 9.165	0.98 ± 10.443
INI, Creatinine, Week 48, n=91, 95	-2.99 ± 9.442	0.47 ± 9.602
NNRTI, Creatinine, Week 4, n=151, 153	2.86 ± 7.456	1.77 ± 6.484
NNRTI, Creatinine, Week 8, n=122, 152	0.86 ± 8.263	1.05 ± 6.790
NNRTI, Creatinine, Week 12, n=146, 152	1.47 ± 7.928	0.44 ± 6.096
NNRTI, Creatinine, Week 16, n=143, 149	1.67 ± 8.934	1.98 ± 8.475
NNRTI, Creatinine, Week 20, n=138, 152	3.04 ± 8.836	1.27 ± 7.023
NNRTI, Creatinine, Week 24, n=143, 151	4.42 ± 14.819	1.28 ± 6.553
NNRTI, Creatinine, Week 28, n=136, 150	3.61 ± 10.627	1.50 ± 7.483
NNRTI, Creatinine, Week 32, n=137, 148	2.26 ± 9.033	2.01 ± 7.811
NNRTI, Creatinine, Week 36, n=135, 147	2.98 ± 10.596	1.54 ± 7.354
NNRTI, Creatinine, Week 40, n=138, 147	3.39 ± 9.496	0.99 ± 7.471
NNRTI, Creatinine, Week 44, n=137, 148	3.24 ± 8.892	1.21 ± 6.686
NNRTI, Creatinine, Week 48, n=131, 147	3.84 ± 11.860	0.69 ± 7.241

Notes
[129] - Safety Population
[130] - Safety Population

No statistical analyses for this end point

Secondary: Change from Baseline values for clinical chemistry parameters using baseline third agent treatment class overtime including Week 48: Creatinine clearance

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End point title

Change from Baseline values for clinical chemistry parameters using baseline third agent treatment class overtime including Week 48: Creatinine clearance

End point description

Blood samples were collected for the analysis of clinical chemistry parameter: creatinine clearance to assess the impact of Baseline third agent treatment class (PI, NNRTI and INI). GFR will be estimated by the central laboratory using the CKD-EPI. Baseline value is defined as the latest pre-treatment assessment with a non-missing value. Change from Baseline value is calculated as the value at the post-dose visit minus the Baseline value. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).

End point type

Secondary

End point timeframe

Baseline (Day 1) and at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44 and 48

End point values	CAB LA+RPV LA (Q4W)	Current ART
Number of subjects analysed	308 ^[131]	308 ^[132]
Units: Milliliters per minute per 1.73meter^2
arithmetic mean (standard deviation)
PI, Week 4, n=51, 53	-2.2 ± 9.77	-2.8 ± 8.02
PI, Week 8, n=34, 53	-1.1 ± 10.19	-1.3 ± 6.58
PI, Week 12, n=50, 52	2.2 ± 11.04	-3.7 ± 6.99
PI, Week 16, n=48, 53	0.9 ± 11.02	-3.1 ± 7.63
PI, Week 20, n=46, 53	-2.2 ± 10.80	-5.0 ± 9.26
PI, Week 24, n=47, 53	-1.0 ± 8.60	-3.8 ± 8.51
PI, Week 28, n=42, 53	-4.2 ± 11.82	-4.0 ± 8.46
PI, Week 32, n=45, 51	-3.2 ± 12.30	-5.2 ± 7.56
PI, Week 36, n=44, 50	-3.8 ± 8.68	-3.6 ± 8.08
PI, Week 40, n=42, 51	-2.4 ± 10.71	-4.9 ± 7.25
PI, Week 44, n=47, 51	-4.5 ± 10.63	-4.2 ± 7.58
PI, Week 48, n=43, 50	-5.6 ± 12.22	-3.1 ± 6.54
INI, Week 4, n=99, 95	1.0 ± 9.51	-2.0 ± 11.28
INI, Week 8, n=72, 98	3.9 ± 9.84	-1.9 ± 9.28
INI, Week 12, n=99, 93	2.1 ± 11.32	-3.1 ± 9.60
INI, Week 16, n=93, 96	3.6 ± 9.71	-0.7 ± 8.59
INI, Week 20, n=93, 97	3.5 ± 9.77	-1.7 ± 9.58
INI, Week 24, n=94, 94	3.9 ± 9.26	-1.8 ± 10.38
INI, Week 28, n=89, 93	3.1 ± 11.02	-1.6 ± 9.55
INI, Week 32, n=92, 95	3.0 ± 10.40	-2.0 ± 9.69
INI, Week 36, n=94, 95	3.7 ± 11.19	-2.3 ± 9.30
INI, Week 40, n=89, 95	2.7 ± 10.45	-2.6 ± 10.14
INI, Week 44, n=91, 94	2.6 ± 9.88	-1.6 ± 10.90
INI, Week 48, n=90, 94	3.0 ± 9.74	-1.6 ± 9.73
NNRTI, Week 4, n=151, 153	-3.4 ± 9.06	-2.3 ± 8.10
NNRTI, Week 8, n=121, 152	-1.1 ± 9.35	-1.3 ± 7.72
NNRTI, Week 12, n=146, 152	-1.7 ± 8.90	-0.5 ± 7.03
NNRTI, Week 16, n=143, 148	-1.8 ± 10.60	-2.3 ± 9.06
NNRTI, Week 20, n=138, 152	-3.7 ± 9.64	-1.9 ± 7.41
NNRTI, Week 24, n=142, 151	-4.3 ± 10.67	-2.0 ± 7.67
NNRTI, Week 28, n=136, 150	-4.3 ± 10.68	-2.4 ± 8.67
NNRTI, Week 32, n=137, 148	-3.3 ± 10.42	-2.8 ± 8.80
NNRTI, Week 36, n=135, 147	-3.8 ± 10.97	-2.5 ± 8.16
NNRTI, Week 40, n=137, 147	-4.4 ± 9.97	-2.0 ± 8.90
NNRTI, Week 44, n=136, 148	-4.4 ± 9.75	-2.0 ± 7.45
NNRTI, Week 48, n=131, 147	-5.2 ± 11.72	-1.6 ± 8.25

Notes
[131] - Safety Population
[132] - Safety Population

No statistical analyses for this end point

Secondary: Change from Baseline values for clinical chemistry parameters using baseline third agent treatment class overtime including Week 48: Lipase

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End point title

Change from Baseline values for clinical chemistry parameters using baseline third agent treatment class overtime including Week 48: Lipase

End point description

Blood samples were collected for the analysis of clinical chemistry parameter: lipase to assess the impact of Baseline third agent treatment class (PI, NNRTI and INI). Baseline value is defined as the latest pre-treatment assessment with a non-missing value. Change from Baseline value is calculated as the value at the post-dose visit minus the Baseline value. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).

End point type

Secondary

End point timeframe

Baseline (Day 1) and at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44 and 48

End point values	CAB LA+RPV LA (Q4W)	Current ART
Number of subjects analysed	308 ^[133]	308 ^[134]
Units: Units per liter
arithmetic mean (standard deviation)
PI, Week 4, n=51, 53	-2.2 ± 16.83	1.2 ± 19.34
PI, Week 8, n=34, 53	-2.6 ± 6.71	2.5 ± 25.36
PI, Week 12, n=49, 52	-1.4 ± 17.24	-2.2 ± 15.95
PI, Week 16, n=47, 53	-0.5 ± 18.71	1.4 ± 17.40
PI, Week 20, n=46, 53	-2.5 ± 17.90	-0.6 ± 17.49
PI, Week 24, n=47, 53	-2.0 ± 16.61	-2.7 ± 16.30
PI, Week 28, n=42, 53	-0.7 ± 18.60	0.2 ± 16.18
PI, Week 32, n=45, 51	-2.2 ± 19.27	2.5 ± 18.35
PI, Week 36, n=44, 50	-0.8 ± 17.96	-1.2 ± 18.18
PI, Week 40, n=42, 51	2.2 ± 26.77	-1.8 ± 19.40
PI, Week 44, n=47, 51	-1.2 ± 18.28	1.4 ± 17.94
PI, Week 48, n=43, 50	-1.5 ± 19.38	-1.3 ± 15.73
INI, Week 4, n=99, 97	8.1 ± 34.32	3.8 ± 30.44
INI, Week 8, n=72, 98	0.7 ± 9.79	-0.5 ± 14.46
INI, Week 12, n=99, 93	4.3 ± 17.70	1.8 ± 21.29
INI, Week 16, n=93, 97	4.4 ± 22.42	0.6 ± 16.13
INI, Week 20, n=94, 97	2.5 ± 17.23	0.9 ± 17.07
INI, Week 24, n=94, 95	2.2 ± 15.17	2.2 ± 18.91
INI, Week 28, n=89, 94	5.6 ± 28.06	5.1 ± 24.20
INI, Week 32, n=92, 95	3.2 ± 18.68	5.4 ± 22.79
INI, Week 36, n=94, 95	5.2 ± 21.04	0.1 ± 13.82
INI, Week 40, n=89, 95	3.5 ± 11.71	1.7 ± 16.60
INI, Week 44, n=91, 94	4.3 ± 21.59	4.8 ± 23.54
INI, Week 48, n=90, 94	5.0 ± 24.95	3.9 ± 23.48
NNRTI, Week 4, n=151, 153	5.7 ± 50.44	0.1 ± 20.35
NNRTI, Week 8, n=121, 152	2.6 ± 25.04	1.5 ± 16.94
NNRTI, Week 12, n=146, 152	3.0 ± 30.94	-1.9 ± 17.59
NNRTI, Week 16, n=145, 149	2.5 ± 27.82	6.1 ± 40.62
NNRTI, Week 20, n=138, 152	0.9 ± 13.53	1.3 ± 37.14
NNRTI, Week 24, n=142, 151	3.4 ± 24.81	5.4 ± 28.22
NNRTI, Week 28, n=136, 150	0.8 ± 24.38	1.2 ± 15.79
NNRTI, Week 32, n=137, 148	9.1 ± 78.96	1.9 ± 21.30
NNRTI, Week 36, n=135, 147	6.9 ± 68.07	1.7 ± 19.14
NNRTI, Week 40, n=138, 147	7.1 ± 43.53	0.5 ± 17.62
NNRTI, Week 44, n=136, 148	1.6 ± 24.46	1.1 ± 20.52
NNRTI, Week 48, n=131, 146	3.1 ± 32.54	0.9 ± 16.60

Notes
[133] - Safety Population
[134] - Safety Population

No statistical analyses for this end point

Secondary: Change from Baseline values for clinical chemistry parameters using baseline third agent treatment class overtime including Week 48

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End point title

Change from Baseline values for clinical chemistry parameters using baseline third agent treatment class overtime including Week 48

End point description

Blood samples were collected for the analysis of clinical chemistry parameters: CO2, chloride, glucose, phosphate, potassium, sodium and urea to assess the impact of Baseline third agent treatment class (PI, NNRTI and INI). Baseline value is defined as the latest pre-treatment assessment with a non-missing value. Change from Baseline value is calculated as the value at the post-dose visit minus the Baseline value.Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles)

End point type

Secondary

End point timeframe

Baseline (Day 1) and at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44 and 48

