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    Clinical Trial Results:
    A Phase III, Randomized, Multicenter, Parallel-group, Open- Label Study Evaluating the Efficacy, Safety, and Tolerability of Long-Acting Intramuscular Cabotegravir and Rilpivirine for Maintenance of Virologic Suppression Following Switch from an Integrase Inhibitor Single Tablet Regimen in HIV-1 Infected Antiretroviral Therapy Naive Adult Participants

    Summary
    EudraCT number
    		 2016-001646-25
    Trial protocol
    		 ES   GB   DE   NL   IT  
    Global end of trial date

    Results information
    Results version number
    		 v1
    This version publication date
    24 Aug 2019
    First version publication date
    24 Aug 2019
    Other versions
    		 v2

    Trial information

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    Trial identification
    Sponsor protocol code
    201584
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    ViiV Healthcare
    Sponsor organisation address
    980 Great West Road, Brentford, Middlesex, United Kingdom,
    Public contact
    GSK Response Center, ViiV Healthcare, 1 8664357343, GSKClinicalSupportHD@gsk.com
    Scientific contact
    GSK Response Center, ViiV Healthcare, 1 8664357343, GSKClinicalSupportHD@gsk.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Interim
    Date of interim/final analysis
    27 Nov 2018
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    30 Aug 2018
    Global end of trial reached?
    No
    General information about the trial
    Main objective of the trial
    To demonstrate the non-inferior antiviral activity of switching to intramuscular CAB LA + RPV LA every 4 weeks compared to continuation of ABC/DTG/3TC over 48 weeks in HIV-1 antiretroviral naïve participants.
    Protection of trial subjects
    Not applicable
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    27 Oct 2016
    Long term follow-up planned
    Yes
    Long term follow-up rationale
    		 Efficacy, Scientific research, Safety
    Long term follow-up duration
    		 12 Months
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Canada: 23
    Country: Number of subjects enrolled
    France: 43
    Country: Number of subjects enrolled
    Germany: 44
    Country: Number of subjects enrolled
    Italy: 38
    Country: Number of subjects enrolled
    Japan: 20
    Country: Number of subjects enrolled
    Netherlands: 5
    Country: Number of subjects enrolled
    Russian Federation: 93
    Country: Number of subjects enrolled
    South Africa: 32
    Country: Number of subjects enrolled
    Spain: 157
    Country: Number of subjects enrolled
    United Kingdom: 25
    Country: Number of subjects enrolled
    United States: 86
    Worldwide total number of subjects
    566
    EEA total number of subjects
    312
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    0
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    563
    From 65 to 84 years
    3
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 This non-inferiority study evaluated antiviral activity of switching to intramuscular long acting carbotegravir (CAB) and rilpivirine (RPV) every 4 weeks compared to continuation of abacavir (ABC)/dolutegravir (DTG)/lamivudine (3TC) over 48 weeks in virologically suppressed participants with human immunodeficiency type 1 infection

    Pre-assignment
    Screening details
    		 A total of 631 participants were enrolled into the Induction Phase of the study. 566 participants were subsequently randomized. Two randomized participants did not receive study treatment. This study was conducted in 11 countries. The results presented are based on Week 48 primary analysis

    Period 1
    Period 1 title
    Overall Study (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 CAB LA + RPV LA (Q4W)
    Arm description
    		 Participants who received ABC/DTG/3TC for 20 Weeks (Week [-20] to Day 1) in the Induction Phase and who have an HIV-1 ribonucleic acid (RNA) <50 copies per millilter (c/mL) at Week (-4) entered Maintenance Phase (Day 1 to Week 100) to begin oral therapy with CAB 30 milligram (mg) + RPV 25 mg once daily for 4 Weeks. At Week 4b visit, participants received last dose of oral CAB + RPV and first dose CAB LA 600 mg + RPV LA 900 mg injections. Participants received intramuscular (IM) injections of CAB LA 400 mg and RPV LA 600 mg at Week 8 and every four weeks (Q4W) through Week 100. After completion of Maintenance Phase, participants who chose to enter Extension Phase will continue 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 (LTFU) period.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Cabotegravir oral
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Participants received cabotegravir (CAB) 30 milligram (mg) tablet 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
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Participants received rilpivirine (RPV) 25 mg tablet once daily from Day 1 to Week 4b approximately the same time each day with a meal

    Investigational medicinal product name
    Cabotegravir Injection
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Participants received CAB 3 milliliter (mL; 600 mg) IM injection at Week 4b after the last dose of CAB oral regimen. Participants then received CAB 2 mL (400 mg) injections every 4 weeks from Week 8 to Week 100

    Investigational medicinal product name
    Rilpivirine Injection
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Participants received RPV 3 mL (900 mg) IM injection at Week 4b after the last dose of RPV oral regimen. Participants then received RPV 2 mL (600 mg) injections every 4 weeks from Week 8 to Week 100

    Arm title
    		 ABC/ DTG/ 3TC
    Arm description
    		 During Maintenance Phase (Day 1 to Week 100), participants continued to receive ABC/DTG/3TC. After completion of Maintenance Phase, participants who chose to enter the Extension Phase have the option to complete the study or switch to CAB LA+RPV LA
    Arm type
    		 Active comparator

    Investigational medicinal product name
    ABC/DTG/3TC Single Tablet Regimen (STR)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Participants received abacavir (ABC) 600 mg/ dolutegravir (DTG) 50 mg/ lamivudine (3TC) 300 mg film coated tablet once daily as single tablet regimen from Day 1 to Week 100

    Number of subjects in period 1
    		CAB LA + RPV LA (Q4W) ABC/ DTG/ 3TC
    Started
    283
    283
    Completed
    0
    0
    Not completed
    283
    283
         Physician decision
    2
    5
         Consent withdrawn by subject
    7
    7
         Adverse event, non-fatal
    9
    4
         On-going at the time of analysis
    258
    261
         Lost to follow-up
    2
    2
         Lack of efficacy
    5
    3
         Protocol deviation
    -
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    CAB LA + RPV LA (Q4W)
    Reporting group description
    		 Participants who received ABC/DTG/3TC for 20 Weeks (Week [-20] to Day 1) in the Induction Phase and who have an HIV-1 ribonucleic acid (RNA) <50 copies per millilter (c/mL) at Week (-4) entered Maintenance Phase (Day 1 to Week 100) to begin oral therapy with CAB 30 milligram (mg) + RPV 25 mg once daily for 4 Weeks. At Week 4b visit, participants received last dose of oral CAB + RPV and first dose CAB LA 600 mg + RPV LA 900 mg injections. Participants received intramuscular (IM) injections of CAB LA 400 mg and RPV LA 600 mg at Week 8 and every four weeks (Q4W) through Week 100. After completion of Maintenance Phase, participants who chose to enter Extension Phase will continue 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 (LTFU) period.

    Reporting group title
    ABC/ DTG/ 3TC
    Reporting group description
    		 During Maintenance Phase (Day 1 to Week 100), participants continued to receive ABC/DTG/3TC. After completion of Maintenance Phase, participants who chose to enter the Extension Phase have the option to complete the study or switch to CAB LA+RPV LA

    Reporting group values
    		 CAB LA + RPV LA (Q4W) ABC/ DTG/ 3TC Total
    Number of subjects
    		 283 283 566
    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)
    		 281 282 563
        From 65-84 years
    		 2 1 3
        85 years and over
    		 0 0 0
    Age Continuous
    Intent-to-Treat Exposed
    Units: Years
        arithmetic mean (standard deviation)
    		 35.9 ( 10.17 ) 36.0 ( 9.82 ) -
    Sex: Female, Male
    Intent-to-Treat Exposed
    Units: Subjects
        Female
    		 63 64 127
        Male
    		 220 219 439
    Race/Ethnicity, Customized
    Units: Subjects
        American Indian or Alaska Native
    		 3 6 9
        Asian-Central/South Asian Heritage
    		 2 1 3
        Asian-East Asian Heritage
    		 1 2 3
        Asian-South East Asian Heritage
    		 1 0 1
        Asian-Japanese Heritage
    		 8 12 20
        Black or African American
    		 47 56 103
        Native Hawaiian or other Pacific Islander
    		 1 0 1
        White-Arabic/North African Heritage
    		 5 3 8
        White-White /Caucasian/European Heritage
    		 211 198 409
        Multiple
    		 4 3 7
        Missing
    		 0 2 2

    End points

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    End points reporting groups
    Reporting group title
    CAB LA + RPV LA (Q4W)
    Reporting group description
    		 Participants who received ABC/DTG/3TC for 20 Weeks (Week [-20] to Day 1) in the Induction Phase and who have an HIV-1 ribonucleic acid (RNA) <50 copies per millilter (c/mL) at Week (-4) entered Maintenance Phase (Day 1 to Week 100) to begin oral therapy with CAB 30 milligram (mg) + RPV 25 mg once daily for 4 Weeks. At Week 4b visit, participants received last dose of oral CAB + RPV and first dose CAB LA 600 mg + RPV LA 900 mg injections. Participants received intramuscular (IM) injections of CAB LA 400 mg and RPV LA 600 mg at Week 8 and every four weeks (Q4W) through Week 100. After completion of Maintenance Phase, participants who chose to enter Extension Phase will continue 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 (LTFU) period.

    Reporting group title
    ABC/ DTG/ 3TC
    Reporting group description
    		 During Maintenance Phase (Day 1 to Week 100), participants continued to receive ABC/DTG/3TC. After completion of Maintenance Phase, participants who chose to enter the Extension Phase have the option to complete the study or switch to CAB LA+RPV LA

    Subject analysis set title
    CAB LA
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Participants in this arm received CAB 30 mg once daily for 4 Weeks during Maintenance Phase (Day 1 to Week 100). At Week 4b visit, participants received last dose of oral CAB and first dose CAB LA 600 mg injections. Participants received IM injections of CAB LA 400 mg at Week 8 and every four weeks through Week 100.

    Subject analysis set title
    RPV LA
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Participants in this arm received RPV 25 mg once daily for 4 Weeks during Maintenance Phase (Day 1 to Week 100). At Week 4b visit, participants received last dose of oral RPV and first dose CAB LA 900 mg injections. Participants received IM injections of RPV LA 600 mg at Week 8 and every four weeks through Week 100.

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

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    End point title
    		 Percentage of participants with virologic failure (HIV-1 ribonucleic acid [RNA] >=50 copies per millilter [mL]) using snapshot algorithm at Week 48
    End point description
    Percentage 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 noninferior antiviral activity of switching to intramuscular (IM) CAB LA+RPV LA every 4 weeks compared to continuation of ABC/DTG/3TC regimen over 48 weeks in HIV-1 infected ARTexperienced participants. The HIV-1 RNA >=50 copies/mL per snapshot algorithm was determined by the last on-treatment HIV-1 RNA measurement within the Week 48 analysis visit window (+/- 6 weeks) or at time of discontinuation (if discontinuation occurred prior to Week 48 for reasons other than Adverse Event). 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) ABC/ DTG/ 3TC
    Number of subjects analysed
    283 [1]
    283 [2]
    Units: Percentage of Participants
        number (not applicable)
    2.1
    2.5
    Notes
    [1] - ITT-E Population
    [2] - ITT-E Population
    Statistical analysis title
    		 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 c/mL) can be concluded if the upper bound of a two-sided 95% confidence interval (CI) for the difference in failure rates between the two treatment arms (CAB – ABC/DTG/3TC) is less than 6%.
    Comparison groups
    CAB LA + RPV LA (Q4W) v ABC/ DTG/ 3TC
    Number of subjects included in analysis
    566
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [3]
    Method
    Parameter type
    		 Adjusted difference in proportion
    Point estimate
    -0.4
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -2.8
         upper limit
    		 2.1
    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 Induction Baseline (Week -20) HIV-1 RNA (<100,000 >=100,000 c/mL)

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

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    End point title
    		 Percentage of participants with HIV-1 RNA <50 copies/mL using snapshot algorithm at Week 48
    End point description
    Percentage 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 ABC/DTG/3TC. The HIV-1 RNA <50 copies/mL per snapshot algorithm was determined by last on-treatment HIV-1 RNA measurement within the Week 48 analysis visit window (+/- 6 weeks). Participants with no data in the analysis window were classificated as non-responders.
    End point type
    Secondary
    End point timeframe
    Week 48
    End point values
    		 CAB LA + RPV LA (Q4W) ABC/ DTG/ 3TC
    Number of subjects analysed
    283 [4]
    283 [5]
    Units: Percentage of Participants
    94
    93
    Notes
    [4] - ITT-E Population
    [5] - ITT-E Population
    Statistical analysis title
    		 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 – ABC/DTG/3TC) is more than -10%
    Comparison groups
    CAB LA + RPV LA (Q4W) v ABC/ DTG/ 3TC
    Number of subjects included in analysis
    566
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [6]
    Method
    Parameter type
    		 Adjusted difference in proportion
    Point estimate
    0.4
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -3.7
         upper limit
    		 4.5
    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 Induction Baseline (Week -20) HIV-1 RNA (<100,000 >=100,000 c/mL)

    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
    Percentage 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 ABC/DTG/3TC
    End point type
    Secondary
    End point timeframe
    Week 48
    End point values
    		 CAB LA + RPV LA (Q4W) ABC/ DTG/ 3TC
    Number of subjects analysed
    283 [7]
    283 [8]
    Units: Percentage of Participants
        number (confidence interval 95%)
    94 (91 to 97)
    94 (91 to 97)
    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) during the Maintenance Phase

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    End point title
    		 Number of participants with confirmed virologic failure (CVF) during the Maintenance Phase
    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.
    End point type
    Secondary
    End point timeframe
    Week 48
    End point values
    		 CAB LA + RPV LA (Q4W) ABC/ DTG/ 3TC
    Number of subjects analysed
    283 [9]
    283 [10]
    Units: Participants
    4
    3
    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
    Plasma for quantitative HIV-1 RNA were collected at indicated time points. 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) ABC/ DTG/ 3TC
    Number of subjects analysed
    283 [11]
    283 [12]
    Units: log10 copies/mL
        arithmetic mean (standard deviation)
    1.513 ( 0.0954 )
    1.518 ( 0.1152 )
    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 at Week 48

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    End point title
    		 Change from Baseline values for plasma HIV-1 RNA at Week 48
    End point description
    Baseline value is defined as the last available recorded value up to and including the date of first Maintenance Phase dose of IP. Change from Baseline was defined as: HIV-1 RNA(log 10) at Week 48 minus HIV-1 RNA(log 10) at Baseline. 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) ABC/ DTG/ 3TC
    Number of subjects analysed
    283 [13]
    283 [14]
    Units: log10 copies/mL
        arithmetic mean (standard deviation)
    -0.006 ( 0.1026 )
    0.001 ( 0.1435 )
    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
    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 ABC/DTG/3TC. 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) ABC/ DTG/ 3TC
    Number of subjects analysed
    283 [15]
    283 [16]
    Units: Cells per cubic millimeter
        arithmetic mean (standard deviation)
    703.2 ( 285.75 )
    731.2 ( 272.49 )
    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 ABC/DTG/3TC. Baseline value is defined as the last available recorded value up to and including the date of first Maintenance Phase dose of IP. Change from Baseline was defined as post-dose visit value at Week 48 minus Maintenance 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) ABC/ DTG/ 3TC
    Number of subjects analysed
    283 [17]
    283 [18]
    Units: Cells per cubic millimeter
        arithmetic mean (standard deviation)
    40.2 ( 195.17 )
    79.9 ( 194.55 )
    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
    Data for participants who experienced disease progression to Centers for Disease Control and Prevention (CDC) Stage III or death has been presented. CDC stage is derived according to lowest post baseline CD4+ T-lympohocyte count and/or occurrence of AIDS-defining conditons (per 2014 CDC criteria).
    End point type
    Secondary
    End point timeframe
    Day 1 up to an average of 59 weeks
    End point values
    		 CAB LA + RPV LA (Q4W) ABC/ DTG/ 3TC
    Number of subjects analysed
    283 [19]
    283 [20]
    Units: Participants
    9
    11
    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 AE is any untoward medical occurrence temporally associated with the use of a study treatment, whether or not considered related to study treatment. A SAE is 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 judgment. Safety Population: all randomized participants who received at least 1 dose of IP during maintenance phase and assessed according to actual treatment received. All Maintenance Phase AEs was presented including AEs with start date occurring on/after date of 1st dose of randomized treatment, up to and including start date of LTFU antiretroviral therapy for participants who discontinued from Q4W arm. Non-SAE counts in >=5% of participants within any arm is reported
    End point type
    Secondary
    End point timeframe
    Day 1 up to an average of 59 Weeks
    End point values
    		 CAB LA + RPV LA (Q4W) ABC/ DTG/ 3TC
    Number of subjects analysed
    283 [21]
    283 [22]
    Units: Participants
        Any non-SAE
    252
    138
        Any SAE
    18
    12
    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 adverse events (AEs) were defined as per The Division of acquired immuno deficiency syndrome (DAIDS) 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. All Maintenance Phase adverse events have been presented, which includes AEs with start date occuring on or after the date of first dose of randomized study treatment, up to and including the start date of LTFU antiretroviral therapy for participants who discontinued from the Q4W arm.
    End point type
    Secondary
    End point timeframe
    Up to Week 48
    End point values
    		 CAB LA + RPV LA (Q4W) ABC/ DTG/ 3TC
    Number of subjects analysed
    283 [23]
    283 [24]
    Units: Participants
        Grade 1
    93
    119
        Grade 2
    143
    95
        Grade 3
    23
    10
        Grade 4
    8
    1
        Grade 5
    0
    0
    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: basophils, eosinophils, leukocytes, lymphocytes, neutrophils, monocytes, and platelets

