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Clinical Trial Results:
Phase I/II Study of the Safety, Acceptability, Tolerability, and Pharmacokinetics of Oral and Long-Acting Injectable Cabotegravir and Long-Acting Injectable Rilpivirine in Virologically Suppressed HIV-Infected Children and Adolescents

Summary
EudraCT number	2022-003113-11
Trial protocol	Outside EU/EEA
Global end of trial date	22 Apr 2025

Results information
Results version number	v1(current)
This version publication date	22 May 2026
First version publication date	22 May 2026
Other versions

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

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Trial information

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Sponsor protocol code

IMPAACT-2017

ISRCTN number

US NCT number

NCT03497676

WHO universal trial number (UTN)

Other trial identifiers

ViiV Protocol Code: 208580, DAIDS-ES Registry Number: 30070

Sponsor organisation name

National Institute of Allergy and Infectious Diseases (NIAID)

Sponsor organisation address

5601 Fishers Lane, Rockville, Maryland, United States, 20852-9831

Public contact

Ellen Townley, Ellen Townley, 240 292-4784, ellen.townley@nih.gov

Scientific contact

Ellen Townley, Ellen Townley, 240 292-4784, ellen.townley@nih.gov

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

Yes

EMA paediatric investigation plan number(s)

EMEA-001418-PIP01-13

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

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

Analysis stage

Final

Date of interim/final analysis

03 Sep 2025

Is this the analysis of the primary completion data?

Global end of trial reached?

Yes

Global end of trial date

22 Apr 2025

Was the trial ended prematurely?

Main objective of the trial

Cohort 1: 1. To confirm the doses for oral CAB followed by injectable CAB LA in adolescents living with HIV who are virologically suppressed by evaluating: - Safety and multiple dose PK of oral CAB through Week 4; - Safety and multiple dose PK of CAB LA through Week 16 2. To confirm doses for injectable RPV LA in adolescents living with HIV who are virologically suppressed. by evaluating safety and multiple dose PK of RPV LA through Week 16. Cohort 2: 1. To assess the safety of CAB + RPV in adolescents living with HIV who are virologically suppressed through: - Week 24 (Cohort 2A: oral followed by injectable); - Week 20 (Cohort 2B: injectable only).

Protection of trial subjects

Vaccines were administered only to eligible participants that had no contraindications to any components of the vaccine and were administered by qualified and trained personnel.

Background therapy

Evidence for comparator

Actual start date of recruitment

03 Apr 2019

Long term follow-up planned

Independent data monitoring committee (IDMC) involvement?

Yes

Number of subjects enrolled per country

Country: Number of subjects enrolled

Thailand: 36

Country: Number of subjects enrolled

Botswana: 25

Country: Number of subjects enrolled

United States: 30

Country: Number of subjects enrolled

Uganda: 20

Country: Number of subjects enrolled

South Africa: 44

Worldwide total number of subjects

155

EEA total number of subjects

Number of subjects enrolled per age group

In utero

Preterm newborn - gestational age < 37 wk

Newborns (0-27 days)

Infants and toddlers (28 days-23 months)

Children (2-11 years)

Adolescents (12-17 years)

155

Adults (18-64 years)

From 65 to 84 years

85 years and over

Subject disposition

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Recruitment details

Accrual for Cohort 1 occurred between April 2019 and November 2021 at 15 different medical clinic sites across Botswana, South Africa, Thailand, and the United States. Accrual for Cohort 2 occurred between July 2021 and August 2022 at 18 different medical clinic sites across Botswana, South Africa, Thailand, Uganda, and the United States.

Screening details

55 participants enrolled in Cohort 1C/1R; 44 continued to Cohort 2, with 100 additional participants enrolled there. Parents/caregivers (n=13) were excluded from participant flow and analyses due to lack of baseline data and no contribution to primary or secondary outcomes.

Period 1 title

Cohort 1 Treatment Initiation to Week 16

Is this the baseline period?

Allocation method

Non-randomised - controlled

Blinding used

Not blinded

Are arms mutually exclusive

Yes

Cohort 1C: CAB

Arm description

Step 1: CAB administered orally as one 30 mg tablet once daily, beginning at the Entry visit, for 4-6 weeks. Step 2 (Q4W dosing): CAB LA administered as three single intramuscular (IM) injections four weeks apart (600 mg injection at Week 4b, 400 mg injection at Week 8, and 400 mg injection at Week 12). Step 2 (Q8W dosing): CAB LA administered as two single IM injections four weeks apart (600 mg injection at Week 4b and 600 mg injection at Week 8). Oral Cabotegravir (CAB): 30 mg tablets administered orally Long-Acting Injectable Cabotegravir (CAB LA): Administered by intramuscular (IM) injection Combination Antiretroviral Therapy (cART): Participants continued their pre-study cART regimen. The antiretroviral drugs in participants' cART regimens were not provided through the study.

Arm type

Experimental

Investigational medicinal product name

Cabotegravir (CAB)

Investigational medicinal product code

Other name

Pharmaceutical forms

Tablet

Routes of administration

Oral use

Dosage and administration details

30 mg tablets administered orally.

Investigational medicinal product name

Long-Acting Injectable Cabotegravir (CAB LA)

Investigational medicinal product code

Other name

Pharmaceutical forms

Injection

Routes of administration

Intramuscular use

Dosage and administration details

Administered by intramuscular (IM) injection.

Investigational medicinal product name

Combination Antiretroviral Therapy (cART)

Investigational medicinal product code

Other name

Pharmaceutical forms

Tablet

Routes of administration

Oral use

Dosage and administration details

Participants continued their pre-study cART regimen. The antiretroviral drugs in participants' cART regimens were not provided through the study.

Cohort 1R: RPV

Arm description

Step 1: RPV administered orally as one 25 mg tablet once daily, beginning at the Entry visit, for 4-6 weeks. Step 2 (Q4W dosing): RPV LA administered as three single IM injections four weeks apart (900 mg injection at Week 4b, 600 mg injection at Week 8, 600 mg injection at and Week 12). Step 2 (Q8W dosing): RPV LA administered as two single IM injections four weeks apart (900 mg injection at Week 4b and 900 mg injection at Week 8). Oral Rilpivirine (RPV): 25 mg tablets administered orally Long-Acting Injectable Rilpivirine (RPV LA): Administered by intramuscular (IM) injection Combination Antiretroviral Therapy (cART): Participants continued their pre-study cART regimen. The antiretroviral drugs in participants' cART regimens were not provided through the study.

Arm type

Experimental

Investigational medicinal product name

Combination Antiretroviral Therapy (cART)

Investigational medicinal product code

Other name

Pharmaceutical forms

Tablet

Routes of administration

Oral use

Dosage and administration details

Participants continued their pre-study cART regimen. The antiretroviral drugs in participants' cART regimens were not provided through the study.

Investigational medicinal product name

Oral Rilpivirine (RPV)

Investigational medicinal product code

Other name

Edurant

Pharmaceutical forms

Tablet

Routes of administration

Oral use

Dosage and administration details

25 mg tablets administered orally.

Investigational medicinal product name

Long-Acting Injectable Rilpivirine (RPV LA)

Investigational medicinal product code

Other name

Pharmaceutical forms

Injection

Routes of administration

Intramuscular use

Dosage and administration details

Administered by intramuscular (IM) injection.

Cohort 2A: Oral CAB + Oral RPV and CAB LA + RPV LA

Arm description

Step 3: CAB administered orally as one 30 mg tablet once daily and RPV administered orally as one 25 mg tablet once daily, beginning at the Entry visit for 4-6 weeks. Step 4: First and second injections: CAB LA administered as a 600 mg IM injection and RPV LA administered as a 900 mg IM injection at Week 4b and at Week 8. Subsequent injections: starting at Week 16, CAB LA administered as a 600 mg IM injection and RPV LA administered as a 900 mg IM injection every eight weeks through Week 96 or final safety extension visit. Oral Cabotegravir (CAB): 30 mg tablets administered orally. Oral Rilpivirine (RPV): 25 mg tablets administered orally. Long-Acting Injectable Cabotegravir (CAB LA): Administered by intramuscular (IM) injection. Long-Acting Injectable Rilpivirine (RPV LA): Administered by intramuscular (IM) injection. Due to system limitations, the number of participants shown as having started and completed this period is 144; however, the actual number is 0.

Arm type

Experimental

Investigational medicinal product name

Cabotegravir (CAB)

Investigational medicinal product code

Other name

Pharmaceutical forms

Tablet

Routes of administration

Oral use

Dosage and administration details

30 mg tablets administered orally.

Investigational medicinal product name

Oral Rilpivirine (RPV)

Investigational medicinal product code

Other name

Edurant

Pharmaceutical forms

Tablet

Routes of administration

Oral use

Dosage and administration details

25 mg tablets administered orally.

Investigational medicinal product name

Long-Acting Injectable Cabotegravir (CAB LA)

Investigational medicinal product code

Other name

Pharmaceutical forms

Injection

Routes of administration

Intramuscular use

Dosage and administration details

Administered by intramuscular (IM) injection.

Investigational medicinal product name

Long-Acting Injectable Rilpivirine (RPV LA)

Investigational medicinal product code

Other name

Pharmaceutical forms

Injection

Routes of administration

Intramuscular use

Dosage and administration details

Administered by intramuscular (IM) injection.

Number of subjects in period 1	Cohort 1C: CAB	Cohort 1R: RPV	Cohort 2A: Oral CAB + Oral RPV and CAB LA + RPV LA
Started	30	25	144
Completed	29	23	144
Not completed	1	2	0
Consent withdrawn by subject	1	1	-
Adverse event, non-fatal	-	1	-

Period 2 title

Cohort 1 Week 16 Through End of Cohort 1

Is this the baseline period?

Allocation method

Non-randomised - controlled

Blinding used

Not blinded

Are arms mutually exclusive

Yes

Cohort 1C: CAB

Arm description

Arm type

Experimental

Investigational medicinal product name

Cabotegravir (CAB)

Investigational medicinal product code

Other name

Pharmaceutical forms

Tablet

Routes of administration

Oral use

Dosage and administration details

30 mg tablets administered orally.

Investigational medicinal product name

Long-Acting Injectable Cabotegravir (CAB LA)

Investigational medicinal product code

Other name

Pharmaceutical forms

Injection

Routes of administration

Intramuscular use

Dosage and administration details

Administered by intramuscular (IM) injection.

Investigational medicinal product name

Combination Antiretroviral Therapy (cART)

Investigational medicinal product code

Other name

Pharmaceutical forms

Tablet

Routes of administration

Oral use

Dosage and administration details

Participants continued their pre-study cART regimen. The antiretroviral drugs in participants' cART regimens were not provided through the study.

Cohort 1R: RPV

Arm description

Arm type

Experimental

Investigational medicinal product name

Combination Antiretroviral Therapy (cART)

Investigational medicinal product code

Other name

Pharmaceutical forms

Tablet

Routes of administration

Oral use

Dosage and administration details

Participants continued their pre-study cART regimen. The antiretroviral drugs in participants' cART regimens were not provided through the study.

Investigational medicinal product name

Oral Rilpivirine (RPV)

Investigational medicinal product code

Other name

Edurant

Pharmaceutical forms

Tablet

Routes of administration

Oral use

Dosage and administration details

25 mg tablets administered orally.

Investigational medicinal product name

Long-Acting Injectable Rilpivirine (RPV LA)

Investigational medicinal product code

Other name

Pharmaceutical forms

Injection

Routes of administration

Intramuscular use

Dosage and administration details

Administered by intramuscular (IM) injection.

Cohort 2A: Oral CAB + Oral RPV and CAB LA + RPV LA

Arm description

Arm type

Experimental

Investigational medicinal product name

Cabotegravir (CAB)

Investigational medicinal product code

Other name

Pharmaceutical forms

Tablet

Routes of administration

Oral use

Dosage and administration details

30 mg tablets administered orally.

Investigational medicinal product name

Oral Rilpivirine (RPV)

Investigational medicinal product code

Other name

Edurant

Pharmaceutical forms

Tablet

Routes of administration

Oral use

Dosage and administration details

25 mg tablets administered orally.

Investigational medicinal product name

Long-Acting Injectable Cabotegravir (CAB LA)

Investigational medicinal product code

Other name

Pharmaceutical forms

Injection

Routes of administration

Intramuscular use

Dosage and administration details

Administered by intramuscular (IM) injection.

Investigational medicinal product name

Long-Acting Injectable Rilpivirine (RPV LA)

Investigational medicinal product code

Other name

Pharmaceutical forms

Injection

Routes of administration

Intramuscular use

Dosage and administration details

Administered by intramuscular (IM) injection.

Number of subjects in period 2	Cohort 1C: CAB	Cohort 1R: RPV	Cohort 2A: Oral CAB + Oral RPV and CAB LA + RPV LA
Started	29	23	144
Completed	28	21	144
Not completed	1	2	0
Consent withdrawn by subject	-	1	-
Lost to follow-up	1	1	-

Period 3 title

Cohort 2 Treatment Initiation to Week 24

Is this the baseline period?

Yes ^[1]

Allocation method

Non-randomised - controlled

Blinding used

Not blinded

Cohort 2A: Oral CAB + Oral RPV and CAB LA + RPV LA

Arm description

Arm type

Experimental

Investigational medicinal product name

Cabotegravir (CAB)

Investigational medicinal product code

Other name

Pharmaceutical forms

Tablet

Routes of administration

Oral use

Dosage and administration details

30 mg tablets administered orally.

Investigational medicinal product name

Oral Rilpivirine (RPV)

Investigational medicinal product code

Other name

Edurant

Pharmaceutical forms

Tablet

Routes of administration

Oral use

Dosage and administration details

25 mg tablets administered orally.