End point values	CAB LA+RPV LA (Q4W)	Current ART
Number of subjects analysed	308 ^[135]	308 ^[136]
Units: Millimoles per liter
arithmetic mean (standard deviation)
PI, CO2, Week 4, n=51, 53	1.3 ± 2.63	0.7 ± 2.34
PI, CO2, Week 8, n=34, 53	0.4 ± 2.36	0.3 ± 2.65
PI, CO2, Week 12, n=50, 52	0.7 ± 2.84	0.2 ± 2.23
PI, CO2, Week 16, n=48, 53	0.8 ± 2.60	0.2 ± 2.32
PI, CO2, Week 20, n=46, 53	0.9 ± 2.53	0.0 ± 2.26
PI, CO2, Week 24, n=47, 53	0.4 ± 2.23	0.1 ± 1.94
PI, CO2, Week 28, n=42, 53	0.6 ± 2.54	-0.2 ± 2.37
PI, CO2, Week 32, n=45, 51	0.5 ± 2.35	-0.2 ± 2.36
PI, CO2, Week 36, n=44, 50	0.5 ± 2.38	-0.4 ± 1.98
PI, CO2, Week 40, n=42, 51	0.5 ± 2.10	0.3 ± 2.26
PI, CO2, Week 44, n=47, 51	0.7 ± 2.29	0.3 ± 2.18
PI, CO2, Week 48, n=43, 50	0.9 ± 2.69	-0.1 ± 1.87
INI, CO2, Week 4, n=99, 97	1.0 ± 2.37	0.8 ± 2.21
INI, CO2, Week 8, n=73, 98	0.5 ± 2.29	0.6 ± 2.46
INI, CO2, Week 12, n=99, 95	0.4 ± 2.27	0.3 ± 2.31
INI, CO2, Week 16, n=93, 96	0.1 ± 2.56	0.6 ± 2.53
INI, CO2, Week 20, n=93, 97	0.1 ± 2.07	0.7 ± 2.25
INI, CO2, Week 24, n=94, 95	0.1 ± 2.32	0.2 ± 2.49
INI, CO2, Week 28, n=89, 93	-0.3 ± 2.30	0.2 ± 2.41
INI, CO2, Week 32, n=93, 95	0.2 ± 2.33	0.1 ± 2.34
INI, CO2, Week 36, n=94, 95	0.0 ± 2.36	0.5 ± 2.58
INI, CO2, Week 40, n=90, 95	0.5 ± 2.43	0.3 ± 2.18
INI, CO2, Week 44, n=91, 94	0.5 ± 2.36	0.7 ± 2.45
INI, CO2, Week 48, n=91, 95	0.1 ± 2.12	0.3 ± 2.53
NNRTI, CO2, Week 4, n=151, 153	0.9 ± 2.60	0.7 ± 2.18
NNRTI, CO2, Week 8, n=122, 152	0.4 ± 2.32	0.8 ± 2.52
NNRTI, CO2, Week 12, n=146, 152	0.5 ± 2.38	0.4 ± 2.51
NNRTI, CO2, Week 16, n=143, 149	0.3 ± 2.25	0.5 ± 2.37
NNRTI, CO2, Week 20, n=138, 152	0.1 ± 2.27	0.2 ± 2.35
NNRTI, CO2, Week 24, n=143, 150	0.3 ± 2.63	0.3 ± 2.57
NNRTI, CO2, Week 28, n=136, 150	0.1 ± 2.54	0.2 ± 2.40
NNRTI, CO2, Week 32, n=137, 148	-0.2 ± 2.39	0.4 ± 2.27
NNRTI, CO2, Week 36, n=135, 147	0.1 ± 2.38	0.5 ± 2.37
NNRTI, CO2, Week 40, n=138, 147	0.4 ± 2.64	0.5 ± 2.38
NNRTI, CO2, Week 44, n=137, 148	0.4 ± 2.35	0.5 ± 2.01
NNRTI, CO2, Week 48, n=131, 147	-0.1 ± 2.47	0.3 ± 2.30
PI, Chloride, Week 4, n=51, 53	0.5 ± 1.80	0.5 ± 2.34
PI, Chloride, Week 8, n=34, 53	0.2 ± 2.59	0.7 ± 2.42
PI, Chloride, Week 12, n=50, 52	0.5 ± 2.39	0.8 ± 2.20
PI, Chloride, Week 16, n=48, 53	0.5 ± 2.46	1.0 ± 2.31
PI, Chloride, Week 20, n=46, 53	0.8 ± 2.20	0.7 ± 2.30
PI, Chloride, Week 24, n=47, 53	1.1 ± 2.07	1.3 ± 2.36
PI, Chloride, Week 28, n=42, 53	1.5 ± 2.19	1.2 ± 3.06
PI, Chloride, Week 32, n=45, 51	0.9 ± 2.43	0.9 ± 2.60
PI, Chloride, Week 36, n=44, 50	1.0 ± 2.28	1.0 ± 3.00
PI, Chloride, Week 40, n=42, 51	1.3 ± 2.35	1.1 ± 2.60
PI, Chloride, Week 44, n=47, 51	1.1 ± 2.21	1.1 ± 2.57
PI, Chloride, Week 48, n=43, 50	0.5 ± 2.10	0.9 ± 2.29
INI, Chloride, Week 4, n=99, 97	0.3 ± 2.02	0.5 ± 1.96
INI, Chloride, Week 8, n=73, 98	0.2 ± 2.02	0.1 ± 2.42
INI, Chloride, Week 12, n=99, 95	0.4 ± 2.53	0.5 ± 2.27
INI, Chloride, Week 16, n=93, 96	0.9 ± 2.45	0.7 ± 2.32
INI, Chloride, Week 20, n=93, 97	1.0 ± 2.44	0.2 ± 2.31
INI, Chloride, Week 24, n=94, 95	0.6 ± 2.46	0.5 ± 2.19
INI, Chloride, Week 28, n=89, 93	0.8 ± 1.92	0.3 ± 2.37
INI, Chloride, Week 32, n=93, 95	0.7 ± 2.39	0.7 ± 2.45
INI, Chloride, Week 36, n=94, 95	0.8 ± 2.20	0.5 ± 2.32
INI, Chloride, Week 40, n=90, 95	0.7 ± 2.24	0.4 ± 2.69
INI, Chloride, Week 44, n=91, 94	0.7 ± 2.38	0.5 ± 2.41
INI, Chloride, Week 48, n=91, 95	0.4 ± 2.37	-0.3 ± 2.36
NNRTI, Chloride, Week 4, n=151, 153	0.4 ± 2.15	0.6 ± 2.17
NNRTI, Chloride, Week 8, n=122, 152	0.4 ± 2.05	0.7 ± 1.91
NNRTI, Chloride, Week 12, n=146, 152	0.4 ± 2.12	0.5 ± 2.27
NNRTI, Chloride, Week 16, n=143, 149	0.5 ± 2.37	0.8 ± 2.20
NNRTI, Chloride, Week 20, n=138, 152	0.7 ± 2.27	1.1 ± 2.40
NNRTI, Chloride, Week 24, n=143, 151	0.5 ± 2.60	1.1 ± 2.24
NNRTI, Chloride, Week 28, n=136, 150	0.8 ± 2.38	1.3 ± 2.39
NNRTI, Chloride, Week 32, n=137, 148	0.8 ± 2.44	1.1 ± 2.15
NNRTI, Chloride, Week 36, n=135, 147	1.0 ± 2.15	1.1 ± 2.37
NNRTI, Chloride, Week 40, n=138, 147	0.6 ± 2.20	1.0 ± 2.84
NNRTI, Chloride, Week 44, n=137, 148	0.6 ± 2.07	1.0 ± 2.08
NNRTI, Chloride, Week 48, n=131, 147	0.6 ± 2.45	0.5 ± 2.36
PI, Glucose, Week 4, n=43, 43	-0.08 ± 0.922	0.32 ± 0.401
PI, Glucose, Week 8, n=25, 41	0.17 ± 0.513	0.22 ± 0.466
PI, Glucose, Week 12, n=40, 42	0.03 ± 0.925	0.27 ± 0.494
PI, Glucose, Week 16, n=39, 43	0.11 ± 1.163	0.28 ± 0.704
PI, Glucose, Week 20, n=35, 41	-0.07 ± 1.058	0.30 ± 0.799
PI, Glucose, Week 24, n=38, 42	0.11 ± 0.705	0.32 ± 0.636
PI, Glucose, Week 28, n=32, 43	-0.03 ± 1.342	0.16 ± 0.441
PI, Glucose, Week 32, n=36, 41	0.23 ± 1.148	0.29 ± 0.600
PI, Glucose, Week 36, n=35, 41	-0.01 ± 1.014	0.22 ± 0.483
PI, Glucose, Week 40, n=34, 40	0.11 ± 1.035	0.18 ± 0.497
PI, Glucose, Week 44, n=40, 40	0.01 ± 1.008	0.20 ± 0.278
PI, Glucose, Week 48, n=39, 48	-0.01 ± 0.977	0.11 ± 0.663
INI, Glucose, Week 4, n=55, 52	0.30 ± 0.613	0.07 ± 0.774
INI, Glucose, Week 8, n=36, 57	0.12 ± 0.595	0.21 ± 1.083
INI, Glucose, Week 12, n=52, 55	0.36 ± 0.996	0.30 ± 1.357
INI, Glucose, Week 16, n=53, 52	0.35 ± 1.437	0.13 ± 0.557
INI, Glucose, Week 20, n=51, 57	0.25 ± 0.515	-0.06 ± 0.676
INI, Glucose, Week 24, n=59, 61	0.24 ± 0.596	0.04 ± 0.652
INI, Glucose, Week 28, n=52, 62	0.17 ± 0.681	0.33 ± 0.763
INI, Glucose, Week 32, n=53, 55	0.48 ± 1.071	0.32 ± 0.876
INI, Glucose, Week 36, n=53, 57	0.34 ± 0.642	0.19 ± 1.063
INI, Glucose, Week 40, n=59, 62	0.36 ± 0.922	0.14 ± 0.566
INI, Glucose, Week 44, n=54, 57	0.33 ± 0.971	0.16 ± 0.626
INI, Glucose, Week 48, n=81, 90	0.04 ± 0.577	-0.03 ± 0.796
NNRTI, Glucose, Week 4, n=116, 124	0.20 ± 0.666	0.24 ± 1.055
NNRTI, Glucose, Week 8, n=90, 116	0.27 ± 0.987	0.23 ± 0.795
NNRTI, Glucose, Week 12, n=112, 119	0.16 ± 0.746	0.11 ± 0.887
NNRTI, Glucose, Week 16, n=115, 116	0.22 ± 0.767	0.33 ± 1.347
NNRTI, Glucose, Week 20, n=106, 118	0.25 ± 0.636	0.28 ± 1.104
NNRTI, Glucose, Week 24, n=115, 121	0.27 ± 0.763	0.16 ± 1.037
NNRTI, Glucose, Week 28, n=104, 120	0.23 ± 0.596	0.30 ± 1.077
NNRTI, Glucose, Week 32, n=103, 117	0.32 ± 0.811	0.24 ± 1.062
NNRTI, Glucose, Week 36, n=102, 117	0.17 ± 0.789	0.31 ± 1.217
NNRTI, Glucose, Week 40, n=100, 111	0.27 ± 0.692	0.33 ± 1.118
NNRTI, Glucose, Week 44, n=99, 116	0.26 ± 0.793	0.35 ± 1.121
NNRTI, Glucose, Week 48, n=118, 136	0.06 ± 0.659	0.02 ± 1.074
PI, Phosphate, Week 4, n=51, 53	0.068 ± 0.1513	0.009 ± 0.1682
PI, Phosphate, Week 8, n=34, 53	0.076 ± 0.2023	-0.019 ± 0.1752
PI, Phosphate, Week 12, n=50, 52	0.025 ± 0.1794	0.007 ± 0.1524
PI, Phosphate, Week 16, n=48, 53	0.056 ± 0.2028	-0.008 ± 0.1610
PI, Phosphate, Week 20, n=46, 53	0.069 ± 0.1864	0.017 ± 0.1924
PI, Phosphate, Week 24, n=47, 53	0.037 ± 0.1971	0.018 ± 0.1735
PI, Phosphate, Week 28, n=42, 53	0.035 ± 0.2140	0.017 ± 0.1971
PI, Phosphate, Week 32, n=45, 51	0.053 ± 0.2191	0.032 ± 0.1545
PI, Phosphate, Week 36, n=44, 50	0.032 ± 0.1818	-0.001 ± 0.1828
PI, Phosphate, Week 40, n=42, 51	0.027 ± 0.2392	0.001 ± 0.1657
PI, Phosphate, Week 44, n=47, 51	0.033 ± 0.2107	0.011 ± 0.1736
PI, Phosphate, Week 48, n=43, 50	0.048 ± 0.1994	0.017 ± 0.1387
INI, Phosphate, Week 4, n=99, 97	0.036 ± 0.1518	0.017 ± 0.1588
INI, Phosphate, Week 8, n=73, 98	0.056 ± 0.1532	0.010 ± 0.1676
INI, Phosphate, Week 12, n=99, 95	0.024 ± 0.2108	0.017 ± 0.1808
INI, Phosphate, Week 16, n=93, 96	0.031 ± 0.1895	0.001 ± 0.1708
INI, Phosphate, Week 20, n=93, 97	0.012 ± 0.1764	0.025 ± 0.1823
INI, Phosphate, Week 24, n=94, 95	0.031 ± 0.1501	-0.011 ± 0.1785
INI, Phosphate, Week 28, n=89, 93	0.032 ± 0.1628	0.006 ± 0.1806
INI, Phosphate, Week 32, n=93, 95	0.012 ± 0.1751	-0.017 ± 0.1827
INI, Phosphate, Week 36, n=94, 95	-0.002 ± 0.1496	-0.001 ± 0.1979
INI, Phosphate, Week 40, n=90, 95	0.018 ± 0.1766	-0.002 ± 0.1721
INI, Phosphate, Week 44, n=91, 94	0.005 ± 0.1695	0.005 ± 0.1977
INI, Phosphate, Week 48, n=91, 95	0.028 ± 0.1684	0.002 ± 0.2072
NNRTI, Phosphate, Week 4, n=151, 153	0.085 ± 0.1785	0.016 ± 0.1580
NNRTI, Phosphate, Week 8, n=122, 152	0.061 ± 0.2002	-0.012 ± 0.1515
NNRTI, Phosphate, Week 12, n=146, 152	0.057 ± 0.1946	0.012 ± 0.1780
NNRTI, Phosphate, Week 16, n=143, 149	0.043 ± 0.2088	0.008 ± 0.1613
NNRTI, Phosphate, Week 20, n=138, 152	0.039 ± 0.1935	-0.002 ± 0.1823
NNRTI, Phosphate, Week 24, n=143, 151	0.050 ± 0.2220	0.012 ± 0.1923
NNRTI, Phosphate, Week 28, n=136, 150	0.040 ± 0.1850	-0.003 ± 0.1789
NNRTI, Phosphate, Week 32, n=137, 148	0.018 ± 0.2056	0.011 ± 0.2020
NNRTI, Phosphate, Week 36, n=135, 147	0.014 ± 0.2069	-0.002 ± 0.1794
NNRTI, Phosphate, Week 40, n=138, 147	0.026 ± 0.2095	-0.006 ± 0.1783
NNRTI, Phosphate, Week 44, n=137, 148	0.041 ± 0.2112	0.000 ± 0.1735
NNRTI, Phosphate, Week 48, n=131, 147	0.034 ± 0.2220	-0.001 ± 0.1619
PI, Potassium, Week 4, n=51, 53	0.12 ± 0.369	0.20 ± 0.447
PI, Potassium, Week 8, n=34, 53	0.05 ± 0.245	0.08 ± 0.307
PI, Potassium, Week 12, n=50, 52	0.12 ± 0.353	0.19 ± 0.388
PI, Potassium, Week 16, n=48, 53	0.02 ± 0.343	0.19 ± 0.398
PI, Potassium, Week 20, n=46, 53	0.05 ± 0.338	0.18 ± 0.420
PI, Potassium, Week 24, n=47, 53	0.01 ± 0.354	0.19 ± 0.384
PI, Potassium, Week 28, n=42, 53	0.09 ± 0.338	0.15 ± 0.342
PI, Potassium, Week 32, n=45, 51	0.02 ± 0.356	0.19 ± 0.408
PI, Potassium, Week 36, n=44, 50	0.12 ± 0.363	0.14 ± 0.371
PI, Potassium, Week 40, n=42, 51	0.09 ± 0.348	0.15 ± 0.394
PI, Potassium, Week 44, n=47, 51	0.10 ± 0.409	0.21 ± 0.433
PI, Potassium, Week 48, n=43, 50	0.02 ± 0.359	0.01 ± 0.409
INI, Potassium, Week 4, n=99, 97	0.03 ± 0.308	0.08 ± 0.335
INI, Potassium, Week 8, n=73, 98	-0.02 ± 0.282	0.06 ± 0.483
INI, Potassium, Week 12, n=99, 95	0.02 ± 0.316	0.01 ± 0.329
INI, Potassium, Week 16, n=93, 96	-0.01 ± 0.286	0.01 ± 0.319
INI, Potassium, Week 20, n=93, 97	0.03 ± 0.333	0.00 ± 0.313
INI, Potassium, Week 24, n=94, 95	0.02 ± 0.304	0.04 ± 0.315
INI, Potassium,Week 28, n=89, 93	0.02 ± 0.422	0.03 ± 0.372
INI, Potassium, Week 32, n=93, 95	0.02 ± 0.322	0.01 ± 0.289
INI, Potassium, Week 36, n=94, 95	0.01 ± 0.345	0.05 ± 0.349
INI, Potassium, Week 40, n=90, 95	0.01 ± 0.288	0.01 ± 0.329
INI, Potassium, Week 44, n=91, 94	0.01 ± 0.265	0.00 ± 0.327
INI, Potassium, Week 48, n=91, 95	-0.03 ± 0.249	-0.01 ± 0.292
NNRTI, Potassium, Week 4, n=151, 153	0.05 ± 0.354	0.10 ± 0.368
NNRTI, Potassium, Week 8, n=122, 152	0.02 ± 0.342	0.05 ± 0.355
NNRTI, Potassium, Week 12, n=146, 152	0.02 ± 0.351	0.08 ± 0.353
NNRTI, Potassium, Week 16, n=143, 149	0.03 ± 0.373	0.05 ± 0.320
NNRTI, Potassium,Week 20, n=138, 152	0.04 ± 0.358	0.03 ± 0.355
NNRTI, Potassium, Week 24, n=143, 150	0.04 ± 0.329	0.04 ± 0.324
NNRTI, Potassium, Week 28, n=136, 150	0.03 ± 0.364	0.08 ± 0.412
NNRTI, Potassium, Week 32, n=137, 148	0.01 ± 0.442	0.02 ± 0.348
NNRTI, Potassium, Week 36, n=135, 147	0.02 ± 0.359	0.05 ± 0.360
NNRTI, Potassium, Week 40, n=138, 147	0.05 ± 0.375	0.08 ± 0.342
NNRTI, Potassium, Week 44, n=137, 148	0.08 ± 0.364	0.07 ± 0.366
NNRTI, Potassium, Week 48, n=131, 147	-0.02 ± 0.311	0.00 ± 0.329
PI, Sodium, Week 4, n=51, 53	0.4 ± 1.93	0.3 ± 2.11
PI, Sodium, Week 8, n=34, 53	0.9 ± 2.21	0.3 ± 2.25
PI, Sodium, Week 12, n=50, 52	0.5 ± 2.09	0.7 ± 1.97
PI, Sodium, Week 16, n=48, 53	0.5 ± 2.30	0.3 ± 2.24
PI, Sodium, Week 20, n=46, 53	0.6 ± 2.15	0.4 ± 2.12
PI, Sodium, Week 24, n=47, 53	0.5 ± 2.33	0.4 ± 2.30
PI, Sodium, Week 28, n=42, 53	1.3 ± 2.06	0.8 ± 2.75
PI, Sodium, Week 32, n=45, 51	0.5 ± 2.47	0.5 ± 2.26
PI, Sodium, Week 36, n=44, 50	0.8 ± 2.21	0.6 ± 2.63
PI, Sodium, Week 40, n=42, 51	0.8 ± 2.20	0.7 ± 2.03
PI, Sodium, Week 44, n=47, 51	0.8 ± 2.10	0.7 ± 2.49
PI, Sodium, Week 48, n=43, 50	0.9 ± 1.98	0.8 ± 1.95
INI, Sodium, Week 4, n=99, 97	0.3 ± 1.62	0.0 ± 1.97
INI, Sodium, Week 8, n=73, 98	0.1 ± 1.98	-0.3 ± 1.87
INI, Sodium, Week 12, n=99, 95	0.3 ± 2.11	0.0 ± 1.69
INI, Sodium, Week 16, n=93, 96	0.3 ± 1.95	0.4 ± 1.97
INI, Sodium, Week 20, n=93, 97	0.5 ± 1.94	0.1 ± 1.86
INI, Sodium, Week 24, n=94, 95	0.5 ± 1.79	0.0 ± 1.73
INI, Sodium, Week 28, n=89, 93	0.5 ± 1.74	-0.3 ± 1.93
INI, Sodium, Week 32, n=93, 95	0.5 ± 1.87	0.2 ± 1.75
INI, Sodium, Week 36, n=94, 95	0.4 ± 1.86	0.3 ± 1.88
INI, Sodium, Week 40, n=90, 95	0.5 ± 1.91	0.2 ± 2.01
INI, Sodium, Week 44, n=91, 94	0.5 ± 1.77	0.3 ± 1.93
INI, Sodium, Week 48, n=91, 95	0.4 ± 2.00	-0.1 ± 1.85
NNRTI, Sodium, Week 4, n=151, 153	0.2 ± 1.95	0.1 ± 1.98
NNRTI, Sodium, Week 8, n=122, 152	0.2 ± 1.91	0.0 ± 1.82
NNRTI, Sodium, Week 12, n=146, 152	0.1 ± 2.04	0.1 ± 2.01
NNRTI, Sodium, Week 16, n=143, 149	-0.1 ± 2.28	-0.2 ± 2.04
NNRTI, Sodium, Week 20, n=138, 152	-0.1 ± 2.14	0.3 ± 1.95
NNRTI, Sodium, Week 24, n=143, 151	0.1 ± 2.14	0.3 ± 1.95
NNRTI, Sodium, Week 28, n=136, 150	0.3 ± 2.29	0.2 ± 2.18
NNRTI, Sodium, Week 32, n=137, 148	0.1 ± 2.01	0.5 ± 1.84
NNRTI, Sodium, Week 36, n=135, 147	0.4 ± 2.05	0.5 ± 2.22
NNRTI, Sodium, Week 40, n=138, 147	0.3 ± 2.04	0.5 ± 2.12
NNRTI, Sodium, Week 44, n=137, 148	0.5 ± 2.17	0.5 ± 1.96
NNRTI, Sodium, Week 48, n=131, 147	0.3 ± 2.39	0.4 ± 1.97
PI, Urea, Week 4, n=51, 53	0.02 ± 1.449	0.01 ± 1.124
PI, Urea, Week 8, n=34, 53	0.21 ± 1.142	-0.02 ± 1.205
PI, Urea, Week 12, n=50, 52	0.04 ± 1.446	-0.01 ± 1.312
PI, Urea, Week 16, n=48, 53	0.25 ± 1.309	0.20 ± 1.377
PI, Urea, Week 20, n=46, 53	0.18 ± 1.425	0.17 ± 1.275
PI, Urea, Week 24, n=47, 53	0.41 ± 1.248	0.10 ± 1.182
PI, Urea, Week 28, n=42, 53	0.18 ± 1.352	0.00 ± 1.236
PI, Urea, Week 32, n=45, 51	0.12 ± 1.567	0.16 ± 1.210
PI, Urea, Week 36, n=44, 50	0.01 ± 1.449	-0.13 ± 1.190
PI, Urea, Week 40, n=42, 51	0.17 ± 1.291	0.33 ± 1.714
PI, Urea, Week 44, n=47, 51	0.36 ± 1.258	0.13 ± 1.276
PI, Urea, Week 48, n=43, 50	0.10 ± 1.303	0.13 ± 1.305
INI, Urea, Week 4, n=99, 97	-0.14 ± 1.477	0.19 ± 1.635
INI, Urea, Week 8, n=73, 98	-0.14 ± 1.799	0.01 ± 1.601
INI, Urea, Week 12, n=99, 95	0.05 ± 1.554	0.21 ± 1.481
INI, Urea, Week 16, n=93, 96	0.01 ± 1.402	0.05 ± 1.375
INI, Urea, Week 20, n=93, 97	0.01 ± 1.531	0.15 ± 1.495
INI, Urea, Week 24, n=94, 95	0.04 ± 1.367	0.12 ± 1.441
INI, Urea, Week 28, n=89, 93	0.01 ± 1.570	-0.02 ± 1.579
INI, Urea, Week 32, n=93, 95	-0.09 ± 1.592	0.01 ± 1.522
INI, Urea, Week 36, n=94, 95	-0.10 ± 1.514	-0.05 ± 1.478
INI, Urea, Week 40, n=90, 95	0.01 ± 1.519	0.12 ± 1.469
INI, Urea, Week 44, n=91, 94	-0.16 ± 1.583	-0.19 ± 1.721
INI, Urea, Week 48, n=91, 95	0.11 ± 1.633	-0.05 ± 1.304
NNRTI, Urea, Week 4, n=151, 153	0.10 ± 1.265	0.04 ± 1.185
NNRTI, Urea, Week 8, n=122, 152	0.16 ± 1.286	0.01 ± 1.252
NNRTI, Urea, Week 12, n=146, 152	0.26 ± 1.290	0.06 ± 1.344
NNRTI, Urea, Week 16, n=143, 149	0.07 ± 1.407	0.28 ± 1.609
NNRTI, Urea, Week 20, n=138, 152	0.25 ± 1.296	0.07 ± 1.507
NNRTI, Urea, Week 24, n=143, 151	0.33 ± 1.499	0.18 ± 1.276
NNRTI, Urea, Week 28, n=136, 150	0.22 ± 1.549	0.02 ± 1.422
NNRTI, Urea, Week 32, n=137, 148	0.41 ± 1.410	0.06 ± 1.416
NNRTI, Urea, Week 36, n=135, 147	0.19 ± 1.339	0.04 ± 1.392
NNRTI, Urea, Week 40, n=138, 147	0.32 ± 1.347	-0.01 ± 1.339
NNRTI, Urea, Week 44, n=137, 148	0.25 ± 1.346	0.10 ± 1.344
NNRTI, Urea, Week 48, n=131, 147	0.37 ± 1.389	-0.02 ± 1.325