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    End point title
    		 Absolute values for hematology parameters over time including Week 48: basophils, 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) ABC/ DTG/ 3TC
    Number of subjects analysed
    283 [25]
    283 [26]
    Units: 10^9 cells per Liter
    arithmetic mean (standard deviation)
        Basophils, Baseline (Day 1), n=283, 283
    0.022 ( 0.0124 )
    0.022 ( 0.0138 )
        Basophils, Week 4, n=277, 270
    0.024 ( 0.0136 )
    0.024 ( 0.0142 )
        Basophils, Week 8, n=210, 272
    0.023 ( 0.0135 )
    0.023 ( 0.0122 )
        Basophils, Week 12, n=267, 272
    0.025 ( 0.0166 )
    0.023 ( 0.0144 )
        Basophils, Week 16, n=247, 259
    0.030 ( 0.0212 )
    0.028 ( 0.0209 )
        Basophils, Week 20, n=247, 259
    0.035 ( 0.0254 )
    0.032 ( 0.0256 )
        Basophils, Week 24, n=256, 260
    0.037 ( 0.0245 )
    0.036 ( 0.0256 )
        Basophils, Week 28, n=239, 258
    0.039 ( 0.0249 )
    0.038 ( 0.0247 )
        Basophils, Week 32, n=246, 263
    0.044 ( 0.0254 )
    0.038 ( 0.0246 )
        Basophils, Week 36, n=250, 259
    0.042 ( 0.0237 )
    0.040 ( 0.0250 )
        Basophils, Week 40, n=244, 245
    0.041 ( 0.0248 )
    0.041 ( 0.0252 )
        Basophils, Week 44, n=249, 260
    0.040 ( 0.0246 )
    0.040 ( 0.0257 )
        Basophils, Week 48, n=239, 258
    0.038 ( 0.0214 )
    0.038 ( 0.0246 )
        Eosinophils, Baseline (Day 1), n=283, 283
    0.142 ( 0.1238 )
    0.141 ( 0.1449 )
        Eosinophils, Week 4, n=277, 270
    0.164 ( 0.1470 )
    0.154 ( 0.1535 )
        Eosinophils, Week 8, n=210, 272
    0.169 ( 0.1401 )
    0.150 ( 0.1393 )
        Eosinophils, Week 12, n=267, 272
    0.165 ( 0.1375 )
    0.157 ( 0.1481 )
        Eosinophils, Week 16, n=247, 259
    0.177 ( 0.1538 )
    0.162 ( 0.1434 )
        Eosinophils, Week 20, n=247, 259
    0.185 ( 0.1617 )
    0.166 ( 0.1675 )
        Eosinophils, Week 24, n=256, 260
    0.193 ( 0.1591 )
    0.172 ( 0.1518 )
        Eosinophils, Week 28, n=239, 258
    0.206 ( 0.1634 )
    0.179 ( 0.1659 )
        Eosinophils, Week 32, n=246, 263
    0.206 ( 0.1779 )
    0.169 ( 0.1466 )
        Eosinophils, Week 36, n=250, 259
    0.209 ( 0.2043 )
    0.172 ( 0.1540 )
        Eosinophils, Week 40, n=244, 245
    0.203 ( 0.1837 )
    0.174 ( 0.1495 )
        Eosinophils, Week 44, n=249, 260
    0.198 ( 0.1867 )
    0.180 ( 0.1723 )
        Eosinophils, Week 48, n=239, 258
    0.182 ( 0.1508 )
    0.172 ( 0.1533 )
        Leukocytes, Baseline (Day 1), n=283, 283
    5.82 ( 1.792 )
    5.68 ( 1.684 )
        Leukocytes, Week 4, n=279, 272
    6.41 ( 1.989 )
    6.11 ( 1.770 )
        Leukocytes, Week 8, n=211, 275
    6.04 ( 1.806 )
    6.00 ( 1.714 )
        Leukocytes, Week 12, n=270, 275
    5.88 ( 1.590 )
    6.08 ( 1.836 )
        Leukocytes, Week 16, n=252, 265
    6.08 ( 2.045 )
    6.11 ( 1.887 )
        Leukocytes, Week 20, n=254, 265
    6.08 ( 1.788 )
    6.15 ( 1.926 )
        Leukocytes, Week 24, n=258, 264
    6.11 ( 1.841 )
    6.16 ( 2.046 )
        Leukocytes, Week 28, n=244, 263
    6.17 ( 1.929 )
    6.17 ( 1.939 )
        Leukocytes, Week 32, n=253, 266
    6.07 ( 1.925 )
    6.12 ( 1.918 )
        Leukocytes, Week 36, n=252, 259
    6.11 ( 1.992 )
    6.23 ( 2.104 )
        Leukocytes, Week 40, n=246, 253
    5.96 ( 1.773 )
    6.12 ( 2.076 )
        Leukocytes, Week 44, n=256, 262
    6.03 ( 2.000 )
    6.19 ( 1.970 )
        Leukocytes, Week 48, n=243, 260
    5.85 ( 1.884 )
    5.99 ( 1.986 )
        Lymphocytes, Baseline (Day 1), n=283, 283
    2.022 ( 0.6893 )
    1.957 ( 0.6408 )
        Lymphocytes, Week 4, n=277, 270
    2.227 ( 0.7321 )
    2.197 ( 0.7198 )
        Lymphocytes, Week 8, n=210, 272
    2.102 ( 0.6980 )
    2.110 ( 0.7015 )
        Lymphocytes, Week 12, n=267, 272
    2.032 ( 0.6095 )
    2.117 ( 0.7162 )
        Lymphocytes, Week 16, n=247, 259
    2.028 ( 0.6931 )
    2.130 ( 0.7245 )
        Lymphocytes, Week 20, n=247, 259
    2.028 ( 0.6284 )
    2.121 ( 0.6995 )
        Lymphocytes, Week 24, n=256, 260
    2.014 ( 0.6456 )
    2.111 ( 0.7092 )
        Lymphocytes, Week 28, n=239, 258
    2.051 ( 0.6592 )
    2.106 ( 0.6679 )
        Lymphocytes, Week 32, n=246, 263
    2.037 ( 0.6543 )
    2.112 ( 0.6950 )
        Lymphocytes, Week 36, n=250, 259
    2.023 ( 0.6878 )
    2.098 ( 0.6921 )
        Lymphocytes, Week 40, n=244, 245
    2.021 ( 0.6646 )
    2.030 ( 0.6357 )
        Lymphocytes, Week 44, n=249, 260
    1.997 ( 0.6748 )
    2.068 ( 0.6754 )
        Lymphocytes, Week 48, n=239, 258
    1.926 ( 0.6126 )
    2.003 ( 0.7651 )
        Monocytes, Baseline (Day 1), n=283, 283
    0.382 ( 0.1666 )
    0.366 ( 0.1705 )
        Monocytes, Week 4, n=277, 270
    0.422 ( 0.1778 )
    0.398 ( 0.1778 )
        Monocytes, Week 8, n=210, 272
    0.415 ( 0.1824 )
    0.380 ( 0.1771 )
        Monocytes, Week 12, n=267, 272
    0.395 ( 0.1662 )
    0.383 ( 0.1570 )
        Monocytes, Week 16, n=247, 259
    0.438 ( 0.1859 )
    0.409 ( 0.1810 )
        Monocytes, Week 20, n=247, 259
    0.455 ( 0.1927 )
    0.423 ( 0.1904 )
        Monocytes, Week 24, n=256, 260
    0.438 ( 0.1859 )
    0.438 ( 0.1897 )
        Monocytes, Week 28, n=239, 258
    0.471 ( 0.1916 )
    0.447 ( 0.2003 )
        Monocytes, Week 32, n=246, 263
    0.462 ( 0.1898 )
    0.459 ( 0.2107 )
        Monocytes, Week 36, n=250, 259
    0.458 ( 0.2116 )
    0.456 ( 0.2021 )
        Monocytes, Week 40, n=244, 245
    0.438 ( 0.1740 )
    0.442 ( 0.2038 )
        Monocytes, Week 44, n=249, 260
    0.440 ( 0.1907 )
    0.428 ( 0.1965 )
        Monocytes, Week 48, n=239, 258
    0.402 ( 0.1911 )
    0.396 ( 0.1857 )
        Neutrophils, Baseline (Day 1), n=283, 283
    3.246 ( 1.3715 )
    3.205 ( 1.2803 )
        Neutrophils, Week 4, n=277, 270
    3.573 ( 1.5681 )
    3.342 ( 1.3344 )
        Neutrophils, Week 8, n=210, 272
    3.334 ( 1.3166 )
    3.316 ( 1.3588 )
        Neutrophils, Week 12, n=267, 272
    3.271 ( 1.2151 )
    3.379 ( 1.4884 )
        Neutrophils, Week 16, n=247, 259
    3.410 ( 1.7208 )
    3.432 ( 1.5052 )
        Neutrophils, Week 20, n=247, 259
    3.406 ( 1.4209 )
    3.433 ( 1.5620 )
        Neutrophils, Week 24, n=256, 260
    3.428 ( 1.4938 )
    3.424 ( 1.6766 )
        Neutrophils, Week 28, n=239, 258
    3.439 ( 1.5379 )
    3.423 ( 1.5514 )
        Neutrophils, Week 32, n=246, 263
    3.367 ( 1.5670 )
    3.392 ( 1.4892 )
        Neutrophils, Week 36, n=250, 259
    3.388 ( 1.5215 )
    3.468 ( 1.6269 )
        Neutrophils, Week 40, n=244, 245
    3.274 ( 1.3654 )
    3.477 ( 1.7021 )
        Neutrophils, Week 44, n=249, 260
    3.398 ( 1.5679 )
    3.503 ( 1.5486 )
        Neutrophils, Week 48, n=239, 258
    3.309 ( 1.4923 )
    3.419 ( 1.5186 )
        Platelets, Baseline (Day 1), n=283, 282
    226.7 ( 55.39 )
    230.6 ( 58.33 )
        Platelets, Week 4, n=278, 269
    233.1 ( 56.85 )
    233.4 ( 56.56 )
        Platelets, Week 8, n=207, 273
    226.9 ( 53.23 )
    232.0 ( 56.31 )
        Platelets, Week 12, n=269, 271
    226.6 ( 55.07 )
    235.5 ( 57.26 )
        Platelets, Week 16, n=251, 263
    225.5 ( 55.49 )
    239.9 ( 70.40 )
        Platelets, Week 20, n=255, 264
    233.8 ( 60.98 )
    243.4 ( 62.06 )
        Platelets, Week 24, n=256, 261
    233.9 ( 58.12 )
    244.2 ( 59.95 )
        Platelets, Week 28, n=245, 258
    233.7 ( 61.56 )
    247.2 ( 63.18 )
        Platelets, Week 32, n=249, 262
    235.0 ( 62.74 )
    245.3 ( 60.25 )
        Platelets, Week 36, n=248, 259
    237.3 ( 58.56 )
    248.1 ( 59.57 )
        Platelets, Week 40, n=244, 254
    233.9 ( 56.93 )
    247.4 ( 63.85 )
        Platelets, Week 44, n=254, 261
    236.7 ( 58.18 )
    249.5 ( 71.56 )
        Platelets, Week 48, n=240, 255
    232.8 ( 57.07 )
    246.0 ( 70.35 )
    Notes
    [25] - Safety Population
    [26] - Safety Population
    No statistical analyses for this end point

    Secondary: Absolute values for hematology parameters over time including Week 48: erythrocyte mean corpuscular volume

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    End point title
    		 Absolute values for hematology parameters over time including Week 48: 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. 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) ABC/ DTG/ 3TC
    Number of subjects analysed
    283 [27]
    283 [28]
    Units: Femtoliters
    arithmetic mean (standard deviation)
        Baseline (Day 1), n=283, 283
    94.8 ( 4.94 )
    94.3 ( 5.69 )
        Week 4, n=279, 273
    94.1 ( 4.77 )
    94.6 ( 5.85 )
        Week 8, n=211, 275
    92.3 ( 4.86 )
    94.6 ( 5.78 )
        Week 12, n=270, 275
    91.0 ( 4.64 )
    94.0 ( 5.81 )
        Week 16, n=254, 265
    89.9 ( 4.43 )
    94.1 ( 5.78 )
        Week 20, n=255, 267
    89.3 ( 4.46 )
    93.9 ( 5.64 )
        Week 24, n=259, 264
    89.4 ( 4.33 )
    93.8 ( 5.69 )
        Week 28, n=246, 265
    89.3 ( 4.64 )
    93.5 ( 5.78 )
        Week 32, n=254, 267
    89.6 ( 4.69 )
    93.6 ( 5.90 )
        Week 36, n=252, 261
    89.5 ( 4.65 )
    94.1 ( 5.65 )
        Week 40, n=246, 255
    90.3 ( 4.62 )
    94.4 ( 6.09 )
        Week 44, n=256, 262
    90.7 ( 5.05 )
    94.6 ( 6.32 )
        Week 48, n=243, 260
    91.2 ( 5.21 )
    95.4 ( 6.60 )
    Notes
    [27] - Safety Population
    [28] - Safety Population
    No statistical analyses for this end point

    Secondary: Absolute values for hematology parameters over time including Week 48: erythrocytes

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    End point title
    		 Absolute values for hematology parameters over time including Week 48: erythrocytes
    End point description
    Blood samples were collected for the analysis of hematology parameters including erythrocytes at indicated timepoints. 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) ABC/ DTG/ 3TC
    Number of subjects analysed
    283 [29]
    283 [30]
    Units: 10^12 cells per Liter
    arithmetic mean (standard deviation)
        Baseline (Day 1), n=283, 283
    4.59 ( 0.434 )
    4.65 ( 0.412 )
        Week 4, n=279, 273
    4.67 ( 0.423 )
    4.62 ( 0.406 )
        Week 8, n=211, 275
    4.76 ( 0.435 )
    4.67 ( 0.410 )
        Week 12, n=270, 275
    4.82 ( 0.435 )
    4.66 ( 0.419 )
        Week 16, n=254, 265
    4.87 ( 0.430 )
    4.66 ( 0.407 )
        Week 20, n=255, 267
    4.89 ( 0.418 )
    4.64 ( 0.410 )
        Week 24, n=259, 264
    4.87 ( 0.418 )
    4.67 ( 0.425 )
        Week 28, n=246, 265
    4.87 ( 0.416 )
    4.69 ( 0.395 )
        Week 32, n=254, 267
    4.83 ( 0.435 )
    4.66 ( 0.418 )
        Week 36, n=252, 261
    4.82 ( 0.403 )
    4.64 ( 0.395 )
        Week 40, n=246, 255
    4.81 ( 0.407 )
    4.63 ( 0.409 )
        Week 44, n=256, 262
    4.79 ( 0.425 )
    4.59 ( 0.403 )
        Week 48, n=243, 260
    4.74 ( 0.443 )
    4.59 ( 0.437 )
    Notes
    [29] - Safety Population
    [30] - Safety Population
    No statistical analyses for this end point

    Secondary: Absolute values for hematology parameters over time including Week 48: hemoglobin

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    End point title
    		 Absolute values for hematology parameters over time including Week 48: hemoglobin
    End point description
    Blood samples were collected for the analysis of hematology parameter including hemoglobin at indicated timepoints. 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) ABC/ DTG/ 3TC
    Number of subjects analysed
    283 [31]
    283 [32]
    Units: Grams per liter
    arithmetic mean (standard deviation)
        Baseline (Day 1), n=283, 283
    142.5 ( 13.59 )
    143.1 ( 13.51 )
        Week 4, n=279, 273
    144.3 ( 13.34 )
    143.4 ( 13.47 )
        Week 8, n=211, 275
    143.9 ( 13.84 )
    144.7 ( 13.59 )
        Week 12, n=270, 275
    144.5 ( 13.89 )
    144.7 ( 14.66 )
        Week 16, n=254, 265
    145.3 ( 13.52 )
    144.6 ( 13.88 )
        Week 20, n=255, 267
    145.4 ( 12.69 )
    144.8 ( 13.87 )
        Week 24, n=259, 264
    145.0 ( 13.14 )
    145.3 ( 14.07 )
        Week 28, n=246, 265
    145.3 ( 12.80 )
    146.5 ( 14.17 )
        Week 32, n=254, 267
    145.1 ( 13.37 )
    146.2 ( 14.80 )
        Week 36, n=252, 261
    144.6 ( 12.27 )
    146.2 ( 13.85 )
        Week 40, n=246, 255
    145.9 ( 12.32 )
    146.2 ( 13.85 )
        Week 44, n=256, 262
    145.1 ( 12.79 )
    145.0 ( 14.13 )
        Week 48, n=243, 260
    143.8 ( 13.56 )
    145.4 ( 14.56 )
    Notes
    [31] - Safety Population
    [32] - Safety Population
    No statistical analyses for this end point

    Secondary: Absolute values for hematology parameters over time including Week 48: hematocrit