Investigational medicinal product name

Long-Acting Injectable Cabotegravir (CAB LA)

Investigational medicinal product code

Other name

Pharmaceutical forms

Injection

Routes of administration

Intramuscular use

Dosage and administration details

Administered by intramuscular (IM) injection.

Investigational medicinal product name

Long-Acting Injectable Rilpivirine (RPV LA)

Investigational medicinal product code

Other name

Pharmaceutical forms

Injection

Routes of administration

Intramuscular use

Dosage and administration details

Administered by intramuscular (IM) injection.

Notes
[1] - Period 1 is not the baseline period. It is expected that period 1 will be the baseline period.
Justification: Due to system limitations, Period 2 was selected as the Baseline period.

Number of subjects in period 3 ^[2] ^[3]	Cohort 2A: Oral CAB + Oral RPV and CAB LA + RPV LA
Started	144
Completed	141
Not completed	3
Non-compliance with study treatment	1
Pregnancy	1
Protocol deviation	1

Notes
[2] - The number of subjects reported to be in the baseline period are not the same as the worldwide number enrolled in the trial. It is expected that these numbers will be the same.
Justification: 55 participants were enrolled into Cohort 1C/1R, and 44 of these participants continued to Cohort 2. An additional 100 participants enrolled into Cohort 2.
[3] - The number of subjects starting the period is not consistent with the number completing the preceding period. It is expected the number of subjects starting the subsequent period will be the same as the number completing the preceding period.
Justification: Only a subset of participants from Period 2 continued into Period 3; therefore, participant numbers are not expected to be equivalent across these periods. Values reported are accurate and reflect actual participant flow.

Period 4 title

Cohort 2 Week 24 to Week 48

Is this the baseline period?

Allocation method

Non-randomised - controlled

Blinding used

Not blinded

Cohort 2A: Oral CAB + Oral RPV and CAB LA + RPV LA

Arm description

Arm type

Experimental

Investigational medicinal product name

Cabotegravir (CAB)

Investigational medicinal product code

Other name

Pharmaceutical forms

Tablet

Routes of administration

Oral use

Dosage and administration details

30 mg tablets administered orally.

Investigational medicinal product name

Oral Rilpivirine (RPV)

Investigational medicinal product code

Other name

Edurant

Pharmaceutical forms

Tablet

Routes of administration

Oral use

Dosage and administration details

25 mg tablets administered orally.

Investigational medicinal product name

Long-Acting Injectable Cabotegravir (CAB LA)

Investigational medicinal product code

Other name

Pharmaceutical forms

Injection

Routes of administration

Intramuscular use

Dosage and administration details

Administered by intramuscular (IM) injection.

Investigational medicinal product name

Long-Acting Injectable Rilpivirine (RPV LA)

Investigational medicinal product code

Other name

Pharmaceutical forms

Injection

Routes of administration

Intramuscular use

Dosage and administration details

Administered by intramuscular (IM) injection.

Number of subjects in period 4	Cohort 2A: Oral CAB + Oral RPV and CAB LA + RPV LA
Started	141
Completed	140
Not completed	1
Lost to follow-up	1

Period 5 title

Cohort 2 Week 48 to Week 96

Is this the baseline period?

Allocation method

Non-randomised - controlled

Blinding used

Not blinded

Cohort 2A: Oral CAB + Oral RPV and CAB LA + RPV LA

Arm description

Arm type

Experimental

Investigational medicinal product name

Cabotegravir (CAB)

Investigational medicinal product code

Other name

Pharmaceutical forms

Tablet

Routes of administration

Oral use

Dosage and administration details

30 mg tablets administered orally.

Investigational medicinal product name

Oral Rilpivirine (RPV)

Investigational medicinal product code

Other name

Edurant

Pharmaceutical forms

Tablet

Routes of administration

Oral use

Dosage and administration details

25 mg tablets administered orally.

Investigational medicinal product name

Long-Acting Injectable Cabotegravir (CAB LA)

Investigational medicinal product code

Other name

Pharmaceutical forms

Injection

Routes of administration

Intramuscular use

Dosage and administration details

Administered by intramuscular (IM) injection.

Investigational medicinal product name

Long-Acting Injectable Rilpivirine (RPV LA)

Investigational medicinal product code

Other name

Pharmaceutical forms

Injection

Routes of administration

Intramuscular use

Dosage and administration details

Administered by intramuscular (IM) injection.

Number of subjects in period 5	Cohort 2A: Oral CAB + Oral RPV and CAB LA + RPV LA
Started	140
Completed	137
Not completed	3
Adverse event, non-fatal	1
Pregnancy	2

Period 6 title

Cohort 2 Safety Extension

Is this the baseline period?

Allocation method

Non-randomised - controlled

Blinding used

Not blinded

Cohort 2A: Oral CAB + Oral RPV and CAB LA + RPV LA

Arm description

Arm type

Experimental

Investigational medicinal product name

Cabotegravir (CAB)

Investigational medicinal product code

Other name

Pharmaceutical forms

Tablet

Routes of administration

Oral use

Dosage and administration details

30 mg tablets administered orally.

Investigational medicinal product name

Oral Rilpivirine (RPV)

Investigational medicinal product code

Other name

Edurant

Pharmaceutical forms

Tablet

Routes of administration

Oral use

Dosage and administration details

25 mg tablets administered orally.

Investigational medicinal product name

Long-Acting Injectable Cabotegravir (CAB LA)

Investigational medicinal product code

Other name

Pharmaceutical forms

Injection

Routes of administration

Intramuscular use

Dosage and administration details

Administered by intramuscular (IM) injection.

Investigational medicinal product name

Long-Acting Injectable Rilpivirine (RPV LA)

Investigational medicinal product code

Other name

Pharmaceutical forms

Injection

Routes of administration

Intramuscular use

Dosage and administration details

Administered by intramuscular (IM) injection.

Number of subjects in period 6 ^[4]	Cohort 2A: Oral CAB + Oral RPV and CAB LA + RPV LA
Started	117
Completed	116
Not completed	1
Lost to follow-up	1

Notes
[4] - The number of subjects starting the period is not consistent with the number completing the preceding period. It is expected the number of subjects starting the subsequent period will be the same as the number completing the preceding period.
Justification: Only a subset of participants from Period 5 continued into Period 6; therefore, participant numbers are not expected to be equivalent across these periods. Values reported are accurate and reflect actual participant flow.

Baseline characteristics

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Reporting group title

Cohort 2A: Oral CAB + Oral RPV and CAB LA + RPV LA

Reporting group description

Reporting group values	Cohort 2A: Oral CAB + Oral RPV and CAB LA + RPV LA	Total
Number of subjects	144	144
Age categorical
Measure Description: Age is summarized as age at first enrollment to either Cohort 1 or Cohort 2. Measure Analysis Population Description: Baseline characteristics are reported separately for Cohort 1 and Cohort 2 participants.
Units: Subjects
In utero	0	0
Preterm newborn infants (gestational age < 37 wks)	0	0
Newborns (0-27 days)	0	0
Infants and toddlers (28 days-23 months)	0	0
Children (2-11 years)	0	0
Adolescents (12-17 years)	144	144
Adults (18-64 years)	0	0
From 65-84 years	0	0
85 years and over	0	0
Age continuous
Measure Description: Age is summarized as age at first enrollment to either Cohort 1 or Cohort 2. Measure Analysis Population Description: Baseline characteristics are reported separately for Cohort 1 and Cohort 2 participants.
Units: years
median (full range (min-max))	15 (12 to 17)	-
Gender categorical
Measure Analysis Population Description: Baseline characteristics are reported separately for Cohort 1 and Cohort 2 participants.
Units: Subjects
Female	74	74
Male	70	70
Ethnicity
Measure Analysis Population Description: Baseline characteristics are reported separately for Cohort 1 and Cohort 2 participants.
Units: Subjects
Hispanic or Latino	3	3
Not Hispanic or Latino	141	141
Race
Measure Analysis Population Description: Baseline characteristics are reported separately for Cohort 1 and Cohort 2 participants.
Units: Subjects
Asian	36	36
Black or African American	106	106
White	2	2
Region of Enrollment
Measure Analysis Population Description: Baseline characteristics are reported separately for Cohort 1 and Cohort 2 participants.
Units: Subjects
United States	20	20
Botswana	25	25
South Africa	43	43
Uganda	20	20
Thailand	36	36
HIV-1 RNA
Measure Description: The last available HIV-1 RNA viral load on or before the first dose of treatment for the corresponding cohort. Measure Analysis Population Description: Baseline characteristics are reported separately for Cohort 1 and Cohort 2 participants.
Units: Subjects
<50 copies/mL	138	138
>=50 copies/mL	6	6
Quality of Life Dimension Scores - Physical Functioning
Units: Units on a scale
median (inter-quartile range (Q1-Q3))	100 (93.8 to 100)	-
Quality of Life Dimension Scores - Emotional Functioning Dimension
Units: Units on a scale
median (inter-quartile range (Q1-Q3))	100 (85 to 100)	-
Quality of Life Dimension Scores - Social Functioning Dimension
Units: Units on a scale
median (inter-quartile range (Q1-Q3))	100 (90 to 100)	-
Quality of Life Dimension Scores - School Functioning Dimension
Units: Units on a scale
median (inter-quartile range (Q1-Q3))	80 (70 to 90)	-
Quality of Life Dimension Scores - Psychosocial Functioning
Units: Units on a scale
median (inter-quartile range (Q1-Q3))	91.7 (83.3 to 96.7)	-
Quality of Life Dimension Scores - Total Functioning
Units: Units on a scale
median (inter-quartile range (Q1-Q3))	94.6 (84.8 to 97.8)	-

End points

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Reporting group title

Cohort 1C: CAB

Reporting group description

Reporting group title

Cohort 1R: RPV

Reporting group description

Reporting group title

Cohort 2A: Oral CAB + Oral RPV and CAB LA + RPV LA

Reporting group description

Reporting group title

Cohort 1C: CAB

Reporting group description

Reporting group title

Cohort 1R: RPV

Reporting group description

Reporting group title

Cohort 2A: Oral CAB + Oral RPV and CAB LA + RPV LA

Reporting group description

Reporting group title

Cohort 2A: Oral CAB + Oral RPV and CAB LA + RPV LA

Reporting group description

Reporting group title

Cohort 2A: Oral CAB + Oral RPV and CAB LA + RPV LA

Reporting group description

Reporting group title

Cohort 2A: Oral CAB + Oral RPV and CAB LA + RPV LA

Reporting group description

Reporting group title

Cohort 2A: Oral CAB + Oral RPV and CAB LA + RPV LA

Reporting group description

Primary: Proportion of Participants Who Had Grade 3 or Higher Adverse Events (AEs) (Cohort 1)

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End point title

Proportion of Participants Who Had Grade 3 or Higher Adverse Events (AEs) (Cohort 1) ^[1]

End point description

Based on the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table, Corrected v2.1, July 2017), AEs are graded 1–5: 1=mild, 2=moderate, 3=severe, 4=life-threatening, 5=death. We present the proportion of participants with at least one Grade 3 or higher AEs through 4 weeks post-treatment initiation with exact 95% confidence interval (CI). The analysis was performed on the Cohort 1 Evaluable population, defined as participants treated only at the cohort dose who either completed treatment through Week 4 with the Week 4 visit, or had death attributable to the study product, a study product–related Grade 3 or higher event (excluding injection site AEs), or permanent discontinuation due to study product–related toxicity (regardless of grade).

End point type

Primary

End point timeframe

Cohort 1 Treatment Initiation through Week 4

Notes
[1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: The analysis of the primary endpoint was descriptive i.e. no statistical hypothesis test was performed.

End point values	Cohort 1C: CAB
Number of subjects analysed	30
Units: Proportion of participants
number (confidence interval 90%)	0 (0 to 0.12)

No statistical analyses for this end point

Primary: Proportion of Participants Who Had Grade 3 or Higher AEs Assessed as Related to Study Product/s (Cohort 1)

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End point title

Proportion of Participants Who Had Grade 3 or Higher AEs Assessed as Related to Study Product/s (Cohort 1) ^[2]

End point description

Based on the DAIDS AE Grading Table (Corrected v2.1, July 2017), AEs are graded 1–5: 1=mild, 2=moderate, 3=severe, 4=life-threatening, 5=death. We present the proportion of participants with at least one Grade 3 or higher AEs through 4 weeks post-treatment initiation with exact 95% CI. The analysis was performed on the Cohort 1 Evaluable population, defined as participants treated only at the cohort dose who either completed treatment through Week 4 with the Week 4 visit, or had death attributable to the study product, a study product–related Grade 3 or higher event (excluding injection site AEs), or permanent discontinuation due to study product–related toxicity (regardless of grade).

End point type

Primary

End point timeframe

Cohort 1 Treatment Initiation through Week 4

Notes
[2] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: The analysis of the primary endpoint was descriptive i.e. no statistical hypothesis test was performed.

End point values	Cohort 1C: CAB
Number of subjects analysed	30
Units: Proportion of participants
number (confidence interval 90%)	0 (0 to 0.12)

No statistical analyses for this end point

Primary: Proportion of Participants Who Had Serious AEs Meeting International Conference on Harmonisation (ICH) Criteria Assessed as Related to the Study Product/s (Cohort 1)

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End point title

Proportion of Participants Who Had Serious AEs Meeting International Conference on Harmonisation (ICH) Criteria Assessed as Related to the Study Product/s (Cohort 1) ^[3]

End point description

AEs were classified as serious per ICH criteria: any event resulting in death, life-threatening condition, inpatient hospitalisation or its prolongation, persistent/significant disability/incapacity, or congenital anomaly/birth defect. We report the proportion of participants with =1 serious AE assessed by the site investigator as related to the study product through 4 weeks post-treatment initiation, with exact 95% CIs. The analysis was performed on the Cohort 1 Evaluable population, defined as participants treated only at the cohort dose who either completed treatment through Week 4 with the Week 4 visit, or had death attributable to the study product, a study product–related Grade 3 or higher event (excluding injection site AEs), or permanent discontinuation due to study product–related toxicity (regardless of grade).