Notes
[135] - Safety Population
[136] - Safety Population

No statistical analyses for this end point

Secondary: Change from Baseline values for fasting lipid panel using baseline third agent treatment class overtime including Week 48

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End point title

Change from Baseline values for fasting lipid panel using baseline third agent treatment class overtime including Week 48

End point description

Blood samples were collected for the analysis of fasting lipid panel: triglycerides, total cholesterol, HDL cholesterol and LDL cholesterol to assess the impact of Baseline third agent treatment class (PI, NNRTI and INI). Baseline value is defined as the latest pre-treatment assessment with a non-missing value. Change from Baseline value is calculated as the value at the post-dose visit minus the Baseline value. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).

End point type

Secondary

End point timeframe

Baseline (Day 1) and at Week 48

End point values	CAB LA+RPV LA (Q4W)	Current ART
Number of subjects analysed	308 ^[137]	308 ^[138]
Units: Millimoles per liter
arithmetic mean (standard deviation)
PI, Triglycerides, Week 48, n=40, 45	-0.733 ± 1.5612	0.060 ± 0.9960
INI, Triglycerides, Week 48, n=72, 77	-0.078 ± 0.4964	-0.117 ± 0.8052
NNRTI, Triglycerides, Week 48, n=119, 120	-0.015 ± 0.6121	-0.014 ± 0.6761
PI, Cholesterol, Week 48, n=40, 45	-0.06 ± 0.629	0.06 ± 0.744
INI, Cholesterol, Week 48, n=72, 77	0.18 ± 0.614	-0.12 ± 0.674
NNRTI, Cholesterol, Week 48, n=119, 120	0.06 ± 0.743	-0.02 ± 0.626
PI, HDL cholesterol, Week 48, n=40, 45	0.130 ± 0.2272	0.001 ± 0.3429
INI, HDL cholesterol, Week 48, n=72, 77	0.074 ± 0.2339	-0.038 ± 0.2308
NNRTI, HDL cholesterol, Week 48, n=119, 120	-0.011 ± 0.2936	0.028 ± 0.2577
PI, LDL cholesterol, Week 48, n=37, 43	0.075 ± 0.5774	0.043 ± 0.5545
INI, LDL cholesterol, Week 48, n=71, 76	0.144 ± 0.4840	-0.015 ± 0.5333
NNRTI, LDL cholesterol, Week 48, n=116, 119	0.078 ± 0.6885	-0.040 ± 0.5246

Notes
[137] - Safety Population
[138] - Safety Population

No statistical analyses for this end point

Secondary: Number of participants with genotypic resistance using baseline third agent through Week 48

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End point title

Number of participants with genotypic resistance using baseline third agent through Week 48