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    End point title
    		 Absolute values for hematology parameters over time including Week 48: hematocrit
    End point description
    Blood samples were collected for the analysis of hematology parameters including hematocrit at indicated timepoints. 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) ABC/ DTG/ 3TC
    Number of subjects analysed
    283 [33]
    283 [34]
    Units: Proportion of red blood cells in blood
    arithmetic mean (standard deviation)
        Baseline (Day 1), n=283, 283
    0.4341 ( 0.03889 )
    0.4370 ( 0.03887 )
        Week 4, n=279, 273
    0.4387 ( 0.03809 )
    0.4363 ( 0.03832 )
        Week 8, n=211, 275
    0.4382 ( 0.04056 )
    0.4403 ( 0.03978 )
        Week 12, n=270, 275
    0.4377 ( 0.04020 )
    0.4373 ( 0.04144 )
        Week 16, n=254, 265
    0.4366 ( 0.03769 )
    0.4371 ( 0.03890 )
        Week 20, n=255, 267
    0.4363 ( 0.03574 )
    0.4349 ( 0.03839 )
        Week 24, n=259, 264
    0.4351 ( 0.03580 )
    0.4366 ( 0.03901 )
        Week 28, n=246, 265
    0.4342 ( 0.03519 )
    0.4374 ( 0.03867 )
        Week 32, n=254, 267
    0.4318 ( 0.03623 )
    0.4347 ( 0.04025 )
        Week 36, n=252, 261
    0.4301 ( 0.03392 )
    0.4349 ( 0.03774 )
        Week 40, n=246, 255
    0.4328 ( 0.03433 )
    0.4358 ( 0.03845 )
        Week 44, n=256, 262
    0.4332 ( 0.03570 )
    0.4328 ( 0.03847 )
        Week 48, n=243, 260
    0.4310 ( 0.03875 )
    0.4361 ( 0.04156 )
    Notes
    [33] - Safety Population
    [34] - 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 timepoints. 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) ABC/ DTG/ 3TC
    Number of subjects analysed
    283 [35]
    283 [36]
    Units: International units per liter
    arithmetic mean (standard deviation)
        ALT, Baseline (Day 1), n=283, 283
    28.7 ( 125.27 )
    19.5 ( 14.76 )
        ALT, Week 4, n=281, 277
    25.1 ( 64.74 )
    17.9 ( 11.10 )
        ALT, Week 8, n=212, 278
    20.8 ( 17.43 )
    18.4 ( 11.34 )
        ALT, Week 12, n=270, 276
    21.4 ( 16.94 )
    19.2 ( 11.29 )
        ALT, Week 16, n=255, 269
    21.6 ( 17.61 )
    20.3 ( 13.34 )
        ALT, Week 20, n=260, 272
    25.8 ( 72.51 )
    19.6 ( 15.78 )
        ALT, Week 24, n=261, 268
    23.9 ( 31.14 )
    19.1 ( 11.91 )
        ALT, Week 28, n=253, 268
    22.5 ( 19.78 )
    19.6 ( 10.73 )
        ALT, Week 32, n=256, 268
    38.5 ( 293.55 )
    19.0 ( 11.56 )
        ALT, Week 36, n=255, 261
    20.3 ( 13.92 )
    21.2 ( 31.68 )
        ALT, Week 40, n=250, 266
    20.9 ( 17.32 )
    19.5 ( 12.35 )
        ALT, Week 44, n=258, 263
    22.2 ( 27.14 )
    19.8 ( 17.43 )
        ALT, Week 48, n=247, 262
    20.1 ( 21.78 )
    19.7 ( 16.58 )
        ALP, Baseline (Day 1), n=283, 283
    66.5 ( 22.06 )
    67.1 ( 22.98 )
        ALP, Week 4, n=281, 277
    66.2 ( 19.56 )
    65.5 ( 17.07 )
        ALP, Week 8, n=212, 278
    66.8 ( 18.82 )
    66.3 ( 17.49 )
        ALP, Week 12, n=270, 276
    66.8 ( 19.80 )
    66.1 ( 17.23 )
        ALP, Week 16, n=255, 269
    66.7 ( 19.96 )
    66.1 ( 17.89 )
        ALP, Week 20, n=260, 272
    67.6 ( 19.11 )
    65.6 ( 16.71 )
        ALP, Week 24, n=261, 268
    67.1 ( 19.68 )
    66.1 ( 17.96 )
        ALP, Week 28, n=253, 268
    67.4 ( 20.05 )
    67.5 ( 18.07 )
        ALP, Week 32, n=256, 268
    68.0 ( 22.17 )
    66.6 ( 17.65 )
        ALP, Week 36, n=255, 261
    69.5 ( 26.86 )
    68.3 ( 20.19 )
        ALP, Week 40, n=250, 266
    67.4 ( 18.94 )
    67.7 ( 18.30 )
        ALP, Week 44, n=258, 263
    67.7 ( 18.59 )
    68.2 ( 18.62 )
        ALP, Week 48, n=247, 262
    66.4 ( 17.95 )
    67.7 ( 18.15 )
        AST, Baseline (Day 1), n=283, 283
    28.8 ( 90.66 )
    22.5 ( 14.80 )
        AST, Week 4, n=281, 277
    25.1 ( 32.67 )
    20.9 ( 8.47 )
        AST, Week 8, n=212, 278
    23.6 ( 20.85 )
    20.5 ( 6.26 )
        AST, Week 12, n=270, 276
    22.8 ( 10.38 )
    21.0 ( 8.14 )
        AST, Week 16, n=255, 269
    23.0 ( 10.71 )
    22.8 ( 14.03 )
        AST, Week 20, n=260, 272
    25.3 ( 32.64 )
    22.7 ( 23.48 )
        AST, Week 24, n=261, 268
    25.9 ( 25.16 )
    21.2 ( 9.73 )
        AST, Week 28, n=253, 268
    24.8 ( 16.50 )
    21.7 ( 10.61 )
        AST, Week 32, n=256, 268
    37.1 ( 233.23 )
    20.7 ( 6.42 )
        AST, Week 36, n=255, 261
    23.0 ( 12.44 )
    22.4 ( 17.37 )
        AST, Week 40, n=250, 266
    23.1 ( 12.22 )
    21.0 ( 6.51 )
        AST, Week 44, n=258, 263
    24.4 ( 15.66 )
    21.9 ( 13.25 )
        AST Week 48, n=247, 262
    22.3 ( 10.98 )
    23.5 ( 42.49 )
        CK, Baseline (Day 1), n=283, 283
    197.8 ( 291.21 )
    199.8 ( 482.84 )
        CK, Week 4, n=280, 277
    230.2 ( 447.94 )
    173.0 ( 220.54 )
        CK, Week 8, n=212, 278
    258.0 ( 928.82 )
    152.9 ( 146.05 )
        CK, Week 12, n=270, 276
    201.8 ( 348.13 )
    182.6 ( 387.61 )
        CK, Week 16, n=255, 269
    179.7 ( 248.71 )
    234.0 ( 576.62 )
        CK, Week 20, n=260, 272
    215.7 ( 539.34 )
    258.9 ( 1109.04 )
        CK, Week 24, n=261, 268
    248.6 ( 628.44 )
    183.1 ( 368.02 )
        CK, Week 28, n=253, 268
    252.7 ( 673.98 )
    194.5 ( 506.24 )
        CK, Week 32, n=256, 268
    175.8 ( 223.16 )
    160.0 ( 176.09 )
        CK, Week 36, n=254, 261
    219.0 ( 507.30 )
    215.2 ( 460.38 )
        CK, Week 40, n=250, 266
    220.5 ( 507.68 )
    149.5 ( 115.14 )
        CK, Week 44, n=258, 263
    254.0 ( 477.19 )
    181.9 ( 428.28 )
        CK, Week 48, n=247, 262
    185.5 ( 227.54 )
    323.6 ( 2637.27 )
    Notes
    [35] - Safety Population
    [36] - 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 timepoints. 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) ABC/ DTG/ 3TC
    Number of subjects analysed
    283 [37]
    283 [38]
    Units: Grams per liter
    arithmetic mean (standard deviation)
        Baseline (Day 1), n=283, 283
    43.8 ( 3.04 )
    44.1 ( 2.80 )
        Week 4, n=280, 277
    43.7 ( 3.03 )
    43.8 ( 2.70 )
        Week 8, n=212, 278
    43.5 ( 2.85 )
    43.9 ( 2.76 )
        Week 12, n=270, 276
    43.7 ( 3.06 )
    44.1 ( 2.87 )
        Week 16, n=255, 269
    44.1 ( 2.99 )
    44.0 ( 2.78 )
        Week 20, n=260, 272
    44.1 ( 3.11 )
    43.9 ( 2.72 )
        Week 24, n=261, 268
    44.3 ( 3.08 )
    44.2 ( 2.60 )
        Week 28, n=253, 268
    44.4 ( 3.09 )
    44.5 ( 2.66 )
        Week 32, n=255, 268
    44.6 ( 3.17 )
    44.4 ( 2.76 )
        Week 36, n=254, 261
    44.1 ( 3.05 )
    44.3 ( 2.63 )
        Week 40, n=250, 266
    44.8 ( 3.02 )
    44.5 ( 2.76 )
        Week 44, n=258, 263
    44.7 ( 2.98 )
    44.4 ( 2.71 )
        Week 48, n=247, 262
    44.6 ( 2.98 )
    44.6 ( 2.86 )
    Notes
    [37] - Safety Population
    [38] - 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 timepoints. 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) ABC/ DTG/ 3TC
    Number of subjects analysed
    283 [39]
    283 [40]
    Units: Micromoles per liter
    arithmetic mean (standard deviation)
        Bilirubin, Baseline (Day 1), n=283, 283
    9.3 ( 5.12 )
    9.4 ( 4.68 )
        Bilirubin, Week 4, n=281, 277
    10.7 ( 6.37 )
    8.9 ( 4.40 )
        Bilirubin, Week 8, n=212, 278
    10.1 ( 4.62 )
    8.8 ( 3.85 )
        Bilirubin, Week 12, n=270, 276
    10.5 ( 5.45 )
    8.6 ( 3.53 )
        Bilirubin, Week 16, n=255, 269
    10.6 ( 5.49 )
    8.7 ( 3.74 )
        Bilirubin, Week 20, n=260, 272
    10.3 ( 5.29 )
    8.5 ( 3.40 )
        Bilirubin, Week 24, n=261, 268
    10.0 ( 5.09 )
    8.9 ( 3.86 )
        Bilirubin, Week 28, n=253, 268
    10.4 ( 5.67 )
    8.6 ( 3.90 )
        Bilirubin, Week 32, n=256, 268
    10.5 ( 7.86 )
    8.7 ( 3.95 )
        Bilirubin, Week 36, n=255, 260
    9.9 ( 6.35 )
    8.5 ( 3.42 )
        Bilirubin, Week 40, n=250, 266
    10.2 ( 5.26 )
    8.5 ( 3.52 )
        Bilirubin, Week 44, n=258, 263
    10.3 ( 5.15 )
    8.8 ( 3.78 )
        Bilirubin, Week 48, n=247, 262
    10.3 ( 5.23 )
    8.9 ( 3.71 )
        Direct bilirubin, Baseline (Day 1), n=283, 283
    2.3 ( 1.32 )
    2.2 ( 1.09 )
        Direct bilirubin, Week 4, n=277, 277
    2.4 ( 1.47 )
    2.1 ( 1.08 )
        Direct bilirubin, Week 8, n=212, 278
    2.4 ( 1.17 )
    2.1 ( 0.93 )
        Direct bilirubin, Week 12, n=269, 273
    2.5 ( 1.26 )
    2.1 ( 0.91 )
        Direct bilirubin, Week 16, n=254, 268
    2.4 ( 1.46 )
    2.1 ( 0.95 )
        Direct bilirubin, Week 20, n=260, 272
    2.4 ( 1.54 )
    2.1 ( 0.90 )
        Direct bilirubin, Week 24, n=260, 266
    2.3 ( 1.20 )
    2.1 ( 0.96 )
        Direct bilirubin, Week 28, n=253, 268
    2.5 ( 1.29 )
    2.1 ( 0.94 )
        Direct bilirubin, Week 32, n=256, 268
    2.5 ( 3.48 )
    2.1 ( 0.94 )
        Direct bilirubin, Week 36, n=255, 260
    2.4 ( 2.24 )
    2.0 ( 0.89 )
        Direct bilirubin, Week 40, n=249, 266
    2.3 ( 1.29 )
    2.1 ( 0.98 )
        Direct bilirubin, Week 44, n=258, 263
    2.4 ( 1.34 )
    2.1 ( 0.95 )
        Direct bilirubin, Week 48, n=247, 262
    2.3 ( 1.26 )
    2.2 ( 1.00 )
        Creatinine, Baseline (Day 1), n=283, 283
    89.00 ( 16.061 )
    85.80 ( 15.660 )
        Creatinine, Week 4, n=280, 277
    82.99 ( 15.599 )
    86.43 ( 14.655 )
        Creatinine, Week 8, n=212, 278
    79.50 ( 14.103 )
    85.50 ( 15.925 )
        Creatinine, Week 12, n=270, 276
    79.25 ( 14.433 )
    84.63 ( 15.155 )
        Creatinine, Week 16, n=255, 269
    79.58 ( 14.509 )
    85.18 ( 14.997 )
        Creatinine, Week 20, n=261, 272
    78.50 ( 13.966 )
    85.02 ( 15.488 )
        Creatinine, Week 24, n=262, 268
    79.10 ( 15.340 )
    85.05 ( 14.690 )
        Creatinine, Week 28, n=253, 268
    78.79 ( 14.741 )
    84.38 ( 15.023 )
        Creatinine, Week 32, n=255, 268
    78.89 ( 14.558 )
    84.50 ( 15.047 )
        Creatinine, Week 36, n=254, 262
    79.58 ( 14.973 )
    84.75 ( 14.352 )
        Creatinine, Week 40, n=250, 266
    79.50 ( 15.615 )
    84.70 ( 14.808 )
        Creatinine, Week 44, n=258, 263
    80.04 ( 15.401 )
    83.90 ( 14.604 )
        Creatinine, Week 48, n=247, 262
    79.95 ( 15.613 )
    90.88 ( 87.655 )
    Notes
    [39] - Safety Population
    [40] - 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 timepoints. 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) ABC/ DTG/ 3TC
    Number of subjects analysed
    283 [41]
    283 [42]
    Units: Millimoles per liter
    arithmetic mean (standard deviation)
        CO2, Baseline (Day 1), n=283, 283
    22.4 ( 2.24 )
    22.4 ( 2.10 )
        CO2, Week 4, n=280, 276
    23.0 ( 2.29 )
    22.6 ( 2.28 )
        CO2, Week 8, n=212, 278
    22.8 ( 2.07 )
    22.3 ( 2.27 )
        CO2, Week 12, n=270, 276
    22.6 ( 2.50 )
    22.2 ( 2.34 )
        CO2, Week 16, n=255, 269
    22.9 ( 2.40 )
    22.3 ( 2.50 )
        CO2, Week 20, n=260, 272
    22.8 ( 2.30 )
    22.4 ( 2.32 )
        CO2, Week 24, n=261, 268
    23.0 ( 2.71 )
    22.8 ( 2.19 )
        CO2, Week 28, n=253, 268
    23.0 ( 2.31 )
    22.8 ( 2.47 )
        CO2, Week 32, n=255, 268
    23.0 ( 2.31 )
    22.7 ( 2.35 )
        CO2, Week 36, n=253, 261
    23.1 ( 2.37 )
    22.5 ( 2.26 )
        CO2, Week 40, n=249, 265
    22.8 ( 2.34 )
    22.6 ( 2.39 )
        CO2, Week 44, n=257, 263
    22.9 ( 2.34 )
    22.4 ( 2.12 )
        CO2, Week 48, n=247, 262
    22.5 ( 2.18 )
    22.3 ( 2.04 )
        Chloride, Baseline (Day 1), n=283, 283
    104.6 ( 2.32 )
    104.3 ( 2.32 )
        Chloride, Week 4, n=280, 277
    104.6 ( 2.22 )
    104.7 ( 2.13 )
        Chloride, Week 8, n=212, 278
    104.7 ( 1.96 )
    104.6 ( 2.32 )
        Chloride, Week 12, n=270, 276
    104.6 ( 2.16 )
    104.7 ( 2.35 )
        Chloride, Week 16, n=255, 269
    104.4 ( 2.31 )
    104.7 ( 2.24 )
        Chloride, Week 20, n=260, 272
    104.3 ( 2.28 )
    104.7 ( 2.06 )
        Chloride, Week 24, n=261, 268
    104.4 ( 2.33 )
    104.5 ( 2.42 )
        Chloride, Week 28, n=253, 268
    104.5 ( 2.20 )
    104.5 ( 2.28 )
        Chloride, Week 32, n=255, 268
    104.4 ( 2.46 )
    104.5 ( 2.33 )
        Chloride, Week 36, n=254, 261
    104.4 ( 2.42 )
    104.7 ( 2.20 )
        Chloride, Week 40, n=250, 266
    104.8 ( 2.55 )
    104.7 ( 2.25 )
        Chloride, Week 44, n=258, 263
    104.7 ( 2.19 )
    105.0 ( 2.22 )
        Chloride, Week 48, n=247, 262
    104.7 ( 2.21 )
    104.7 ( 2.28 )
        Glucose, Baseline (Day 1), n=283, 283
    5.21 ( 1.632 )
    5.17 ( 0.932 )
        Glucose, Week 4, n=236, 230
    5.27 ( 1.322 )
    5.23 ( 0.734 )
        Glucose, Week 8, n=172, 227
    5.31 ( 1.347 )
    5.19 ( 0.644 )
        Glucose, Week 12, n=229, 216
    5.26 ( 0.911 )
    5.27 ( 0.616 )
        Glucose, Week 16, n=204, 213
    5.36 ( 1.804 )
    5.28 ( 0.801 )
        Glucose, Week 20, n=209, 218
    5.32 ( 0.735 )
    5.26 ( 0.634 )
        Glucose, Week 24, n=221, 214
    5.35 ( 1.219 )
    5.21 ( 0.634 )
        Glucose, Week 28, n=207, 211
    5.35 ( 1.633 )
    5.23 ( 0.614 )
        Glucose, Week 32, n=201, 213
    5.44 ( 1.355 )
    5.27 ( 0.600 )
        Glucose, Week 36, n=199, 204
    5.35 ( 0.797 )
    5.31 ( 0.960 )
        Glucose, Week 40, n=203, 202
    5.44 ( 1.319 )
    5.35 ( 0.753 )
        Glucose, Week 44, n=208, 202
    5.34 ( 0.991 )
    5.35 ( 0.709 )
        Glucose, Week 48, n=248, 251
    5.22 ( 0.895 )
    5.22 ( 0.690 )
        Phosphate, Baseline (Day 1), n=283, 283
    1.103 ( 0.1747 )
    1.097 ( 0.1765 )
        Phosphate, Week 4, n=279, 277
    1.137 ( 0.1774 )
    1.112 ( 0.1850 )
        Phosphate, Week 8, n=212, 278
    1.096 ( 0.1742 )
    1.114 ( 0.1858 )
        Phosphate, Week 12, n=270, 276
    1.097 ( 0.1802 )
    1.106 ( 0.1876 )
        Phosphate, Week 16, n=255, 269
    1.104 ( 0.1806 )
    1.119 ( 0.1823 )
        Phosphate, Week 20, n=260, 272
    1.078 ( 0.1843 )
    1.114 ( 0.1812 )
        Phosphate, Week 24, n=261, 268
    1.106 ( 0.1797 )
    1.109 ( 0.1791 )
        Phosphate, Week 28, n=253, 268
    1.094 ( 0.1814 )
    1.119 ( 0.1893 )
        Phosphate, Week 32, n=255, 268
    1.105 ( 0.1769 )
    1.104 ( 0.1945 )
        Phosphate, Week 36, n=254, 261
    1.102 ( 0.1862 )
    1.122 ( 0.1872 )
        Phosphate, Week 40, n=250, 266
    1.093 ( 0.1699 )
    1.114 ( 0.1837 )
        Phosphate, Week 44, n=258, 263
    1.096 ( 0.1851 )
    1.120 ( 0.1903 )
        Phosphate, Week 48, n=247, 262
    1.096 ( 0.1888 )
    1.120 ( 0.2341 )
        Potassium, Baseline (Day 1), n=283, 283
    4.12 ( 0.301 )
    4.14 ( 0.288 )
        Potassium, Week 4, n=280, 277
    4.27 ( 0.308 )
    4.20 ( 0.327 )
        Potassium, Week 8, n=212, 278
    4.22 ( 0.302 )
    4.22 ( 0.343 )
        Potassium, Week 12, n=270, 276
    4.21 ( 0.305 )
    4.19 ( 0.282 )
        Potassium, Week 16, n=255, 269
    4.21 ( 0.283 )
    4.18 ( 0.303 )
        Potassium, Week 20, n=260, 272
    4.21 ( 0.320 )
    4.19 ( 0.313 )
        Potassium, Week 24, n=261, 268
    4.24 ( 0.322 )
    4.21 ( 0.312 )
        Potassium, Week 28, n=253, 268
    4.20 ( 0.298 )
    4.23 ( 0.294 )
        Potassium, Week 32, n=255, 268
    4.21 ( 0.295 )
    4.21 ( 0.315 )
        Potassium, Week 36, n=254, 261
    4.21 ( 0.314 )
    4.22 ( 0.314 )
        Potassium, Week 40, n=250, 266
    4.19 ( 0.301 )
    4.20 ( 0.305 )
        Potassium, Week 44, n=258, 263
    4.21 ( 0.302 )
    4.21 ( 0.324 )
        Potassium, Week 48, n=247, 262
    4.13 ( 0.288 )
    4.17 ( 0.449 )
        Sodium, Baseline (Day 1), n=283, 283
    139.2 ( 1.89 )
    139.2 ( 1.76 )
        Sodium, Week 4, n=280, 277
    139.5 ( 1.98 )
    139.4 ( 1.83 )
        Sodium, Week 8, n=212, 278
    139.4 ( 1.78 )
    139.3 ( 1.86 )
        Sodium, Week 12, n=270, 276
    139.5 ( 1.80 )
    139.3 ( 1.84 )
        Sodium, Week 16, n=255, 269
    139.4 ( 1.76 )
    139.4 ( 1.94 )
        Sodium, Week 20, n=260, 272
    139.4 ( 1.75 )
    139.5 ( 1.77 )
        Sodium, Week 24, n=261, 268
    139.3 ( 1.82 )
    139.4 ( 1.95 )
        Sodium, Week 28, n=253, 268
    139.4 ( 1.80 )
    139.5 ( 1.83 )
        Sodium, Week 32, n=255, 268
    139.4 ( 1.83 )
    139.4 ( 1.72 )
        Sodium, Week 36, n=254, 261
    139.3 ( 1.87 )
    139.5 ( 1.70 )
        Sodium, Week 40, n=250, 266
    139.3 ( 2.04 )
    139.5 ( 1.84 )
        Sodium, Week 44, n=258, 263
    139.5 ( 1.95 )
    139.6 ( 1.79 )
        Sodium, Week 48, n=247, 262
    139.4 ( 1.68 )
    139.5 ( 1.75 )
        Urea, Baseline (Day 1), n=283, 283
    5.30 ( 1.468 )
    5.17 ( 1.458 )
        Urea, Week 4, n=280, 277
    5.33 ( 1.424 )
    5.14 ( 1.508 )
        Urea, Week 8, n=212, 278
    5.32 ( 1.485 )
    5.12 ( 1.480 )
        Urea, Week 12, n=270, 276
    5.28 ( 1.424 )
    5.20 ( 1.574 )
        Urea, Week 16, n=255, 269
    5.26 ( 1.385 )
    5.20 ( 1.561 )
        Urea, Week 20, n=260, 272
    5.18 ( 1.349 )
    5.22 ( 1.483 )
        Urea, Week 24, n=261, 268
    5.38 ( 1.489 )
    5.11 ( 1.449 )
        Urea, Week 28, n=253, 268
    5.32 ( 1.422 )
    5.21 ( 1.406 )
        Urea, Week 32, n=255, 268
    5.43 ( 1.440 )
    5.17 ( 1.491 )
        Urea, Week 36, n=254, 261
    5.31 ( 1.396 )
    5.23 ( 1.556 )
        Urea, Week 40, n=250, 266
    5.40 ( 1.523 )
    5.26 ( 1.566 )
        Urea, Week 44, n=258, 263
    5.38 ( 1.543 )
    5.24 ( 1.512 )
        Urea, Week 48, n=247, 262
    5.37 ( 1.402 )
    5.27 ( 2.305 )
    Notes
    [41] - Safety Population
    [42] - 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 timepoints. 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) ABC/ DTG/ 3TC
    Number of subjects analysed
    283 [43]
    283 [44]
    Units: Units per liter
    arithmetic mean (standard deviation)
        Baseline (Day 1), n=283, 283
    31.0 ( 21.04 )
    30.9 ( 28.89 )
        Week 4, n=278, 276
    31.7 ( 27.17 )
    32.6 ( 24.73 )
        Week 8, n=211, 278
    31.5 ( 21.15 )
    31.3 ( 19.96 )
        Week 12, n=270, 276
    31.4 ( 23.94 )
    33.6 ( 23.37 )
        Week 16, n=254, 269
    30.8 ( 22.39 )
    32.1 ( 18.99 )
        Week 20, n=260, 270
    31.3 ( 23.46 )
    31.9 ( 19.13 )
        Week 24, n=260, 268
    31.3 ( 22.60 )
    32.2 ( 21.08 )
        Week 28, n=253, 268
    30.3 ( 18.71 )
    33.0 ( 22.56 )
        Week 32, n=254, 268
    33.5 ( 35.38 )
    33.2 ( 32.95 )
        Week 36, n=254, 261
    31.5 ( 20.49 )
    31.2 ( 20.03 )
        Week 40, n=250, 266
    32.6 ( 27.07 )
    32.1 ( 22.19 )
        Week 44, n=258, 263
    36.3 ( 45.04 )
    33.0 ( 24.09 )
        Week 48, n=247, 261
    30.1 ( 20.31 )
    32.6 ( 28.96 )
    Notes
    [43] - Safety Population
    [44] - 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) will be 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) ABC/ DTG/ 3TC
    Number of subjects analysed
    283 [45]
    283 [46]
    Units: Milliliter per minute per 1.73meter^2
    arithmetic mean (standard deviation)
        Baseline (Day 1), n=283, 283
    94.3 ( 17.61 )
    97.9 ( 17.70 )
        Week 4, n=278, 277
    101.2 ( 16.56 )
    96.5 ( 17.14 )
        Week 8, n=211, 278
    104.9 ( 15.64 )
    98.1 ( 17.46 )
        Week 12, n=270, 276
    104.8 ( 16.08 )
    98.6 ( 17.77 )
        Week 16, n=254, 269
    104.2 ( 15.03 )
    97.6 ( 16.84 )
        Week 20, n=261, 271
    105.5 ( 15.19 )
    98.0 ( 17.67 )
        Week 24, n=261, 268
    105.1 ( 16.05 )
    97.9 ( 17.33 )
        Week 28, n=253, 268
    105.3 ( 16.18 )
    98.8 ( 17.40 )
        Week 32, n=254, 268
    105.1 ( 16.10 )
    98.8 ( 17.39 )
        Week 36, n=254, 262
    104.7 ( 15.88 )
    98.0 ( 16.60 )
        Week 40, n=250, 266
    104.3 ( 16.47 )
    98.3 ( 17.25 )
        Week 44, n=258, 263
    104.4 ( 16.73 )
    98.9 ( 16.67 )
        Week 48, n=247, 261
    103.6 ( 16.34 )
    96.9 ( 18.21 )
    Notes
    [45] - Safety Population
    [46] - Safety Population
    No statistical analyses for this end point

    Secondary: Absolute values for fasting lipid panel overtime including Week 48

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    End point title
    		 Absolute values for fasting lipid panel 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, high density lipoprotein (HDL)cholesterol, low density lipoprotein (LDL) cholesterol and triglycerides. 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) ABC/ DTG/ 3TC
    Number of subjects analysed
    283 [47]
    283 [48]
    Units: Millimoles per liter
    arithmetic mean (standard deviation)
        Total Cholesterol, Baseline (Day 1), n=268, 275
    4.44 ( 0.928 )
    4.42 ( 0.986 )
        Total Cholesterol, Week 48, n=240, 239
    4.65 ( 1.021 )
    4.46 ( 0.944 )
        HDL cholesterol, Baseline (Day 1), n=268, 275
    1.249 ( 0.3761 )
    1.302 ( 0.3851 )
        HDL cholesterol, Week 48, n=240, 239
    1.359 ( 0.4096 )
    1.376 ( 0.4335 )
        LDL cholesterol, Baseline (Day 1), n=267, 275
    2.557 ( 0.7991 )
    2.529 ( 0.7870 )
        LDL cholesterol, Week 48, n=238, 237
    2.697 ( 0.9158 )
    2.472 ( 0.7693 )
        Triglycerides, Baseline (Day 1), n=268, 275
    1.387 ( 0.9142 )
    1.294 ( 0.7392 )
        Triglycerides, Week 48, n=240, 239
    1.323 ( 0.9333 )
    1.341 ( 0.9059 )
    Notes
    [47] - Safety Population
    [48] - Safety Population
    No statistical analyses for this end point