End point type

Primary

End point timeframe

Cohort 1 Treatment Initiation through Week 4

Notes
[3] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: The analysis of the primary endpoint was descriptive i.e. no statistical hypothesis test was performed.

End point values	Cohort 1C: CAB
Number of subjects analysed	30
Units: Proportion of participants
number (confidence interval 90%)	0 (0 to 0.12)

No statistical analyses for this end point

Primary: Proportion of Participants Who Permanently Discontinued Study Products Due to AEs Assessed as Related to Study Product/s (Cohort 1)

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End point title

Proportion of Participants Who Permanently Discontinued Study Products Due to AEs Assessed as Related to Study Product/s (Cohort 1) ^[4]

End point description

We present the proportion of participants who permanently discontinued study product due to AEs assessed as related to study product by the site investigator of record through 4 weeks post-treatment initiation, bounded by an exact 95% CIs. The analysis was performed on the Cohort 1 Evaluable population, defined as participants treated only at the cohort dose who either completed treatment through Week 4 with the Week 4 visit, or had death attributable to the study product, a study product–related Grade 3 or higher event (excluding injection site AEs), or permanent discontinuation due to study product–related toxicity (regardless of grade).

End point type

Primary

End point timeframe

Cohort 1 Treatment Initiation through Week 4

Notes
[4] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: The analysis of the primary endpoint was descriptive i.e. no statistical hypothesis test was performed.

End point values	Cohort 1C: CAB
Number of subjects analysed	30
Units: Proportion of participants
number (confidence interval 90%)	0 (0 to 0.12)

No statistical analyses for this end point

Primary: Proportion of Participants Who Died Due to AEs Assessed as Related to Study Product/s (Cohort 1)

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End point title

Proportion of Participants Who Died Due to AEs Assessed as Related to Study Product/s (Cohort 1) ^[5]

End point description

We present the proportion of participants who died due to AEs assessed as related to study product by the site investigator of record through 4 weeks post-treatment initiation, bounded by an exact 95% CI. The analysis was performed on the Cohort 1 Evaluable population, defined as participants treated only at the cohort dose who either completed treatment through Week 4 with the Week 4 visit, or had death attributable to the study product, a study product–related Grade 3 or higher event (excluding injection site AEs), or permanent discontinuation due to study product–related toxicity (regardless of grade).

End point type

Primary

End point timeframe

Cohort 1 Treatment Initiation through Week 4

Notes
[5] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: The analysis of the primary endpoint was descriptive i.e. no statistical hypothesis test was performed.

End point values	Cohort 1C: CAB
Number of subjects analysed	30
Units: Proportion of participants
number (confidence interval 90%)	0 (0 to 0.12)

No statistical analyses for this end point

Primary: Proportion of Participants Who Had Grade 3 or Higher AEs (Cohort 1)

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End point title

Proportion of Participants Who Had Grade 3 or Higher AEs (Cohort 1) ^[6]

End point description

Based on the DAIDS AE Grading Table (Corrected v2.1, July 2017), AEs are graded 1–5: 1=mild, 2=moderate, 3=severe, 4=life-threatening, 5=death. We present the proportion of participants with at least one Grade 3 or higher AEs through 16 weeks post-treatment initiation with exact 95% CI. The analysis was performed on the Cohort 1 Evaluable population, defined as participants treated only at the cohort dose who either completed treatment through Week 16 with the Week 16 visit, or had death attributable to the study product, a study product–related Grade 3 or higher event (excluding injection site AEs), or permanent discontinuation due to study product–related toxicity (regardless of grade).

End point type

Primary

End point timeframe

Cohort 1 Treatment Initiation through Week 16

Notes
[6] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: The analysis of the primary endpoint was descriptive i.e. no statistical hypothesis test was performed.

End point values	Cohort 1C: CAB	Cohort 1R: RPV
Number of subjects analysed	29	23
Units: Proportion of participants
number (confidence interval 95%)	0.24 (0.10 to 0.44)	0.22 (0.07 to 0.44)

No statistical analyses for this end point

Primary: Proportion of Participants Who Had Grade 3 or Higher AEs Assessed as Related to Study Product/s (Cohort 1)

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End point title

Proportion of Participants Who Had Grade 3 or Higher AEs Assessed as Related to Study Product/s (Cohort 1) ^[7]

End point description

Based on the DAIDS AE Grading Table (Corrected v2.1, July 2017), AEs are graded 1–5: 1=mild, 2=moderate, 3=severe, 4=life-threatening, 5=death. We present the proportion of participants with at least one Grade 3 or higher AEs through 16 weeks post-treatment initiation with exact 95% CI. The analysis was performed on the Cohort 1 Evaluable population, defined as participants treated only at the cohort dose who either completed treatment through Week 16 with the Week 16 visit, or had death attributable to the study product, a study product–related Grade 3 or higher event (excluding injection site AEs), or permanent discontinuation due to study product–related toxicity (regardless of grade).

End point type

Primary

End point timeframe

Cohort 1 Treatment Initiation through Week 16

Notes
[7] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: The analysis of the primary endpoint was descriptive i.e. no statistical hypothesis test was performed.

End point values	Cohort 1C: CAB	Cohort 1R: RPV
Number of subjects analysed	29	23
Units: Proportion of participants
number (confidence interval 90%)	0.035 (0.001 to 0.18)	0.04 (0.001 to 0.22)

No statistical analyses for this end point

Primary: Proportion of Participants Who Had Serious AEs Meeting ICH Criteria Assessed as Related to the Study Product/s (Cohort 1)

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End point title

Proportion of Participants Who Had Serious AEs Meeting ICH Criteria Assessed as Related to the Study Product/s (Cohort 1) ^[8]

End point description

AEs were classified as serious per ICH criteria: any event resulting in death, life-threatening condition, inpatient hospitalisation or its prolongation, persistent/significant disability/incapacity, or congenital anomaly/birth defect. We report the proportion of participants with =1 serious AE assessed by the site investigator as related to the study product through 16 weeks post-treatment initiation, with exact 95% CIs. The analysis was performed on the Cohort 1 Evaluable population, defined as participants treated only at the cohort dose who either completed treatment through Week 16 with the Week 16 visit, or had death attributable to the study product, a study product–related Grade 3 or higher event (excluding injection site AEs), or permanent discontinuation due to study product–related toxicity (regardless of grade).

End point type

Primary

End point timeframe

Cohort 1 Treatment Initiation through Week 16

Notes
[8] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: The analysis of the primary endpoint was descriptive i.e. no statistical hypothesis test was performed.

End point values	Cohort 1C: CAB	Cohort 1R: RPV
Number of subjects analysed	29	23
Units: Proportion of participants
number (confidence interval 90%)	0 (0 to 0.12)	0 (0 to 0.15)

No statistical analyses for this end point

Primary: Proportion of Participants Who Permanently Discontinued Study Products Due to AEs Assessed as Related to Study Product/s (Cohort 1)

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End point title

Proportion of Participants Who Permanently Discontinued Study Products Due to AEs Assessed as Related to Study Product/s (Cohort 1) ^[9]

End point description

We present the proportion of participants who permanently discontinued study product due to AEs assessed as related to study product by the site investigator of record through 16 weeks post-treatment initiation, bounded by an exact 95% CIs. The analysis was performed on the Cohort 1 Evaluable population, defined as participants treated only at the cohort dose who either completed treatment through Week 16 with the Week 16 visit, or had death attributable to the study product, a study product–related Grade 3 or higher event (excluding injection site AEs), or permanent discontinuation due to study product–related toxicity (regardless of grade).

End point type

Primary

End point timeframe

Cohort 1 Treatment Initiation through Week 16

Notes
[9] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: The analysis of the primary endpoint was descriptive i.e. no statistical hypothesis test was performed.

End point values	Cohort 1C: CAB	Cohort 1R: RPV
Number of subjects analysed	29	23
Units: Proportion of participants
number (confidence interval 90%)	0 (0 to 0.12)	0.044 (0.001 to 0.22)

No statistical analyses for this end point

Primary: Proportion of Participants Who Died Due to AEs Assessed as Related to Study Product/s (Cohort 1)

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End point title

Proportion of Participants Who Died Due to AEs Assessed as Related to Study Product/s (Cohort 1) ^[10]

End point description

We present the proportion of participants who died due to AEs assessed as related to study product by the site investigator of record through 16 weeks post-treatment initiation, bounded by an exact 95% CI. The analysis was performed on the Cohort 1 Evaluable population, defined as participants treated only at the cohort dose who either completed treatment through Week 16 with the Week 16 visit, or had death attributable to the study product, a study product–related Grade 3 or higher event (excluding injection site AEs), or permanent discontinuation due to study product–related toxicity (regardless of grade).

End point type

Primary

End point timeframe

Cohort 1 Treatment Initiation through Week 16

Notes
[10] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: The analysis of the primary endpoint was descriptive i.e. no statistical hypothesis test was performed.

End point values	Cohort 1C: CAB	Cohort 1R: RPV
Number of subjects analysed	29	23
Units: Proportion of participants
number (confidence interval 90%)	0 (0 to 0.12)	0 (0 to 0.15)

No statistical analyses for this end point

Primary: Proportion of Participants Who Had Grade 3 or Higher AEs (Cohort 2)

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End point title

Proportion of Participants Who Had Grade 3 or Higher AEs (Cohort 2) ^[11]

End point description

Based on the DAIDS AE Grading Table (Corrected v2.1, July 2017), AEs are graded 1–5: 1=mild, 2=moderate, 3=severe, 4=life-threatening, 5=death. We present the proportion of participants with at least one Grade 3 or higher AEs through 24 weeks post-Cohort 2 treatment initiation with exact 95% CI. The analysis was performed on the Cohort 2 Naive Evaluable population, defined as Cohort 2 participants who did not participate in Cohort 1, were treated exclusively at the final recommended Cohort 2 dose, and either completed all treatment regimens through the Week 24 visit, or experienced death attributable to the study product(s), a study product(s)-related Grade 3 or higher event (excluding ISR AEs), or permanent discontinuation due to study product(s)-related toxicity during the dose-finding period.

End point type

Primary

End point timeframe

Cohort 2 Treatment Initiation through Week 24

Notes
[11] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: The analysis of the primary endpoint was descriptive i.e. no statistical hypothesis test was performed.

End point values	Cohort 2A: Oral CAB + Oral RPV and CAB LA + RPV LA
Number of subjects analysed	98
Units: Proportion of Participants
number (confidence interval 95%)	0.10 (0.05 to 0.18)

No statistical analyses for this end point

Primary: Proportion of Participants Who Had Grade 3 or Higher AEs Assessed as Related to Study Product/s (Cohort 2)

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End point title

Proportion of Participants Who Had Grade 3 or Higher AEs Assessed as Related to Study Product/s (Cohort 2) ^[12]

End point description

Based on the DAIDS AE Grading Table (Corrected v2.1, July 2017), AEs are graded 1–5: 1=mild, 2=moderate, 3=severe, 4=life-threatening, 5=death. We present the proportion of participants with at least one Grade 3 or higher AEs through 24 weeks post-Cohort 2 treatment initiation with exact 95% CI. The analysis was performed on the Cohort 2 Naive Evaluable population, defined as Cohort 2 participants who did not participate in Cohort 1, were treated exclusively at the final recommended Cohort 2 dose, and either completed all treatment regimens through the Week 24 visit, or experienced death attributable to the study product(s), a study product(s)-related Grade 3 or higher event (excluding ISR AEs), or permanent discontinuation due to study product(s)-related toxicity during the dose-finding period.

End point type

Primary

End point timeframe

Cohort 2 Treatment Initiation through Week 24

Notes
[12] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: The analysis of the primary endpoint was descriptive i.e. no statistical hypothesis test was performed.

End point values	Cohort 2A: Oral CAB + Oral RPV and CAB LA + RPV LA
Number of subjects analysed	98
Units: Proportion of participants
number (confidence interval 95%)	0 (0 to 0.04)

No statistical analyses for this end point

Primary: Proportion of Participants Who Had Serious AEs Meeting ICH Criteria Assessed as Related to the Study Product/s (Cohort 2)

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End point title

Proportion of Participants Who Had Serious AEs Meeting ICH Criteria Assessed as Related to the Study Product/s (Cohort 2) ^[13]

End point description

AEs were classified as serious per ICH criteria: any event resulting in death, life-threatening condition, inpatient hospitalisation or its prolongation, persistent/significant disability/incapacity, or congenital anomaly/birth defect. We report the proportion of participants with =1 serious AE assessed by the site investigator as related to the study product through 16 weeks post-treatment initiation, with exact 95% CIs. The analysis was performed on the Cohort 2 Naive Evaluable population, defined as Cohort 2 participants who did not participate in Cohort 1, were treated exclusively at the final recommended Cohort 2 dose, and either completed all treatment regimens through the Week 24 visit, or experienced death attributable to the study product(s), a study product(s)-related Grade 3 or higher event (excluding ISR AEs), or permanent discontinuation due to study product(s)-related toxicity during the dose-finding period.