End point description

End point type

Secondary

End point timeframe

At the time of CVF

End point values	CAB LA+RPV LA (Q4W)	Current ART
Number of subjects analysed	3 ^[139]	4 ^[140]
Units: Participants
PI, INI, DTG, resistant, n=1, 0	0	0
PI, INI, DTG, resistance possible, n=1, 0	0	0
PI, INI, DTG, sensitive, n=1, 0	1	0
PI, INI, EVG, resistant, n=1, 0	0	0
PI, INI, EVG, resistance possible, n=1, 0	0	0
PI, INI, EVG, sensitive, n=1, 0	1	0
PI, INI, RAL, resistant, n=1, 0	0	0
PI, INI, RAL, resistance possible, n=1, 0	0	0
PI, INI, RAL, sensitive, n=1, 0	1	0
PI, NNRTI, DLV, resistant, n=1, 0	0	0
PI, NNRTI, DLV, resistance possible, n=1, 0	0	0
PI, NNRTI, DLV, sensitive, n=1, 0	1	0
PI, NNRTI, EFV, resistant, n=1, 0	0	0
PI, NNRTI, EFV, resistance possible, n=1, 0	0	0
PI, NNRTI, EFV, sensitive, n=1, 0	1	0
PI, NNRTI, ETR, resistant, n=1, 0	0	0
PI, NNRTI, ETR, resistance possible, n=1, 0	0	0
PI, NNRTI, ETR, sensitive, n=1, 0	1	0
PI, NNRTI, NVP, resistant, n=1, 0	0	0
PI, NNRTI, NVP, resistance possible, n=1, 0	0	0
PI, NNRTI, NVP, sensitive, n=1, 0	1	0
PI, NNRTI, RPV, resistant, n=1, 0	1	0
PI, NNRTI, RPV, resistance possible, n=1, 0	0	0
PI, NNRTI, RPV, sensitive, n=1, 0	0	0
PI, NRTI, 3TC, resistant, n=1, 0	0	0
PI, NNRTI, 3TC, resistance possible, n=1, 0	0	0
PI, NRTI, 3TC, sensitive, n=1, 0	1	0
PI, NRTI, ABC, resistant, n=1, 0	0	0
PI, NRTI, ABC, resistance possible, n=1, 0	0	0
PI, NRTI, ABC, sensitive, n=1, 0	1	0
PI, NRTI, FTC, resistant, n=1, 0	0	0
PI, NRTI, FTC, resistance possible, n=1, 0	0	0
PI, NRTI, FTC, sensitive, n=1, 0	1	0
PI, NRTI, TDF, resistant, n=1, 0	0	0
PI, NRTI, TDF, resistance possible, n=1, 0	0	0
PI, NRTI, TDF, sensitive, n=1, 0	1	0
PI, NRTI, ZDV, resistant, n=1, 0	0	0
PI, NRTI, ZDV, resistance possible, n=1, 0	0	0
PI, NRTI, ZDV, sensitive, n=1, 0	1	0
PI, NRTI, d4T, resistant, n=1, 0	0	0
PI, NRTI, d4T, resistance possible, n=1, 0	0	0
PI, NRTI, d4T, sensitive, n=1, 0	1	0
PI, NRTI, ddI, resistant, n=1, 0	0	0
PI, NRTI, ddI, resistance possible, n=1, 0	0	0
PI, NRTI, ddI, sensitive, n=1, 0	1	0
PI, PI, ATV, resistant, n=1, 0	0	0
PI, PI, ATV, resistance possible, n=1, 0	0	0
PI, PI, ATV, sensitive, n=1, 0	1	0
PI, PI, ATV/r, resistant, n=1, 0	0	0
PI, PI, ATV/r, resistance possible, n=1, 0	0	0
PI, PI, ATV/r, sensitive, n=1, 0	1	0
PI, PI, DRV/r, resistant, n=1, 0	0	0
PI, PI, DRV/r, resistance possible, n=1, 0	0	0
PI, PI, DRV/r, sensitive, n=1, 0	1	0
PI, PI, FPV/r, resistant, n=1, 0	0	0
PI, PI, FPV/r, resistance possible, n=1, 0	0	0
PI, PI, FPV/r, sensitive, n=1, 0	1	0
PI, PI, IDV/r, resistant, n=1, 0	0	0
PI, PI, IDV/r, resistance possible, n=1, 0	0	0
PI, PI, IDV/r, sensitive, n=1, 0	1	0
PI, PI, LPV/r, resistant, n=1, 0	0	0
PI, PI, LPV/r, resistance possible, n=1, 0	0	0
PI, PI, LPV/r, sensitive, n=1, 0	1	0
PI, PI, NFV, resistant, n=1, 0	0	0
PI, PI, NFV, resistance possible, n=1, 0	0	0
PI, PI, NFV, sensitive, n=1, 0	1	0
PI, PI, RTV, resistant, n=1, 0	0	0
PI, PI, RTV, resistance possible, n=1, 0	0	0
PI, PI, RTV, sensitive, n=1, 0	1	0
PI, PI, SQV/r, resistant, n=1, 0	0	0
PI, PI, SQV/r, resistance possible, n=1, 0	0	0
PI, PI, SQV/r, sensitive, n=1, 0	1	0
PI, PI, TPV/r, resistant, n=1, 0	0	0
PI, PI, TPV/r, resistance possible, n=1, 0	0	0
PI, PI, TPV/r, sensitive, n=1, 0	1	0
INI, INI, DTG, resistant, n=0, 3	0	0
INI, INI, DTG, resistance possible, n=0, 3	0	0
INI, INI, DTG, sensitive, n=0, 3	0	3
INI, INI, EVG, resistant, n=0, 3	0	0
INI, INI, EVG, resistance possible, n=0, 3	0	0
INI, INI, EVG, sensitive, n=0, 3	0	3
INI, INI, RAL, resistant, n=0, 3	0	0
INI, INI, RAL, resistance possible, n=0, 3	0	0
INI, INI, RAL, sensitive, n=0, 3	0	3
INI, NNRTI, DLV, resistant, n=0, 3	0	0
INI, INI, DLV, resistance possible, n=0, 3	0	0
INI, NNRTI, DLV, sensitive, n=0, 3	0	3
INI, NNRTI, EFV, resistant, n=0, 3	0	0
INI, INI, EFV, resistance possible, n=0, 3	0	0
INI, NNRTI, EFV, sensitive, n=0, 3	0	3
INI, NNRTI, ETR, resistant,, n=0, 3	0	0
INI, NNRTI, ETR, resistance possible, n=0, 3	0	0
INI, NNRTI, ETR, sensitive, n=0, 3	0	3
INI, NNRTI, NVP, resistant, n=0, 3	0	0
INI, NNRTI, NVP, resistance possible, n=0, 3	0	0
INI, NNRTI, NVP, sensitive, n=0, 3	0	3
INI, NNRTI, RPV, resistant, n=0, 3	0	1
INI, NNRTI, RPV, resistance possible, n=0, 3	0	0
INI, NNRTI, RPV, sensitive, n=0, 3	0	2
INI, NRTI, 3TC, resistant, n=0, 3	0	1
INI, NNRTI, 3TC, resistance possible, n=0, 3	0	0
INI, NRTI, 3TC, sensitive, n=0, 3	0	2
INI, NRTI, ABC, resistant, n=0, 3	0	0
INI, NRTI, ABC, resistance possible,, n=0, 3	0	0
INI, NRTI, ABC, sensitive, n=0, 3	0	3
INI, NRTI, FTC, resistant, n=0, 3	0	1
INI, NRTI, FTC, resistance possible, n=0, 3	0	0
INI, NRTI, FTC, sensitive, n=0, 3	0	2
INI, NRTI, TDF, resistant, n=0, 3	0	0
INI, NRTI, TDF, resistance possible, n=0, 3	0	0
INI, NRTI, TDF, sensitive, n=0, 3	0	3
INI, NRTI, ZDV, resistant, n=0, 3	0	0
INI, NRTI, ZDV, resistance possible, n=0, 3	0	0
INI, NRTI, ZDV, sensitive, n=0, 3	0	3
INI, NRTI, d4T, resistant, n=0, 3	0	0
INI, NRTI, d4T, resistance possible, n=0, 3	0	0
INI, NRTI, d4T, sensitive, n=0, 3	0	3
INI, NRTI, ddI, resistant, n=0, 3	0	0
INI, NRTI, ddI, resistance possible, n=0, 3	0	1
INI, NRTI, ddI, sensitive, n=0, 3	0	2
INI, PI, ATV, resistant, n=0, 3	0	0
INI, PI, ATV, resistance possible, n=0, 3	0	0
INI, PI, ATV, sensitive, n=0, 3	0	3
INI, PI, ATV/r, n=0, 3	0	0
INI, PI, ATV/r, resistance possible, n=0, 3	0	0
INI, PI, ATV/r, sensitive, n=0, 3	0	3
INI, PI, DRV/r, resistant, n=0, 3	0	0
INI, PI, DRV/r, resistance possible, n=0, 3	0	0
INI, PI, DRV/r, sensitive, n=0, 3	0	3
INI, PI, FPV/r, resistant, n=0, 3	0	0
INI, PI, FPV/r, resistance possible, n=0, 3	0	0
INI, PI, FPV/r, sensitive, n=0, 3	0	3
INI, PI, IDV/r, resistant, n=0, 3	0	0
INI, PI, IDV/r, resistance possible, n=0, 3	0	0
INI, PI, IDV/r, sensitive, n=0, 3	0	3
INI, PI, LPV/r, resistant, n=0, 3	0	0
INI, PI, LPV/r, resistance possible, n=0, 3	0	0
INI, PI, LPV/r, sensitive, n=0, 3	0	3
INI, PI, NFV, resistant, n=0, 3	0	0
INI, PI, NFV, resistance possible, n=0, 3	0	0
INI, PI, NFV, sensitive, n=0, 3	0	3
INI, PI, RTV, resistant, n=0, 3	0	0
INI, PI, RTV, resistance possible, n=0, 3	0	0
INI, PI, RTV, sensitive, n=0, 3	0	3
INI, PI, SQV/r, resistant, n=0, 3	0	0
INI, PI, SQV/r, resistance possible, n=0, 3	0	0
INI, PI, SQV/r, sensitive, n=0, 3	0	3
INI, PI, TPV/r, resistant, n=0, 3	0	0
INI, PI, TPV/r, resistance possible, n=0, 3	0	0
INI, PI, TPV/r, sensitive, n=0, 3	0	3
NNRTI, INI, DTG, resistant, n=2, 1	0	0
NNRTI, INI, DTG, resistance possible, n=2, 1	0	0
NNRTI, INI, DTG, sensitive, n=2, 1	2	1
NNRTI, INI, EVG, resistant, n=2, 1	1	0
NNRTI, INI, EVG, resistance possible, n=2, 1	0	0
NNRTI, INI, EVG, sensitive, n=2, 1	1	1
NNRTI, INI, RAL, resistant, n=2, 1	1	0
NNRTI, INI, RAL, resistance possible, n=2, 1	0	0
NNRTI, INI, RAL, sensitive, n=2, 1	1	1
NNRTI, NNRTI, DLV, resistant, n=2, 1	0	0
NNRTI, INI, DLV, resistance possible, n=2, 1	0	0
NNRTI, NNRTI, DLV, sensitive, n=2, 1	2	1
NNRTI, NNRTI, EFV, resistant, n=2, 1	1	1
NNRTI, INI, EFV, resistance possible, n=2, 1	0	0
NNRTI, NNRTI, EFV, sensitive, n=2, 1	1	0
NNRTI, NNRTI, ETR, resistant, n=2, 1	0	0
NNRTI, NNRTI, ETR, resistance possible,n=2, 1	2	0
NNRTI, NNRTI, ETR, sensitive, n=2, 1	0	1
NNRTI, NNRTI, NVP, resistant, n=2, 1	1	1
NNRTI, NNRTI, NVP, resistance possible, n=2, 1	0	0
NNRTI, NNRTI, NVP, sensitive, n=2, 1	1	0
NNRTI, NNRTI, RPV, resistant, n=2, 1	2	0
NNRTI, NNRTI, RPV, resistance possible, n=2, 1	0	0
NNRTI, NNRTI, RPV, sensitive, n=2, 1	0	1
NNRTI, NRTI, 3TC, resistant, n=2, 1	0	1
NNRTI, NNRTI, 3TC, resistance possible, n=2, 1	0	0
NNRTI, NRTI, 3TC, sensitive, n=2, 1	2	0
NNRTI, NRTI, ABC, resistant, n=2, 1	0	0
NNRTI, NRTI, ABC, resistance possible, n=2, 1	0	0
NNRTI, NRTI, ABC, sensitive, n=2, 1	2	1
NNRTI, NRTI, FTC, resistant, n=2, 1	0	1
NNRTI, NRTI, FTC, resistance possible, n=2, 1	0	0
NNRTI, NRTI, FTC, sensitive, n=2, 1	2	0
NNRTI, NRTI, TDF, resistant, n=2, 1	0	0
NNRTI, NRTI, TDF, resistance possible, n=2, 1	0	0
NNRTI, NRTI, TDF, sensitive, n=2, 1	2	1
NNRTI, NRTI, ZDV, resistant, n=2, 1	0	0
NNRTI, NRTI, ZDV, resistance possible, n=2, 1	0	0
NNRTI, NRTI, ZDV, sensitive, n=2, 1	2	1
NNRTI, NRTI, d4T, resistant, n=2, 1	0	0
NNRTI, NRTI, d4T, resistance possible, n=2, 1	0	0
NNRTI, NRTI, d4T, sensitive, n=2, 1	2	1
NNRTI, NRTI, ddI, resistant, n=2, 1	0	0
NNRTI, NRTI, ddI, resistance possible, n=2, 1	0	1
NNRTI, NRTI, ddI, sensitive, n=2, 1	2	0
NNRTI, PI, ATV, resistant, n=2, 1	1	0
NNRTI, PI, ATV, resistance possible, n=2, 1	0	0
NNRTI, PI, ATV, sensitive, n=2, 1	1	1
NNRTI, PI, ATV/r, resistant, n=2, 1	0	0
NNRTI, PI, ATV/r, resistance possible, n=2, 1	1	0
NNRTI, PI, ATV/r, sensitive, n=2, 1	1	1
NNRTI, PI, DRV/r, resistant, n=2, 1	0	0
NNRTI, PI, DRV/r, resistance possible, n=2, 1	0	0
NNRTI, PI, DRV/r, sensitive, n=2, 1	2	1
NNRTI, PI, FPV/r, resistant, n=2, 1	0	0
NNRTI, PI, FPV/r, resistance possible, n=2, 1	0	0
NNRTI, PI, FPV/r, sensitive, n=2, 1	2	1
NNRTI, PI, IDV/r, resistant, n=2, 1	0	0
NNRTI, PI, IDV/r, resistance possible, n=2, 1	0	0
NNRTI, PI, IDV/r, sensitive, n=2, 1	2	1
NNRTI, PI, LPV/r, resistant, n=2, 1	0	0
NNRTI, PI, LPV/r, resistance possible, n=2, 1	0	0
NNRTI, PI, LPV/r, sensitive, n=2, 1	2	1
NNRTI, PI, NFV, resistant, n=2, 1	1	0
NNRTI, PI, NFV, resistance possible, n=2, 1	0	0
NNRTI, PI, NFV, sensitive, n=2, 1	1	1
NNRTI, PI, RTV, resistant, n=2, 1	0	0
NNRTI, PI, RTV, resistance possible, n=2, 1	0	0
NNRTI, PI, RTV, sensitive, n=2, 1	2	1
NNRTI, PI, SQV/r, resistant, n=2, 1	0	0
NNRTI, PI, SQV/r, resistance possible, n=2, 1	0	0
NNRTI, PI, SQV/r, sensitive, n=2, 1	2	1
NNRTI, PI, TPV/r, resistant, n=2, 1	0	0
NNRTI, PI, TPV/r, resistance possible, n=2, 1	0	0
NNRTI, PI, TPV/r, sensitive, n=2, 1	2	1

Notes
[139] - CVF Population
[140] - CVF Population

No statistical analyses for this end point

Secondary: Number of participants with phenotypic resistance using baseline third agent through Week 48

Top of page

End point title

Number of participants with phenotypic resistance using baseline third agent through Week 48

End point description

Plasma samples were collected from participants who met confirmed virologic withdrawal criteria to assess the impact of Baseline third agent treatment class (PI, NNRTI and INI).Phenotypic Resistance data for the following drugs:CAB, DTG, EVG, RAL, DLV, EFV, ETR, NVP, RPV, 3TC, ABC, FTC, TDF, ZDV, d4T, ddI, ATV, DRV, FPV, IDV, LPV, NFV, RTV, SQV and TPV in participants meeting CVF criteria has been presented.Phenotypic resistance, partially sensitive, and Sensitive were defined based on FC value from Monogram as:resistance (FC>clinical higher cutoff/biologic cutoff), partially sensitive (FC <=clinical higher cutoff and > clinical lower cutoff), sensitive (FC <= clinical lower cutoff/biologic cutoff). Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).