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

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    End point title
    		 Number of participants with abnormal urinalysis parameter 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 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) ABC/ DTG/ 3TC
    Number of subjects analysed
    283 [49]
    283 [50]
    Units: Participants
    number (not applicable)
        Urine bilirubin,Baseline (Day 1),Trace, n=276, 276
    0
    0
        Urine bilirubin, Baseline (Day 1), 1+, n=276, 276
    15
    22
        Urine bilirubin, Baseline (Day 1), 2+, n=276, 276
    0
    1
        Urine bilirubin, Baseline (Day 1), 3+, n=276, 276
    0
    0
        Urine glucose, Baseline (Day 1), Trace, n=282, 282
    0
    1
        Urine glucose, Baseline (Day 1), 1+, n=282, 282
    2
    0
        Urine glucose, Baseline (Day 1), 2+, n=282, 282
    0
    0
        Urine glucose, Baseline (Day 1), 3+, n=282, 282
    1
    1
        Urine ketones, Baseline (Day 1), Trace, n=276, 276
    30
    29
        Urine ketones, Baseline (Day 1), 1+, n=276, 276
    4
    2
        Urine ketones, Baseline (Day 1), 2+, n=276, 276
    0
    1
        Urine ketones, Baseline (Day 1), 3+, n=276, 276
    0
    0
        Urine leukocyte esterase,Baseline,Trace,n=276, 276
    22
    21
        Urine leukocyte esterase, Baseline, 1+, n=276, 276
    12
    14
        Urine leukocyte esterase, Baseline, 2+, n=276, 276
    9
    9
        Urine leukocyte esterase, Baseline, 3+, n=276, 276
    3
    3
        Urine nitrite, Baseline, positive, n=276, 276
    6
    9
        Urine occult blood, Baseline, Trace, n=276, 276
    13
    9
        Urine occult blood, Baseline, 1+, n=276, 276
    5
    6
        Urine occult blood, Baseline, 2+, n=276, 276
    6
    3
        Urine occult blood, Baseline, 3+, n=276, 276
    3
    2
        Urine protein, Baseline, Trace, n=276, 276
    25
    20
        Urine protein, Baseline, 1+, n=276, 276
    4
    10
        Urine protein, Baseline, 2+, n=276, 276
    3
    7
        Urine protein, Baseline, 3+, n=276, 276
    0
    0
        Urine bilirubin, Week 4, Trace, n=278, 272
    0
    0
        Urine bilirubin, Week 4, 1+, n=278, 272
    14
    28
        Urine bilirubin, Week 4, 2+, n=278, 272
    0
    0
        Urine bilirubin, Week 4, 3+, n=278, 272
    0
    0
        Urine glucose, Week 4, Trace, n=278, 272
    0
    0
        Urine glucose, Week 4, 1+, n=278, 272
    0
    2
        Urine glucose, Week 4, 2+, n=278, 272
    0
    0
        Urine glucose, Week 4, 3+, n=278, 272
    1
    0
        Urine ketones, Week 4, Trace, n=278, 272
    20
    21
        Urine ketones, Week 4, 1+, n=278, 272
    1
    5
        Urine ketones, Week 4, 2+, n=278, 272
    0
    0
        Urine ketones, Week 4, 3+, n=278, 272
    1
    0
        Urine leukocyte esterase, Week 4, Trace,n=278, 272
    19
    23
        Urine leukocyte esterase, Week 4, 1+, n=278, 272
    9
    17
        Urine leukocyte esterase, Week 4, 2+, n=278, 272
    6
    6
        Urine leukocyte esterase, Week 4, 3+, n=278, 272
    2
    4
        Urine nitrite, Week 4, positive, n=278, 272
    2
    10
        Urine occult blood, Week 4, Trace, n=278, 272
    11
    13
        Urine occult blood, Week 4, 1+, n=278, 272
    8
    3
        Urine occult blood, Week 4, 2+, n=278, 272
    5
    1
        Urine occult blood, Week 4, 3+, n=278, 272
    0
    6
        Urine protein, Week 4, Trace, n=278, 272
    12
    24
        Urine protein, Week 4, 1+, n=278, 272
    4
    11
        Urine protein, Week 4, 2+, n=278, 272
    1
    3
        Urine protein, Week 4, 3+, n=278, 272
    1
    1
        Urine bilirubin, Week 24, Trace, n=195, 258
    0
    0
        Urine bilirubin, Week 24, 1+, n=195, 258
    7
    14
        , Urine bilirubin, Week 24, 2+, n=195, 258
    0
    0
        Urine bilirubin, Week 24, 3+, n=195, 258
    0
    0
        Urine glucose, Week 24, Trace, n=195, 258
    0
    0
        Urine glucose, Week 24, 1+, n=195, 258
    0
    0
        Urine glucose, Week 24, 2+, n=195, 258
    1
    0
        Urine glucose, Week 24, 3+, n=195, 258
    1
    1
        Urine ketones, Week 24, Trace, n=195, 258
    13
    9
        Urine ketones, Week 24, 1+, n=195, 258
    0
    2
        Urine ketones, Week 24, 2+, n=195, 258
    0
    0
        Urine ketones, Week 24, 3+, n=195, 258
    0
    0
        Urine leukocyte esterase,Week 24, Trace,n=195, 258
    15
    28
        Urine leukocyte esterase, Week 24, 1+, n=195, 258
    8
    12
        Urine leukocyte esterase, Week 24, 2+, n=195, 258
    3
    10
        Urine leukocyte esterase, Week 24, 3+, n=195, 258
    1
    3
        Urine nitrite, Week 24, positive, n=195, 258
    4
    5
        Urine occult blood, Week 24, Trace, n=195, 258
    9
    9
        Urine occult blood, Week 24, 1+, n=195, 258
    3
    8
        Urine occult blood, Week 24, 2+, n=195, 258
    3
    2
        Urine occult blood, Week 24, 3+, n=195, 258
    1
    3
        Urine protein, Week 24, Trace, n=195, 258
    11
    21
        Urine protein, Week 24, 1+, n=195, 258
    4
    7
        Urine protein, Week 24, 2+, n=195, 258
    2
    4
        Urine protein, Week 24, 3+, n=195, 258
    0
    1
        Urine bilirubin, Week 48, Trace, n=261, 259
    0
    0
        Urine bilirubin, Week 48, 1+, n=261, 259
    9
    12
        Urine bilirubin, Week 48, 2+, n=261, 259
    0
    0
        Urine bilirubin, Week 48, 3+, n=261, 259
    0
    1
        Urine glucose, Week 48, Trace, n=261, 259
    0
    0
        Urine glucose, Week 48, 1+, n=261, 259
    1
    0
        Urine glucose, Week 48, 2+, n=261, 259
    0
    0
        Urine glucose, Week 48, 3+, n=261, 259
    2
    0
        Urine ketones, Week 48, Trace, n=261, 259
    12
    13
        Urine ketones, Week 48, 1+, n=261, 259
    0
    4
        Urine ketones, Week 48, 2+, n=261, 259
    0
    0
        Urine ketones, Week 48, 3+, n=261, 259
    0
    0
        Urine leukocyte esterase, Week 48,Trace,n=261, 259
    12
    15
        Urine leukocyte esterase, Week 48, 1+, n=261, 259
    5
    10
        Urine leukocyte esterase, Week 48, 2+, n=261, 259
    4
    7
        Urine leukocyte esterase, Week 48, 3+, n=261, 259
    2
    2
        Urine nitrite, Week 48, positive, n=261, 259
    2
    6
        Urine occult blood, Week 48, Trace, n=261, 259
    9
    8
        Urine occult blood, Week 48, 1+, n=261, 259
    4
    6
        Urine occult blood, Week 48, 2+, n=261, 259
    8
    3
        Urine occult blood, Week 48, 3+, n=261, 259
    1
    0
        Urine protein, Week 48, Trace, n=261, 259
    14
    23
        Urine protein, Week 48, 1+, n=261, 259
    5
    8
        Urine protein, Week 48, 2+, n=261, 259
    6
    6
        Urine protein, Week 48, 3+, n=261, 259
    0
    0
    Notes
    [49] - Safety Population
    [50] - 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
    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). 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) ABC/ DTG/ 3TC
    Number of subjects analysed
    283 [51]
    283 [52]
    Units: Participants
    number (not applicable)
        Baseline (Day 1), pH=5, n=276, 276
    36
    32
        Baseline (Day 1), pH=5.5, n=276, 276
    104
    101
        Baseline (Day 1), pH=6, n=276, 276
    66
    62
        Baseline (Day 1), pH=6.5, n=276, 276
    29
    35
        Baseline (Day 1), pH=7, n=276, 276
    27
    27
        Baseline (Day 1), pH=7.5, n=276, 276
    7
    12
        Baseline (Day 1), pH=8, n=276, 276
    4
    4
        Baseline (Day 1), pH=8.5, n=276, 276
    2
    1
        Baseline (Day 1), pH>9.0, n=276, 276
    1
    2
        Week 4, pH=5, n=278, 272
    33
    41
        Week 4, pH=5.5, n=278, 272
    83
    81
        Week 4, pH=6, n=278, 272
    68
    71
        Week 4, pH=6.5, n=278, 272
    48
    36
        Week 4, pH=7, n=278, 272
    25
    22
        Week 4, pH=7.5, n=278, 272
    10
    12
        Week 4, pH=8, n=278, 272
    5
    5
        Week 4, pH=8.5, n=278, 272
    6
    1
        Week 4, pH>9.0, n=278, 272
    0
    3
        Week 24, pH=5, n=195, 258
    42
    50
        Week 24, pH=5.5, n=195, 258
    55
    78
        Week 24, pH=6, n=195, 258
    47
    51
        Week 24, pH=6.5, n=195, 258
    19
    46
        Week 24, pH=7, n=195, 258
    22
    16
        Week 24, pH=7.5, n=195, 258
    4
    13
        Week 24, pH=8, n=195, 258
    3
    2
        Week 24, pH=8.5, n=195, 258
    3
    1
        Week 24, pH>9.0, n=195, 258
    0
    1
        Week 48, pH=5, n=261, 259
    54
    57
        Week 48, pH=5.5, n=261, 259
    81
    77
        Week 48, pH=6, n=261, 259
    50
    61
        Week 48, pH=6.5, n=261, 259
    30
    27
        Week 48, pH=7, n=261, 259
    24
    18
        Week 48, pH=7.5, n=261, 259
    14
    10
        Week 48, pH=8, n=261, 259
    5
    4
        Week 48, pH=8.5, n=261, 259
    2
    3
        Week 48, pH>9.0, n=261, 259
    1
    2
    Notes
    [51] - Safety Population
    [52] - 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 last available recorded value up to and including the date of first Maintenance Phase dose of IP. 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) ABC/ DTG/ 3TC
    Number of subjects analysed
    283 [53]
    283 [54]
    Units: 10^9 cells per Liter
    arithmetic mean (standard deviation)
        Basophils, Week 4, n=277, 270
    0.002 ( 0.0155 )
    0.002 ( 0.0155 )
        Basophils, Week 8, n=210, 272
    0.002 ( 0.0161 )
    0.001 ( 0.0153 )
        Basophils, Week 12, n=267, 272
    0.003 ( 0.0181 )
    0.001 ( 0.0157 )
        Basophils, Week 16, n=247, 259
    0.008 ( 0.0215 )
    0.006 ( 0.0227 )
        Basophils, Week 20, n=247, 259
    0.013 ( 0.0250 )
    0.010 ( 0.0271 )
        Basophils, Week 24, n=256, 260
    0.015 ( 0.0247 )
    0.014 ( 0.0269 )
        Basophils, Week 28, n=239, 258
    0.017 ( 0.0265 )
    0.016 ( 0.0251 )
        Basophils, Week 32, n=246, 263
    0.022 ( 0.0266 )
    0.017 ( 0.0227 )
        Basophils, Week 36, n=250, 259
    0.021 ( 0.0235 )
    0.018 ( 0.0249 )
        Basophils, Week 40, n=244, 245
    0.020 ( 0.0252 )
    0.019 ( 0.0243 )
        Basophils, Week 44, n=249, 260
    0.018 ( 0.0246 )
    0.018 ( 0.0265 )
        Basophils, Week 48, n=239, 258
    0.016 ( 0.0218 )
    0.016 ( 0.0243 )
        Eosinophils, Week 4, n=277, 270
    0.024 ( 0.1099 )
    0.013 ( 0.1220 )
        Eosinophils, Week 8, n=210, 272
    0.023 ( 0.1101 )
    0.009 ( 0.1075 )
        Eosinophils, Week 12, n=267, 272
    0.023 ( 0.1305 )
    0.018 ( 0.1082 )
        Eosinophils, Week 16, n=247, 259
    0.037 ( 0.1425 )
    0.022 ( 0.1262 )
        Eosinophils, Week 20, n=247, 259
    0.044 ( 0.1478 )
    0.027 ( 0.1288 )
        Eosinophils, Week 24, n=256, 260
    0.051 ( 0.1307 )
    0.030 ( 0.1124 )
        Eosinophils, Week 28, n=239, 258
    0.061 ( 0.1367 )
    0.037 ( 0.1393 )
        Eosinophils, Week 32, n=246, 263
    0.061 ( 0.1556 )
    0.029 ( 0.1158 )
        Eosinophils, Week 36, n=250, 259
    0.070 ( 0.1797 )
    0.030 ( 0.1303 )
        Eosinophils, Week 40, n=244, 245
    0.062 ( 0.1623 )
    0.035 ( 0.1155 )
        Eosinophils, Week 44, n=249, 260
    0.057 ( 0.1598 )
    0.038 ( 0.1410 )
        Eosinophils, Week 48, n=239, 258
    0.039 ( 0.1416 )
    0.030 ( 0.1183 )
        Leukocytes, Week 4, n=279, 272
    0.57 ( 1.404 )
    0.42 ( 1.383 )
        Leukocytes, Week 8, n=211, 275
    0.18 ( 1.278 )
    0.32 ( 1.374 )
        Leukocytes, Week 12, n=270, 275
    0.07 ( 1.402 )
    0.40 ( 1.465 )
        Leukocytes, Week 16, n=252, 265
    0.32 ( 1.641 )
    0.41 ( 1.621 )
        Leukocytes, Week 20, n=254, 265
    0.27 ( 1.505 )
    0.44 ( 1.480 )
        Leukocytes, Week 24, n=258, 264
    0.34 ( 1.581 )
    0.45 ( 1.725 )
        Leukocytes, Week 28, n=244, 263
    0.34 ( 1.713 )
    0.48 ( 1.551 )
        Leukocytes, Week 32, n=253, 266
    0.28 ( 1.726 )
    0.42 ( 1.748 )
        Leukocytes, Week 36, n=252, 259
    0.34 ( 1.549 )
    0.52 ( 1.789 )
        Leukocytes, Week 40, n=246, 253
    0.16 ( 1.497 )
    0.42 ( 1.614 )
        Leukocytes, Week 44, n=256, 262
    0.22 ( 1.732 )
    0.49 ( 1.626 )
        Leukocytes, Week 48, n=243, 260
    0.09 ( 1.455 )
    0.29 ( 1.520 )
        Lymphocytes, Week 4, n=277, 270
    0.198 ( 0.5156 )
    0.231 ( 0.5066 )
        Lymphocytes, Week 8, n=210, 272
    0.054 ( 0.4812 )
    0.155 ( 0.5088 )
        Lymphocytes, Week 12, n=267, 272
    0.012 ( 0.4632 )
    0.164 ( 0.5560 )
        Lymphocytes, Week 16, n=247, 259
    0.020 ( 0.4971 )
    0.158 ( 0.5246 )
        Lymphocytes, Week 20, n=247, 259
    0.030 ( 0.4889 )
    0.146 ( 0.5292 )
        Lymphocytes, Week 24, n=256, 260
    0.014 ( 0.5195 )
    0.148 ( 0.5716 )
        Lymphocytes, Week 28, n=239, 258
    0.021 ( 0.5389 )
    0.145 ( 0.5469 )
        Lymphocytes, Week 32, n=246, 263
    0.021 ( 0.5195 )
    0.129 ( 0.5812 )
        Lymphocytes, Week 36, n=250, 259
    0.028 ( 0.5261 )
    0.132 ( 0.5258 )
        Lymphocytes, Week 40, n=244, 245
    0.006 ( 0.5303 )
    0.054 ( 0.5106 )
        Lymphocytes, Week 44, n=249, 260
    -0.021 ( 0.6176 )
    0.098 ( 0.5139 )
        Lymphocytes, Week 48, n=239, 258
    -0.074 ( 0.5191 )
    0.039 ( 0.5936 )
        Monocytes, Week 4, n=277, 270
    0.038 ( 0.1269 )
    0.031 ( 0.1528 )
        Monocytes, Week 8, n=210, 272
    0.022 ( 0.1464 )
    0.013 ( 0.1600 )
        Monocytes, Week 12, n=267, 272
    0.016 ( 0.1234 )
    0.018 ( 0.1613 )
        Monocytes, Week 16, n=247, 259
    0.059 ( 0.1548 )
    0.035 ( 0.1618 )
        Monocytes, Week 20, n=247, 259
    0.070 ( 0.1583 )
    0.053 ( 0.1790 )
        Monocytes, Week 24, n=256, 260
    0.059 ( 0.1442 )
    0.070 ( 0.1599 )
        Monocytes, Week 28, n=239, 258
    0.086 ( 0.1584 )
    0.077 ( 0.1806 )
        Monocytes, Week 32, n=246, 263
    0.081 ( 0.1530 )
    0.088 ( 0.1841 )
        Monocytes, Week 36, n=250, 259
    0.084 ( 0.1685 )
    0.086 ( 0.1772 )
        Monocytes, Week 40, n=244, 245
    0.056 ( 0.1378 )
    0.076 ( 0.1651 )
        Monocytes, Week 44, n=249, 260
    0.062 ( 0.1522 )
    0.057 ( 0.1558 )
        Monocytes, Week 48, n=239, 258
    0.024 ( 0.1395 )
    0.031 ( 0.1389 )
        Neutrophils, Week 4, n=277, 270
    0.313 ( 1.3508 )
    0.130 ( 1.1869 )
        Neutrophils, Week 8, n=210, 272
    0.084 ( 1.1310 )
    0.125 ( 1.2775 )
        Neutrophils, Week 12, n=267, 272
    0.032 ( 1.3016 )
    0.185 ( 1.3016 )
        Neutrophils, Week 16, n=247, 259
    0.215 ( 1.5752 )
    0.211 ( 1.4233 )
        Neutrophils, Week 20, n=247, 259
    0.132 ( 1.4116 )
    0.217 ( 1.3130 )
        Neutrophils, Week 24, n=256, 260
    0.218 ( 1.4890 )
    0.217 ( 1.4694 )
        Neutrophils, Week 28, n=239, 258
    0.193 ( 1.5833 )
    0.221 ( 1.3274 )
        Neutrophils, Week 32, n=246, 263
    0.144 ( 1.5739 )
    0.175 ( 1.5009 )
        Neutrophils, Week 36, n=250, 259
    0.170 ( 1.3865 )
    0.243 ( 1.4938 )
        Neutrophils, Week 40, n=244, 245
    0.055 ( 1.4372 )
    0.259 ( 1.4739 )
        Neutrophils, Week 44, n=249, 260
    0.156 ( 1.5382 )
    0.273 ( 1.4445 )
        Neutrophils, Week 48, n=239, 258
    0.110 ( 1.3697 )
    0.201 ( 1.3169 )
        Platelets, Week 4, n=278, 269
    5.7 ( 29.10 )
    4.3 ( 31.11 )
        Platelets, Week 8, n=207, 273
    -0.9 ( 29.09 )
    2.2 ( 35.14 )
        Platelets, Week 12, n=269, 271
    0.8 ( 32.49 )
    6.2 ( 36.23 )
        Platelets, Week 16, n=251, 263
    1.6 ( 33.34 )
    9.3 ( 51.53 )
        Platelets, Week 20, n=255, 264
    7.6 ( 38.18 )
    13.4 ( 39.24 )
        Platelets, Week 24, n=256, 261
    6.5 ( 36.11 )
    14.4 ( 35.15 )
        Platelets, Week 28, n=245, 258
    8.6 ( 38.23 )
    18.4 ( 38.56 )
        Platelets, Week 32, n=249, 262
    7.9 ( 40.22 )
    14.6 ( 34.28 )
        Platelets, Week 36, n=248, 259
    12.1 ( 38.48 )
    18.6 ( 35.81 )
        Platelets, Week 40, n=244, 254
    8.2 ( 36.08 )
    17.7 ( 43.30 )
        Platelets, Week 44, n=254, 261
    9.4 ( 38.42 )
    19.3 ( 47.64 )
        Platelets, Week 48, n=240, 255
    7.7 ( 39.61 )
    16.4 ( 47.45 )
    Notes
    [53] - Safety Population
    [54] - Safety Population
    No statistical analyses for this end point

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

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    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 last available recorded value up to and including the date of first Maintenance phase dose of IP. 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) ABC/ DTG/ 3TC
    Number of subjects analysed
    283 [55]
    283 [56]
    Units: Femtoliters
    arithmetic mean (standard deviation)
        Week 4, n=279, 273
    -0.7 ( 1.66 )
    0.2 ( 1.56 )
        Week 8, n=211, 275
    -2.5 ( 2.33 )
    0.2 ( 2.06 )
        Week 12, n=270, 275
    -3.8 ( 2.49 )
    -0.3 ( 2.48 )
        Week 16, n=254, 265
    -5.1 ( 2.63 )
    -0.2 ( 2.65 )
        Week 20, n=255, 267
    -5.6 ( 2.72 )
    -0.5 ( 2.55 )
        Week 24, n=259, 264
    -5.6 ( 2.85 )
    -0.5 ( 2.58 )
        Week 28, n=246, 265
    -5.6 ( 2.97 )
    -0.9 ( 2.52 )
        Week 32, n=254, 267
    -5.3 ( 3.02 )
    -0.9 ( 2.55 )
        Week 36, n=252, 261
    -5.3 ( 3.00 )
    -0.6 ( 2.45 )
        Week 40, n=246, 255
    -4.8 ( 3.02 )
    -0.1 ( 2.64 )
        Week 44, n=256, 262
    -4.2 ( 3.12 )
    0.2 ( 2.81 )
        Week 48, n=243, 260
    -3.7 ( 3.12 )
    1.0 ( 2.93 )
    Notes
    [55] - Safety Population
    [56] - Safety Population
    No statistical analyses for this end point

    Secondary: Change from Baseline for hematology parameters: erythrocytes

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    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 last available recorded value up to and including the date of first Maintenance phase dose of IP. 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) ABC/ DTG/ 3TC
    Number of subjects analysed
    283 [57]
    283 [58]
    Units: 10^12 cells per Liter
    arithmetic mean (standard deviation)
        Week 4, n=279, 273
    0.08 ( 0.226 )
    -0.03 ( 0.228 )
        Week 8, n=211, 275
    0.18 ( 0.249 )
    0.02 ( 0.239 )
        Week 12, n=270, 275
    0.23 ( 0.269 )
    0.01 ( 0.273 )
        Week 16, n=254, 265
    0.30 ( 0.263 )
    0.01 ( 0.255 )
        Week 20, n=255, 267
    0.31 ( 0.272 )
    -0.01 ( 0.242 )
        Week 24, n=259, 264
    0.31 ( 0.254 )
    0.02 ( 0.242 )
        Week 28, n=246, 265
    0.29 ( 0.248 )
    0.04 ( 0.259 )
        Week 32, n=254, 267
    0.25 ( 0.283 )
    0.01 ( 0.259 )
        Week 36, n=252, 261
    0.23 ( 0.263 )
    -0.01 ( 0.250 )
        Week 40, n=246, 255
    0.23 ( 0.246 )
    -0.01 ( 0.239 )
        Week 44, n=256, 262
    0.21 ( 0.234 )
    -0.06 ( 0.243 )
        Week 48, n=243, 260
    0.16 ( 0.264 )
    -0.06 ( 0.257 )
    Notes
    [57] - Safety Population
    [58] - Safety Population
    No statistical analyses for this end point