End point type

Primary

End point timeframe

Cohort 2 Treatment Initiation through Week 24

Notes
[13] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: The analysis of the primary endpoint was descriptive i.e. no statistical hypothesis test was performed.

End point values	Cohort 2A: Oral CAB + Oral RPV and CAB LA + RPV LA
Number of subjects analysed	98
Units: Proportion of participants
number (confidence interval 95%)	0 (0 to 0.4)

No statistical analyses for this end point

Primary: Proportion of Participants Who Permanently Discontinued Study Products Due to AEs Assessed as Related to Study Product/s (Cohort 2)

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End point title

Proportion of Participants Who Permanently Discontinued Study Products Due to AEs Assessed as Related to Study Product/s (Cohort 2) ^[14]

End point description

We present the proportion of participants who permanently discontinued study product due to AEs assessed as related to study product by the site investigator of record through 24 weeks post-Cohort 2 treatment initiation, bounded by an exact 95% CI. We present the proportion of participants who permanently discontinued study product due to AEs assessed as related to study product by the site investigator of record through 24 weeks post-Cohort 2 treatment initiation, bounded by an exact 95% CI.

End point type

Primary

End point timeframe

Cohort 2 Treatment Initiation through Week 24

Notes
[14] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: The analysis of the primary endpoint was descriptive i.e. no statistical hypothesis test was performed.

End point values	Cohort 2A: Oral CAB + Oral RPV and CAB LA + RPV LA
Number of subjects analysed	98
Units: Proportion pf participants
number (confidence interval 95%)	0 (0 to 0.4)

No statistical analyses for this end point

Primary: Proportion of Participants Who Died Due to AEs Assessed as Related to Study Product/s (Cohort 2)

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End point title

Proportion of Participants Who Died Due to AEs Assessed as Related to Study Product/s (Cohort 2) ^[15]

End point description

We present the proportion of participants who died due to AEs assessed as related to study product by the site investigator of record through 24 weeks post-Cohort 2 treatment initiation, bounded by an exact 95% CI. The analysis was performed on the Cohort 2 Naive Evaluable population, defined as Cohort 2 participants who did not participate in Cohort 1, were treated exclusively at the final recommended Cohort 2 dose, and either completed all treatment regimens through the Week 24 visit, or experienced death attributable to the study product(s), a study product(s)-related Grade 3 or higher event (excluding ISR AEs), or permanent discontinuation due to study product(s)-related toxicity during the dose-finding period.

End point type

Primary

End point timeframe

Cohort 2 Treatment Initiation through Week 24

Notes
[15] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: The analysis of the primary endpoint was descriptive i.e. no statistical hypothesis test was performed.

End point values	Cohort 2A: Oral CAB + Oral RPV and CAB LA + RPV LA
Number of subjects analysed	98
Units: Proportion of participants
number (confidence interval 95%)	0 (0 to 0.04)

No statistical analyses for this end point

Primary: Geometric Mean Area Under the Plasma Concentration-time Curve (AUC) for Step 1 Oral CAB (Cohort 1C)

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End point title

Geometric Mean Area Under the Plasma Concentration-time Curve (AUC) for Step 1 Oral CAB (Cohort 1C) ^[16]

End point description

AUC calculated using non-compartmental methods with linear up-log down trapezoidal rule (Phoenix WinNonlin v 8.3, Certara). We present the geometric mean of the AUC with associated geometric coefficient of variation. The analysis was performed on the Cohort 1 All Treated population, defined as Cohort 1 participants who have taken at least 1 dose of any study product on Cohort 1 and had an available AUC measurement.

End point type

Primary

End point timeframe

Week 2: Samples collected pre-dose and 1, 2, 3, 4, 8, and (for Q4W dosing) 24 hours post-dose

Notes
[16] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: The analysis of the primary endpoint was descriptive i.e. no statistical hypothesis test was performed.

End point values	Cohort 1C: CAB
Number of subjects analysed	29
Units: (h*ug)/mL
geometric mean (geometric coefficient of variation)	139 ( 59.1 )

No statistical analyses for this end point

Primary: Apparent Body Clearance (CL/F) of Step 1 Oral CAB (Cohort 1C)

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End point title

Apparent Body Clearance (CL/F) of Step 1 Oral CAB (Cohort 1C) ^[17]

End point description

We present the geometric mean of the total body clearance of CAB and associated geometric coefficient of variation, based on analysis of intensive pharmacokinetic (PK) samples. The analysis was performed on the Cohort 1 All Treated population, defined as Cohort 1 participants who have taken at least 1 dose of any study product on Cohort 1 and had an available total body clearance measurement.

End point type

Primary

End point timeframe

Week 2: Samples collected pre-dose and 1, 2, 3, 4, 8 and (for Q4W dosing) 24 hours post-dose

Notes
[17] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: The analysis of the primary endpoint was descriptive i.e. no statistical hypothesis test was performed.

End point values	Cohort 1C: CAB
Number of subjects analysed	29
Units: mL/h
geometric mean (geometric coefficient of variation)	216.0 ( 59.1 )

No statistical analyses for this end point

Primary: Geometric Mean Maximum Plasma Concentration (Cmax) of Oral CAB (Cohort 1C)

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End point title

Geometric Mean Maximum Plasma Concentration (Cmax) of Oral CAB (Cohort 1C) ^[18]

End point description

We present the geometric mean of the maximum plasma concentration of CAB and associated geometric coefficient of variation, based on analysis of intensive PK samples. The analysis was performed on the Cohort 1 All Treated population, defined as Cohort 1 participants who have taken at least 1 dose of any study product on Cohort 1 and had an available Cmax measurement.

End point type

Primary

End point timeframe

Week 2: Samples collected pre-dose and 1, 2, 3, 4, 8 and (for Q4W dosing) 24 hours post-dose

Notes
[18] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: The analysis of the primary endpoint was descriptive i.e. no statistical hypothesis test was performed.

End point values	Cohort 1C: CAB
Number of subjects analysed	29
Units: ug/mL
geometric mean (geometric coefficient of variation)	8.90 ( 43.1 )

No statistical analyses for this end point

Primary: Time of Maximum Concentration (Tmax) of Oral CAB (Cohort 1C)

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End point title

Time of Maximum Concentration (Tmax) of Oral CAB (Cohort 1C) ^[19]

End point description

We present the mean time of maximum concentration of CAB and associated standard deviation, based on analysis of intensive PK samples. The analysis was performed on the Cohort 1 All Treated population, defined as Cohort 1 participants who have taken at least 1 dose of any study product on Cohort 1 and had an available Tmax measurement.

End point type

Primary

End point timeframe

Week 2: Samples collected pre-dose and 1, 2, 3, 4, 8, and (for Q4W dosing) 24 hours post-dose

Notes
[19] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: The analysis of the primary endpoint was descriptive i.e. no statistical hypothesis test was performed.

End point values	Cohort 1C: CAB
Number of subjects analysed	29
Units: h
arithmetic mean (standard deviation)	2.73 ( 1.13 )

No statistical analyses for this end point

Primary: Geometric Mean Pre-Dose Concentration (C0) of Oral CAB (Cohort 1C)

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End point title

Geometric Mean Pre-Dose Concentration (C0) of Oral CAB (Cohort 1C) ^[20]

End point description

We present the geometric mean pre-dose CAB concentration and associated geometric coefficient of variation, based on analysis of intensive PK samples. The analysis was performed on the Cohort 1 All Treated population, defined as Cohort 1 participants who have taken at least 1 dose of any study product on Cohort 1 and had an available pre-dose concentration measurement.

End point type

Primary

End point timeframe

Week 2: Samples collected pre-dose and 1, 2, 3, 4, 8, and (for Q4W dosing) 24 hours post-dose

Notes
[20] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: The analysis of the primary endpoint was descriptive i.e. no statistical hypothesis test was performed.

End point values	Cohort 1C: CAB
Number of subjects analysed	29
Units: ug/mL
geometric mean (geometric coefficient of variation)	4.09 ( 96.1 )

No statistical analyses for this end point

Primary: Geometric Mean Concentration of LA CAB/LA RPV at Week 16 (Cohort 1 Q4W)

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End point title

Geometric Mean Concentration of LA CAB/LA RPV at Week 16 (Cohort 1 Q4W) ^[21]

End point description

We present the geometric mean concentration of LA CAB/LA RPV and associated geometric coefficients of variation for participants on the Q4W dosing regimen, based on analysis of pre-dose PK sample. The analysis was performed on the Cohort 1 Q4W population, defined as Cohort 1 participants who received the Q4W dosing regimen on Cohort 1.

End point type

Primary

End point timeframe

Week 16

Notes
[21] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: The analysis of the primary endpoint was descriptive i.e. no statistical hypothesis test was performed.

End point values	Cohort 1C: CAB	Cohort 1R: RPV
Number of subjects analysed	8	12
Units: ug/mL
geometric mean (geometric coefficient of variation)	2.91 ( 58.8 )	0.0644 ( 59.9 )

No statistical analyses for this end point

Primary: Geometric Mean Cmax of LA CAB/LA RPV (Cohort 1 Q4W)

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End point title

Geometric Mean Cmax of LA CAB/LA RPV (Cohort 1 Q4W) ^[22]

End point description

We present the geometric mean of the maximum plasma concentration of LA CAB/LA RPV and associated geometric coefficient of variation for the first injection in participants on the Q4W dosing regimen, based on analysis of intensive PK samples. The analysis was performed on the Cohort 1 Q4W population, defined as Cohort 1 participants who received the Q4W dosing regimen on Cohort 1.

End point type

Primary

End point timeframe

Samples collected at Weeks 4b, 5, 6, and 8

Notes
[22] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: The analysis of the primary endpoint was descriptive i.e. no statistical hypothesis test was performed.

End point values	Cohort 1C: CAB	Cohort 1R: RPV
Number of subjects analysed	8	13
Units: ug/mL
geometric mean (geometric coefficient of variation)	9.56 ( 32.2 )	0.132 ( 35.5 )

No statistical analyses for this end point

Primary: Tmax of LA CAB/LA RPV (Cohort 1 Q4W)

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End point title

Tmax of LA CAB/LA RPV (Cohort 1 Q4W) ^[23]

End point description

We present the mean time of maximum concentration of LA CAB/LA RPV at the first injection and associated standard deviation for participants on the Q4W dosing regimen, based on analysis of intensive PK samples. The analysis was performed on the Cohort 1 participants who received the Q4W dosing regimen on Cohort 1.

End point type

Primary

End point timeframe

Samples collected at Weeks 4b, 5, 6, 8

Notes
[23] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: The analysis of the primary endpoint was descriptive i.e. no statistical hypothesis test was performed.

End point values	Cohort 1C: CAB	Cohort 1R: RPV
Number of subjects analysed	8	13
Units: h
arithmetic mean (standard deviation)	1.50 ( 0.551 )	89.6 ( 162 )

No statistical analyses for this end point

Primary: Geometric Mean Pre-Dose Concentration (C0) of LA CAB/LA RPV (Cohort 1 Q4W)

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End point title

Geometric Mean Pre-Dose Concentration (C0) of LA CAB/LA RPV (Cohort 1 Q4W) ^[24]

End point description

We present the geometric mean pre-dose concentrations of each injection and associated geometric coefficient of variation for participants on the Q4W dosing regimen, based on analysis of pre-dose PK samples. The analysis was performed on the Cohort 1 participants who received the Q4W dosing regimen on Cohort 1.

End point type

Primary

End point timeframe

Week 4b, Week 8, Week 12

Notes
[24] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: The analysis of the primary endpoint was descriptive i.e. no statistical hypothesis test was performed.

End point values	Cohort 1C: CAB	Cohort 1R: RPV
Number of subjects analysed	8	13
Units: ug/mL
geometric mean (geometric coefficient of variation)
Week 4b	5.46 ( 39.6 )	0.0704 ( 227 )
Week 8	2.10 ( 37.0 )	0.0441 ( 75.9 )
Week 12	2.73 ( 76.7 )	0.0555 ( 56.7 )

No statistical analyses for this end point

Primary: Geometric Mean Concentration of LA CAB/LA RPV at Week 16 (Cohort 1 Q8W)

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End point title

Geometric Mean Concentration of LA CAB/LA RPV at Week 16 (Cohort 1 Q8W) ^[25]

End point description

We present the geometric mean concentration of LA CAB/LA RPV and associated geometric coefficients of variation for participants on the Q4W dosing regimen, based on analysis of the pre-dose PK sample. The analysis was performed on the Cohort 1 participants who received the Q8W dosing regimen on Cohort 1.

End point type

Primary

End point timeframe

Week 16

Notes
[25] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: The analysis of the primary endpoint was descriptive i.e. no statistical hypothesis test was performed.

End point values	Cohort 1C: CAB	Cohort 1R: RPV
Number of subjects analysed	21	10
Units: ug/mL
geometric mean (geometric coefficient of variation)	1.01 ( 237 )	0.0449 ( 38.2 )

No statistical analyses for this end point

Primary: Geometric Mean Cmax of LA CAB/LA RPV (Cohort 1 Q8W)

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End point title

Geometric Mean Cmax of LA CAB/LA RPV (Cohort 1 Q8W) ^[26]

End point description

We present the geometric mean of the maximum plasma concentration of LA CAB/LA RPV and associated geometric coefficient of variation for the first injection in participants on the Q8W dosing regimen, based on analysis of intensive PK samples. The analysis was performed on the Cohort 1 participants who received the Q8W dosing regimen on Cohort 1.

End point type

Primary

End point timeframe

Samples collected at Weeks 4b, 5, and 8

Notes
[26] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: The analysis of the primary endpoint was descriptive i.e. no statistical hypothesis test was performed.