End point type

Secondary

End point timeframe

At the time of CVF

End point values	CAB LA+RPV LA (Q4W)	Current ART
Number of subjects analysed	3 ^[141]	4 ^[142]
Units: Participants
PI, INI, CAB, resistant , n=1, 0	0	0
PI, INI, CAB, sensitive, n=1, 0	1	0
PI, INI, DTG, resistant, n=1, 0	0	0
PI, INI, DTG, partially sensitive, n=1, 0	0	0
PI, INI, DTG, sensitive, n=1, 0	1	0
PI, INI, EVG, resistant, n=1, 0	0	0
PI, INI, EVG, sensitive, n=1, 0	1	0
PI, INI, RAL, resistant, n=1, 0	0	0
PI, INI, RAL, sensitive, n=1, 0	1	0
PI, NNRTI, DLV, resistant, n=1, 0	0	0
PI, NNRTI, DLV, sensitive, n=1, 0	1	0
PI, NNRTI, EFV, resistant, n=1, 0	0	0
PI, NNRTI, EFV, sensitive, n=1, 0	1	0
PI, NNRTI, ETR, resistant, n=1, 0	0	0
PI, NNRTI, ETR, partially sensitive, n=1, 0	0	0
PI, NNRTI, ETR, sensitive, n=1, 0	1	0
PI, NNRTI, NVP, resistant, n=1, 0	0	0
PI, NNRTI, NVP, sensitive, n=1, 0	1	0
PI, NNRTI, RPV, resistant, n=1, 0	1	0
PI, NNRTI, RPV, sensitive, n=1, 0	0	0
PI, NRTI, 3TC, resistant, n=1, 0	0	0
PI, NRTI, 3TC, sensitive, n=1, 0	1	0
PI, NRTI, ABC, resistant, n=1, 0	0	0
PI, NRTI, ABC, partially sensitive, n=1, 0	0	0
PI, NRTI, ABC, sensitive, n=1, 0	1	0
PI, NRTI, FTC, resistant, n=1, 0	0	0
PI, NRTI, FTC, sensitive, n=1, 0	1	0
PI, NRTI, TDF, resistant, n=1, 0	0	0
PI, NRTI, TDF, partially sensitive, n=1, 0	0	0
PI, NRTI, TDF, sensitive, n=1, 0	1	0
PI, NRTI, ZDV, resistant, n=1, 0	0	0
PI, NRTI, ZDV, sensitive, n=1, 0	1	0
PI, NRTI, d4T, resistant, n=1, 0	0	0
PI, NRTI, d4T, sensitive, n=1, 0	1	0
PI, NRTI, ddI, resistant, n=1, 0	0	0
PI, NRTI, ddI, partially sensitive, n=1, 0	0	0
PI, NRTI, ddI, sensitive, n=1, 0	1	0
PI, PI, ATV, resistant, n=1, 0	0	0
PI, PI, ATV, sensitive, n=1, 0	1	0
PI, PI, DRV, resistant, n=1, 0	0	0
PI, PI, DRV, partially sensitive, n=1, 0	0	0
PI, PI, DRV, sensitive, n=1, 0	1	0
PI, PI, FPV, resistant, n=1, 0	0	0
PI, PI, FPV, partially sensitive, n=1, 0	0	0
PI, PI, FPV, sensitive, n=1, 0	1	0
PI, PI, IDV, resistant, n=1, 0	0	0
PI, PI, IDV, sensitive, n=1, 0	1	0
PI, PI, LPV, resistant, n=1, 0	0	0
PI, PI, LPV, partially sensitive, n=1, 0	0	0
PI, PI, LPV, sensitive, n=1, 0	1	0
PI, PI, NFV, resistant, n=1, 0	0	0
PI, PI, NFV, sensitive, n=1, 0	1	0
PI, PI, RTV, resistant, n=1, 0	0	0
PI, PI, RTV, sensitive, n=1, 0	1	0
PI, PI, SQV, resistant, n=1, 0	0	0
PI, PI, SQV, partially sensitive, n=1, 0	0	0
PI, PI, SQV, sensitive, n=1, 0	1	0
PI, PI, TPV, resistant, n=1, 0	0	0
PI, PI, TPV, partially sensitive, n=1, 0	0	0
PI, PI, TPV, sensitive, n=1, 0	1	0
INI, INI, CAB, resistant , n=0, 3	0	0
INI, INI, CAB, sensitive, n=0, 3	0	3
INI, INI, DTG, resistant, n=0, 3	0	0
INI, INI, DTG, partially sensitive, n=0, 3	0	0
INI, INI, DTG, sensitive, n=0, 3	0	3
INI, INI, EVG, resistant, n=0, 3	0	0
INI, INI, EVG, sensitive, n=0, 3	0	3
INI, INI, RAL, resistant, n=0, 3	0	0
INI, INI, RAL, sensitive, n=0, 3	0	3
INI, NNRTI, DLV, resistant, n=0, 3	0	0
INI, NNRTI, DLV, sensitive, n=0, 3	0	3
INI, NNRTI, EFV, resistant, n=0, 3	0	0
INI, NNRTI, EFV, sensitive, n=0, 3	0	3
INI, NNRTI, ETR, resistant, n=0, 3	0	0
INI, NNRTI, ETR, partially sensitive, n=0, 3	0	0
INI, NNRTI, ETR, sensitive, n=0, 3	0	3
INI, NNRTI, NVP, resistant, n=0, 3	0	0
INI, NNRTI, NVP, sensitive, n=0, 3	0	3
INI, NNRTI, RPV, resistant, n=0, 3	0	0
INI, NNRTI, RPV, sensitive, n=0, 3	0	3
INI, NRTI, 3TC, resistant, n=0, 3	0	1
INI, NRTI, 3TC, sensitive, n=0, 3	0	2
INI, NRTI, ABC, resistant, n=0, 3	0	0
INI, NRTI, ABC, partially sensitive, n=0, 3	0	0
INI, NRTI, ABC, sensitive, n=0, 3	0	3
INI, NRTI, FTC, resistant, n=0, 3	0	1
INI, NRTI, FTC, sensitive, n=0, 3	0	2
INI, NRTI, TDF, resistant, n=0, 3	0	0
INI, NRTI, TDF, partially sensitive, n=0, 3	0	0
INI, NRTI, TDF, sensitive, n=0, 3	0	3
INI, NRTI, ZDV, resistant, n=0, 3	0	0
INI, NRTI, ZDV, sensitive, n=0, 3	0	3
INI, NRTI, d4T, resistant, n=0, 3	0	0
INI, NRTI, d4T, sensitive, n=0, 3	0	3
INI, NRTI, ddI, resistant, n=0, 3	0	0
INI, NRTI, ddI, partially sensitive, n=0, 3	0	0
INI, NRTI, ddI, sensitive, n=0, 3	0	3
INI, PI, ATV, resistant, n=0, 3	0	0
INI, PI, ATV, sensitive, n=0, 3	0	3
INI, PI, DRV, resistant, n=0, 3	0	0
INI, PI, DRV, partially sensitive, n=0, 3	0	0
INI, PI, DRV, sensitive, n=0, 3	0	3
INI, PI, FPV, resistant, n=0, 3	0	0
INI, PI, FPV, partially sensitive, n=0, 3	0	0
INI, PI, FPV, sensitive, n=0, 3	0	3
INI, PI, IDV, resistant, n=0, 3	0	0
INI, PI, IDV, sensitive, n=0, 3	0	3
INI, PI, LPV, resistant, n=0, 3	0	0
INI, PI, LPV, partially sensitive, n=0, 3	0	0
INI, PI, LPV, sensitive, n=0, 3	0	3
INI, PI, NFV, resistant, n=0, 3	0	0
INI, PI, NFV, sensitive, n=0, 3	0	3
INI, PI, RTV, resistant, n=0, 3	0	0
INI, PI, RTV, sensitive, n=0, 3	0	3
INI, PI, SQV, resistant, n=0, 3	0	0
INI, PI, SQV, partially sensitive, n=0, 3	0	0
INI, PI, SQV, sensitive, n=0, 3	0	3
INI, PI, TPV, resistant, n=0, 3	0	0
INI, PI, TPV, partially sensitive, n=0, 3	0	0
INI, PI, TPV, sensitive, n=0, 3	0	3
NNRTI, INI, CAB, resistant , n=2, 1	1	0
NNRTI, INI, CAB, sensitive, n=2, 1	1	1
NNRTI, INI, DTG, resistant, n=2, 1	0	0
NNRTI, INI, DTG, partially sensitive, n=2, 1	0	0
NNRTI, INI, DTG, sensitive, n=2, 1	2	1
NNRTI, INI, EVG, resistant, n=2, 1	1	0
NNRTI, INI, EVG, sensitive, n=2, 1	1	1
NNRTI, INI, RAL, resistant, n=2, 1	1	0
NNRTI, INI, RAL, sensitive, n=2, 1	1	1
NNRTI, NNRTI, DLV, resistant, n=2, 0	2	0
NNRTI, NNRTI, DLV, sensitive, n=2, 0	0	0
NNRTI, NNRTI, EFV, resistant, n=2, 0	2	0
NNRTI, NNRTI, EFV, sensitive, n=2, 0	0	0
NNRTI, NNRTI, ETR, resistant, n=2, 0	0	0
NNRTI, NNRTI, ETR, partially sensitive, n=2, 0	2	0
NNRTI, NNRTI, ETR, sensitive, n=2, 0	0	0
NNRTI, NNRTI, NVP, resistant, n=2, 0	2	0
NNRTI, NNRTI, NVP, sensitive, n=2, 0	0	0
NNRTI, NNRTI, RPV, resistant, n=2, 0	2	0
NNRTI, NNRTI, RPV, sensitive, n=2, 0	0	0
NNRTI, NRTI, 3TC, resistant, n=2, 0	0	0
NNRTI, NRTI, 3TC, sensitive, n=2, 0	2	0
NNRTI, NRTI, ABC, resistant, n=2, 0	0	0
NNRTI, NRTI, ABC, partially sensitive, n=2, 0	0	0
NNRTI, NRTI, ABC, sensitive, n=2, 0	2	0
NNRTI, NRTI, FTC, resistant, n=2, 0	0	0
NNRTI, NRTI, FTC, sensitive, n=2, 0	2	0
NNRTI, NRTI, TDF, resistant, n=2, 0	0	0
NNRTI, NRTI, TDF, partially sensitive, n=2, 0	0	0
NNRTI, NRTI, TDF, sensitive, n=2, 0	2	0
NNRTI, NRTI, ZDV, resistant, n=2, 0	1	0
NNRTI, NRTI, ZDV, sensitive, n=2, 0	1	0
NNRTI, NRTI, d4T, resistant, n=2, 0	0	0
NNRTI, NRTI, d4T, sensitive, n=2, 0	2	0
NNRTI, NRTI, ddI, resistant, n=2, 0	0	0
NNRTI, NRTI, ddI, partially sensitive, n=2, 0	0	0
NNRTI, NRTI, ddI, sensitive, n=2, 0	2	0
NNRTI, PI, ATV, resistant, n=2, 0	0	0
NNRTI, PI, ATV, sensitive, n=2, 0	2	0
NNRTI, PI, DRV, resistant, n=2, 0	0	0
NNRTI, PI, DRV, partially sensitive, n=2, 0	0	0
NNRTI, PI, DRV, sensitive, n=2, 0	2	0
NNRTI, PI, FPV, resistant, n=2, 0	0	0
NNRTI, PI, FPV, partially sensitive, n=2, 0	0	0
NNRTI, PI, FPV, sensitive, n=2, 0	2	0
NNRTI, PI, IDV, resistant, n=2, 0	0	0
NNRTI, PI, IDV, sensitive, n=2, 0	2	0
NNRTI, PI, LPV, resistant, n=2, 0	0	0
NNRTI, PI, LPV, partially sensitive, n=2, 0	0	0
NNRTI, PI, LPV, sensitive, n=2, 0	2	0
NNRTI, PI, NFV, resistant, n=2, 0	0	0
NNRTI, PI, NFV, sensitive, n=2, 0	2	0
NNRTI, PI, RTV, resistant, n=2, 0	0	0
NNRTI, PI, RTV, sensitive, n=2, 0	2	0
NNRTI, PI, SQV, resistant, n=2,0	0	0
NNRTI, PI, SQV, partially sensitive, n=2, 0	0	0
NNRTI, PI, SQV, sensitive, n=2, 0	2	0
NNRTI, PI, TPV, resistant, n=2, 0	0	0
NNRTI, PI, TPV, partially sensitive, n=2, 0	0	0
NNRTI, PI, TPV, sensitive, n=2, 0	2	0

Notes
[141] - CVF Population
[142] - CVF Population

No statistical analyses for this end point

Secondary: Change from Week 5 in dimension scores using percerption of injection questionnaire (PIN)-Last Observation Carried Forward (LOCF) in Q4W arm

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End point title

Change from Week 5 in dimension scores using percerption of injection questionnaire (PIN)-Last Observation Carried Forward (LOCF) in Q4W arm ^[143]

End point description

PIN questionnaire explores bother of pain at injection site and injection site reactions (ISR),anxiety before and after injection, willingness to receive HIV injectable treatment, following visit and satisfaction with mode of treatment administration of individuals receiving injection and perceptions associated with receiving injections.This measure contains 21 items: pain at injection site, local site reactions, impact on functioning and willingness to pursue injectable treatment outside clinical trial. Scores range from 1 to 5; questions are phrased to ensure that 1:most favorable perception of vaccination, and 5:most unfavorable.Dimension scores include bother from ISR, leg movement, sleep and acceptability.Score of a domain is calculated as mean of all items with domain.Higher scores represent worse perception of injection.LOCF was primary method of analysis. Only those participants with data available at specified data points were analyzed(represented by n= X in category titles)

End point type

Secondary

End point timeframe

Week 5 and at Weeks 41 and 48

Notes
[143] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: The endpoint was analyzed specifically for CAB LA+RPV LA (Q4W) arm

End point values	CAB LA+RPV LA (Q4W)
Number of subjects analysed	296 ^[144]
Units: Scores on a scale
arithmetic mean (standard deviation)
Bother of ISRs, Week 41	-0.21 ± 0.532
Bother of ISRs, Week 48	-0.21 ± 0.524
Leg movement, Week 41	-0.52 ± 0.903
Leg movement, Week 48	-0.59 ± 0.950
Sleep, Week 41	-0.56 ± 0.877
Sleep, Week 48	-0.56 ± 0.937
Acceptance, Week 41	-0.49 ± 1.094
Acceptance, Week 48	-0.54 ± 1.080

Notes
[144] - ITT-E Population

No statistical analyses for this end point

Secondary: Percentage of participants with extremely or very acceptable pain and local reaction: acceptability score on PIN questionnaire in Q4W arm

Top of page

End point title

Percentage of participants with extremely or very acceptable pain and local reaction: acceptability score on PIN questionnaire in Q4W arm ^[145]