    Secondary: Change from Baseline for hematology parameters: hematocrit

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    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 last available recorded value up to and including the date of first Maintenance phase dose of IP. 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) ABC/ DTG/ 3TC
    Number of subjects analysed
    283 [59]
    283 [60]
    Units: Proportion of red blood cells in blood
    arithmetic mean (standard deviation)
        Week 4, n=279, 273
    0.0046 ( 0.02082 )
    -0.0013 ( 0.02213 )
        Week 8, n=211, 275
    0.0053 ( 0.02344 )
    0.0026 ( 0.02314 )
        Week 12, n=270, 275
    0.0040 ( 0.02383 )
    -0.0000 ( 0.02618 )
        Week 16, n=254, 265
    0.0035 ( 0.02338 )
    -0.0003 ( 0.02489 )
        Week 20, n=255, 267
    0.0024 ( 0.02335 )
    -0.0033 ( 0.02323 )
        Week 24, n=259, 264
    0.0021 ( 0.02299 )
    -0.0012 ( 0.02337 )
        Week 28, n=246, 265
    -0.0003 ( 0.02262 )
    -0.0001 ( 0.02460 )
        Week 32, n=254, 267
    -0.0017 ( 0.02607 )
    -0.0032 ( 0.02503 )
        Week 36, n=252, 261
    -0.0041 ( 0.02515 )
    -0.0032 ( 0.02407 )
        Week 40, n=246, 255
    -0.0014 ( 0.02461 )
    -0.0017 ( 0.02388 )
        Week 44, n=256, 262
    -0.0011 ( 0.02230 )
    -0.0045 ( 0.02328 )
        Week 48, n=243, 260
    -0.0027 ( 0.02571 )
    -0.0019 ( 0.02572 )
    Notes
    [59] - Safety Population
    [60] - Safety Population
    No statistical analyses for this end point

    Secondary: Change from Baseline for hematology parameters: hemoglobin

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    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 last available recorded value up to and including the date of first Maintenance Phase dose of IP. 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) ABC/ DTG/ 3TC
    Number of subjects analysed
    283 [61]
    283 [62]
    Units: Grams per liter
    arithmetic mean (standard deviation)
        Week 4, n=279, 273
    1.8 ( 6.59 )
    0.1 ( 6.47 )
        Week 8, n=211, 275
    1.9 ( 7.29 )
    1.3 ( 7.26 )
        Week 12, n=270, 275
    2.1 ( 7.47 )
    1.5 ( 8.28 )
        Week 16, n=254, 265
    2.9 ( 6.98 )
    1.4 ( 7.88 )
        Week 20, n=255, 267
    2.9 ( 7.43 )
    1.4 ( 7.18 )
        Week 24, n=259, 264
    2.7 ( 7.32 )
    2.0 ( 7.11 )
        Week 28, n=246, 265
    2.7 ( 6.80 )
    3.3 ( 7.75 )
        Week 32, n=254, 267
    2.7 ( 8.08 )
    2.9 ( 7.73 )
        Week 36, n=252, 261
    2.0 ( 7.93 )
    2.8 ( 7.73 )
        Week 40, n=246, 255
    3.2 ( 7.91 )
    3.1 ( 7.85 )
        Week 44, n=256, 262
    2.5 ( 7.66 )
    1.8 ( 7.62 )
        Week 48, n=243, 260
    1.4 ( 7.98 )
    2.1 ( 8.33 )
    Notes
    [61] - Safety Population
    [62] - 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. Baseline value is defined as the last available recorded value up to and including the date of first Maintenance Phase dose of IP. 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) ABC/ DTG/ 3TC
    Number of subjects analysed
    283 [63]
    283 [64]
    Units: International units per liter
    arithmetic mean (standard deviation)
        ALT, Week 4, n=281, 277
    3.7 ( 49.90 )
    -1.4 ( 11.14 )
        ALT, Week 8, n=212, 278
    1.0 ( 14.28 )
    -0.9 ( 11.86 )
        ALT, Week 12, n=270, 276
    1.0 ( 15.80 )
    -0.1 ( 13.27 )
        ALT, Week 16, n=255, 269
    1.2 ( 16.61 )
    1.5 ( 13.99 )
        ALT, Week 20, n=260, 272
    5.3 ( 72.80 )
    0.2 ( 17.04 )
        ALT, Week 24, n=261, 268
    3.3 ( 30.00 )
    -0.4 ( 12.75 )
        ALT, Week 28, n=253, 268
    1.9 ( 18.82 )
    0.2 ( 12.72 )
        ALT, Week 32, n=256, 268
    18.1 ( 293.85 )
    -0.4 ( 13.08 )
        ALT, Week 36, n=255, 261
    -0.1 ( 14.10 )
    1.7 ( 32.63 )
        ALT, Week 40, n=250, 266
    0.6 ( 17.42 )
    0.0 ( 14.84 )
        ALT, Week 44, n=258, 263
    1.7 ( 27.55 )
    0.8 ( 16.75 )
        ALT, Week 48, n=247, 262
    -0.2 ( 22.91 )
    0.1 ( 18.81 )
        ALP, Week 4, n=281, 277
    0.3 ( 11.04 )
    -1.3 ( 15.74 )
        ALP, Week 8, n=212, 278
    0.6 ( 10.41 )
    -0.5 ( 17.00 )
        ALP, Week 12, n=270, 276
    1.4 ( 12.71 )
    -0.7 ( 17.40 )
        ALP, Week 16, n=255, 269
    0.8 ( 10.34 )
    -0.3 ( 17.99 )
        ALP, Week 20, n=260, 272
    1.5 ( 10.20 )
    -1.1 ( 17.35 )
        ALP, Week 24, n=261, 268
    1.2 ( 9.57 )
    -0.7 ( 17.03 )
        ALP, Week 28, n=253, 268
    1.4 ( 10.57 )
    0.6 ( 17.28 )
        ALP, Week 32, n=256, 268
    1.9 ( 15.42 )
    -0.3 ( 18.11 )
        ALP, Week 36, n=255, 261
    3.3 ( 20.31 )
    1.3 ( 20.90 )
        ALP, Week 40, n=250, 266
    1.8 ( 9.84 )
    0.7 ( 18.50 )
        ALP, Week 44, n=258, 263
    1.4 ( 11.00 )
    1.2 ( 17.62 )
        ALP, Week 48, n=247, 262
    1.1 ( 12.75 )
    0.7 ( 17.54 )
        AST, Week 4, n=281, 277
    1.5 ( 24.47 )
    -1.6 ( 14.58 )
        AST, Week 8, n=212, 278
    0.7 ( 19.90 )
    -2.0 ( 14.13 )
        AST, Week 12, n=270, 276
    -0.3 ( 10.74 )
    -1.5 ( 15.34 )
        AST, Week 16, n=255, 269
    -0.1 ( 11.31 )
    1.0 ( 16.68 )
        AST, Week 20, n=260, 272
    2.3 ( 32.28 )
    0.2 ( 26.46 )
        AST, Week 24, n=261, 268
    2.8 ( 24.22 )
    -1.5 ( 16.00 )
        AST, Week 28, n=253, 268
    1.7 ( 15.85 )
    -0.9 ( 16.99 )
        AST, Week 32, n=256, 268
    14.0 ( 233.48 )
    -1.9 ( 14.68 )
        AST, Week 36, n=255, 261
    -0.1 ( 12.22 )
    -0.2 ( 22.03 )
        AST, Week 40, n=250, 266
    0.2 ( 13.31 )
    -1.5 ( 15.24 )
        AST, Week 44, n=258, 263
    1.3 ( 16.49 )
    -0.5 ( 18.31 )
        AST Week 48, n=247, 262
    -0.8 ( 11.88 )
    0.8 ( 44.70 )
        CK, Week 4, n=280, 277
    31.1 ( 456.63 )
    -27.0 ( 523.89 )
        CK, Week 8, n=212, 278
    53.5 ( 907.83 )
    -46.6 ( 499.91 )
        CK, Week 12, n=270, 276
    1.2 ( 420.32 )
    -17.2 ( 605.92 )
        CK, Week 16, n=255, 269
    -18.0 ( 316.74 )
    40.2 ( 746.32 )
        CK, Week 20, n=260, 272
    19.2 ( 536.70 )
    57.3 ( 1208.73 )
        CK, Week 24, n=261, 268
    47.3 ( 635.42 )
    -19.6 ( 605.13 )
        CK, Week 28, n=253, 268
    49.9 ( 669.37 )
    -8.5 ( 705.35 )
        CK, Week 32, n=256, 268
    -24.5 ( 298.70 )
    -42.5 ( 509.77 )
        CK, Week 36, n=254, 261
    14.7 ( 515.62 )
    12.2 ( 674.76 )
        CK, Week 40, n=250, 266
    24.8 ( 544.72 )
    -51.7 ( 497.70 )
        CK, Week 44, n=258, 263
    54.8 ( 526.28 )
    -20.1 ( 652.24 )
        CK, Week 48, n=247, 262
    -17.8 ( 309.33 )
    121.1 ( 2682.33 )
    Notes
    [63] - Safety Population
    [64] - 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 last available recorded value up to and including the date of first Maintenance Phase dose of IP. 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) ABC/ DTG/ 3TC
    Number of subjects analysed
    283 [65]
    283 [66]
    Units: Grams per liter
    arithmetic mean (standard deviation)
        Week 4, n=280, 277
    -0.1 ( 2.15 )
    -0.3 ( 2.14 )
        Week 8, n=212, 278
    -0.1 ( 2.32 )
    -0.3 ( 2.25 )
        Week 12, n=270, 276
    -0.1 ( 2.38 )
    0.0 ( 2.58 )
        Week 16, n=255, 269
    0.2 ( 2.23 )
    -0.1 ( 2.48 )
        Week 20, n=260, 272
    0.2 ( 2.51 )
    -0.2 ( 2.47 )
        Week 24, n=261, 268
    0.5 ( 2.28 )
    0.2 ( 2.37 )
        Week 28, n=253, 268
    0.5 ( 2.42 )
    0.4 ( 2.32 )
        Week 32, n=255, 268
    0.7 ( 2.47 )
    0.4 ( 2.60 )
        Week 36, n=254, 261
    0.3 ( 2.44 )
    0.3 ( 2.52 )
        Week 40, n=250, 266
    0.9 ( 2.42 )
    0.5 ( 2.46 )
        Week 44, n=258, 263
    0.9 ( 2.44 )
    0.4 ( 2.49 )
        Week 48, n=247, 262
    0.7 ( 2.40 )
    0.5 ( 2.63 )
    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: 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 last available recorded value up to and including the date of first Maintenance Phase dose of IP. 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) ABC/ DTG/ 3TC
    Number of subjects analysed
    283 [67]
    283 [68]
    Units: Micromoles per liter
    arithmetic mean (standard deviation)
        Bilirubin, Week 4, n=281, 277
    1.4 ( 4.74 )
    -0.3 ( 3.77 )
        Bilirubin, Week 8, n=212, 278
    0.9 ( 4.04 )
    -0.5 ( 4.17 )
        Bilirubin, Week 12, n=270, 276
    1.2 ( 4.15 )
    -0.7 ( 4.51 )
        Bilirubin, Week 16, n=255, 269
    1.2 ( 4.30 )
    -0.3 ( 3.61 )
        Bilirubin, Week 20, n=260, 272
    1.1 ( 4.14 )
    -0.7 ( 4.02 )
        Bilirubin, Week 24, n=261, 268
    0.8 ( 4.12 )
    -0.4 ( 3.85 )
        Bilirubin, Week 28, n=253, 268
    1.2 ( 4.41 )
    -0.7 ( 3.75 )
        Bilirubin, Week 32, n=256, 268
    1.3 ( 6.44 )
    -0.6 ( 4.05 )
        Bilirubin, Week 36, n=255, 260
    0.6 ( 5.36 )
    -0.7 ( 4.28 )
        Bilirubin, Week 40, n=250, 266
    0.9 ( 4.31 )
    -0.8 ( 4.32 )
        Bilirubin, Week 44, n=258, 263
    1.2 ( 4.34 )
    -0.4 ( 4.28 )
        Bilirubin, Week 48, n=247, 262
    1.1 ( 4.18 )
    -0.3 ( 4.17 )
        Direct bilirubin, Week 4, n=277, 277
    0.2 ( 1.40 )
    -0.1 ( 1.33 )
        Direct bilirubin, Week 8, n=212, 278
    0.2 ( 1.30 )
    -0.1 ( 1.19 )
        Direct bilirubin, Week 12, n=269, 273
    0.2 ( 1.22 )
    0.0 ( 1.22 )
        Direct bilirubin, Week 16, n=254, 268
    0.2 ( 1.44 )
    -0.1 ( 1.14 )
        Direct bilirubin, Week 20, n=260, 272
    0.2 ( 1.57 )
    -0.1 ( 1.14 )
        Direct bilirubin, Week 24, n=260, 266
    0.1 ( 1.46 )
    -0.1 ( 1.10 )
        Direct bilirubin, Week 28, n=253, 268
    0.2 ( 1.26 )
    -0.1 ( 1.22 )
        Direct bilirubin, Week 32, n=256, 268
    0.3 ( 3.39 )
    -0.1 ( 1.08 )
        Direct bilirubin, Week 36, n=255, 260
    0.1 ( 2.18 )
    -0.1 ( 1.16 )
        Direct bilirubin, Week 40, n=249, 266
    0.1 ( 1.42 )
    -0.1 ( 1.26 )
        Direct bilirubin, Week 44, n=258, 263
    0.2 ( 1.41 )
    -0.1 ( 1.19 )
        Direct bilirubin, Week 48, n=247, 262
    0.0 ( 1.41 )
    0.0 ( 1.19 )
        Creatinine, Week 4, n=280, 277
    -6.07 ( 9.696 )
    0.61 ( 7.635 )
        Creatinine, Week 8, n=212, 278
    -9.25 ( 9.936 )
    -0.24 ( 8.838 )
        Creatinine, Week 12, n=270, 276
    -9.89 ( 9.703 )
    -1.20 ( 8.710 )
        Creatinine, Week 16, n=255, 269
    -9.75 ( 9.572 )
    -0.33 ( 8.964 )
        Creatinine, Week 20, n=261, 272
    -10.10 ( 9.839 )
    -0.68 ( 8.700 )
        Creatinine, Week 24, n=262, 268
    -9.73 ( 9.499 )
    -0.75 ( 8.327 )
        Creatinine, Week 28, n=253, 268
    -10.34 ( 9.731 )
    -1.33 ( 8.892 )
        Creatinine, Week 32, n=255, 268
    -9.77 ( 9.166 )
    -1.26 ( 9.243 )
        Creatinine, Week 36, n=254, 262
    -9.57 ( 9.712 )
    -0.74 ( 8.565 )
        Creatinine, Week 40, n=250, 266
    -9.60 ( 10.656 )
    -1.10 ( 7.875 )
        Creatinine, Week 44, n=258, 263
    -9.02 ( 9.562 )
    -1.91 ( 8.306 )
        Creatinine, Week 48, n=247, 262
    -8.97 ( 9.742 )
    5.00 ( 85.535 )
    Notes
    [67] - Safety Population
    [68] - 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 last available recorded value up to and including the date of first Maintenance Phase dose of IP. 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) ABC/ DTG/ 3TC
    Number of subjects analysed
    283 [69]
    283 [70]
    Units: Millimoles per liter
    arithmetic mean (standard deviation)
        CO2, Week 4, n=280, 276
    0.6 ( 2.67 )
    0.2 ( 2.32 )
        CO2, Week 8, n=212, 278
    0.2 ( 2.51 )
    -0.1 ( 2.24 )
        CO2, Week 12, n=270, 276
    0.2 ( 2.56 )
    -0.1 ( 2.26 )
        CO2, Week 16, n=255, 269
    0.4 ( 2.55 )
    -0.1 ( 2.72 )
        CO2, Week 20, n=260, 272
    0.3 ( 2.52 )
    0.1 ( 2.38 )
        CO2, Week 24, n=261, 268
    0.6 ( 2.84 )
    0.4 ( 2.56 )
        CO2, Week 28, n=253, 268
    0.5 ( 2.51 )
    0.4 ( 2.39 )
        CO2, Week 32, n=255, 268
    0.5 ( 2.72 )
    0.3 ( 2.37 )
        CO2, Week 36, n=253, 261
    0.7 ( 2.54 )
    0.2 ( 2.35 )
        CO2, Week 40, n=249, 265
    0.4 ( 2.53 )
    0.2 ( 2.61 )
        CO2, Week 44, n=257, 263
    0.4 ( 2.71 )
    0.1 ( 2.37 )
        CO2, Week 48, n=247, 262
    0.0 ( 2.70 )
    0.0 ( 2.27 )
        Chloride, Week 4, n=280, 277
    0.0 ( 2.13 )
    0.5 ( 2.17 )
        Chloride, Week 8, n=212, 278
    0.0 ( 2.05 )
    0.3 ( 2.14 )
        Chloride, Week 12, n=270, 276
    0.0 ( 2.10 )
    0.4 ( 2.16 )
        Chloride, Week 16, n=255, 269
    -0.2 ( 2.32 )
    0.3 ( 2.39 )
        Chloride, Week 20, n=260, 272
    -0.3 ( 2.49 )
    0.4 ( 2.15 )
        Chloride, Week 24, n=261, 268
    -0.2 ( 2.40 )
    0.2 ( 2.47 )
        Chloride, Week 28, n=253, 268
    -0.2 ( 2.21 )
    0.1 ( 2.18 )
        Chloride, Week 32, n=255, 268
    -0.2 ( 2.37 )
    0.3 ( 2.34 )
        Chloride, Week 36, n=254, 261
    -0.1 ( 2.46 )
    0.4 ( 2.37 )
        Chloride, Week 40, n=250, 266
    0.1 ( 2.35 )
    0.4 ( 2.20 )
        Chloride, Week 44, n=258, 263
    0.1 ( 2.40 )
    0.7 ( 2.23 )
        Chloride, Week 48, n=247, 262
    0.0 ( 2.23 )
    0.3 ( 2.09 )
        Phosphate, Week 4, n=279, 277
    0.032 ( 0.1865 )
    0.014 ( 0.1771 )
        Phosphate, Week 8, n=212, 278
    -0.016 ( 0.1834 )
    0.017 ( 0.1855 )
        Phosphate, Week 12, n=270, 276
    -0.010 ( 0.1825 )
    0.009 ( 0.1772 )
        Phosphate, Week 16, n=255, 269
    0.000 ( 0.1789 )
    0.017 ( 0.1892 )
        Phosphate, Week 20, n=260, 272
    -0.029 ( 0.1932 )
    0.016 ( 0.1764 )
        Phosphate, Week 24, n=261, 268
    -0.001 ( 0.1907 )
    0.011 ( 0.1852 )
        Phosphate, Week 28, n=253, 268
    -0.007 ( 0.1894 )
    0.019 ( 0.1882 )
        Phosphate, Week 32, n=255, 268
    -0.004 ( 0.1806 )
    0.005 ( 0.2092 )
        Phosphate, Week 36, n=254, 261
    -0.006 ( 0.1798 )
    0.021 ( 0.1965 )
        Phosphate, Week 40, n=250, 266
    -0.011 ( 0.1851 )
    0.015 ( 0.1753 )
        Phosphate, Week 44, n=258, 263
    -0.004 ( 0.1824 )
    0.020 ( 0.1801 )
        Phosphate, Week 48, n=247, 262
    -0.007 ( 0.1784 )
    0.020 ( 0.2333 )
        Potassium, Week 4, n=280, 277
    0.15 ( 0.334 )
    0.06 ( 0.368 )
        Potassium, Week 8, n=212, 278
    0.10 ( 0.348 )
    0.08 ( 0.346 )
        Potassium, Week 12, n=270, 276
    0.09 ( 0.352 )
    0.05 ( 0.305 )
        Potassium, Week 16, n=255, 269
    0.10 ( 0.321 )
    0.04 ( 0.314 )
        Potassium, Week 20, n=260, 272
    0.09 ( 0.374 )
    0.04 ( 0.364 )
        Potassium, Week 24, n=261, 268
    0.12 ( 0.353 )
    0.07 ( 0.309 )
        Potassium, Week 28, n=253, 268
    0.08 ( 0.341 )
    0.08 ( 0.350 )
        Potassium, Week 32, n=255, 268
    0.09 ( 0.334 )
    0.06 ( 0.345 )
        Potassium, Week 36, n=254, 261
    0.10 ( 0.353 )
    0.08 ( 0.347 )
        Potassium, Week 40, n=250, 266
    0.07 ( 0.347 )
    0.06 ( 0.345 )
        Potassium, Week 44, n=258, 263
    0.08 ( 0.353 )
    0.06 ( 0.338 )
        Potassium, Week 48, n=247, 262
    0.01 ( 0.343 )
    0.03 ( 0.496 )
        Sodium, Week 4, n=280, 277
    0.3 ( 2.25 )
    0.2 ( 1.95 )
        Sodium, Week 8, n=212, 278
    0.1 ( 1.98 )
    0.1 ( 1.92 )
        Sodium, Week 12, n=270, 276
    0.3 ( 1.84 )
    0.1 ( 1.89 )
        Sodium, Week 16, n=255, 269
    0.2 ( 2.10 )
    0.3 ( 2.21 )
        Sodium, Week 20, n=260, 272
    0.2 ( 2.08 )
    0.4 ( 1.79 )
        Sodium, Week 24, n=261, 268
    0.2 ( 2.02 )
    0.2 ( 2.12 )
        Sodium, Week 28, n=253, 268
    0.2 ( 1.88 )
    0.4 ( 1.82 )
        Sodium, Week 32, n=255, 268
    0.3 ( 2.13 )
    0.3 ( 2.02 )
        Sodium, Week 36, n=254, 261
    0.2 ( 2.16 )
    0.4 ( 1.94 )
        Sodium, Week 40, n=250, 266
    0.1 ( 2.08 )
    0.4 ( 2.13 )
        Sodium, Week 44, n=258, 263
    0.3 ( 2.30 )
    0.4 ( 2.01 )
        Sodium, Week 48, n=247, 262
    0.2 ( 2.11 )
    0.3 ( 1.72 )
        Urea, Week 4, n=280, 277
    0.04 ( 1.292 )
    -0.05 ( 1.240 )
        Urea, Week 8, n=212, 278
    0.04 ( 1.315 )
    -0.05 ( 1.278 )
        Urea, Week 12, n=270, 276
    -0.01 ( 1.287 )
    0.04 ( 1.340 )
        Urea, Week 16, n=255, 269
    0.02 ( 1.394 )
    0.01 ( 1.171 )
        Urea, Week 20, n=260, 272
    -0.07 ( 1.359 )
    0.04 ( 1.190 )
        Urea, Week 24, n=261, 268
    0.09 ( 1.459 )
    -0.08 ( 1.154 )
        Urea, Week 28, n=253, 268
    0.02 ( 1.412 )
    0.02 ( 1.230 )
        Urea, Week 32, n=255, 268
    0.16 ( 1.364 )
    -0.03 ( 1.330 )
        Urea, Week 36, n=254, 261
    0.05 ( 1.451 )
    0.04 ( 1.265 )
        Urea, Week 40, n=250, 266
    0.07 ( 1.466 )
    0.05 ( 1.312 )
        Urea, Week 44, n=258, 263
    0.12 ( 1.361 )
    0.03 ( 1.290 )
        Urea, Week 48, n=247, 262
    0.09 ( 1.362 )
    0.06 ( 2.189 )
    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 last available recorded value up to and including the date of first Maintenance Phase dose of IP. 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) ABC/ DTG/ 3TC
    Number of subjects analysed
    283 [71]
    283 [72]
    Units: Units per liter
    arithmetic mean (standard deviation)
        Week 4, n=278, 276
    1.6 ( 23.51 )
    1.8 ( 30.92 )
        Week 8, n=211, 278
    0.8 ( 19.07 )
    0.4 ( 27.41 )
        Week 12, n=270, 276
    1.3 ( 18.55 )
    2.5 ( 29.44 )
        Week 16, n=254, 269
    0.8 ( 20.27 )
    1.2 ( 27.24 )
        Week 20, n=260, 270
    1.6 ( 16.26 )
    0.8 ( 27.96 )
        Week 24, n=260, 268
    0.9 ( 18.74 )
    0.9 ( 27.58 )
        Week 28, n=253, 268
    -0.4 ( 16.73 )
    1.8 ( 29.09 )
        Week 32, n=254, 268
    2.9 ( 29.88 )
    2.0 ( 34.42 )
        Week 36, n=254, 261
    1.0 ( 17.45 )
    -0.1 ( 28.89 )
        Week 40, n=250, 266
    2.3 ( 22.71 )
    0.6 ( 27.95 )
        Week 44, n=258, 263
    5.7 ( 41.87 )
    1.6 ( 29.05 )
        Week 48, n=247, 261
    0.7 ( 16.14 )
    1.1 ( 32.35 )
    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 will be estimated by the central laboratory using the CKD-EPI. Baseline value is defined as the last available recorded value up to and including the date of first Maintenance Phase dose of IP. 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) ABC/ DTG/ 3TC
    Number of subjects analysed
    283 [73]
    283 [74]
    Units: Milliliter per minute per 1.73meter^2
    arithmetic mean (standard deviation)
        Week 4, n=278, 277
    6.9 ( 10.16 )
    -1.2 ( 8.72 )
        Week 8, n=211, 278
    10.0 ( 11.83 )
    0.2 ( 9.13 )
        Week 12, n=270, 276
    10.7 ( 11.49 )
    0.9 ( 9.83 )
        Week 16, n=254, 269
    10.4 ( 11.28 )
    -0.3 ( 10.23 )
        Week 20, n=261, 271
    10.9 ( 11.45 )
    0.3 ( 9.90 )
        Week 24, n=261, 268
    10.5 ( 11.38 )
    0.2 ( 9.63 )
        Week 28, n=253, 268
    10.9 ( 11.90 )
    1.0 ( 9.90 )
        Week 32, n=254, 268
    10.6 ( 11.45 )
    1.1 ( 10.05 )
        Week 36, n=254, 262
    10.3 ( 11.94 )
    0.2 ( 10.08 )
        Week 40, n=250, 266
    10.2 ( 12.57 )
    0.7 ( 9.19 )
        Week 44, n=258, 263
    9.8 ( 11.61 )
    1.4 ( 9.88 )
        Week 48, n=247, 261
    9.5 ( 11.35 )
    -0.7 ( 10.86 )
    Notes
    [73] - Safety Population
    [74] - Safety Population
    No statistical analyses for this end point