End point values	Cohort 1C: CAB	Cohort 1R: RPV
Number of subjects analysed	21	10
Units: ug/mL
geometric mean (geometric coefficient of variation)	6.42 ( 42.2 )	0.129 ( 39.4 )

No statistical analyses for this end point

Primary: Tmax of LA CAB/LA RPV (Cohort 1 Q8W)

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End point title

Tmax of LA CAB/LA RPV (Cohort 1 Q8W) ^[27]

End point description

We present the mean time of maximum concentration of LA CAB/LA RPV at the first injection and associated standard deviation for participants on the Q8W dosing regimen, based on analysis of intensive PK samples. The analysis was performed on the Cohort 1 participants who received the Q8W dosing regimen on Cohort 1.

End point type

Primary

End point timeframe

Samples collected at Weeks 4b, 5, and 8

Notes
[27] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: The analysis of the primary endpoint was descriptive i.e. no statistical hypothesis test was performed.

End point values	Cohort 1C: CAB	Cohort 1R: RPV
Number of subjects analysed	21	10
Units: h
arithmetic mean (standard deviation)	1.84 ( 0.829 )	18.6 ( 53.5 )

No statistical analyses for this end point

Primary: Geometric Mean Pre-Dose Concentration (C0) of LA CAB/LA RPV (Cohort 1 Q8W)

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End point title

Geometric Mean Pre-Dose Concentration (C0) of LA CAB/LA RPV (Cohort 1 Q8W) ^[28]

End point description

We present the geometric mean pre-dose concentration of the first injection and associated geometric coefficient of variation for participants on the Q4W dosing regimen, based on analysis of pre-dose PK samples. The analysis was performed on the Cohort 1 participants who received the Q8W dosing regimen on Cohort 1.

End point type

Primary

End point timeframe

Week 4b, Week 8

Notes
[28] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: The analysis of the primary endpoint was descriptive i.e. no statistical hypothesis test was performed.

End point values	Cohort 1C: CAB	Cohort 1R: RPV
Number of subjects analysed	21	10
Units: ug/mL
geometric mean (geometric coefficient of variation)
Week 4b	2.89 ( 194 )	0.0703 ( 24.8 )
Week 8	1.33 ( 105 )	0.0327 ( 28.8 )

No statistical analyses for this end point

Secondary: Proportion of Participants With HIV-1 RNA <50 Copies/mL (Cohort 1)

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End point title

Proportion of Participants With HIV-1 RNA <50 Copies/mL (Cohort 1)

End point description

We present the proportion of participants with results of HIV-1 RNA < 50 copies/mL at Week 16. The analysis was performed on the Cohort 1 All Treated population, defined as Cohort 1 participants who have taken at least 1 dose of any study product on Cohort 1.

End point type

Secondary

End point timeframe

Week 16

End point values	Cohort 1C: CAB	Cohort 1R: RPV
Number of subjects analysed	28	22
Units: Proportion of participants
number (not applicable)	0.964	1.00

No statistical analyses for this end point

Secondary: Proportion of Participants Who Reported "Hurts Whole Lot" or "Hurts Worst" in Regards to Being Bothered by Pain During Injection of CAB LA of RPV LA (Cohort 1)

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End point title

Proportion of Participants Who Reported "Hurts Whole Lot" or "Hurts Worst" in Regards to Being Bothered by Pain During Injection of CAB LA of RPV LA (Cohort 1)

End point description

Results collected via administration of Pain During Injection survey to participants after receiving injection. Pain during injections was assessed using the Faces Pain Scale-Revised which includes 6 visual and text options: "no hurt," "hurts little bit," "hurts little more," "hurts even more," "hurts whole lot" and "hurts worst". The analysis was performed on the Cohort 1 All Treated population, defined as Cohort 1 participants who have taken at least 1 dose of any study product on Cohort 1.

End point type

Secondary

End point timeframe

Week 8

End point values	Cohort 1C: CAB	Cohort 1R: RPV
Number of subjects analysed	29	23
Units: Proportion of participants
number (not applicable)	0	0.043

No statistical analyses for this end point

Secondary: Median Dimension of Quality of Life Scores

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End point title

Median Dimension of Quality of Life Scores

End point description

A commonly used 23-item Pediatric Quality of Life Inventory, the PedsQLTM, was used to measure physical, emotional, and social dimensions of health as well as school functioning. Question responses were used to generate scores from 0-100 (100 being the best quality of life) based on the PedsQLTM guidelines. The number of participants drops slightly for the school functioning result as not all participants are eligible to answer these school-related questions. The analysis was performed on the Cohort 1 All Treated population, defined as Cohort 1 participants who have taken at least 1 dose of any study product on Cohort 1.

End point type

Secondary

End point timeframe

Week 16

End point values	Cohort 1C: CAB	Cohort 1R: RPV
Number of subjects analysed	29	23
Units: Score on a scale
median (inter-quartile range (Q1-Q3))
Physical Functioning	96.9 (90.6 to 100)	100 (93.8 to 100)
Emotional Functioning	95 (80 to 100)	95 (90 to 100)
Social Functioning	100 (95 to 100)	100 (95 to 100)
School Functioning	80 (65 to 90)	85 (80 to 95)
Psychosocial Functioning	91.7 (76.7 to 96.7)	91.7 (86.7 to 96.7)
Total Functioning	93.5 (82.6 to 96.7)	94.6 (90.2 to 97.8)

No statistical analyses for this end point

Secondary: Proportion of Participants Who Had Grade 3 or Higher AEs (Cohort 2)

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End point title

Proportion of Participants Who Had Grade 3 or Higher AEs (Cohort 2)

End point description

Based on the DAIDS AE Grading Table (Corrected v2.1, July 2017), AEs are graded 1–5: 1=mild, 2=moderate, 3=severe, 4=life-threatening, 5=death. We present the proportion of participants with at least one Grade 3 or higher AEs through 16 weeks post-treatment initiation with exact 95% CI. The analysis was performed on the Cohort 2 Naive Evaluable population, defined as Cohort 2 participants who did not participate in Cohort 1, were treated exclusively on the final recommended dose for Cohort 2, and either (1) completed all treatment regimens through Week 48 visit or (2) experienced any of the following: death attributable to the study product(s); study product(s)-related Grade 3 or higher event (excluding ISR AEs); OR permanently discontinued from treatment due to study product(s)-related toxicity during the treatment period.

End point type

Secondary

End point timeframe

Cohort 2 treatment initiation through Week 48

End point values	Cohort 2A: Oral CAB + Oral RPV and CAB LA + RPV LA
Number of subjects analysed	97
Units: Proportion of participants
number (confidence interval 95%)	0.14 (0.08 to 0.23)

No statistical analyses for this end point

Secondary: Proportion of Participants Who Had Grade 3 or Higher AEs Assessed as Related to Study Product/s (Cohort 2)

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End point title

Proportion of Participants Who Had Grade 3 or Higher AEs Assessed as Related to Study Product/s (Cohort 2)

End point description

Based on the DAIDS AE Grading Table (Corrected v2.1, July 2017), AEs are graded 1–5: 1=mild, 2=moderate, 3=severe, 4=life-threatening, 5=death. We present the proportion of participants with at least one Grade 3 or higher AEs through 16 weeks post-treatment initiation with exact 95% CI. The analysis was performed on the Cohort 2 Naive Evaluable population, defined as Cohort 2 participants who did not participate in Cohort 1, were treated exclusively on the final recommended dose for Cohort 2, and either (1) completed all treatment regimens through Week 48 visit or (2) experienced any of the following: death attributable to the study product(s); study product(s)-related Grade 3 or higher event (excluding ISR AEs); OR permanently discontinued from treatment due to study product(s)-related toxicity during the treatment period.

End point type

Secondary

End point timeframe

Cohort 2 treatment initiation through Week 48

End point values	Cohort 2A: Oral CAB + Oral RPV and CAB LA + RPV LA
Number of subjects analysed	97
Units: Proportion of participants
number (confidence interval 95%)	0.02 (0.003 to 0.07)

No statistical analyses for this end point

Secondary: Proportion of Participants Who Had Serious (S) AEs Meeting ICH Criteria Assessed as Related to the Study Product/s (Cohort 2)

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End point title

Proportion of Participants Who Had Serious (S) AEs Meeting ICH Criteria Assessed as Related to the Study Product/s (Cohort 2)

End point description

SAEs were classified as serious per ICH criteria (death, life-threatening, hospitalisation/prolongation, significant disability/incapacity, or congenital anomaly). We present the proportion of participants with at least one SAE assessed as related to study product by the site investigator through 48 weeks post-Cohort 2 treatment initiation, bounded by an exact 95% CI. The analysis was performed on the Cohort 2 Naive Evaluable population, defined as Cohort 2 participants who did not participate in Cohort 1, were treated exclusively at the final recommended Cohort 2 dose, and either completed all treatment regimens through the Week 24 visit, or experienced death attributable to the study product(s), a study product(s)-related Grade 3 or higher event (excluding ISR AEs), or permanent discontinuation due to study product(s)-related toxicity toxicity during the treatment period.

End point type

Secondary

End point timeframe

Cohort 2 treatment initiation through Week 48

End point values	Cohort 2A: Oral CAB + Oral RPV and CAB LA + RPV LA
Number of subjects analysed	97
Units: Proportion of participants
number (confidence interval 95%)	0 (0 to 0.04)

No statistical analyses for this end point

Secondary: Proportion of Participants Who Permanently Discontinued Study Products Due to AEs Assessed as Related to Study Product/s (Cohort 2)

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End point title

Proportion of Participants Who Permanently Discontinued Study Products Due to AEs Assessed as Related to Study Product/s (Cohort 2)

End point description

We present the proportion of participants who permanently discontinued study product due to AEs assessed as related to study product by the site investigator of record through 48 weeks post-Cohort 2 treatment initiation, bounded by an exact 95% CI. The analysis was performed on the Cohort 2 Naive Evaluable population, defined as Cohort 2 participants who did not participate in Cohort 1, were treated exclusively on the final recommended dose for Cohort 2, and either (1) completed all treatment regimens through Week 48 visit or (2) experienced any of the following: death attributable to the study product(s); study product(s)-related Grade 3 or higher event (excluding ISR AEs); OR permanently discontinued from treatment due to study product(s)-related toxicity during the treatment period.

End point type

Secondary

End point timeframe

Cohort 2 treatment initiation through Week 48

End point values	Cohort 2A: Oral CAB + Oral RPV and CAB LA + RPV LA
Number of subjects analysed	97
Units: Proportion of participants
number (confidence interval 95%)	0 (0 to 0.04)

No statistical analyses for this end point

Secondary: Proportion of Participants Who Died Due to AEs Assessed as Related to Study Product/s (Cohort 2)

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End point title

Proportion of Participants Who Died Due to AEs Assessed as Related to Study Product/s (Cohort 2)

End point description

We present the proportion of participants who died due to AEs assessed as related to study product by the site investigator of record through 48 weeks post-Cohort 2 treatment initiation, bounded by an exact 95% CI. The analysis was performed on the Cohort 2 Naive Evaluable population, defined as Cohort 2 participants who did not participate in Cohort 1, were treated exclusively on the final recommended dose for Cohort 2, and either (1) completed all treatment regimens through Week 48 visit or (2) experienced any of the following: death attributable to the study product(s); study product(s)-related Grade 3 or higher event (excluding ISR AEs); OR permanently discontinued from treatment due to study product(s)-related toxicity during the treatment period.

End point type

Secondary

End point timeframe

Cohort 2 treatment initiation through Week 48

End point values	Cohort 2A: Oral CAB + Oral RPV and CAB LA + RPV LA
Number of subjects analysed	97
Units: Proportion of participants
number (confidence interval 95%)	0 (0 to 0.04)

No statistical analyses for this end point

Secondary: Proportion of Participants With Plasma HIV-1 RNA >=50 Copies/mL per FDA Snapshot (Cohort 2)

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End point title

Proportion of Participants With Plasma HIV-1 RNA >=50 Copies/mL per FDA Snapshot (Cohort 2)

End point description

We present the proportion of participants with HIV-1 RNA >= 50 copies/mL and associated exact 95% CI (Clopper-Pearson) per the FDA snapshot, based on laboratory evaluations. The analysis was performed on the Cohort 2 Naive Evaluable population, defined as Cohort 2 participants who did not participate in Cohort 1, were treated exclusively on the final recommended dose for Cohort 2, and either (1) completed all treatment regimens through Week 24 visit or (2) experienced any of the following: death attributable to the study product(s); study product(s)-related Grade 3 or higher event (excluding ISR AEs); OR permanently discontinued from treatment due to study product(s)-related toxicity during the treatment period

End point type

Secondary

End point timeframe

Week 24

End point values	Cohort 2A: Oral CAB + Oral RPV and CAB LA + RPV LA
Number of subjects analysed	98
Units: Proportion of participants
number (confidence interval 95%)	0.02 (0.002 to 0.07)

No statistical analyses for this end point

Secondary: Proportion of Participants With Plasma HIV-1 RNA >=200 Copies/mL per FDA Snapshot (Cohort 2)

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End point title

Proportion of Participants With Plasma HIV-1 RNA >=200 Copies/mL per FDA Snapshot (Cohort 2)

End point description

We present the proportion of participants with HIV-1 RNA >= 200 copies/mL and associated exact 95% CI (Clopper-Pearson) per the FDA snapshot, based on laboratory evaluations. The analysis was performed on the Cohort 2 Naive Evaluable population, defined as Cohort 2 participants who did not participate in Cohort 1, were treated exclusively at the final recommended Cohort 2 dose, and either completed all treatment regimens through the Week 24 visit, or experienced death attributable to the study product(s), a study product(s)-related Grade 3 or higher event (excluding ISR AEs), or permanent discontinuation due to study product(s)-related toxicity during the treatment period.