End point description

PIN questionnaire explores bother of pain at injection site and injection site reactions (ISR),anxiety before and after injection, willingness to receive HIV injectable treatment, following visit and satisfaction with mode of treatment administration of individuals receiving injection and perceptions associated with receiving injections.This measure contains 21 items: pain at injection site, local site reactions, impact on functioning and willingness to pursue injectable treatment outside clinical trial. Scores range from 1 to 5; questions are phrased to ensure that 1:most favorable perception of vaccination, and 5:most unfavorable.Dimension scores include bother from ISR, leg movement, sleep and acceptability.Score of a domain is calculated as mean of all items with domain.Higher scores represent worse perception of injection.LOCF was primary method of analysis.Only those participants with data available at specified data points were analyzed(represented by n= X in category titles)

End point type

Secondary

End point timeframe

Weeks 5, 41 and 48

Notes
[145] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: The endpoint was analyzed specifically for CAB LA+RPV LA (Q4W) arm

End point values	CAB LA+RPV LA (Q4W)
Number of subjects analysed	308 ^[146]
Units: Percentage of participants
number (not applicable)
Local reaction, Week 5, total, n=296	141
Local reaction,Week 5, very acceptable, n=296	77
Local reaction, Week 5, moderate, n=296	54
Local reaction, Week 5, little, n=296	15
Local reaction, Week 5, not at all, n=296	9
Pain, Week 5, total, n=296	86
Pain, Week 5, very acceptable, n=296	103
Pain, Week 5, moderate, n=296	59
Pain, Week 5, little, n=296	29
Pain, Week 5, not at all, n=296	19
Local reaction, Week 41, total, n=300	188
Local reaction, Week 41, very acceptable, n=300	77
Local reaction, Week 41, moderate, n=300	24
Local reaction, Week 41, little, n=300	6
Local reaction, Week 41, not at all, n=300	5
Pain, Week 41, total, n=300	166
Pain, Week 41, very acceptable, n=300	85
Pain, Week 41, moderate, n=300	31
Pain, Week 41, little, n=300	12
Pain, Week 41, not at all, n=300	6
Local reaction, week 48, total, n=303	202
Local reaction, Week 48, very acceptable, n=303	69
Local reaction, Week 48, moderate, n=303	21
Local reaction, Week 48, little, n=303	8
Local reaction, Week 48, not at all, n=303	3
Pain, Week 48, total, n=303	168
Pain, Week 48, very acceptable, n=303	95
Pain, Week 48, moderate, n=303	26
Pain, Week 48, little, n=303	11
Pain, Week 48, not at all, n=303	3

Notes
[146] - ITT-E Population

No statistical analyses for this end point

Secondary: Change from Baseline in life satisfaction (LISAT) using HIV/AIDs-targeted quality of life (HATQoL) questionnaire

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End point title

Change from Baseline in life satisfaction (LISAT) using HIV/AIDs-targeted quality of life (HATQoL) questionnaire

End point description

The HATQoL questionnaire was used to assess health related QoL (HRQoL). It comprises of three dimensions:LISAT, medication worries (MEDWO) and disclosure worries (DISWO).Total imputed value score for LISAT is calculated on a 0-100 scale using formula:LISAT 100=[100 divided by (20 minus 4)]*(LISAT minus 4). A response of 5 in LISAT score shows satisfaction all of time and 1 as none of time. The higher the score, the greater satisfaction to life and the less worry.Transformed dimension score for each domain was summarized and analyzed. LOCF was used as primary method of analysis. Measure type was considered as mean for adjusted mean and dispersion measure as 95% confidence interval (CI).Baseline value is defined as latest pre-treatment assessment with a non-missing value.Change from Baseline value is calculated as value at post-dose visit minus Baseline value. Only those participants with data available at specified data points were analyzed (represented by n= X in category titles)

End point type

Secondary

End point timeframe

Baseline (Day 1) and at Weeks 24 and 48

End point values	CAB LA+RPV LA (Q4W)	Current ART
Number of subjects analysed	308 ^[147]	308 ^[148]
Units: Scores on a scale
arithmetic mean (confidence interval 95%)
Week 24, n=292, 291	1.0 (-0.6 to 2.6)	1.1 (-0.5 to 2.7)
Week 48, n=292, 297	1.1 (-0.6 to 2.8)	0.1 (-1.6 to 1.7)

Notes
[147] - ITT-E Population
[148] - ITT-E Population

Statistical Analysis 1

Statistical analysis description

Treatment comparison at Week 24 for the groups CAB LA+ RPV LA and current ART is presented.

Comparison groups

CAB LA+RPV LA (Q4W) v Current ART

Number of subjects included in analysis

616

Analysis specification

Pre-specified

Analysis type

other

P-value

= 0.944

Method

ANCOVA

Parameter type

Adjusted difference

Point estimate

-0.1

Confidence interval

level

95%

sides

2-sided

lower limit

-2.4

upper limit

2.2

Statistical Analysis 2

Statistical analysis description

Treatment comparison at Week 48 for the groups CAB LA+ RPV LA and current ART is presented.

Comparison groups

CAB LA+RPV LA (Q4W) v Current ART

Number of subjects included in analysis

616

Analysis specification

Pre-specified

Analysis type

other

P-value

= 0.385

Method

ANCOVA

Parameter type

Adjusted difference

Point estimate

Confidence interval

level

95%

sides

2-sided

lower limit

-1.3

upper limit

3.4

Secondary: Change from Baseline in HIV medication, MEDWO using HATQoL

Top of page

End point title

Change from Baseline in HIV medication, MEDWO using HATQoL

End point description

The HATQoL questionnaire was used to assess health related QoL (HRQoL). It comprises of three dimensions: LISAT, medication worries(MEDWO)and disclosure worries (DISWO). Total imputed value score for MEDWO is calculated on a 0-100 scale using formula: MEDWO 100=[100 divided by (20 minus 5)]*(MEDWO minus 5).A response of 1 in MEDWO score shows less medication worries all of time and 5 as none of time. Higher the score, the greater satisfaction to life and less worry. Transformed dimension score for each domain was summarized and analyzed. LOCF was primary method of analysis. Measure type was considered as mean for adjusted mean and dispersion measure as 95% CI. Baseline value is defined as latest pre-treatment assessment with a non-missing value. Change from Baseline value is calculated as value at post-dose visit minus Baseline value. Only those participants with data available at specified data points were analyzed (represented by n= X in category titles)

End point type

Secondary

End point timeframe

Baseline and at Weeks 24 and 48

End point values	CAB LA+RPV LA (Q4W)	Current ART
Number of subjects analysed	308 ^[149]	308 ^[150]
Units: Scores on a scale
arithmetic mean (confidence interval 95%)
Week 24, n=292, 290	4.2 (2.7 to 5.8)	-0.7 (-2.2 to 0.9)
Week 48, n=292, 296	4.0 (2.3 to 5.7)	-2.4 (-4.1 to -0.8)

Notes
[149] - ITT-E Population
[150] - ITT-E Population

Statistical Analysis 1

Statistical analysis description

Treatment comparison at Week 24 for the groups CAB LA+ RPV LA and current ART is presented

Comparison groups

CAB LA+RPV LA (Q4W) v Current ART

Number of subjects included in analysis

616

Analysis specification

Pre-specified

Analysis type

other

P-value

< 0.001

Method

ANCOVA

Parameter type

Adjusted difference

Point estimate

4.9

Confidence interval

level

95%

sides

2-sided

lower limit

2.8

upper limit

7.1

Statistical Analysis 2

Statistical analysis description

Treatment comparison at Week 48 for the groups CAB LA+ RPV LA and current ART is presented

Comparison groups

CAB LA+RPV LA (Q4W) v Current ART

Number of subjects included in analysis

616

Analysis specification

Pre-specified

Analysis type

other

P-value

< 0.001

Method

ANCOVA

Parameter type

Adjusted difference

Point estimate

6.4

Confidence interval

level

95%

sides

2-sided

lower limit

upper limit

8.8

Secondary: Change from Baseline in DISWO using HATQoL

Top of page

End point title

Change from Baseline in DISWO using HATQoL

End point description

The HATQoL questionnaire was used to assess the health related QoL (HRQoL). It comprises of three dimensions: LISAT, medication worries (MEDWO) and disclosure worries (DISWO). Total imputed value score for DISWO is calculated on a 0-100 scale using the formula: DISWO 100=[100 divided by (20 minus 5)]*(DISWO minus 5). A response of 1 in DISWO score shows less medication worries all of time and 5 as none of the time.Higher the score, the greater satisfaction to life and less worry.Transformed dimension score for each domain was summarized and analyzed.LOCF was used as primary method of analysis. Measure type was considered as mean for adjusted mean and dispersion measure as 95% CI. Baseline value is defined as latest pre-treatment assessment with a non-missing value. Change from Baseline value is calculated as value at post-dose visit minus Baseline value.Only those participants with data available at specified data points were analyzed (represented by n= X in category titles)

End point type

Secondary

End point timeframe

Baseline and at Weeks 24 and 48

End point values	CAB LA+RPV LA (Q4W)	Current ART
Number of subjects analysed	308 ^[151]	308 ^[152]
Units: Scores on a scale
arithmetic mean (confidence interval 95%)
Week 24, n=291, 290	8.3 (5.6 to 11.0)	3.0 (0.3 to 5.8)
Week 48, n=291, 296	4.6 (1.7 to 7.6)	2.6 (-0.3 to 5.6)

Notes
[151] - ITT-E Population
[152] - ITT-E Population

Statistical Analysis 1

Statistical analysis description

Treatment comparison at Week 24 for the groups CAB LA+ RPV LA and current ART is presented

Comparison groups

Current ART v CAB LA+RPV LA (Q4W)

Number of subjects included in analysis

616

Analysis specification

Pre-specified

Analysis type

other

P-value

= 0.008

Method

ANCOVA

Parameter type

Adjusted difference

Point estimate

5.3

Confidence interval

level

95%

sides

2-sided

lower limit

1.4

upper limit

9.1

Statistical Analysis 2

Statistical analysis description

Treatment comparison at Week 48 for the groups CAB LA+ RPV LA and current ART is presented

Comparison groups

CAB LA+RPV LA (Q4W) v Current ART

Number of subjects included in analysis

616

Analysis specification

Pre-specified

Analysis type

other

P-value

= 0.347

Method

ANCOVA

Parameter type

Adjusted difference

Point estimate

Confidence interval

level

95%

sides

2-sided

lower limit

-2.2

upper limit

6.2

Secondary: Change from Baseline in health status using 12-item short form survey (SF-12)

Top of page

End point title

Change from Baseline in health status using 12-item short form survey (SF-12)

End point description

The SF-12 questionnaire consists of 7 questions which measures degree of general health status and mental health distress. Each question is scored 0-5, except for question 2 scored 0-3. HRQoL using SF-12 for total score, physical component summary (PCS) and mental component summary (MCS) were assessed for two treatment groups.Missing Total or component scores was imputed using LOCF.PCS/MCS are calculated using computer software purchased from QualityMetric (http://www.qualitymetric.com).The higher the score, the better will be the health status.Measure type was considered as mean for adjusted mean and dispersion measure as 95% CI. Baseline value is defined as latest pre-treatment assessment with a non-missing value.Change from Baseline value is calculated as value at post-dose visit minus Baseline value.Only those participants with data available at specified data points were analyzed (represented by n= X in category titles).

End point type

Secondary

End point timeframe

Baseline and at Weeks 24 and 48

End point values	CAB LA+RPV LA (Q4W)	Current ART
Number of subjects analysed	308 ^[153]	308 ^[154]
Units: Scores on a scale
arithmetic mean (confidence interval 95%)
Total score, Week 24, n=291, 289	0.0 (-0.3 to 0.4)	-0.2 (-0.5 to 0.1)
Total score, Week 48, n=293, 296	-0.0 (-0.4 to 0.3)	0.0 (-0.3 to 0.4)
MCS, Week 24, n=289, 286	0.288 (-0.579 to 1.155)	-0.388 (-1.259 to 0.484)
MCS, Week 48, n=291, 293	0.260 (-0.638 to 1.158)	-0.375 (-1.270 to 0.520)
PCS, Week 24, n=286, 288	0.650 (0.087 to 1.213)	-0.047 (-0.608 to 0.514)
PCS, Week 48, n=288, 295	0.758 (0.184 to 1.332)	0.062 (-0.505 to 0.629)

Notes
[153] - ITT-E Population
[154] - ITT-E Population

Statistical Analysis 1

Statistical analysis description

Treatment comparison of SF-12 total scores at Week 24 for the groups CAB LA+ RPV LA and current ART is presented

Comparison groups

CAB LA+RPV LA (Q4W) v Current ART

Number of subjects included in analysis

616

Analysis specification

Pre-specified

Analysis type

other

P-value

= 0.344

Method

ANCOVA

Parameter type

Adjusted difference

Point estimate

0.2

Confidence interval

level

95%

sides

2-sided

lower limit

-0.2

upper limit

0.7

Statistical Analysis 2

Statistical analysis description

Treatment comparison of SF-12 total scores at Week 48 for the groups CAB LA+ RPV LA and current ART is presented

Comparison groups

CAB LA+RPV LA (Q4W) v Current ART

Number of subjects included in analysis

616

Analysis specification

Pre-specified

Analysis type

other

P-value

= 0.785

Method

ANCOVA

Parameter type

Adjusted difference

Point estimate

-0.1

Confidence interval

level

95%

sides

2-sided

lower limit

-0.6

upper limit

0.4

Statistical Analysis 3

Statistical analysis description

Treatment comparison of SF-12 MCS at Week 24 for the groups CAB LA+ RPV LA and current ART is presented

Comparison groups

CAB LA+RPV LA (Q4W) v Current ART

Number of subjects included in analysis

616

Analysis specification

Pre-specified

Analysis type

other

P-value

= 0.282

Method

ANCOVA

Parameter type

Adjusted difference

Point estimate

0.676

Confidence interval

level

95%

sides

2-sided

lower limit

-0.557

upper limit

1.909

Statistical Analysis 4

Statistical analysis description

Treatment comparison of SF-12 MCS at Week 48 for the groups CAB LA+ RPV LA and current ART is presented

Comparison groups

CAB LA+RPV LA (Q4W) v Current ART

Number of subjects included in analysis

616

Analysis specification

Pre-specified

Analysis type

other

P-value

= 0.327

Method

ANCOVA

Parameter type

Adjusted difference

Point estimate

0.635

Confidence interval

level

95%

sides

2-sided

lower limit

-0.637

upper limit

1.907

Statistical Analysis 5

Statistical analysis description

Treatment comparison of SF-12 PCS at Week 24 for the groups CAB LA+ RPV LA and current ART is presented