    Secondary: Change from Baseline values for fasting lipid panel and glucose overtime including Week 48

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    End point title
    		 Change from Baseline values for fasting lipid panel and glucose overtime including Week 48
    End point description
    Blood samples were collected at Baseline and at Week 48 to assess glucose and fasting lipids which included total cholesterol, high density lipoprotein (HDL)cholesterol, low density lipoprotein (LDL) cholesterol and triglycerides. Only fasting data is presented for glucose and lipids. Baseline value is defined as the last available fasting recorded value up to and including the date of first Maintenance Phase dose of IP. Change from Baseline value is calculated as the value at Week 48 visit (if collected while fasting) 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) ABC/ DTG/ 3TC
    Number of subjects analysed
    283 [75]
    283 [76]
    Units: Millimoles per liter
    arithmetic mean (standard deviation)
        Glucose, Week 48, n=248, 251
    0.02 ( 1.220 )
    0.04 ( 0.923 )
        Total Cholesterol, Week 48, n=240, 239
    0.09 ( 0.658 )
    0.05 ( 0.607 )
        HDL cholesterol, Week 48, n=240, 239
    0.109 ( 0.2587 )
    0.076 ( 0.2478 )
        LDL cholesterol, Week 48, n=238, 237
    0.122 ( 0.5807 )
    -0.045 ( 0.5384 )
        Triglycerides, Week 48, n=240, 239
    -0.085 ( 0.7167 )
    0.073 ( 0.8361 )
    Notes
    [75] - Safety Population
    [76] - 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 last available recorded value up to and including the date of first Maintenance Phase dose of IP. 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) ABC/ DTG/ 3TC
    Number of subjects analysed
    283 [77]
    283 [78]
    Units: Grams per mole
    arithmetic mean (standard deviation)
        Urine albumin/creatinine ratio, Week 4,n=199, 194
    0.36 ( 6.714 )
    0.23 ( 4.062 )
        Urine albumin/creatinine ratio, Week 24,n=137, 184
    0.30 ( 4.941 )
    1.06 ( 7.186 )
        Urine albumin/creatinine ratio, Week 48,n=181, 184
    -0.53 ( 17.469 )
    0.19 ( 3.944 )
        Urine protein/creatinine, Week 4, n=211, 215
    -0.16 ( 18.641 )
    0.19 ( 6.439 )
        Urine protein/creatinine, Week 24, n=151, 204
    2.23 ( 35.187 )
    1.32 ( 12.171 )
        Urine protein/creatinine, Week 48, n=194, 197
    -1.86 ( 21.898 )
    0.26 ( 8.180 )
    Notes
    [77] - Safety Population
    [78] - 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 last available recorded value up to and including the date of first Maintenance Phase dose of IP. 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) ABC/ DTG/ 3TC
    Number of subjects analysed
    283 [79]
    283 [80]
    Units: Micromoles per liter
    arithmetic mean (standard deviation)
        Week 4, n=277, 272
    -519.5 ( 9558.55 )
    -429.0 ( 9540.31 )
        Week 24, n=193, 258
    -597.4 ( 9405.95 )
    -17.1 ( 9575.04 )
        Week 48, n=260, 258
    -1359.2 ( 9059.43 )
    -505.4 ( 8873.05 )
    Notes
    [79] - Safety Population
    [80] - 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 last available recorded value up to and including the date of first Maintenance Phase dose of IP. 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) ABC/ DTG/ 3TC
    Number of subjects analysed
    283 [81]
    283 [82]
    Units: Micromoles per liter
    arithmetic mean (standard deviation)
        Week 4, n=275, 273
    1.842 ( 18.4414 )
    -0.693 ( 18.4830 )
        Week 24, n=192, 260
    0.585 ( 19.2777 )
    -0.689 ( 16.9500 )
        Week 48, n=259, 258
    0.043 ( 17.3741 )
    0.304 ( 16.7073 )
    Notes
    [81] - Safety Population
    [82] - 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 last available recorded value up to and including the date of first Maintenance Phase dose of IP. 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) ABC/ DTG/ 3TC
    Number of subjects analysed
    283 [83]
    283 [84]
    Units: Nanomoles per liter
        arithmetic mean (standard deviation)
    -0.33 ( 0.938 )
    -0.24 ( 0.932 )
    Notes
    [83] - Safety Population
    [84] - 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. Baseline value is defined as the last available recorded value up to and including the date of first Maintenance Phase dose of IP. 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.
    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) ABC/ DTG/ 3TC
    Number of subjects analysed
    283
    283
    Units: Ratio of urine density to water density
    arithmetic mean (standard deviation)
        Week 4, n=271, 266
    -0.0004 ( 0.00837 )
    -0.0005 ( 0.00798 )
        Week 24, n=191, 252
    -0.0001 ( 0.00805 )
    -0.0002 ( 0.00825 )
        Week 48, n=255, 252
    -0.0009 ( 0.00784 )
    -0.0007 ( 0.00783 )
    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). Baseline value is defined as the last available recorded value up to and including the date of first Maintenance Phase dose of IP. 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) ABC/ DTG/ 3TC
    Number of subjects analysed
    283 [85]
    283 [86]
    Units: pH
    arithmetic mean (standard deviation)
        Week 4, n=271, 266
    0.12 ( 0.833 )
    0.01 ( 0.884 )
        Week 24, n=191, 252
    -0.01 ( 0.889 )
    -0.07 ( 0.910 )
        Week 48, n=255, 252
    0.01 ( 0.926 )
    -0.10 ( 0.988 )
    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. All Maintenance Phase adverse events (start date occurring on or after the date of first dose of randomized study treatment) leading to withdrawal have been presented.
    End point type
    Secondary
    End point timeframe
    Up to Week 48
    End point values
    		 CAB LA + RPV LA (Q4W) ABC/ DTG/ 3TC
    Number of subjects analysed
    283 [87]
    283 [88]
    Units: Participants
    9
    4
    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 last available recorded fasting value up to and including the date of first Maintenance Phase dose of IP. Percentage change from baseline is calculated as: value at Week 48 (if collected while fasting) 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) ABC/ DTG/ 3TC
    Number of subjects analysed
    283 [89]
    283 [90]
    Units: Millimoles per liter
    arithmetic mean (standard deviation)
        Cholesterol, Week 48, Overall, n=240, 239
    5.09 ( 15.695 )
    2.32 ( 14.456 )
        HDL cholesterol, Week 48, Overall, n=240, 239
    15.448 ( 78.5208 )
    7.361 ( 20.3088 )
        LDL cholesterol, Week 48, Overall, n=238, 237
    7.048 ( 29.2139 )
    0.462 ( 23.9648 )
        Triglycerides, Week 48, Overall, n=240, 239
    2.633 ( 44.1663 )
    14.252 ( 62.2823 )
    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
    Plasma samples were collected from participants who met confirmed virologic withdrawal criteria.Phenotypic Resistance data for drugs:CAB, DTG,elvitegravir (EVG), raltegravir(RAL),delavirdine(DLV),efavirenz(EFV),etravirine(ETR),nevirapine(NVP),RPV,3TC, ABC,emtricitabine(FTC),tenofovir(TDF),zidovudine(ZDV),stavudine(d4T),didanosine(ddI),atazanavir(ATV),darunavir(DRV),fosamprenavir(FPV),indinavir(IDV),lopinavir(LPV),nelfinavir(NFV),ritonavir(RTV), saquinavir(SQV) and tipranavir (TPV) is presented.Phenotypic resistance, partially sensitive, and Sensitive are based on fold change(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). CVF population comprised of participants in ITT-E population who met CVF criteria. Only participants with data available at specified data points were analyzed.
    End point type
    Secondary
    End point timeframe
    Week 48
    End point values
    		 CAB LA + RPV LA (Q4W) ABC/ DTG/ 3TC
    Number of subjects analysed
    3 [91]
    3 [92]
    Units: Participants
    number (not applicable)
        INI, CAB, sensitive
    0
    3
        INI, CAB, partially sensitive
    0
    0
        INI, CAB, resistant
    3
    0
        INI, DTG, sensitive
    3
    3
        INI, DTG, partially sensitive
    0
    0
        INI, DTG, resistant
    0
    0
        INI, EVG, sensitive
    0
    3
        INI, EVG, partially sensitive
    0
    0
        INI, EVG, resistant
    3
    0
        INI, RAL, sensitive
    0
    3
        INI, RAL, partially sensitive
    0
    0
        INI, RAL, resistant
    3
    0
        NNRTI, DLV, sensitive
    1
    3
        NNRTI, DLV, partially sensitive
    0
    0
        NNRTI, DLV, resistant
    2
    0
        NNRTI, EFV, sensitive
    1
    3
        NNRTI, EFV, partially sensitive
    0
    0
        NNRTI, EFV, resistant
    2
    0
        NNRTI, ETR, sensitive
    2
    3
        NNRTI, ETR, partially sensitive
    1
    0
        NNRTI, ETR, resistant
    0
    0
        NNRTI, NVP, sensitive
    1
    3
        NNRTI, NVP, partially sensitive
    0
    0
        NNRTI, NVP, resistant
    2
    0
        NNRTI, RPV, sensitive
    1
    3
        NNRTI, RPV, partially sensitive
    0
    0
        NNRTI, RPV, resistant
    2
    0
        NRTI, 3TC, sensitive
    3
    3
        NRTI, 3TC, partially sensitive
    0
    0
        NRTI, 3TC, resistant
    0
    0
        NRTI, ABC, sensitive
    3
    3
        NRTI, ABC, partially sensitive
    0
    0
        NRTI, ABC, resistant
    0
    0
        NRTI, FTC, sensitive
    3
    0
        NRTI, FTC, partially sensitive
    0
    0
        NRTI, FTC, resistant
    0
    0
        NRTI, TDF, sensitive
    1
    3
        NRTI, TDF, partially sensitive
    2
    0
        NRTI, TDF, resistant
    0
    0
        NRTI, ZDV, sensitive
    2
    3
        NRTI, ZDV, partially sensitive
    0
    0
        NRTI, ZDV, resistant
    1
    0
        NRTI, d4T, sensitive
    3
    3
        NRTI, d4T, partially sensitive
    0
    0
        NRTI, d4T, resistant
    0
    0
        NRTI, ddI, sensitive
    3
    3
        NRTI, ddI, partially sensitive
    0
    0
        NRTI, ddI, resistant
    0
    0
        PI, ATV, sensitive
    3
    3
        PI, ATV, partially sensitive
    0
    0
        PI, ATV, resistant
    0
    0
        PI, DRV, sensitive
    3
    3
        PI, DRV, partially sensitive
    0
    0
        PI, DRV, resistant
    0
    0
        PI, FPV, sensitive
    3
    3
        PI, FPV, partially sensitive
    0
    0
        PI, FPV, resistant
    0
    0
        PI, IDV, sensitive
    3
    3
        PI, IDV, partially sensitive
    0
    0
        PI, IDV, resistant
    0
    0
        PI, LPV, sensitive
    3
    3
        PI, LPV, partially sensitive
    0
    0
        PI, LPV, resistant
    0
    0
        PI, NFV, sensitive
    3
    3
        PI, NFV, partially sensitive
    0
    0
        PI, NFV, resistant
    0
    0
        PI, RTV, sensitive
    3
    3
        PI, RTV, partially sensitive
    0
    0
        PI, RTV, resistant
    0
    0
        PI, SQV, sensitive
    3
    3
        PI, SQV, partially sensitive
    0
    0
        PI, SQV, resistant
    0
    0
        PI, TPV, sensitive
    3
    3
        PI, TPV, partially sensitive
    0
    0
        PI, TPV, resistant
    0
    0
    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.
    End point type
    Secondary
    End point timeframe
    Week 48
    End point values
    		 CAB LA + RPV LA (Q4W) ABC/ DTG/ 3TC
    Number of subjects analysed
    3 [93]
    3 [94]
    Units: Participants
    number (not applicable)
        INI, DTG, resistant
    0
    0
        INI, DTG, resistance possible
    2
    0
        INI, DTG, sensitive
    1
    3
        INI, EVG, resistant
    2
    0
        INI, EVG, resistance possible
    0
    0
        INI, EVG, sensitive
    1
    3
        INI, RAL, resistant
    2
    0
        INI, RAL, resistance possible
    0
    0
        INI, RAL, sensitive
    1
    3
        NNRTI, DLV, resistant
    0
    0
        NNRTI, DLV, resistance possible
    0
    0
        NNRTI, DLV, sensitive
    3
    3
        NNRTI, EFV, resistant
    0
    0
        INI, EFV, resistance possible
    1
    0
        NNRTI, EFV, sensitive
    2
    3
        NNRTI, ETR, resistant
    0
    0
        NNRTI, ETR, resistance possible
    0
    0
        NNRTI, ETR, sensitive
    3
    3
        NNRTI, NVP, resistant
    0
    0
        NNRTI, NVP, resistance possible
    1
    0
        NNRTI, NVP, sensitive
    2
    3
        NNRTI, RPV, resistant
    3
    0
        NNRTI, RPV, resistance possible
    0
    0
        NNRTI, RPV, sensitive
    0
    3
        NRTI, 3TC, resistant
    0
    0
        NNRTI, 3TC, resistance possible
    0
    0
        NRTI, 3TC, sensitive
    3
    3
        NRTI, ABC, resistant
    0
    0
        NRTI, ABC, resistance possible
    0
    0
        NRTI, ABC, sensitive
    3
    3
        NRTI, FTC, resistant
    0
    0
        NRTI, FTC, resistance possible
    0
    0
        NRTI, FTC, sensitive
    3
    3
        NRTI, TDF, resistant
    0
    0
        NRTI, TDF, resistance possible
    0
    0
        NRTI, TDF, sensitive
    3
    3
        NRTI, ZDV, resistant
    0
    0
        NRTI, ZDV, resistance possible
    0
    0
        NRTI, ZDV, sensitive
    3
    3
        NRTI, d4T, resistant
    0
    0
        NRTI, d4T, resistance possible
    0
    0
        NRTI, d4T, sensitive
    3
    3
        NRTI, ddI, resistant
    0
    0
        NRTI, ddI, resistance possible
    0
    0
        NRTI, ddI, sensitive
    3
    3
        PI, ATV, resistant
    0
    0
        PI, ATV, resistance possible
    0
    0
        PI, ATV, sensitive
    3
    3
        PI, ATV/r, resistant
    0
    0
        PI, ATV/r, resistance possible
    0
    0
        PI, ATV/r, sensitive
    3
    3
        PI, DRV/r, resistant
    0
    0
        PI, DRV/r, resistance possible
    0
    0
        PI, DRV/r, sensitive
    3
    3
        PI, FPV/r, resistant
    0
    0
        PI, FPV/r, resistance possible
    0
    0
        PI, FPV/r, sensitive
    3
    3
        PI, IDV/r, resistant
    0
    0
        PI, IDV/r, resistance possible
    0
    0
        PI, IDV/r, sensitive
    3
    3
        PI, LPV/r, resistant
    0
    0
        PI, LPV/r, resistance possible
    0
    0
        PI, LPV/r, sensitive
    3
    3
        PI, NFV, resistant
    0
    0
        PI, NFV, resistance possible
    0
    0
        PI, NFV, sensitive
    3
    3
        PI, RTV, resistant
    0
    0
        PI, RTV, resistance possible
    0
    0
        PI, RTV, sensitive
    3
    3
        PI, SQV/r, resistant
    0
    0
        PI, SQV/r, resistance possible
    0
    0
        PI, SQV/r, sensitive
    3
    3
        PI, TPV/r, resistant
    0
    0
        PI, TPV/r, resistance possible
    1
    0
        PI, TPV/r, sensitive
    2
    3
    Notes
    [93] - CVF Population
    [94] - CVF Population
    No statistical analyses for this end point