End point type

Secondary

End point timeframe

Week 24

End point values	Cohort 2A: Oral CAB + Oral RPV and CAB LA + RPV LA
Number of subjects analysed	98
Units: Proportion of participants
number (confidence interval 95%)	0 (0 to 0.037)

No statistical analyses for this end point

Secondary: Proportion of Participants With Plasma HIV-1 RNA >=50 Copies/mL per FDA Snapshot (Cohort 2)

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End point title

Proportion of Participants With Plasma HIV-1 RNA >=50 Copies/mL per FDA Snapshot (Cohort 2)

End point description

We present the proportion of participants with HIV-1 RNA >= 50 copies/mL and associated exact 95% CI (Clopper-Pearson) per the FDA snapshot, based on laboratory evaluations. The analysis was performed on the Cohort 2 Naive Evaluable population, defined as Cohort 2 participants who did not participate in Cohort 1, were treated exclusively at the final recommended Cohort 2 dose, and either completed all treatment regimens through the Week 48 visit, or experienced death attributable to the study product(s), a study product(s)-related Grade 3 or higher event (excluding ISR AEs), or permanent discontinuation due to study product(s)-related toxicity during the treatment period.

End point type

Secondary

End point timeframe

Week 48

End point values	Cohort 2A: Oral CAB + Oral RPV and CAB LA + RPV LA
Number of subjects analysed	97
Units: Proportion of participants
number (confidence interval 95%)	0 (0 to 0.04)

No statistical analyses for this end point

Secondary: Proportion of Participants With Plasma HIV-1 RNA >=200 Copies/mL per FDA Snapshot (Cohort 2)

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End point title

Proportion of Participants With Plasma HIV-1 RNA >=200 Copies/mL per FDA Snapshot (Cohort 2)

End point description

We present the proportion of participants with HIV-1 RNA >= 200 copies/mL and associated exact 95% CI (Clopper-Pearson) per the FDA snapshot, based on laboratory evaluations. The analysis was performed on the Cohort 2 Naive Evaluable population, defined as Cohort 2 participants who did not participate in Cohort 1, were treated exclusively at the final recommended Cohort 2 dose, and either completed all treatment regimens through the Week 48 visit, or experienced death attributable to the study product(s), a study product(s)-related Grade 3 or higher event (excluding ISR AEs), or permanent discontinuation due to study product(s)-related toxicity during the treatment period.

End point type

Secondary

End point timeframe

Week 48

End point values	Cohort 2A: Oral CAB + Oral RPV and CAB LA + RPV LA
Number of subjects analysed	97
Units: Proportion of participants
number (confidence interval 95%)	0 (0 to 0.04)

No statistical analyses for this end point

Secondary: Geometric Mean Pre-Dose Concentration (C0) of Oral CAB and Oral RPV (Cohort 2)

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End point title

Geometric Mean Pre-Dose Concentration (C0) of Oral CAB and Oral RPV (Cohort 2)

End point description

We present the geometric mean of the pre-dose concentration of oral CAB and oral RPV and associated coefficient of variation, based on analysis of pre-dose PK sample. The analysis was performed on the Cohort 2 All Treated population, defined as Cohort 2 participants who have taken at least 1 dose of any study product on Cohort 2.

End point type

Secondary

End point timeframe

Week 2

End point values	Cohort 2A: Oral CAB + Oral RPV and CAB LA + RPV LA
Number of subjects analysed	144
Units: ug/mL
geometric mean (geometric coefficient of variation)
CAB concentration	6.65 ( 42.3 )
RPV concentration	0.0708 ( 59.0 )

No statistical analyses for this end point

Secondary: Geometric Mean Ratio of Pre-dose CAB and RPV Concentrations at Week 24: Pre-dose CAB and RPV Concentrations at Week 8 (Cohort 2)

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End point title

Geometric Mean Ratio of Pre-dose CAB and RPV Concentrations at Week 24: Pre-dose CAB and RPV Concentrations at Week 8 (Cohort 2)

End point description

We present the geometric mean of the ratios of pre-dose CAB and RPV concentrations at Week 24:Week 8 and associated coefficient of variation, based on analysis of pre-dose PK samples. The analysis was performed on the Cohort 2 All Treated population, defined as Cohort 2 participants who have taken at least 1 dose of any study product on Cohort 2.

End point type

Secondary

End point timeframe

Week 8 and Week 24

End point values	Cohort 2A: Oral CAB + Oral RPV and CAB LA + RPV LA
Number of subjects analysed	139
Units: Ratio
geometric mean (geometric coefficient of variation)
CAB Ratio	1.14 ( 107 )
RPV Ratio	1.35 ( 47.1 )

No statistical analyses for this end point

Secondary: Geometric Mean Ratio of Pre-dose CAB and RPV Concentrations at Week 24: Pre-dose CAB and RPV Concentrations at Week 16 (Cohort 2)

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End point title

Geometric Mean Ratio of Pre-dose CAB and RPV Concentrations at Week 24: Pre-dose CAB and RPV Concentrations at Week 16 (Cohort 2)

End point description

We present the geometric mean of the ratios of pre-dose CAB and RPV concentrations at Week 24:Week 16 and associated coefficient of variation, based on analysis of pre-dose PK samples. The analysis was performed on the Cohort 2 All Treated population, defined as Cohort 2 participants who have taken at least 1 dose of any study product on Cohort 2.

End point type

Secondary

End point timeframe

Week 16 and Week 24

End point values	Cohort 2A: Oral CAB + Oral RPV and CAB LA + RPV LA
Number of subjects analysed	139
Units: Ratio
geometric mean (geometric coefficient of variation)
CAB Ratio	0.974 ( 47.0 )
RPV Ratio	1.22 ( 32.7 )

No statistical analyses for this end point

Secondary: Geometric Mean Ratio of Pre-dose CAB and RPV Concentrations at Week 48: Pre-dose CAB and RPV Concentrations at Week 8 (Cohort 2)

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End point title

Geometric Mean Ratio of Pre-dose CAB and RPV Concentrations at Week 48: Pre-dose CAB and RPV Concentrations at Week 8 (Cohort 2)

End point description

We present the geometric mean of the ratios of pre-dose CAB and RPV concentrations at Week 48:Week 8 and associated coefficient of variation, based on analysis of pre-dose PK samples. The analysis was performed on the Cohort 2 All Treated population, defined as Cohort 2 participants who have taken at least 1 dose of any study product on Cohort 2.

End point type

Secondary

End point timeframe

Week 8 and Week 48

End point values	Cohort 2A: Oral CAB + Oral RPV and CAB LA + RPV LA
Number of subjects analysed	138
Units: Ratio
geometric mean (geometric coefficient of variation)
CAB Ratio	1.31 ( 97.6 )
RPV Ratio	1.84 ( 47.1 )

No statistical analyses for this end point

Secondary: Geometric Mean Ratio of Pre-dose CAB and RPV Concentrations at Week 48: Pre-dose CAB and RPV Concentrations at Week 16 (Cohort 2)

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End point title

Geometric Mean Ratio of Pre-dose CAB and RPV Concentrations at Week 48: Pre-dose CAB and RPV Concentrations at Week 16 (Cohort 2)

End point description

We present the geometric mean of the ratios of pre-dose CAB and RPV concentrations at Week 48:Week 16 and associated coefficient of variation, based on analysis of pre-dose PK samples. The analysis was performed on the Cohort 2 All Treated population, defined as Cohort 2 participants who have taken at least 1 dose of any study product on Cohort 2.

End point type

Secondary

End point timeframe

Week 16 and Week 48

End point values	Cohort 2A: Oral CAB + Oral RPV and CAB LA + RPV LA
Number of subjects analysed	138
Units: Ratio
geometric mean (geometric coefficient of variation)
CAB Ratio	1.12 ( 50.9 )
RPV Ratio	1.68 ( 37.9 )

No statistical analyses for this end point

Adverse events

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Timeframe for reporting adverse events

Cohort 1: entry to final visit (Week 16, early discontinuation, long-term safety follow-up, or Cohort 2 entry). Cohort 2: entry to final visit (Week 96, early discontinuation, long-term safety follow-up, or safety extension visit).

Adverse event reporting additional description

According to the protocol, safety outcomes for Cohorts 1C and 1R are summarized regardless of dosing regimen. Adverse events are presented by cohort, not regimen, which is reported only for PK outcomes. Adverse events were not collected for enrolled parents/caregivers in Cohorts 1 or 2.

Assessment type

Systematic

Dictionary name

MedDRA

Dictionary version

28.0

Reporting group title

Cohort 1C: CAB

Reporting group description

Reporting group title

Cohort 1R: RPV

Reporting group description

Reporting group title

Cohort 2A: Oral CAB + Oral RPV and CAB LA + RPV LA

Reporting group description

Serious adverse events	Cohort 1C: CAB	Cohort 1R: RPV	Cohort 2A: Oral CAB + Oral RPV and CAB LA + RPV LA
Total subjects affected by serious adverse events
subjects affected / exposed	1 / 30 (3.33%)	0 / 25 (0.00%)	9 / 144 (6.25%)
number of deaths (all causes)	0	0	0
number of deaths resulting from adverse events	0	0	0
Investigations
Aspartate aminotransferase increased
subjects affected / exposed	0 / 30 (0.00%)	0 / 25 (0.00%)	1 / 144 (0.69%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Blood creatine phosphokinase increased
subjects affected / exposed	0 / 30 (0.00%)	0 / 25 (0.00%)	1 / 144 (0.69%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Injury, poisoning and procedural complications
Radius fracture
subjects affected / exposed	0 / 30 (0.00%)	0 / 25 (0.00%)	1 / 144 (0.69%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Pregnancy, puerperium and perinatal conditions
Cephalo-pelvic disproportion
subjects affected / exposed	0 / 30 (0.00%)	0 / 25 (0.00%)	1 / 144 (0.69%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Prolonged labour
subjects affected / exposed	0 / 30 (0.00%)	0 / 25 (0.00%)	1 / 144 (0.69%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Umbilical cord around neck
subjects affected / exposed	0 / 30 (0.00%)	0 / 25 (0.00%)	1 / 144 (0.69%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Immune system disorders
Anaphylactic reaction
subjects affected / exposed	0 / 30 (0.00%)	0 / 25 (0.00%)	1 / 144 (0.69%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Eye disorders
Cataract
subjects affected / exposed	0 / 30 (0.00%)	0 / 25 (0.00%)	1 / 144 (0.69%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Gastrointestinal disorders
Gastritis alcoholic haemorrhagic
subjects affected / exposed	1 / 30 (3.33%)	0 / 25 (0.00%)	1 / 144 (0.69%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Musculoskeletal and connective tissue disorders
Rhabdomyolysis
subjects affected / exposed	0 / 30 (0.00%)	0 / 25 (0.00%)	1 / 144 (0.69%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Infections and infestations
Dengue fever
subjects affected / exposed	0 / 30 (0.00%)	0 / 25 (0.00%)	1 / 144 (0.69%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Malaria
subjects affected / exposed	0 / 30 (0.00%)	0 / 25 (0.00%)	2 / 144 (1.39%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Respiratory tract infection
subjects affected / exposed	0 / 30 (0.00%)	0 / 25 (0.00%)	1 / 144 (0.69%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Typhoid fever
subjects affected / exposed	0 / 30 (0.00%)	0 / 25 (0.00%)	1 / 144 (0.69%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0