Comparison groups

CAB LA+RPV LA (Q4W) v Current ART

Number of subjects included in analysis

616

Analysis specification

Pre-specified

Analysis type

other

P-value

= 0.086

Method

ANCOVA

Parameter type

Adjusted difference

Point estimate

0.697

Confidence interval

level

95%

sides

2-sided

lower limit

-0.1

upper limit

1.494

Statistical Analysis 6

Statistical analysis description

Treatment comparison of SF-12 PCS at Week 48 for the groups CAB LA+ RPV LA and current ART is presented

Comparison groups

CAB LA+RPV LA (Q4W) v Current ART

Number of subjects included in analysis

616

Analysis specification

Pre-specified

Analysis type

other

P-value

= 0.092

Method

ANCOVA

Parameter type

Adjusted difference

Point estimate

0.696

Confidence interval

level

95%

sides

2-sided

lower limit

-0.113

upper limit

1.505

Secondary: Change from Baseline in total treatment satisfaction using HIV treatment satisfaction questionnaire (HIVTSQs) at Weeks 4b, 24 and 44

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End point title

Change from Baseline in total treatment satisfaction using HIV treatment satisfaction questionnaire (HIVTSQs) at Weeks 4b, 24 and 44

End point description

HIVTSQ total treatment satisfaction score is computed with 1-11 items. Items 1-11 are summed to produce score with possible range:-33 to 33.Item12 in scale calculated as individual score. Higher the score, greater improvement in satisfaction with treatment; lower score, greater the deterioration in satisfaction with treatment. A score of 0 represents no change. A maximum of 5 items can be missing, Missing scores are imputed with mean of completed item scores. If 6 or more items are missing, overall treatment satisfaction score should not be computed and will remain missing. LOCF was primary method of analysis. Baseline value is defined as latest pre-treatment assessment with a non-missing value. Change from Baseline value is calculated as value at post-dose visit minus Baseline value. Data is presented with respect to actual treatment received by participants. Only those participants with data available at specified data points were analyzed(represented by n=X in category titles)

End point type

Secondary

End point timeframe

Baseline and at Weeks 4b, 24 and 44

End point values	CAB LA+RPV LA (Q4W)	Current ART
Number of subjects analysed	308 ^[155]	308 ^[156]
Units: Scores on a scale
arithmetic mean (standard deviation)
Week 4b, n=295, 0	3.99 ± 8.982	99999 ± 99999
Week 24, n=300, 288	6.39 ± 10.328	1.08 ± 8.510
Week 44, n=300, 294	6.02 ± 10.808	0.54 ± 9.877

Notes
[155] - ITT-E Population. 99999 indicates data not available due to insufficient participants
[156] - ITT-E Population. 99999 indicates data not available due to insufficient participants

No statistical analyses for this end point

Secondary: Change in treatment satisfaction over time using HIVTSQ change (HIVTSQc) at Week 48 in Q4W arm

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End point title

Change in treatment satisfaction over time using HIVTSQ change (HIVTSQc) at Week 48 in Q4W arm ^[157]

End point description

The HIVTSQtotal treatment satisfaction score is computed with 1-11 items.These 1-11 items are summed to produce score with possible range:-33 to 33.Item12 in scale calculated as individual score.Higher the score,greater improvement in satisfaction with treatment;lower score,greater the deterioration in satisfaction with treatment.A score of 0 represents no change.A maximum of 5 items can be missing,missing scores are imputed with mean of completed item scores.If 6or more items are missing,overall treatment satisfaction score should not be computed and will remain missing.LOCF was primary method of analysis.Baseline value is defined as latest pre-treatment assessment with a non-missing value. Change from Baseline value is calculated as value at post-dose visit minus Baseline value.Data has been presented with respect to actual treatment received to the participants.Only those participants with data available at specified data points were analyzed

End point type

Secondary

End point timeframe

Week 48

Notes
[157] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: The endpoint was analyzed specifically for CAB LA+RPV LA (Q4W) arm

End point values	CAB LA+RPV LA (Q4W)
Number of subjects analysed	275 ^[158]
Units: Scores on a scale
arithmetic mean (standard deviation)	29.05 ± 6.978

Notes
[158] - ITT-E Population

No statistical analyses for this end point

Secondary: Change from Baseline in treatment acceptance at Weeks 8, 24 and 48 using “General acceptance” dimension of the Chronic Treatment Acceptance (ACCEPT) questionnaire

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End point title

Change from Baseline in treatment acceptance at Weeks 8, 24 and 48 using “General acceptance” dimension of the Chronic Treatment Acceptance (ACCEPT) questionnaire

End point description

ACCEPT questionnaire is generic medication acceptance measure assessing how participants weigh advantages and disadvantages of long-term medication. It consists 25 items, capture six dimensions.3 questions focus on general acceptance of study medication will be analyzed. Items on scale are rated1-5 scores:1:totally disagree,2:somewhat disagree,3:somewhat agree,4:totally agree and 5:I don’t know. Total score of dimension is calculated as mean of recoded items of dimension and linearly transformed to scale from 0-100. Total Score=(mean of recoded items in dimension minus1)divided by2*100.LOCF was primary method of analysis. Measure type is mean for adjusted mean and dispersion measure: 95% CI. Baseline value is latest pre-treatment assessment with a non-missing value. Change from Baseline value is calculated as value at post-dose visit minus Baseline value. Only those participants with data available at specified data points were analyzed(represented by n=X in category titles)

End point type

Secondary

End point timeframe

Baseline and at Weeks 8, 24 and 48

End point values	CAB LA+RPV LA (Q4W)	Current ART
Number of subjects analysed	308 ^[159]	308 ^[160]
Units: Scores on a scale
arithmetic mean (confidence interval 95%)
Week 8, n=302, 287	8.9 (6.3 to 11.6)	1.0 (-1.7 to 3.8)
Week 24, n=303, 295	12.3 (9.9 to 14.8)	5.5 (3.0 to 8.0)
Week 48, n=302, 298	13.7 (11.2 to 16.3)	3.0 (0.4 to 5.6)

Notes
[159] - ITT-E Population
[160] - ITT-E Population

Statistical Analysis 1

Statistical analysis description

Treatment comparison at Week 8 for the groups CAB LA+ RPV LA and current ART is presented

Comparison groups

CAB LA+RPV LA (Q4W) v Current ART

Number of subjects included in analysis

616

Analysis specification

Pre-specified

Analysis type

other

P-value

< 0.001

Method

ANCOVA

Parameter type

Adjusted difference

Point estimate

7.9

Confidence interval

level

95%

sides

2-sided

lower limit

4.1

upper limit

11.7

Statistical Analysis 2

Statistical analysis description

Treatment comparison Week 24 for the groups CAB LA+ RPV LA and current ART is presented

Comparison groups

CAB LA+RPV LA (Q4W) v Current ART

Number of subjects included in analysis

616

Analysis specification

Pre-specified

Analysis type

other

P-value

< 0.001

Method

ANCOVA

Parameter type

Adjusted difference

Point estimate

6.9

Confidence interval

level

95%

sides

2-sided

lower limit

3.3

upper limit

10.4

Statistical Analysis 3

Statistical analysis description

Treatment comparison at Week 48 for the groups CAB LA+ RPV LA and current ART is presented

Comparison groups

CAB LA+RPV LA (Q4W) v Current ART

Number of subjects included in analysis

616

Analysis specification

Pre-specified

Analysis type

other

P-value

< 0.001

Method

ANCOVA

Parameter type

Adjusted difference

Point estimate

10.7

Confidence interval

level

95%

sides

2-sided

lower limit

7.1

upper limit

14.4

Secondary: Change from 4b in tolerability of injection at Week 5, 40 and 41 using numeric rating scale (NRS) within CAB LA+RPV LA arm

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End point title

Change from 4b in tolerability of injection at Week 5, 40 and 41 using numeric rating scale (NRS) within CAB LA+RPV LA arm ^[161]

End point description

The NRS questionnaire is used to assess the tolerability of injections in CAB LA+RPV LA arm only. The questionnaire consists of one single question and will assess maximum level of pain experienced with the most recent injections ranking from no pain (0) to extreme pain (10). Missing scores was imputed using LOCF. Only those participants with data available at the specified data points were analyzed

End point type

Secondary

End point timeframe

Weeks 4b, 5, 40 and 41

Notes
[161] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: The endpoint was analyzed specifically for CAB LA+RPV LA (Q4W) arm

End point values	CAB LA+RPV LA (Q4W)
Number of subjects analysed	278 ^[162]
Units: Scores on a scale
arithmetic mean (standard deviation)
Week 5	2.0 ± 2.94
Week 40	0.5 ± 2.79
Week 41	0.4 ± 2.83

Notes
[162] - ITT-E Population

No statistical analyses for this end point

Secondary: Change from Baseline in individual item scores of HIVTSQc at Weeks 4b, 24 and 44

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End point title

Change from Baseline in individual item scores of HIVTSQc at Weeks 4b, 24 and 44

End point description

HIVTSQc is a 12 item questionnaire. The individual treatment change item scores on HIVTSQc scale are rated as +3 (‘much more satisfied’, ‘much more convenient’, ‘much more flexible’,etc.) to -3 (‘much less satisfied’, ‘much less convenient’, ‘much less flexible’, etc.). The higher the score, the greater the improvement in satisfaction with each aspect of treatment and the lower the score, the greater the deterioration in satisfaction with each aspect of treatment. LOCF was used as primary method of analysis. Baseline value is defined as the latest pre-treatment assessment with a non-missing value. Change from Baseline value is calculated as the value at the post-dose visit minus the Baseline value. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles). 99999 indicates data was not available due to insufficient participants.

End point type

Secondary

End point timeframe

Baseline and Weeks 4b, 24 and 44

End point values	CAB LA+RPV LA (Q4W)	Current ART
Number of subjects analysed	308 ^[163]	308 ^[164]
Units: Scores on a scale
arithmetic mean (standard deviation)
Item 1; Week 4b; n=294, 0	0.3 ± 1.42	99999 ± 99999
Item 1; Week 24; n=300, 287	0.4 ± 1.46	-0.1 ± 1.04
Item 1; Week 44; n=300, 293	0.5 ± 1.42	-0.1 ± 1.21
Item 2; Week 4b; n=295, 0	0.0 ± 0.60	99999 ± 99999
Item 2; Week 24; n=300, 287	0.1 ± 0.70	0.0 ± 0.68
Item 2; Week 44; n=300, 293	0.1 ± 0.84	-0.1 ± 0.82
Item 3; Week 4b; n=295, 0	0.4 ± 1.35	99999 ± 99999
Item 3; Week 24; n=300, 288	0.3 ± 1.47	0.1 ± 1.12
Item 3; Week 44; n=300, 294	0.3 ± 1.45	0.0 ± 1.26
Item 4; Week 4b; n=295, 0	0.3 ± 1.21	99999 ± 99999
Item 4; Week 24; n=300, 288	0.5 ± 1.29	-0.0 ± 1.16
Item 4; Week 44; n=300, 294	0.4 ± 1.30	-0.1 ± 1.22
Item 5; Week 4b; n=295, 0	0.5 ± 1.24	99999 ± 99999
Item 5; Week 24; n=300, 288	0.8 ± 1.32	0.1 ± 1.31
Item 5; Week 44; n=300, 294	0.8 ± 1.42	0.0 ± 1.37
Item 6; Week 4b; n=294, 0	0.5 ± 1.63	99999 ± 99999
Item 6; Week 24; n=299, 288	0.8 ± 1.77	0.2 ± 1.79
Item 6; Week 44; n=299, 293	0.9 ± 1.72	0.2 ± 1.78
Item 7; Week 4b; n=295, 0	0.2 ± 0.90	99999 ± 99999
Item 7; Week 24; n=300, 288	0.2 ± 0.94	0.1 ± 1.00
Item 7; Week 44; n=300, 294	0.2 ± 0.99	0.2 ± 1.08
Item 8; Week 4b; n=294, 0	0.3 ± 1.21	99999 ± 99999
Item 8; Week 24; n=299, 288	0.7 ± 1.27	0.1 ± 1.20
Item 8; Week 44; n=299, 294	0.6 ± 1.31	0.0 ± 1.27
Item 9; Week 4b; n=294, 0	0.4 ± 1.22	99999 ± 99999
Item 9; Week 24; n=299, 288	0.6 ± 1.27	0.1 ± 1.20
Item 9; Week 44; n=299, 294	0.5 ± 1.32	0.0 ± 1.25
Item 10; Week 4b; n=293, 0	0.8 ± 1.44	99999 ± 99999
Item 10; Week 24; n=298, 287	1.2 ± 1.56	0.3 ± 1.38
Item 10; Week 44; n=298, 293	1.1 ± 1.64	0.2 ± 1.60
Item 11; Week 4b; n=292, 0	0.4 ± 1.23	99999 ± 99999
Item 11; Week 24; n=297, 287	0.7 ± 1.31	0.1 ± 1.28
Item 11; Week 44; n=297, 293	0.6 ± 1.45	0.1 ± 1.38
Item 12; Week 4b; n=293, 0	0.3 ± 1.41	99999 ± 99999
Item 12; Week 24; n=298, 287	0.0 ± 1.52	0.1 ± 1.14
Item 12; Week 44; n=298, 293	0.0 ± 1.58	0.2 ± 1.17

Notes
[163] - ITT-E Population
[164] - ITT-E Population

No statistical analyses for this end point

Secondary: Number of participants with different demographic parameters for inter-subject variability

Top of page

End point title

Number of participants with different demographic parameters for inter-subject variability

End point description

Blood samples were planned to be collected at indicated time points for PK analysis of CAB LA and RPV LA. Demographic parameters including, but not limited to, age, sex, race, body weight, body mass index, and relevant laboratory parameters were planned to be evaluated as potential predictors of inter subject variability for pharmacokinetic parameters. This was an exploratory Outcome Measure. Data will not be analyzed and reported.

End point type

Secondary

End point timeframe

Upto Week 48

End point values	CAB LA	RPV LA
Number of subjects analysed	0 ^[165]	0 ^[166]
Units: Participants

Notes
[165] - PK Population
[166] - PK Population

No statistical analyses for this end point

Adverse events

Top of page

Timeframe for reporting adverse events

Up to Week 52

Adverse event reporting additional description

AEs and SAEs were collected in Safety population.