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

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    End point title
    		 Area under the curve (AUC) for CAB LA and RPV LA evaluable
    End point description
    Blood samples were collected at indicated time points to analyse AUC concentration in plasma for CAB LA. 99999 indicates data was not available due to sparse sampling post IM dosing. Pharmacokinetic (PK) Population includes all participants who received CAB and / or RPV and undergo PK sampling during the study, and provide CAB and /or RPV plasma concentration data.
    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, 41, 2 hours post-dose at Weeks 4 and 48
    End point values
    		 CAB LA RPV LA
    Number of subjects analysed
    283 [95]
    283 [96]
    Units: Hours*microgram per milliliter
        geometric mean (confidence interval 95%)
    99999 (99999 to 99999)
    99999 (99999 to 99999)
    Notes
    [95] - PK Population
    [96] - PK 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 were collected at indicated time points for PK analysis of CAB 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
    		 CAB LA
    Number of subjects analysed
    278
    Units: Microgram per milliliter
    geometric mean (confidence interval 95%)
        Pre-dose, Week 8, n=250
    1.5616 (1.4508 to 1.6808)
        Pre-dose, Week 12, n=237
    2.0141 (1.8990 to 2.1362)
        Pre-dose, Week 16, n=215
    2.0960 (1.9740 to 2.2255)
        Pre-dose, Week 20, n=233
    2.1739 (2.0580 to 2.2963)
        Pre-dose, Week 24, n=227
    2.3827 (2.2731 to 2.4976)
        Pre-dose, Week 28, n=220
    2.4683 (2.3421 to 2.6013)
        Pre-dose, Week 32, n=219
    2.6729 (2.5339 to 2.8196)
        Pre-dose, Week 36, n=215
    2.8590 (2.7096 to 3.0165)
        Pre-dose, Week 40, n=210
    2.9378 (2.7872 to 3.0966)
        Pre-dose, Week 44, n=217
    3.0133 (2.8739 to 3.1595)
        Pre-dose, Week 48, n=197
    3.1325 (2.9454 to 3.3315)
    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 were 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
    278
    Units: Nanograms per milliliter
    geometric mean (confidence interval 95%)
        Pre-dose, Week 8, n=251
    41.23 (38.74 to 43.88)
        Pre-dose, Week 12, n=236
    46.86 (43.82 to 50.12)
        Pre-dose, Week 16, n=217
    50.01 (47.06 to 53.15)
        Pre-dose, Week 20, n=233
    52.76 (49.79 to 55.91)
        Pre-dose, Week 24, n=228
    55.56 (52.48 to 58.82)
        Pre-dose, Week 28, n=220
    59.46 (55.43 to 63.79)
        Pre-dose, Week 32, n=220
    66.88 (62.95 to 71.05)
        Pre-dose, Week 36, n=215
    69.09 (64.90 to 73.55)
        Pre-dose, Week 40, n=210
    75.71 (71.38 to 80.29)
        Pre-dose, Week 44, n=216
    77.96 (73.87 to 82.28)
        Pre-dose, Week 48, n=197
    82.38 (77.82 to 87.22)
    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
    236
    Units: Micrograms per milliliter
        geometric mean (confidence interval 95%)
    4.0334 (3.8488 to 4.2269)
    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
    236
    Units: Nanograms per milliliter
        geometric mean (confidence interval 95%)
    106.3 (101.03 to 111.28)
    No statistical analyses for this end point

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

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    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
    Up to Week 48
    End point values
    		 CAB LA RPV LA
    Number of subjects analysed
    0 [97]
    0 [98]
    Units: Participants
        number (not applicable)
    Notes
    [97] - PK Population
    [98] - PK Population
    No statistical analyses for this end point

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

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    End point title
    		 Change from Week 5 in dimension scores using perception of injection questionnaire (PIN)-Last Observation Carried Forward (LOCF) [99]
    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 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 analysed. p-value was derived only for acceptance: <0.001.
    End point type
    Secondary
    End point timeframe
    Weeks 5 and at Weeks 41 and 48
    Notes
    [99] - 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: This endpoint is specific to CAB LA + RPV LA (Q4W) arm.
    End point values
    		 CAB LA + RPV LA (Q4W)
    Number of subjects analysed
    270 [100]
    Units: Scores on a scale
    arithmetic mean (standard deviation)
        Bother of ISRs, Week 41
    -0.14 ( 0.551 )
        Bother of ISRs, Week 48
    -0.14 ( 0.639 )
        Leg movement, Week 41
    -0.58 ( 0.880 )
        Leg movement, Week 48
    -0.63 ( 0.964 )
        Sleep, Week 41
    -0.57 ( 0.925 )
        Sleep, Week 48
    -0.58 ( 1.033 )
        Acceptance, Week 41
    -0.36 ( 0.959 )
        Acceptance, Week 48
    -0.40 ( 0.943 )
    Notes
    [100] - 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

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    End point title
    		 Percentage of participants with extremely or very acceptable pain and local reaction: acceptability score on PIN questionnaire [101]
    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
    [101] - 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: This endpoint is specific to CAB LA + RPV LA (Q4W) arm.
    End point values
    		 CAB LA + RPV LA (Q4W)
    Number of subjects analysed
    283 [102]
    Units: Percentage of participants
    number (not applicable)
        Local reactions, Week 5, totally acceptable, n=270
    47
        Local reactions,Week 5, very acceptable, n=270
    29
        Local reactions, Week 5, moderate, n=270
    16
        Local reactions, Week 5, little acceptable, n=270
    6
        Local reactions, Week 5, not at all, n=270
    3
        Pain, Week 5, totally acceptable, n=270
    33
        Pain, Week 5, very acceptable, n=270
    28
        Pain, Week 5, moderate acceptable, n=270
    24
        Pain, Week 5, little acceptable, n=270
    11
        Pain, Week 5, not at all acceptable, n=270
    5
        Local reactions, week 41, totally, n=276
    57
        Local reactions, Week 41, very acceptable, n=276
    29
        Local reactions, Week 41, moderate, n=276
    11
        Local reactions, Week 41, little acceptable, n=276
    3
        Local reactions, Week 41, not at all, n=276
    0.7
        Pain, Week 41, totally acceptable, n=276
    45
        Pain, Week 41, very acceptable, n=276
    35
        Pain, Week 41, moderate acceptable, n=276
    14
        Pain, Week 41, little acceptable, n=276
    4
        Pain, Week 41, not at all acceptable, n=276
    1
        Local reactions, week 48, totally, n=278
    55
        Local reactions, Week 48, very acceptable, n=278
    31
        Local reactions, Week 48, moderate, n=278
    11
        Local reactions, Week 48, little acceptable, n=278
    2
        Local reactions, Week 48, not at all, n=278
    0.7
        Pain, Week 48, totally acceptable, n=278
    49
        Pain, Week 48, very acceptable, n=278
    35
        Pain, Week 48, moderate acceptable, n=278
    12
        Pain, Week 48 little acceptable, n=278
    3
        Pain, Week 48, not at all acceptable, n=278
    0.7
    Notes
    [102] - 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
    HATQoL comprises of three dimensions LISAT, medication worries (MEDWO) and disclosure worries (DISWO). For LISAT domain, each question is scored as 1-5, where 5 corresponds to satisfaction ‘all of time’ and 1 as ‘none of time’. Total score for LISAT domain (sum of item scores for questions 1a to 1d) is transformed to a 0-100 scale using formula:[100/(20 minus 4)]*(raw total score for LISAT minus 4). Higher LISAT score, greater satisfaction to life. Transformed dimension score for each domain was summarized and analyzed. LOCF was primary method of analysis. Measure type was mean for adjusted mean and dispersion measure as 95% CI. Baseline value is defined as last available value up to and including date of first Maintenance phase dose of IP. Change from Baseline value is calculated as value at post-dose visit minus Baseline value. Only 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) ABC/ DTG/ 3TC
    Number of subjects analysed
    283 [103]
    283 [104]
    Units: Scores on a scale
    arithmetic mean (confidence interval 95%)
        Week 24, n=252, 253
    0.4 (-1.3 to 2.1)
    -0.8 (-2.5 to 0.9)
        Week 48, n=253, 258
    0.9 (-0.8 to 2.6)
    0.0 (-1.6 to 1.7)
    Notes
    [103] - ITT-E Population
    [104] - ITT-E Population
    Statistical analysis title
    		 Statistical Analysis 1
    Comparison groups
    CAB LA + RPV LA (Q4W) v ABC/ DTG/ 3TC
    Number of subjects included in analysis
    566
    Analysis specification
    Pre-specified
    Analysis type
    		 other [105]
    P-value
    		 = 0.307
    Method
    		 ANCOVA
    Parameter type
    		 Adjusted difference
    Point estimate
    1.2
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.1
         upper limit
    		 3.6
    Notes
    [105] - Treatment comparison at Week 24 is presented, adjusted for Maintenance Baseline (Day 1) Score, Induction Baseline (Week -20) HIV-1 RNA (<100,000, >=100,000 c/mL), gender at birth, age (<50, >= 50 Years) and race (white, non-white).
    Statistical analysis title
    		 Statistical Analysis 2
    Comparison groups
    CAB LA + RPV LA (Q4W) v ABC/ DTG/ 3TC
    Number of subjects included in analysis
    566
    Analysis specification
    Pre-specified
    Analysis type
    		 other [106]
    P-value
    		 = 0.472
    Method
    		 ANCOVA
    Parameter type
    		 Adjusted difference
    Point estimate
    0.9
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.5
         upper limit
    		 3.2
    Notes
    [106] - Treatment comparison at Week 48 is presented, adjusted for Maintenance Baseline (Day 1) Score, Induction Baseline (Week -20) HIV-1 RNA (<100,000, >=100,000 c/mL), gender at birth, age (<50, >= 50 Years) and race (white, non-white).

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

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    End point title
    		 Change from Baseline in HIV medication, MEDWO using HATQoL
    End point description
    HATQoL comprises of three dimensions: LISAT, MEDWO and DISWO. For the MEDWO domain, each question is scored as 1-5, where 5 is associated with medication worry ‘none of the time’ and 1 as ‘all of the time’. Total score for MEDWO domain (sum of item scores for questions 2a to 3e) is transformed to a 0-100 scale using formula: [100/(25 minus 5)]* (raw total score for MEDWO minus 5). Higher MEDWO scores correspond to lower medication worries. 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 the last available value up to and including the date of first Maintenance phase dose of IP. 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) ABC/ DTG/ 3TC
    Number of subjects analysed
    283 [107]
    283 [108]
    Units: Scores on a scale
    arithmetic mean (confidence interval 95%)
        Week 24, n=252, 253
    3.2 (1.6 to 4.7)
    1.4 (-0.1 to 3.0)
        Week 48, n=253, 258
    1.4 (-0.3 to 3.1)
    1.3 (-0.4 to 3.0)
    Notes
    [107] - ITT-E Population
    [108] - ITT-E Population
    Statistical analysis title
    		 Statistical Analysis 1
    Comparison groups
    CAB LA + RPV LA (Q4W) v ABC/ DTG/ 3TC
    Number of subjects included in analysis
    566
    Analysis specification
    Pre-specified
    Analysis type
    		 other [109]
    P-value
    		 = 0.116
    Method
    		 ANCOVA
    Parameter type
    		 Adjusted difference
    Point estimate
    1.8
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.4
         upper limit
    		 3.9
    Notes
    [109] - Treatment comparison at Week 24 is presented, adjusted for Maintenance Baseline (Day 1) Score, Induction Baseline (Week -20) HIV-1 RNA (<100,000, >=100,000 c/mL), gender at birth, age (<50, >= 50 Years) and race (white, non-white).
    Statistical analysis title
    		 Statistical Analysis 2
    Comparison groups
    CAB LA + RPV LA (Q4W) v ABC/ DTG/ 3TC
    Number of subjects included in analysis
    566
    Analysis specification
    Pre-specified
    Analysis type
    		 other [110]
    P-value
    		 = 0.944
    Method
    		 ANCOVA
    Parameter type
    		 Adjusted difference
    Point estimate
    0.1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -2.3
         upper limit
    		 2.5
    Notes
    [110] - Treatment comparison at Week 48 is presented, adjusted for Maintenance Baseline (Day 1) Score, Induction Baseline (Week -20) HIV-1 RNA (<100,000, >=100,000 c/mL), gender at birth, age (<50, >= 50 Years) and race (white, non-white).

    Secondary: Change from Baseline in DISWO using HATQoL

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    End point title
    		 Change from Baseline in DISWO using HATQoL
    End point description
    HATQoL comprises of three dimensions: LISAT, MEDWO and DISWO. For the DISWO domain, each question is scored as 1-5, where 5 is associated with disclosure worry ‘none of the time’ and 1 as ‘all of the time’. Total score for DISWO domain (sum of item scores for questions 3a to 3e) is transformed to a 0-100 scale using formula: [100/(25 minus 5)]* (raw total score for DISWO minus 5). Higher DISWO total scores correspond to lower disclosure worries. 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 last available value up to and including date of first Maintenance phase dose of IP. 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) ABC/ DTG/ 3TC
    Number of subjects analysed
    283 [111]
    283 [112]
    Units: Scores on a scale
    arithmetic mean (confidence interval 95%)
        Week 24, n=252, 253
    -0.8 (-3.9 to 2.3)
    0.5 (-2.6 to 3.6)
        Week 48, n=253, 258
    -3.6 (-6.6 to -0.6)
    1.1 (-1.9 to 4.0)
    Notes
    [111] - ITT-E Population
    [112] - ITT-E Population
    Statistical analysis title
    		 Statistical Analysis 2
    Comparison groups
    CAB LA + RPV LA (Q4W) v ABC/ DTG/ 3TC
    Number of subjects included in analysis
    566
    Analysis specification
    Pre-specified
    Analysis type
    		 other [113]
    P-value
    		 = 0.033
    Method
    		 ANCOVA
    Parameter type
    		 Adjusted difference
    Point estimate
    -4.6
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -8.9
         upper limit
    		 -0.4
    Notes
    [113] - Treatment comparison at Week 48 is presented, adjusted for Maintenance Baseline (Day 1) Score, Induction Baseline (Week -20) HIV-1 RNA (<100,000, >=100,000 c/mL), gender at birth, age (<50, >= 50 Years) and race (white, non-white).
    Statistical analysis title
    		 Statistical Analysis 1
    Comparison groups
    CAB LA + RPV LA (Q4W) v ABC/ DTG/ 3TC
    Number of subjects included in analysis
    566
    Analysis specification
    Pre-specified
    Analysis type
    		 other [114]
    P-value
    		 = 0.552
    Method
    		 ANCOVA
    Parameter type
    		 Adjusted difference
    Point estimate
    -1.3
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -5.7
         upper limit
    		 3
    Notes
    [114] - Treatment comparison at Week 24 is presented, adjusted for Maintenance Baseline (Day 1) Score, Induction Baseline (Week -20) HIV-1 RNA (<100,000, >=100,000 c/mL), gender at birth, age (<50, >= 50 Years) and race (white, non-white).

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

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    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 physical component summary (PCS) and mental component summary (MCS) were assessed for two treatment groups.Missing 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 the last available recorded value up to and including the date of first Maintenance phase dose of IP. Change from Baseline value is calculated as value at post-dose visit 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 and at Weeks 24 and 48
    End point values
    		 CAB LA + RPV LA (Q4W) ABC/ DTG/ 3TC
    Number of subjects analysed
    283 [115]
    283 [116]
    Units: Scores on a scale
    arithmetic mean (confidence interval 95%)
        MCS, Week 24, n=251, 253
    -0.045 (-0.963 to 0.874)
    -1.066 (-1.980 to -0.151)
        MCS, Week 48, n=252, 258
    -0.013 (-0.973 to 0.947)
    -1.116 (-2.065 to -0.167)
        PCS, Week 24, n=251, 253
    -0.019 (-0.568 to 0.531)
    -0.201 (-0.748 to 0.347)
        PCS, Week 48, n=252, 258
    -0.294 (-0.881 to 0.293)
    -0.126 (-0.706 to 0.455)
    Notes
    [115] - ITT-E Population
    [116] - ITT-E Population
    Statistical analysis title
    		 Statistical Analysis 1
    Comparison groups
    CAB LA + RPV LA (Q4W) v ABC/ DTG/ 3TC
    Number of subjects included in analysis
    566
    Analysis specification
    Pre-specified
    Analysis type
    		 other [117]
    P-value
    		 = 0.122
    Method
    		 ANCOVA
    Parameter type
    		 Adjusted difference
    Point estimate
    1.021
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.275
         upper limit
    		 2.318
    Notes
    [117] - Treatment comparison of SF-12 MCS at Week 24 is presented, adjusted for Maintenance Baseline (Day 1) Score, Induction Baseline (Week -20) HIV-1 RNA (<100,000, >=100,000 c/mL), gender at birth, age (<50, >= 50 Years) and race (white, non-white).
    Statistical analysis title
    		 Statistical Analysis 2
    Comparison groups
    CAB LA + RPV LA (Q4W) v ABC/ DTG/ 3TC
    Number of subjects included in analysis
    566
    Analysis specification
    Pre-specified
    Analysis type
    		 other [118]
    P-value
    		 = 0.109
    Method
    		 ANCOVA
    Parameter type
    		 Adjusted difference
    Point estimate
    1.103
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.248
         upper limit
    		 2.453
    Notes
    [118] - Treatment comparison of SF-12 MCS at Week 48 is presented, adjusted for Maintenance Baseline (Day 1) Score, Induction Baseline (Week -20) HIV-1 RNA (<100,000, >=100,000 c/mL), gender at birth, age (<50, >= 50 Years) and race (white, non-white).
    Statistical analysis title
    		 Statistical Analysis 3
    Comparison groups
    CAB LA + RPV LA (Q4W) v ABC/ DTG/ 3TC
    Number of subjects included in analysis
    566
    Analysis specification
    Pre-specified
    Analysis type
    		 other [119]
    P-value
    		 = 0.645
    Method
    		 ANCOVA
    Parameter type
    		 Adjusted difference
    Point estimate
    0.182
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.594
         upper limit
    		 0.958
    Notes
    [119] - Treatment comparison of SF-12 PCS at Week 24 is presented, adjusted for Maintenance Baseline (Day 1) Score, Induction Baseline (Week -20) HIV-1 RNA (<100,000, >=100,000 c/mL), gender at birth, age (<50, >= 50 Years) and race (white, non-white).
    Statistical analysis title
    		 Statistical Analysis 4
    Comparison groups
    CAB LA + RPV LA (Q4W) v ABC/ DTG/ 3TC
    Number of subjects included in analysis
    566
    Analysis specification
    Pre-specified
    Analysis type
    		 other [120]
    P-value
    		 = 0.689
    Method
    		 ANCOVA
    Parameter type
    		 Adjusted difference
    Point estimate
    -0.169
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.994
         upper limit
    		 0.657
    Notes
    [120] - Treatment comparison of SF-12 PCS at Week 48 is presented, adjusted for Maintenance Baseline (Day 1) Score, Induction Baseline (Week -20) HIV-1 RNA (<100,000, >=100,000 c/mL), gender at birth, age (<50, >= 50 Years) and race (white, non-white).

    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
    HIVTSQs (status version) total treatment satisfaction score is computed with 1-11 items. Items 1-11 are summed to produce score with possible range of 0 to 66. 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. LOCF was primary method of analysis. Baseline value is defined as the last available value up to and including the date of first Maintenance phase dose of IP. Change from Baseline value is calculated as value at post-dose visit minus Baseline value. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles). Adjusted mean and 95% CI of adjusted mean values has been presented.
    End point type
    Secondary
    End point timeframe
    Baseline and at Weeks 4b, 24 and 44
    End point values
    		 CAB LA + RPV LA (Q4W) ABC/ DTG/ 3TC
    Number of subjects analysed
    283 [121]
    283 [122]
    Units: Scores on a scale
    arithmetic mean (confidence interval 95%)
        Week 4b, n=257, 0
    0.2 (-0.5 to 1.0)
    99999 (99999 to 99999)
        Week 24, n=257, 253
    1.6 (0.5 to 2.5)
    -0.5 (-1.4 to 0.3)
        Week 44, n=257, 256
    1.3 (0.5 to 2.1)
    0.5 (-0.3 to 1.4)
    Notes
    [121] - ITT-E Population. 99999 indicates data not available due to insufficient participants
    [122] - ITT-E Population. 99999 indicates data not available due to insufficient participants
    Statistical analysis title
    		 Statistical Analysis 2
    Comparison groups
    CAB LA + RPV LA (Q4W) v ABC/ DTG/ 3TC
    Number of subjects included in analysis
    566
    Analysis specification
    Pre-specified
    Analysis type
    		 other [123]
    P-value
    		 = 0.217
    Method
    		 ANCOVA
    Parameter type
    		 Adjusted difference
    Point estimate
    0.7
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.4
         upper limit
    		 1.9
    Notes
    [123] - Treatment comparison at Week 44 is presented, adjusted for Maintenance Baseline (Day 1) Score, Induction Baseline (Week -20) HIV-1 RNA (<100,000, >=100,000 c/mL), gender at birth, age (<50, >= 50 Years) and race (white, non-white).
    Statistical analysis title
    		 Statistical Analysis 1
    Comparison groups
    CAB LA + RPV LA (Q4W) v ABC/ DTG/ 3TC
    Number of subjects included in analysis
    566
    Analysis specification
    Pre-specified
    Analysis type
    		 other [124]
    P-value
    		 < 0.001
    Method
    		 ANCOVA
    Parameter type
    		 Adjusted difference
    Point estimate
    2.2
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1
         upper limit
    		 3.4
    Notes
    [124] - Treatment comparison at Week 24 is presented, adjusted for Maintenance Baseline (Day 1) Score, Induction Baseline (Week -20) HIV-1 RNA (<100,000, >=100,000 c/mL), gender at birth, age (<50, >= 50 Years) and race (white, non-white).

    Secondary: Change in treatment satisfaction over time using HIVTSQc at Week 48

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    End point title
    		 Change in treatment satisfaction over time using HIVTSQc at Week 48
    End point description
    HIVTSQc (change version) total treatment satisfaction score is computed with 1-11 items. Items 1-11 are summed to produce score with possible range:-33 to 33. Higher scores represent greater improvement in treatment satisfaction compared to satisfaction with treatment received during the induction phase; lower scores representedeterioration in satisfaction with treatment. A score of 0 represents no change. LOCF was primary method of analysis. Baseline value is defined as the last available value up to and including the date of first Maintenance phase dose of IP. Change from Baseline value is calculated as value at post-dose visit minus Baseline value. 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) ABC/ DTG/ 3TC
    Number of subjects analysed
    263 [125]
    266 [126]
    Units: Scores on a scale
        arithmetic mean (standard error)
    29.6 ( 0.49 )
    25.5 ( 0.48 )
    Notes
    [125] - ITT-E Population.
    [126] - ITT-E Population.
    Statistical analysis title
    		 Statistical Analysis 1
    Comparison groups
    CAB LA + RPV LA (Q4W) v ABC/ DTG/ 3TC
    Number of subjects included in analysis
    529
    Analysis specification
    Pre-specified
    Analysis type
    		 other [127]
    P-value
    		 < 0.001
    Method
    		 ANOVA
    Parameter type
    		 Difference
    Point estimate
    4.1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 2.8
         upper limit
    		 5.5
    Notes
    [127] - Treatment comparison of HIVTSQc-total treatment satisfaction score at Week 48 is presented, adjusted for Induction Baseline (Week -20) HIV-1 RNA (<100,000, >=100,000 c/mL), gender at birth, age (<50, >= 50 Years) and race (white, non-white).