Frequency threshold for reporting non-serious adverse events: 0%

Non-serious adverse events	Cohort 1C: CAB	Cohort 1R: RPV	Cohort 2A: Oral CAB + Oral RPV and CAB LA + RPV LA
Total subjects affected by non serious adverse events
subjects affected / exposed	28 / 30 (93.33%)	23 / 25 (92.00%)	136 / 144 (94.44%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Fibroadenoma of breast
subjects affected / exposed	0 / 30 (0.00%)	0 / 25 (0.00%)	2 / 144 (1.39%)
occurrences all number	0	0	2
Pyogenic granuloma
subjects affected / exposed	0 / 30 (0.00%)	0 / 25 (0.00%)	1 / 144 (0.69%)
occurrences all number	0	0	1
Vascular disorders
Hot flush
subjects affected / exposed	0 / 30 (0.00%)	0 / 25 (0.00%)	1 / 144 (0.69%)
occurrences all number	0	0	1
Hypertension
subjects affected / exposed	6 / 30 (20.00%)	0 / 25 (0.00%)	6 / 144 (4.17%)
occurrences all number	6	0	6
Hypotension
subjects affected / exposed	0 / 30 (0.00%)	0 / 25 (0.00%)	2 / 144 (1.39%)
occurrences all number	0	0	2
Pallor
subjects affected / exposed	0 / 30 (0.00%)	0 / 25 (0.00%)	1 / 144 (0.69%)
occurrences all number	0	0	1
Systolic hypertension
subjects affected / exposed	0 / 30 (0.00%)	0 / 25 (0.00%)	1 / 144 (0.69%)
occurrences all number	0	0	1
General disorders and administration site conditions
Asthenia
subjects affected / exposed	0 / 30 (0.00%)	1 / 25 (4.00%)	6 / 144 (4.17%)
occurrences all number	0	1	6
Chest discomfort
subjects affected / exposed	2 / 30 (6.67%)	2 / 25 (8.00%)	4 / 144 (2.78%)
occurrences all number	2	2	4
Chills
subjects affected / exposed	1 / 30 (3.33%)	0 / 25 (0.00%)	6 / 144 (4.17%)
occurrences all number	1	0	6
Complication of device insertion
subjects affected / exposed	0 / 30 (0.00%)	0 / 25 (0.00%)	1 / 144 (0.69%)
occurrences all number	0	0	1
Fatigue
subjects affected / exposed	1 / 30 (3.33%)	0 / 25 (0.00%)	8 / 144 (5.56%)
occurrences all number	1	0	8
Immediate post-injection reaction
subjects affected / exposed	0 / 30 (0.00%)	0 / 25 (0.00%)	1 / 144 (0.69%)
occurrences all number	0	0	1
Influenza like illness
subjects affected / exposed	0 / 30 (0.00%)	0 / 25 (0.00%)	1 / 144 (0.69%)
occurrences all number	0	0	1
Injection site bruising
subjects affected / exposed	0 / 30 (0.00%)	0 / 25 (0.00%)	1 / 144 (0.69%)
occurrences all number	0	0	1
Injection site erythema
subjects affected / exposed	0 / 30 (0.00%)	0 / 25 (0.00%)	1 / 144 (0.69%)
occurrences all number	0	0	1
Injection site hypoaesthesia
subjects affected / exposed	0 / 30 (0.00%)	1 / 25 (4.00%)	1 / 144 (0.69%)
occurrences all number	0	1	1
Injection site induration
subjects affected / exposed	0 / 30 (0.00%)	0 / 25 (0.00%)	3 / 144 (2.08%)
occurrences all number	0	0	3
Injection site joint pain
subjects affected / exposed	0 / 30 (0.00%)	0 / 25 (0.00%)	1 / 144 (0.69%)
occurrences all number	0	0	1
Injection site nodule
subjects affected / exposed	0 / 30 (0.00%)	1 / 25 (4.00%)	6 / 144 (4.17%)
occurrences all number	0	1	6
Injection site pain
subjects affected / exposed	9 / 30 (30.00%)	9 / 25 (36.00%)	57 / 144 (39.58%)
occurrences all number	9	9	57
Injection site pruritus
subjects affected / exposed	0 / 30 (0.00%)	0 / 25 (0.00%)	2 / 144 (1.39%)
occurrences all number	0	0	2
Injection site swelling
subjects affected / exposed	1 / 30 (3.33%)	1 / 25 (4.00%)	8 / 144 (5.56%)
occurrences all number	1	1	8
Malaise
subjects affected / exposed	0 / 30 (0.00%)	0 / 25 (0.00%)	3 / 144 (2.08%)
occurrences all number	0	0	3
Medical device pain
subjects affected / exposed	0 / 30 (0.00%)	0 / 25 (0.00%)	1 / 144 (0.69%)
occurrences all number	0	0	1
Mucosal discolouration
subjects affected / exposed	0 / 30 (0.00%)	0 / 25 (0.00%)	1 / 144 (0.69%)
occurrences all number	0	0	1
Mucosal disorder
subjects affected / exposed	0 / 30 (0.00%)	1 / 25 (4.00%)	1 / 144 (0.69%)
occurrences all number	0	1	1
Mucosal hyperaemia
subjects affected / exposed	0 / 30 (0.00%)	1 / 25 (4.00%)	0 / 144 (0.00%)
occurrences all number	0	1	0
Nodule
subjects affected / exposed	0 / 30 (0.00%)	0 / 25 (0.00%)	1 / 144 (0.69%)
occurrences all number	0	0	1
Non-cardiac chest pain
subjects affected / exposed	1 / 30 (3.33%)	0 / 25 (0.00%)	10 / 144 (6.94%)
occurrences all number	1	0	10
Pain
subjects affected / exposed	1 / 30 (3.33%)	0 / 25 (0.00%)	4 / 144 (2.78%)
occurrences all number	1	0	4
Peripheral swelling
subjects affected / exposed	0 / 30 (0.00%)	0 / 25 (0.00%)	1 / 144 (0.69%)
occurrences all number	0	0	1
Pyrexia
subjects affected / exposed	2 / 30 (6.67%)	1 / 25 (4.00%)	26 / 144 (18.06%)
occurrences all number	2	1	26
Suprapubic pain
subjects affected / exposed	0 / 30 (0.00%)	0 / 25 (0.00%)	1 / 144 (0.69%)
occurrences all number	0	0	1
Swelling face
subjects affected / exposed	0 / 30 (0.00%)	1 / 25 (4.00%)	1 / 144 (0.69%)
occurrences all number	0	1	1
Vaccination site pain
subjects affected / exposed	1 / 30 (3.33%)	0 / 25 (0.00%)	1 / 144 (0.69%)
occurrences all number	1	0	1
Vessel puncture site pain
subjects affected / exposed	0 / 30 (0.00%)	0 / 25 (0.00%)	1 / 144 (0.69%)
occurrences all number	0	0	1
Immune system disorders
Food allergy
subjects affected / exposed	0 / 30 (0.00%)	0 / 25 (0.00%)	1 / 144 (0.69%)
occurrences all number	0	0	1
Hypersensitivity
subjects affected / exposed	0 / 30 (0.00%)	2 / 25 (8.00%)	2 / 144 (1.39%)
occurrences all number	0	2	2
Seasonal allergy
subjects affected / exposed	0 / 30 (0.00%)	2 / 25 (8.00%)	1 / 144 (0.69%)
occurrences all number	0	2	1
Social circumstances
Physical assault
subjects affected / exposed	0 / 30 (0.00%)	0 / 25 (0.00%)	1 / 144 (0.69%)
occurrences all number	0	0	1
Sexual abuse
subjects affected / exposed	0 / 30 (0.00%)	1 / 25 (4.00%)	1 / 144 (0.69%)
occurrences all number	0	1	1
Substance use
subjects affected / exposed	0 / 30 (0.00%)	0 / 25 (0.00%)	1 / 144 (0.69%)
occurrences all number	0	0	1
Reproductive system and breast disorders
Abnormal uterine bleeding
subjects affected / exposed	0 / 30 (0.00%)	0 / 25 (0.00%)	3 / 144 (2.08%)
occurrences all number	0	0	3
Adnexa uteri mass
subjects affected / exposed	0 / 30 (0.00%)	0 / 25 (0.00%)	1 / 144 (0.69%)
occurrences all number	0	0	1
Amenorrhoea
subjects affected / exposed	0 / 30 (0.00%)	0 / 25 (0.00%)	1 / 144 (0.69%)
occurrences all number	0	0	1
Breast discharge
subjects affected / exposed	0 / 30 (0.00%)	0 / 25 (0.00%)	1 / 144 (0.69%)
occurrences all number	0	0	1
Breast mass
subjects affected / exposed	0 / 30 (0.00%)	0 / 25 (0.00%)	1 / 144 (0.69%)
occurrences all number	0	0	1
Breast pain
subjects affected / exposed	0 / 30 (0.00%)	0 / 25 (0.00%)	1 / 144 (0.69%)
occurrences all number	0	0	1
Breast swelling
subjects affected / exposed	0 / 30 (0.00%)	0 / 25 (0.00%)	1 / 144 (0.69%)
occurrences all number	0	0	1
Breast tenderness
subjects affected / exposed	0 / 30 (0.00%)	0 / 25 (0.00%)	1 / 144 (0.69%)
occurrences all number	0	0	1
Dysmenorrhoea
subjects affected / exposed	1 / 30 (3.33%)	2 / 25 (8.00%)	5 / 144 (3.47%)
occurrences all number	1	2	5
Heavy menstrual bleeding
subjects affected / exposed	1 / 30 (3.33%)	0 / 25 (0.00%)	2 / 144 (1.39%)
occurrences all number	1	0	2
Menstruation irregular
subjects affected / exposed	0 / 30 (0.00%)	2 / 25 (8.00%)	1 / 144 (0.69%)
occurrences all number	0	2	1
Ovarian cyst
subjects affected / exposed	0 / 30 (0.00%)	0 / 25 (0.00%)	1 / 144 (0.69%)
occurrences all number	0	0	1
Penile pain
subjects affected / exposed	0 / 30 (0.00%)	0 / 25 (0.00%)	1 / 144 (0.69%)
occurrences all number	0	0	1
Perineal pain
subjects affected / exposed	1 / 30 (3.33%)	0 / 25 (0.00%)	0 / 144 (0.00%)
occurrences all number	1	0	0
Vaginal discharge
subjects affected / exposed	0 / 30 (0.00%)	0 / 25 (0.00%)	1 / 144 (0.69%)
occurrences all number	0	0	1
Vaginal haemorrhage
subjects affected / exposed	0 / 30 (0.00%)	0 / 25 (0.00%)	3 / 144 (2.08%)
occurrences all number	0	0	3
Respiratory, thoracic and mediastinal disorders
Cough
subjects affected / exposed	9 / 30 (30.00%)	6 / 25 (24.00%)	52 / 144 (36.11%)
occurrences all number	9	6	52
Dry throat
subjects affected / exposed	0 / 30 (0.00%)	1 / 25 (4.00%)	1 / 144 (0.69%)
occurrences all number	0	1	1
Dysphonia
subjects affected / exposed	0 / 30 (0.00%)	0 / 25 (0.00%)	2 / 144 (1.39%)
occurrences all number	0	0	2
Dyspnoea
subjects affected / exposed	0 / 30 (0.00%)	2 / 25 (8.00%)	5 / 144 (3.47%)
occurrences all number	0	2	5
Epistaxis
subjects affected / exposed	1 / 30 (3.33%)	0 / 25 (0.00%)	2 / 144 (1.39%)
occurrences all number	1	0	2
Increased upper airway secretion
subjects affected / exposed	0 / 30 (0.00%)	0 / 25 (0.00%)	1 / 144 (0.69%)
occurrences all number	0	0	1
Lung hypoinflation
subjects affected / exposed	0 / 30 (0.00%)	1 / 25 (4.00%)	1 / 144 (0.69%)
occurrences all number	0	1	1
Nasal congestion
subjects affected / exposed	4 / 30 (13.33%)	5 / 25 (20.00%)	28 / 144 (19.44%)
occurrences all number	4	5	28
Nasal inflammation
subjects affected / exposed	0 / 30 (0.00%)	1 / 25 (4.00%)	1 / 144 (0.69%)
occurrences all number	0	1	1
Nasal mucosal discolouration
subjects affected / exposed	1 / 30 (3.33%)	3 / 25 (12.00%)	2 / 144 (1.39%)
occurrences all number	1	3	2
Nasal mucosal disorder
subjects affected / exposed	1 / 30 (3.33%)	4 / 25 (16.00%)	2 / 144 (1.39%)
occurrences all number	1	4	2
Nasal mucosal hypertrophy
subjects affected / exposed	0 / 30 (0.00%)	1 / 25 (4.00%)	1 / 144 (0.69%)
occurrences all number	0	1	1
Nasal pruritus
subjects affected / exposed	0 / 30 (0.00%)	0 / 25 (0.00%)	1 / 144 (0.69%)
occurrences all number	0	0	1
Oropharyngeal discomfort
subjects affected / exposed	0 / 30 (0.00%)	0 / 25 (0.00%)	1 / 144 (0.69%)
occurrences all number	0	0	1
Oropharyngeal pain
subjects affected / exposed	6 / 30 (20.00%)	5 / 25 (20.00%)	29 / 144 (20.14%)
occurrences all number	6	5	29
Pharyngeal erythema
subjects affected / exposed	0 / 30 (0.00%)	2 / 25 (8.00%)	3 / 144 (2.08%)
occurrences all number	0	2	3
Productive cough
subjects affected / exposed	1 / 30 (3.33%)	0 / 25 (0.00%)	14 / 144 (9.72%)
occurrences all number	1	0	14
Rhinitis allergic
subjects affected / exposed	0 / 30 (0.00%)	0 / 25 (0.00%)	4 / 144 (2.78%)
occurrences all number	0	0	4
Rhinorrhoea
subjects affected / exposed	2 / 30 (6.67%)	5 / 25 (20.00%)	26 / 144 (18.06%)
occurrences all number	2	5	26
Sinus congestion
subjects affected / exposed	0 / 30 (0.00%)	0 / 25 (0.00%)	1 / 144 (0.69%)
occurrences all number	0	0	1
Sinus pain
subjects affected / exposed	0 / 30 (0.00%)	1 / 25 (4.00%)	1 / 144 (0.69%)
occurrences all number	0	1	1
Sneezing
subjects affected / exposed	1 / 30 (3.33%)	2 / 25 (8.00%)	6 / 144 (4.17%)
occurrences all number	1	2	6
Snoring
subjects affected / exposed	0 / 30 (0.00%)	1 / 25 (4.00%)	1 / 144 (0.69%)
occurrences all number	0	1	1