Assessment type

Systematic

Dictionary name

MedDRA

Dictionary version

21.0

Reporting group title

CAB LA+RPV LA (Q4W)

Reporting group description

Reporting group title

Current ART

Reporting group description

Serious adverse events	CAB LA+RPV LA (Q4W)	Current ART
Total subjects affected by serious adverse events
subjects affected / exposed	13 / 308 (4.22%)	14 / 308 (4.55%)
number of deaths (all causes)	0	1
number of deaths resulting from adverse events
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Anogenital warts
subjects affected / exposed	0 / 308 (0.00%)	1 / 308 (0.32%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Papillary thyroid cancer
subjects affected / exposed	1 / 308 (0.32%)	0 / 308 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Seminoma
subjects affected / exposed	0 / 308 (0.00%)	1 / 308 (0.32%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Investigations
Liver function test abnormal
subjects affected / exposed	1 / 308 (0.32%)	0 / 308 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Injury, poisoning and procedural complications
Animal bite
subjects affected / exposed	0 / 308 (0.00%)	1 / 308 (0.32%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Eye injury
subjects affected / exposed	0 / 308 (0.00%)	1 / 308 (0.32%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Overdose
subjects affected / exposed	0 / 308 (0.00%)	1 / 308 (0.32%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 1
Skull fracture
subjects affected / exposed	0 / 308 (0.00%)	1 / 308 (0.32%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Pregnancy, puerperium and perinatal conditions
Abortion missed
subjects affected / exposed	1 / 308 (0.32%)	0 / 308 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Abortion spontaneous
subjects affected / exposed	0 / 308 (0.00%)	1 / 308 (0.32%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Nervous system disorders
Cerebrovascular accident
subjects affected / exposed	0 / 308 (0.00%)	1 / 308 (0.32%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
General disorders and administration site conditions
Chest discomfort
subjects affected / exposed	0 / 308 (0.00%)	1 / 308 (0.32%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Gastrointestinal disorders
Colitis
subjects affected / exposed	0 / 308 (0.00%)	2 / 308 (0.65%)
occurrences causally related to treatment / all	0 / 0	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Pancreatitis acute
subjects affected / exposed	1 / 308 (0.32%)	0 / 308 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Vomiting
subjects affected / exposed	1 / 308 (0.32%)	0 / 308 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Hepatobiliary disorders
Cholecystitis acute
subjects affected / exposed	1 / 308 (0.32%)	0 / 308 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Hepatocellular injury
subjects affected / exposed	1 / 308 (0.32%)	0 / 308 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Hyperbilirubinaemia
subjects affected / exposed	1 / 308 (0.32%)	0 / 308 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Respiratory, thoracic and mediastinal disorders
Respiratory distress
subjects affected / exposed	0 / 308 (0.00%)	1 / 308 (0.32%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Psychiatric disorders
Suicidal ideation
subjects affected / exposed	0 / 308 (0.00%)	1 / 308 (0.32%)
occurrences causally related to treatment / all	0 / 0	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Musculoskeletal and connective tissue disorders
Back pain
subjects affected / exposed	1 / 308 (0.32%)	0 / 308 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Infections and infestations
Hepatitis A
subjects affected / exposed	1 / 308 (0.32%)	1 / 308 (0.32%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Acute hepatitis B
subjects affected / exposed	1 / 308 (0.32%)	0 / 308 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Anal abscess
subjects affected / exposed	0 / 308 (0.00%)	1 / 308 (0.32%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Appendicitis
subjects affected / exposed	0 / 308 (0.00%)	1 / 308 (0.32%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Gastroenteritis Escherichia coli
subjects affected / exposed	1 / 308 (0.32%)	0 / 308 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Liver abscess
subjects affected / exposed	1 / 308 (0.32%)	0 / 308 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Pneumonia
subjects affected / exposed	0 / 308 (0.00%)	1 / 308 (0.32%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Pyelonephritis acute
subjects affected / exposed	1 / 308 (0.32%)	0 / 308 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Viral infection
subjects affected / exposed	1 / 308 (0.32%)	0 / 308 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0

Frequency threshold for reporting non-serious adverse events: 5%

Non-serious adverse events	CAB LA+RPV LA (Q4W)	Current ART
Total subjects affected by non serious adverse events
subjects affected / exposed	263 / 308 (85.39%)	117 / 308 (37.99%)
Nervous system disorders
Headache
subjects affected / exposed	34 / 308 (11.04%)	17 / 308 (5.52%)
occurrences all number	48	19
General disorders and administration site conditions
Injection site pain
subjects affected / exposed	231 / 308 (75.00%)	0 / 308 (0.00%)
occurrences all number	1208	0
Injection site nodule
subjects affected / exposed	37 / 308 (12.01%)	0 / 308 (0.00%)
occurrences all number	54	0
Injection site induration
subjects affected / exposed	30 / 308 (9.74%)	0 / 308 (0.00%)
occurrences all number	54	0
Pyrexia
subjects affected / exposed	21 / 308 (6.82%)	9 / 308 (2.92%)
occurrences all number	29	9
Fatigue
subjects affected / exposed	22 / 308 (7.14%)	6 / 308 (1.95%)
occurrences all number	29	9
Injection site swelling
subjects affected / exposed	23 / 308 (7.47%)	0 / 308 (0.00%)
occurrences all number	48	0
Gastrointestinal disorders
Diarrhoea
subjects affected / exposed	22 / 308 (7.14%)	15 / 308 (4.87%)
occurrences all number	24	17
Respiratory, thoracic and mediastinal disorders
Cough
subjects affected / exposed	16 / 308 (5.19%)	14 / 308 (4.55%)
occurrences all number	20	16
Musculoskeletal and connective tissue disorders
Back pain
subjects affected / exposed	20 / 308 (6.49%)	10 / 308 (3.25%)
occurrences all number	22	12
Infections and infestations
Nasopharyngitis
subjects affected / exposed	52 / 308 (16.88%)	42 / 308 (13.64%)
occurrences all number	87	58
Upper respiratory tract infection
subjects affected / exposed	32 / 308 (10.39%)	25 / 308 (8.12%)
occurrences all number	48	30
Influenza
subjects affected / exposed	17 / 308 (5.52%)	14 / 308 (4.55%)
occurrences all number	19	15
Respiratory tract infection viral
subjects affected / exposed	11 / 308 (3.57%)	17 / 308 (5.52%)
occurrences all number	12	23

More information

Top of page

Were there any global substantial amendments to the protocol? Yes

16 Sep 2016

Amendment No.1: requirements for South Korea; update I/E criteria age per local regulatory; add IP labels to Appendix 8.

02 Nov 2016

Amendment No.2: requirements for Sweden; protocol details and clarifications requested by MPA.

13 Dec 2016

Amendment No.3: contact MM if rash occurs during OLI period; add lipid objective and endpoint; IP dosing at Day 1 visit clarity; allow serum pregnancy testing instead of urine testing when not available; CAB, RPV exposure may persist for more than 1 year after IM injections; use of HAART for 1 year after last CAB+RPV injection, females use adequate contraception for 1 year after last CAB+RPV injection; treatment with glucocorticoids up to 21 days; definition of change in ART regimen for I/E criteria; contact MM upon serofast RPR result for screening syphilis test; remove requirement to record frequency of IP taken and treatment delays or dose reductions of IP in eCRF; indicate drugs known to cause TdP to be used with caution with RPV; remove limits on duration of topical imiquimod; clarity on reflexive testing for HBV DNA for participants with + anti-HBc, - HBsAg, - anti-HBs results; temperature collection to T&E table; site plans for managing risks for suicide related events; PK sample window collection clarity; PRO timings clarification; prohibited meds clarification; remove collection of pregnancy information for female partners of male study participants; details of injection device for IM administration collected within eCRF; local labs approved by MM for eligibility in special circumstances; screening HLA-B*5701 result is not required for eligibility status.

07 Nov 2017

Amendment No.4: potential rollover of participants to study 207966; snapshot virologic response replaced with proportion of participants with plasma HIV-1 RNA < 50 c/mL over time; exploratory analyses evaluating virologic, immunologic responses in treatment arms limited to Week 48 analysis; pregnancy and follow-up pregnancy event form report timing updated; updated references for CAB, RPV IBs.

Were there any global interruptions to the trial? No

Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.

None reported

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Clinical trials

Trial information

Trial information

Subject disposition

Subject disposition

Baseline characteristics

Baseline characteristics

End points

End points

Primary: Number of participants with virologic failure (HIV-1 ribonucleic acid [RNA] >=50 copies per milliliter [c/mL]) using snapshot algorithm at Week 48

Primary: Number of participants with virologic failure (HIV-1 ribonucleic acid [RNA] >=50 copies per milliliter [c/mL]) using snapshot algorithm at Week 48

Secondary: Number of participants with HIV-1 RNA <50 copies/mL using snapshot algorithm at Week 48

Secondary: Number of participants with HIV-1 RNA <50 copies/mL using snapshot algorithm at Week 48

Secondary: Number of participants with HIV-1 RNA <200 copies/mL using snapshot algorithm at Week 48

Secondary: Number of participants with HIV-1 RNA <200 copies/mL using snapshot algorithm at Week 48

Secondary: Number of participants with confirmed virologic failure (CVF)

Secondary: Number of participants with confirmed virologic failure (CVF)

Secondary: Absolute values for plasma HIV-1 RNA at Week 48

Secondary: Absolute values for plasma HIV-1 RNA at Week 48

Secondary: Change from Baseline values for plasma HIV-1 RNA

Secondary: Change from Baseline values for plasma HIV-1 RNA

Secondary: Absolute values for CD4+ lymphocyte count at Week 48

Secondary: Absolute values for CD4+ lymphocyte count at Week 48

Secondary: Change from Baseline values for CD4+ lymphocyte count at Week 48

Secondary: Change from Baseline values for CD4+ lymphocyte count at Week 48

Secondary: Number of participants with disease progression

Secondary: Number of participants with disease progression

Secondary: Number of participants with non-serious adverse events (non-SAEs) and serious adverse events (SAEs)

Secondary: Number of participants with non-serious adverse events (non-SAEs) and serious adverse events (SAEs)

Secondary: Number of participants with severity of adverse events

Secondary: Number of participants with severity of adverse events

Secondary: Absolute values for hematology parameters over time including Week 48: basophil, eosinophils, leukocytes, lymphocytes, neutrophils, monocytes, and platelets

Secondary: Absolute values for hematology parameters over time including Week 48: basophil, eosinophils, leukocytes, lymphocytes, neutrophils, monocytes, and platelets

Secondary: Absolute values for hematology parameters: erythrocyte mean corpuscular volume

Secondary: Absolute values for hematology parameters: erythrocyte mean corpuscular volume

Secondary: Absolute values for hematology parameters: erythrocytes

Secondary: Absolute values for hematology parameters: erythrocytes

Secondary: Absolute values for hematology parameters: hemoglobin

Secondary: Absolute values for hematology parameters: hemoglobin

Secondary: Absolute values for hematology parameters: hematocrit

Secondary: Absolute values for hematology parameters: hematocrit

Secondary: Change from Baseline for hematology parameters: basophil, eosinophils, leukocytes, lymphocytes, neutrophils, monocytes, and platelets

Secondary: Change from Baseline for hematology parameters: basophil, eosinophils, leukocytes, lymphocytes, neutrophils, monocytes, and platelets

Secondary: Change from Baseline for hematology parameters: erythrocyte mean corpuscular volume

Secondary: Change from Baseline for hematology parameters: erythrocyte mean corpuscular volume

Secondary: Change from Baseline for hematology parameters: erythrocytes

Secondary: Change from Baseline for hematology parameters: erythrocytes

Secondary: Change from Baseline for hematology parameters: hematocrit

Secondary: Change from Baseline for hematology parameters: hematocrit

Secondary: Change from Baseline for hematology parameters: hemoglobin

Secondary: Change from Baseline for hematology parameters: hemoglobin

Secondary: Absolute values for clinical chemistry parameters over time including Week 48: Alanine aminotransferase (ALT), alkaline phosphatase (ALP), aspartate aminotransferase (AST) and creatinine kinase (CK)

Secondary: Absolute values for clinical chemistry parameters over time including Week 48: Alanine aminotransferase (ALT), alkaline phosphatase (ALP), aspartate aminotransferase (AST) and creatinine kinase (CK)

Secondary: Absolute values for clinical chemistry parameter over time including Week 48: Albumin

Secondary: Absolute values for clinical chemistry parameter over time including Week 48: Albumin

Secondary: Absolute values for clinical chemistry parameters over time including Week 48: bilirubin, direct bilirubin and creatinine

Secondary: Absolute values for clinical chemistry parameters over time including Week 48: bilirubin, direct bilirubin and creatinine

Secondary: Absolute values for clinical chemistry parameters: total carbon-dioxide (CO2), chloride, glucose, phosphate, potassium, sodium and urea over time including Week 48

Secondary: Absolute values for clinical chemistry parameters: total carbon-dioxide (CO2), chloride, glucose, phosphate, potassium, sodium and urea over time including Week 48

Secondary: Absolute values for clinical chemistry parameter over time including Week 48: Lipase

Secondary: Absolute values for clinical chemistry parameter over time including Week 48: Lipase

Secondary: Absolute values for clinical chemistry parameter over time including Week 48: Creatinine clearance

Secondary: Absolute values for clinical chemistry parameter over time including Week 48: Creatinine clearance

Secondary: Number of participants with abnormal urinalysis parameters over time including Week 48

Secondary: Number of participants with abnormal urinalysis parameters over time including Week 48

Secondary: Number of participants with urine potential of hydrogen (pH) over time including Week 48

Secondary: Number of participants with urine potential of hydrogen (pH) over time including Week 48

Secondary: Change from Baseline in clinical chemistry parameters over time including Week 48: ALT, ALP, AST and CK

Secondary: Change from Baseline in clinical chemistry parameters over time including Week 48: ALT, ALP, AST and CK

Secondary: Change from Baseline values for clinical chemistry parameter over time including Week 48: Albumin

Secondary: Change from Baseline values for clinical chemistry parameter over time including Week 48: Albumin

Secondary: Change from Baseline values for clinical chemistry parameters over time including Week 48: Bilirubin, direct bilirubin and creatinine

Secondary: Change from Baseline values for clinical chemistry parameters over time including Week 48: Bilirubin, direct bilirubin and creatinine

Secondary: Change from Baseline values for clinical chemistry parameters over time including Week 48

Secondary: Change from Baseline values for clinical chemistry parameters over time including Week 48

Secondary: Change from Baseline values for fasting lipid panel over time including Week 48

Secondary: Change from Baseline values for fasting lipid panel over time including Week 48

Secondary: Change from Baseline values for clinical chemistry parameter over time including Week 48: Lipase

Secondary: Change from Baseline values for clinical chemistry parameter over time including Week 48: Lipase

Secondary: Change from Baseline values for clinical chemistry parameter over time including Week 48: Creatinine clearance