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

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    End point title
    		 Change from Baseline in individual item scores of HIVTSQs at Weeks 4b, 24 and 44
    End point description
    HIVTSQs (status version) is a 12 item questionnaire. The individual item scores are ratedas 6 (very satisfied, convenient, flexible, etc.) to 0 (very dissatisfied, inconvenient, inflexible, etc.). Higher scores represent greater treatment satisfaction as compared to the past few weeks. LOCF was used as primary method of analysis. Baseline value is defined as the last available value up to and including the date of first Maintenance phase dose of IP. 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 and at Weeks 4b, 24 and 44
    End point values
    		 CAB LA + RPV LA (Q4W) ABC/ DTG/ 3TC
    Number of subjects analysed
    283 [128]
    283 [129]
    Units: Scores on a scale
    arithmetic mean (standard deviation)
        Item 1; Week 4b, n=257, 0
    -0.0 ( 0.91 )
    99999 ( 99999 )
        Item 1; Week 24, n=257, 255
    0.1 ( 0.96 )
    -0.0 ( 0.95 )
        Item 1; Week 44, n=257, 258
    0.0 ( 1.02 )
    0.0 ( 0.93 )
        Item 2; Week 4b, n=257, 0
    0.0 ( 0.61 )
    99999 ( 99999 )
        Item 2; Week 24, n=257, 255
    -0.0 ( 0.62 )
    -0.0 ( 0.87 )
        Item 2; Week 44, n=257, 258
    -0.1 ( 0.61 )
    0.1 ( 0.62 )
        Item 3; Week 4b, n=257, 0
    0.2 ( 1.02 )
    99999 ( 99999 )
        Item 3; Week 24, n=257, 255
    -0.1 ( 1.21 )
    -0.0 ( 1.16 )
        Item 3; Week 44, n=257, 258
    -0.0 ( 1.35 )
    0.1 ( 1.22 )
        Item 4; Week 4b, n=257, 0
    0.1 ( 1.02 )
    99999 ( 99999 )
        Item 4; Week 24, n=257, 255
    0.1 ( 1.03 )
    -0.0 ( 1.14 )
        Item 4; Week 44, n=257, 258
    0.0 ( 1.08 )
    0.1 ( 1.10 )
        Item 5; Week 4b, n=257, 0
    0.1 ( 0.98 )
    99999 ( 99999 )
        Item 5; Week 24, n=257, 255
    0.4 ( 1.22 )
    -0.1 ( 1.05 )
        Item 5; Week 44, n=257, 258
    0.3 ( 1.28 )
    0.0 ( 1.06 )
        Item 6; Week 4b, n=257, 0
    0.1 ( 1.40 )
    99999 ( 99999 )
        Item 6; Week 24, n=257, 255
    0.3 ( 1.47 )
    -0.1 ( 1.63 )
        Item 6; Week 44, n=257, 258
    0.3 ( 1.70 )
    0.2 ( 1.48 )
        Item 7; Week 4b, n=257, 0
    0.0 ( 0.83 )
    99999 ( 99999 )
        Item 7; Week 24, n=257, 255
    0.0 ( 0.79 )
    0.0 ( 1.02 )
        Item 7; Week 44, n=257, 258
    0.1 ( 0.85 )
    0.1 ( 0.95 )
        Item 8; Week 4b, n=257, 0
    -0.0 ( 1.06 )
    99999 ( 99999 )
        Item 8; Week 24, n=257, 255
    0.2 ( 1.22 )
    -0.0 ( 1.11 )
        Item 8; Week 44, n=257, 258
    0.2 ( 1.27 )
    0.1 ( 1.16 )
        Item 9; Week 4b, n=257, 0
    -0.1 ( 0.85 )
    99999 ( 99999 )
        Item 9; Week 24, n=257, 255
    0.0 ( 0.78 )
    -0.1 ( 1.11 )
        Item 9; Week 44, n=257, 258
    0.0 ( 0.85 )
    0.0 ( 1.01 )
        Item 10; Week 4b, n=257, 0
    -0.1 ( 1.16 )
    99999 ( 99999 )
        Item 10; Week 24, n=257, 256
    0.4 ( 1.28 )
    -0.1 ( 1.35 )
        Item 10; Week 44, n=257, 259
    0.4 ( 1.33 )
    -0.0 ( 1.20 )
        Item 11; Week 4b, n=257, 0
    -0.0 ( 1.02 )
    99999 ( 99999 )
        Item 11; Week 24, n=257, 255
    0.2 ( 1.18 )
    -0.1 ( 0.99 )
        Item 11; Week 44, n=257, 258
    0.1 ( 1.18 )
    0.0 ( 0.97 )
        Item 12; Week 4b, n=257, 0
    -0.0 ( 0.99 )
    99999 ( 99999 )
        Item 12; Week 24, n=257, 255
    -0.4 ( 1.26 )
    0.1 ( 1.19 )
        Item 12; Week 44, n=257, 258
    -0.5 ( 1.20 )
    0.1 ( 1.29 )
    Notes
    [128] - ITT-E Population. 99999 indicates data not available due to insufficient participants
    [129] - ITT-E Population. 99999 indicates data not available due to insufficient participants
    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, capturing six dimensions. 3 questions focusing on general acceptance of study medication were analyzed. Items scores are rated as 1-5 :1-totally disagree,2-somewhat disagree,3-somewhat agree,4-totally agree and 5-I don’t know. Acceptance domain score (ranging from 0 to 100) is calculated using following formula:100*(mean of recoded items in dimension minus 1) divided by 2.LOCF was primary method of analysis. Measure type is mean for adjusted mean and dispersion measure: 95% CI. Baseline value is defined as the last available value up to and including the date of first Maintenance phase dose of IP. 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) ABC/ DTG/ 3TC
    Number of subjects analysed
    283 [130]
    283 [131]
    Units: Scores on a scale
    arithmetic mean (confidence interval 95%)
        Week 8, n=253, 256
    3.3 (0.8 to 5.8)
    1.2 (-1.3 to 3.6)
        Week 24, 255, 261
    3.7 (1.1 to 6.4)
    1.1 (-1.5 to 3.7)
        Week 48, n=255, 262
    3.0 (0.4 to 5.6)
    0.8 (-1.7 to 3.4)
    Notes
    [130] - ITT-E Population
    [131] - ITT-E Population
    Statistical analysis title
    		 Statistical Analysis 1
    Comparison groups
    CAB LA + RPV LA (Q4W) v ABC/ DTG/ 3TC
    Number of subjects included in analysis
    566
    Analysis specification
    Pre-specified
    Analysis type
    		 other [132]
    P-value
    		 = 0.232
    Method
    		 ANCOVA
    Parameter type
    		 Adjusted difference
    Point estimate
    2.2
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.4
         upper limit
    		 5.7
    Notes
    [132] - Treatment comparison at Week 8 is presented, adjusted for Maintenance Baseline (Day 1) Score, Induction Baseline (Week -20) HIV-1 RNA (<100,000, >=100,000 c/mL), gender at birth, age (<50, >= 50 Years) and race (white, non-white).
    Statistical analysis title
    		 Statistical Analysis 3
    Comparison groups
    CAB LA + RPV LA (Q4W) v ABC/ DTG/ 3TC
    Number of subjects included in analysis
    566
    Analysis specification
    Pre-specified
    Analysis type
    		 other [133]
    P-value
    		 = 0.236
    Method
    		 ANCOVA
    Parameter type
    		 Adjusted difference
    Point estimate
    2.2
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.4
         upper limit
    		 5.8
    Notes
    [133] - Treatment comparison at Week 48 is presented, adjusted for Maintenance Baseline (Day 1) Score, Induction Baseline (Week -20) HIV-1 RNA (<100,000, >=100,000 c/mL), gender at birth, age (<50, >= 50 Years) and race (white, non-white).
    Statistical analysis title
    		 Statistical Analysis 2
    Comparison groups
    CAB LA + RPV LA (Q4W) v ABC/ DTG/ 3TC
    Number of subjects included in analysis
    566
    Analysis specification
    Pre-specified
    Analysis type
    		 other [134]
    P-value
    		 = 0.154
    Method
    		 ANCOVA
    Parameter type
    		 Adjusted difference
    Point estimate
    2.7
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1
         upper limit
    		 6.4
    Notes
    [134] - Treatment comparison Week 24 is presented, adjusted for Maintenance Baseline (Day 1) Score, Induction Baseline (Week -20) HIV-1 RNA (<100,000, >=100,000 c/mL), gender at birth, age (<50, >= 50 Years) and race (white, non-white).

    Secondary: Change from 4b in tolerability of injection at Weeks 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 Weeks 5, 40 and 41 using numeric rating scale (NRS) within CAB LA+RPV LA arm [135]
    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
    [135] - 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: This endpoint is specific to CAB LA + RPV LA (Q4W) arm.
    End point values
    		 CAB LA + RPV LA (Q4W)
    Number of subjects analysed
    263 [136]
    Units: Scores on a scale
    arithmetic mean (standard deviation)
        Week 5
    1.8 ( 2.78 )
        Week 40
    0.8 ( 2.72 )
        Week 41
    0.4 ( 2.69 )
    Notes
    [136] - ITT-E Population
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Non-serious AEs and SAEs were collected up to an average of 59 weeks
    Adverse event reporting additional description
    AEs and SAEs were collected in Safety population.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    21.0
    Reporting groups
    Reporting group title
    ABC/ DTG/ 3TC
    Reporting group description
    		 During Maintenance Phase (Day 1 to Week 100), participants continued to receive ABC/DTG/3TC. After completion of Maintenance Phase, participants who chose to enter the Extension Phase have the option to complete the study or switch to CAB LA+RPV LA

    Reporting group title
    CAB LA+RPV LA (Q4W)
    Reporting group description
    		 Participants who received ABC/DTG/3TC for 20 Weeks (Week [-20] to Day 1) in the Induction Phase and who have an HIV-1 ribonucleic acid (RNA) <50 copies per millilter (c/mL) at Week (-4) entered Maintenance Phase (Day 1 to Week 100) to begin oral therapy with CAB 30 milligram (mg) + RPV 25 mg once daily for 4 Weeks. At Week 4b visit, participants received last dose of oral CAB + RPV and first dose CAB LA 600 mg + RPV LA 900 mg injections. Participants received intramuscular (IM) injections of CAB LA 400 mg and RPV LA 600 mg at Week 8 and every four weeks (Q4W) through Week 100. After completion of Maintenance Phase, participants who chose to enter Extension Phase will continue 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.

    Serious adverse events
    		 ABC/ DTG/ 3TC CAB LA+RPV LA (Q4W)
    Total subjects affected by serious adverse events
         subjects affected / exposed
    12 / 283 (4.24%)
    18 / 283 (6.36%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Anogenital warts
         subjects affected / exposed
    1 / 283 (0.35%)
    1 / 283 (0.35%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Adenocarcinoma of colon
         subjects affected / exposed
    0 / 283 (0.00%)
    1 / 283 (0.35%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Breast cancer
         subjects affected / exposed
    1 / 283 (0.35%)
    0 / 283 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Kaposi's sarcoma
         subjects affected / exposed
    1 / 283 (0.35%)
    0 / 283 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Investigations
    Weight decreased
         subjects affected / exposed
    0 / 283 (0.00%)
    1 / 283 (0.35%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Laceration
         subjects affected / exposed
    0 / 283 (0.00%)
    1 / 283 (0.35%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Road traffic accident
         subjects affected / exposed
    1 / 283 (0.35%)
    0 / 283 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tibia fracture
         subjects affected / exposed
    1 / 283 (0.35%)
    0 / 283 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vascular disorders
    Peripheral artery thrombosis
         subjects affected / exposed
    0 / 283 (0.00%)
    1 / 283 (0.35%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Peripheral ischaemia
         subjects affected / exposed
    0 / 283 (0.00%)
    1 / 283 (0.35%)
         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
    Pyrexia
         subjects affected / exposed
    0 / 283 (0.00%)
    1 / 283 (0.35%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Systemic inflammatory response syndrome
         subjects affected / exposed
    1 / 283 (0.35%)
    0 / 283 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Anal fistula
         subjects affected / exposed
    0 / 283 (0.00%)
    1 / 283 (0.35%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Colitis
         subjects affected / exposed
    0 / 283 (0.00%)
    1 / 283 (0.35%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Enterocolitis
         subjects affected / exposed
    0 / 283 (0.00%)
    1 / 283 (0.35%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Large intestine perforation
         subjects affected / exposed
    1 / 283 (0.35%)
    0 / 283 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Rectal fissure
         subjects affected / exposed
    1 / 283 (0.35%)
    0 / 283 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Umbilical hernia
         subjects affected / exposed
    0 / 283 (0.00%)
    1 / 283 (0.35%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Reproductive system and breast disorders
    Priapism
         subjects affected / exposed
    0 / 283 (0.00%)
    1 / 283 (0.35%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Bile duct stone
         subjects affected / exposed
    0 / 283 (0.00%)
    1 / 283 (0.35%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cholecystitis
         subjects affected / exposed
    0 / 283 (0.00%)
    1 / 283 (0.35%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hydrocholecystis
         subjects affected / exposed
    0 / 283 (0.00%)
    1 / 283 (0.35%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Psychiatric disorders
    Drug abuse
         subjects affected / exposed
    1 / 283 (0.35%)
    0 / 283 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Suicide attempt
         subjects affected / exposed
    1 / 283 (0.35%)
    0 / 283 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Arthritis
         subjects affected / exposed
    0 / 283 (0.00%)
    1 / 283 (0.35%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Hepatitis A
         subjects affected / exposed
    1 / 283 (0.35%)
    3 / 283 (1.06%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Anal abscess
         subjects affected / exposed
    1 / 283 (0.35%)
    0 / 283 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bronchitis pneumococcal
         subjects affected / exposed
    1 / 283 (0.35%)
    0 / 283 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastroenteritis
         subjects affected / exposed
    1 / 283 (0.35%)
    0 / 283 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pyelonephritis
         subjects affected / exposed
    0 / 283 (0.00%)
    1 / 283 (0.35%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Viral infection
         subjects affected / exposed
    1 / 283 (0.35%)
    0 / 283 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Diabetic ketoacidosis
         subjects affected / exposed
    0 / 283 (0.00%)
    1 / 283 (0.35%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 ABC/ DTG/ 3TC CAB LA+RPV LA (Q4W)
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    138 / 283 (48.76%)
    252 / 283 (89.05%)
    Nervous system disorders
    Headache
         subjects affected / exposed
    21 / 283 (7.42%)
    39 / 283 (13.78%)
         occurrences all number
    24
    48
    Dizziness
         subjects affected / exposed
    3 / 283 (1.06%)
    15 / 283 (5.30%)
         occurrences all number
    3
    17
    General disorders and administration site conditions
    Injection site pain
         subjects affected / exposed
    0 / 283 (0.00%)
    227 / 283 (80.21%)
         occurrences all number
    0
    1879
    Injection site nodule
         subjects affected / exposed
    0 / 283 (0.00%)
    44 / 283 (15.55%)
         occurrences all number
    0
    86
    Injection site induration
         subjects affected / exposed
    0 / 283 (0.00%)
    38 / 283 (13.43%)
         occurrences all number
    0
    82
    Pyrexia
         subjects affected / exposed
    4 / 283 (1.41%)
    21 / 283 (7.42%)
         occurrences all number
    4
    33
    Injection site swelling
         subjects affected / exposed
    0 / 283 (0.00%)
    23 / 283 (8.13%)
         occurrences all number
    0
    38
    Injection site pruritus
         subjects affected / exposed
    0 / 283 (0.00%)
    16 / 283 (5.65%)
         occurrences all number
    0
    25
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    25 / 283 (8.83%)
    32 / 283 (11.31%)
         occurrences all number
    30
    40
    Nausea
         subjects affected / exposed
    11 / 283 (3.89%)
    16 / 283 (5.65%)
         occurrences all number
    12
    17
    Haemorrhoids
         subjects affected / exposed
    3 / 283 (1.06%)
    16 / 283 (5.65%)
         occurrences all number
    4
    18
    Musculoskeletal and connective tissue disorders
    Back pain
         subjects affected / exposed
    13 / 283 (4.59%)
    22 / 283 (7.77%)
         occurrences all number
    14
    26
    Infections and infestations
    Nasopharyngitis
         subjects affected / exposed
    48 / 283 (16.96%)
    56 / 283 (19.79%)
         occurrences all number
    70
    92
    Upper respiratory tract infection
         subjects affected / exposed
    28 / 283 (9.89%)
    38 / 283 (13.43%)
         occurrences all number
    35
    50
    Influenza
         subjects affected / exposed
    20 / 283 (7.07%)
    25 / 283 (8.83%)
         occurrences all number
    22
    27
    Gastroenteritis
         subjects affected / exposed
    10 / 283 (3.53%)
    15 / 283 (5.30%)
         occurrences all number
    10
    18
    Pharyngitis
         subjects affected / exposed
    9 / 283 (3.18%)
    15 / 283 (5.30%)
         occurrences all number
    9
    16
    Metabolism and nutrition disorders
    Vitamin D deficiency
         subjects affected / exposed
    13 / 283 (4.59%)
    23 / 283 (8.13%)
         occurrences all number
    13
    23

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    13 Dec 2016
    Amendment No.1: New Medical Monitor contact information; added lipid objective and endpoint to table in Synopsis; PRO assessments and timing clarification; provision of CAB+RPV LA until available in public/private sectors; allowed use of local labs for eligibility in exceptional circumstances; updated Time & Events Table; timing of ABC/DTG/3TC on the Day 1; continued use of contraception for at least 52 weeks after the last injection; revised text regarding provision of ‘bridging’ supply; CAB+RPV exposure may persist for more than 1 year after injections; edits to prohibited medication information; indicated drugs that cause TdP should be used with caution with RPV; background NRTI is not IP and accountability not required; film coat color for DTG changed from white to yellow; removed “protect from light” (for Triumeq and Tivicay); collection of device details for IM dosing in eCRF; additional information added regarding randomization schedule; added text stating investigator must discuss long-term study commitment with potential participants; added statement regarding serofast Screening RPR results; allowed serum pregnancy testing where required locally (e.g. when urine testing is not available); added option for PRO assessments to be collected on paper instrument if needed; removed information requiring collection of pregnancy information for female partners of male study participants; other minor corrections (e.g., typos, links, etc).
    19 Jul 2017
    Amendment No.2: Modified text to allow dose reduction for participants who have a decline in creatinine clearance to <50 mL/min during the Induction Phase; clarify that for participants not eligible to continue into the Maintenance Phase, only samples with HIV-1 RNA > 400 c/mL will be sent for resistance testing; add mitigation for electrocardiogram (ECG) pad removal; clarify +- 3 day window is for all oral dosing (both Induction and Maintenance Phase); add "LA Arm" back to columns for Week 68, 76, 84, 92 on Time and Events Schedule (hidden when column was narrowed); clarify Week 104b visit is specific to those participants transitioning from oral IP to CAB LA + RPV LA; clarification added to footnote ‘p’ that genetics sample can be collected at any visit after signing informed consent, but Week [-20] preferred; correct footnote on Week 5 visit to reflect footnote 't'; add footnote 'y' back to Time and Events column for Withdrawal Visit (for Induction Phase); add clarification to Time and Events column that Injection Site Reaction (ISR) assessments are only conducted for subjects receiving injections. Administrative typographical errors corrected (e.g. clarification provided regarding genetics sample taken after participants are enrolled into the study [vs when participants are randomized]), and investigator brochure (IB) references updated, references added.
    25 Jun 2018
    Amendment No.3: Changes for Amendment 3 were primarily made to the protocol to manage and mitigate risks following identification of a potential safety issue related to neural tube defect in infants born to women with exposure to DTG at the time of conception. - A Risk Assessment table was added to include language regarding risk and mitigation of neural tube defects seen with DTG. - The withdrawal criteria were updated to include a reminder that females of reproductive potential who change their minds and desire to be pregnant should also be withdrawn from the study. - The Time and Events table was updated to include a reminder for investigators to check at every visit that females of reproductive potential are avoiding pregnancy. Additionally, clarifications were provided for the following: - the DTG IB should be referenced for additional risks, safety information, drug interactions, etc.; - ‘suspected’ was added to the text prior to the bulleted definition of suspected virologic failure; - specific storage conditions were removed from the protocol for IP, and a statement added to store according to product label; - insulin was removed from the section regarding clinical assessments performed during the study; - timeframe for pregnancy reporting and follow-up were updated to 24 hours to align with current reporting process; - prescribing information and IB references were updated.
    24 Sep 2018
    Amendment No.4: The primary reason for protocol amendment 04 was to allow an optional (vs mandatory) oral lead-in for participants randomized to the ABC/DTG/3TC arm who choose to continue into the Extension Phase of the study and receive CAB LA + RPV LA. The Appendix for contraceptive guidance and collection of pregnancy information was updated to be consistent with current protocol template text. Other minor clarifications were made as needed, e.g., the Columbia Suicide Severity Rating Scale (eCSSRs) timing in the footnote for the Time and Events Table, updated abbreviations, etc.

    Interruptions (globally)
    Were there any global interruptions to the trial? No

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported
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