Throat irritation
subjects affected / exposed	1 / 30 (3.33%)	3 / 25 (12.00%)	3 / 144 (2.08%)
occurrences all number	1	3	3
Tonsillar erythema
subjects affected / exposed	0 / 30 (0.00%)	0 / 25 (0.00%)	3 / 144 (2.08%)
occurrences all number	0	0	3
Tonsillar hypertrophy
subjects affected / exposed	0 / 30 (0.00%)	0 / 25 (0.00%)	2 / 144 (1.39%)
occurrences all number	0	0	2
Tonsillar inflammation
subjects affected / exposed	0 / 30 (0.00%)	1 / 25 (4.00%)	1 / 144 (0.69%)
occurrences all number	0	1	1
Upper-airway cough syndrome
subjects affected / exposed	0 / 30 (0.00%)	0 / 25 (0.00%)	1 / 144 (0.69%)
occurrences all number	0	0	1
Wheezing
subjects affected / exposed	0 / 30 (0.00%)	1 / 25 (4.00%)	3 / 144 (2.08%)
occurrences all number	0	1	3
Psychiatric disorders
Agitation
subjects affected / exposed	0 / 30 (0.00%)	0 / 25 (0.00%)	1 / 144 (0.69%)
occurrences all number	0	0	1
Anxiety
subjects affected / exposed	1 / 30 (3.33%)	0 / 25 (0.00%)	2 / 144 (1.39%)
occurrences all number	1	0	2
Attention deficit hyperactivity disorder
subjects affected / exposed	0 / 30 (0.00%)	0 / 25 (0.00%)	1 / 144 (0.69%)
occurrences all number	0	0	1
Depression
subjects affected / exposed	1 / 30 (3.33%)	0 / 25 (0.00%)	1 / 144 (0.69%)
occurrences all number	1	0	1
Insomnia
subjects affected / exposed	2 / 30 (6.67%)	2 / 25 (8.00%)	4 / 144 (2.78%)
occurrences all number	2	2	4
Major depression
subjects affected / exposed	0 / 30 (0.00%)	0 / 25 (0.00%)	1 / 144 (0.69%)
occurrences all number	0	0	1
Post-traumatic stress disorder
subjects affected / exposed	1 / 30 (3.33%)	0 / 25 (0.00%)	1 / 144 (0.69%)
occurrences all number	1	0	1
Stress
subjects affected / exposed	1 / 30 (3.33%)	0 / 25 (0.00%)	0 / 144 (0.00%)
occurrences all number	1	0	0
Investigations
Alanine aminotransferase increased
subjects affected / exposed	0 / 30 (0.00%)	0 / 25 (0.00%)	4 / 144 (2.78%)
occurrences all number	0	0	4
Aspartate aminotransferase increased
subjects affected / exposed	0 / 30 (0.00%)	0 / 25 (0.00%)	2 / 144 (1.39%)
occurrences all number	0	0	2
Blood bilirubin increased
subjects affected / exposed	1 / 30 (3.33%)	0 / 25 (0.00%)	1 / 144 (0.69%)
occurrences all number	1	0	1
Blood creatine phosphokinase increased
subjects affected / exposed	1 / 30 (3.33%)	3 / 25 (12.00%)	19 / 144 (13.19%)
occurrences all number	1	3	19
Blood creatinine increased
subjects affected / exposed	1 / 30 (3.33%)	0 / 25 (0.00%)	2 / 144 (1.39%)
occurrences all number	1	0	2
Blood glucose increased
subjects affected / exposed	0 / 30 (0.00%)	0 / 25 (0.00%)	1 / 144 (0.69%)
occurrences all number	0	0	1
Blood pressure diastolic increased
subjects affected / exposed	1 / 30 (3.33%)	0 / 25 (0.00%)	3 / 144 (2.08%)
occurrences all number	1	0	3
Blood pressure increased
subjects affected / exposed	6 / 30 (20.00%)	0 / 25 (0.00%)	23 / 144 (15.97%)
occurrences all number	6	0	23
Blood pressure systolic increased
subjects affected / exposed	1 / 30 (3.33%)	0 / 25 (0.00%)	15 / 144 (10.42%)
occurrences all number	1	0	15
Breath sounds abnormal
subjects affected / exposed	0 / 30 (0.00%)	0 / 25 (0.00%)	1 / 144 (0.69%)
occurrences all number	0	0	1
Creatinine renal clearance decreased
subjects affected / exposed	2 / 30 (6.67%)	1 / 25 (4.00%)	7 / 144 (4.86%)
occurrences all number	2	1	7
Electrocardiogram PR prolongation
subjects affected / exposed	1 / 30 (3.33%)	0 / 25 (0.00%)	1 / 144 (0.69%)
occurrences all number	1	0	1
Glomerular filtration rate decreased
subjects affected / exposed	0 / 30 (0.00%)	0 / 25 (0.00%)	2 / 144 (1.39%)
occurrences all number	0	0	2
Haemoglobin decreased
subjects affected / exposed	2 / 30 (6.67%)	0 / 25 (0.00%)	9 / 144 (6.25%)
occurrences all number	2	0	9
Lipase increased
subjects affected / exposed	0 / 30 (0.00%)	1 / 25 (4.00%)	0 / 144 (0.00%)
occurrences all number	0	1	0
Low density lipoprotein increased
subjects affected / exposed	0 / 30 (0.00%)	0 / 25 (0.00%)	1 / 144 (0.69%)
occurrences all number	0	0	1
Neutrophil count decreased
subjects affected / exposed	0 / 30 (0.00%)	2 / 25 (8.00%)	5 / 144 (3.47%)
occurrences all number	0	2	5
Platelet count decreased
subjects affected / exposed	0 / 30 (0.00%)	0 / 25 (0.00%)	1 / 144 (0.69%)
occurrences all number	0	0	1
SARS-CoV-2 test positive
subjects affected / exposed	0 / 30 (0.00%)	0 / 25 (0.00%)	1 / 144 (0.69%)
occurrences all number	0	0	1
Weight decreased
subjects affected / exposed	0 / 30 (0.00%)	0 / 25 (0.00%)	5 / 144 (3.47%)
occurrences all number	0	0	5
Weight increased
subjects affected / exposed	0 / 30 (0.00%)	1 / 25 (4.00%)	1 / 144 (0.69%)
occurrences all number	0	1	1
Injury, poisoning and procedural complications
Adverse event following immunisation
subjects affected / exposed	1 / 30 (3.33%)	0 / 25 (0.00%)	1 / 144 (0.69%)
occurrences all number	1	0	1
Animal bite
subjects affected / exposed	0 / 30 (0.00%)	0 / 25 (0.00%)	1 / 144 (0.69%)
occurrences all number	0	0	1
Arthropod bite
subjects affected / exposed	0 / 30 (0.00%)	0 / 25 (0.00%)	1 / 144 (0.69%)
occurrences all number	0	0	1
Contusion
subjects affected / exposed	0 / 30 (0.00%)	0 / 25 (0.00%)	1 / 144 (0.69%)
occurrences all number	0	0	1
Incision site pain
subjects affected / exposed	0 / 30 (0.00%)	0 / 25 (0.00%)	1 / 144 (0.69%)
occurrences all number	0	0	1
Injection related reaction
subjects affected / exposed	0 / 30 (0.00%)	0 / 25 (0.00%)	3 / 144 (2.08%)
occurrences all number	0	0	3
Limb injury
subjects affected / exposed	0 / 30 (0.00%)	1 / 25 (4.00%)	2 / 144 (1.39%)
occurrences all number	0	1	2
Perineal injury
subjects affected / exposed	1 / 30 (3.33%)	0 / 25 (0.00%)	0 / 144 (0.00%)
occurrences all number	1	0	0
Post procedural inflammation
subjects affected / exposed	0 / 30 (0.00%)	1 / 25 (4.00%)	1 / 144 (0.69%)
occurrences all number	0	1	1
Postoperative wound complication
subjects affected / exposed	0 / 30 (0.00%)	1 / 25 (4.00%)	1 / 144 (0.69%)
occurrences all number	0	1	1
Procedural pain
subjects affected / exposed	0 / 30 (0.00%)	2 / 25 (8.00%)	4 / 144 (2.78%)
occurrences all number	0	2	4
Product administration error
subjects affected / exposed	0 / 30 (0.00%)	0 / 25 (0.00%)	2 / 144 (1.39%)
occurrences all number	0	0	2
Scar
subjects affected / exposed	1 / 30 (3.33%)	0 / 25 (0.00%)	1 / 144 (0.69%)
occurrences all number	1	0	1
Skin abrasion
subjects affected / exposed	0 / 30 (0.00%)	0 / 25 (0.00%)	2 / 144 (1.39%)
occurrences all number	0	0	2
Skin laceration
subjects affected / exposed	0 / 30 (0.00%)	1 / 25 (4.00%)	4 / 144 (2.78%)
occurrences all number	0	1	4
Stab wound
subjects affected / exposed	0 / 30 (0.00%)	0 / 25 (0.00%)	1 / 144 (0.69%)
occurrences all number	0	0	1
Thermal burn
subjects affected / exposed	1 / 30 (3.33%)	0 / 25 (0.00%)	2 / 144 (1.39%)
occurrences all number	1	0	2
Traumatic pain
subjects affected / exposed	0 / 30 (0.00%)	0 / 25 (0.00%)	2 / 144 (1.39%)
occurrences all number	0	0	2
Upper limb fracture
subjects affected / exposed	0 / 30 (0.00%)	0 / 25 (0.00%)	1 / 144 (0.69%)
occurrences all number	0	0	1
Wound
subjects affected / exposed	1 / 30 (3.33%)	0 / 25 (0.00%)	1 / 144 (0.69%)
occurrences all number	1	0	1
Wound complication
subjects affected / exposed	0 / 30 (0.00%)	0 / 25 (0.00%)	1 / 144 (0.69%)
occurrences all number	0	0	1
Wound secretion
subjects affected / exposed	0 / 30 (0.00%)	0 / 25 (0.00%)	1 / 144 (0.69%)
occurrences all number	0	0	1
Congenital, familial and genetic disorders
Sickle cell trait
subjects affected / exposed	0 / 30 (0.00%)	1 / 25 (4.00%)	1 / 144 (0.69%)
occurrences all number	0	1	1
Cardiac disorders
Bradycardia
subjects affected / exposed	2 / 30 (6.67%)	0 / 25 (0.00%)	3 / 144 (2.08%)
occurrences all number	2	0	3
Palpitations
subjects affected / exposed	0 / 30 (0.00%)	0 / 25 (0.00%)	1 / 144 (0.69%)
occurrences all number	0	0	1
Sinus bradycardia
subjects affected / exposed	1 / 30 (3.33%)	0 / 25 (0.00%)	2 / 144 (1.39%)
occurrences all number	1	0	2
Tachycardia
subjects affected / exposed	0 / 30 (0.00%)	1 / 25 (4.00%)	7 / 144 (4.86%)
occurrences all number	0	1	7
Nervous system disorders
Delayed sleep phase
subjects affected / exposed	0 / 30 (0.00%)	1 / 25 (4.00%)	1 / 144 (0.69%)
occurrences all number	0	1	1
Dizziness
subjects affected / exposed	1 / 30 (3.33%)	3 / 25 (12.00%)	10 / 144 (6.94%)
occurrences all number	1	3	10
Dysgeusia
subjects affected / exposed	0 / 30 (0.00%)	0 / 25 (0.00%)	1 / 144 (0.69%)
occurrences all number	0	0	1
Headache
subjects affected / exposed	3 / 30 (10.00%)	8 / 25 (32.00%)	42 / 144 (29.17%)
occurrences all number	3	8	42
Migraine
subjects affected / exposed	0 / 30 (0.00%)	0 / 25 (0.00%)	1 / 144 (0.69%)
occurrences all number	0	0	1
Presyncope
subjects affected / exposed	0 / 30 (0.00%)	0 / 25 (0.00%)	2 / 144 (1.39%)
occurrences all number	0	0	2
Restless legs syndrome
subjects affected / exposed	0 / 30 (0.00%)	1 / 25 (4.00%)	1 / 144 (0.69%)
occurrences all number	0	1	1
Sciatica
subjects affected / exposed	0 / 30 (0.00%)	0 / 25 (0.00%)	1 / 144 (0.69%)
occurrences all number	0	0	1
Seizure
subjects affected / exposed	0 / 30 (0.00%)	0 / 25 (0.00%)	1 / 144 (0.69%)
occurrences all number	0	0	1
Sleep paralysis
subjects affected / exposed	1 / 30 (3.33%)	0 / 25 (0.00%)	0 / 144 (0.00%)
occurrences all number	1	0	0
Somnolence
subjects affected / exposed	0 / 30 (0.00%)	1 / 25 (4.00%)	2 / 144 (1.39%)
occurrences all number	0	1	2
Speech disorder
subjects affected / exposed	0 / 30 (0.00%)	0 / 25 (0.00%)	1 / 144 (0.69%)
occurrences all number	0	0	1
Syncope
subjects affected / exposed	0 / 30 (0.00%)	1 / 25 (4.00%)	2 / 144 (1.39%)
occurrences all number	0	1	2
Blood and lymphatic system disorders
Anaemia
subjects affected / exposed	2 / 30 (6.67%)	0 / 25 (0.00%)	2 / 144 (1.39%)
occurrences all number	2	0	2
Iron deficiency anaemia
subjects affected / exposed	2 / 30 (6.67%)	0 / 25 (0.00%)	8 / 144 (5.56%)
occurrences all number	0	0	8
Lymphadenopathy
subjects affected / exposed	0 / 30 (0.00%)	2 / 25 (8.00%)	5 / 144 (3.47%)
occurrences all number	0	2	5
Microcytic anaemia
subjects affected / exposed	0 / 30 (0.00%)	0 / 25 (0.00%)	2 / 144 (1.39%)
occurrences all number	0	0	2
Neutropenia
subjects affected / exposed	1 / 30 (3.33%)	0 / 25 (0.00%)	2 / 144 (1.39%)
occurrences all number	0	0	2
Normocytic anaemia
subjects affected / exposed	0 / 30 (0.00%)	0 / 25 (0.00%)	2 / 144 (1.39%)
occurrences all number	0	0	2
Thrombocytopenia
subjects affected / exposed	0 / 30 (0.00%)	0 / 25 (0.00%)	1 / 144 (0.69%)
occurrences all number	0	0	1
Ear and labyrinth disorders
Ear canal erythema
subjects affected / exposed	1 / 30 (3.33%)	1 / 25 (4.00%)	1 / 144 (0.69%)
occurrences all number	1	1	1
Ear discomfort
subjects affected / exposed	0 / 30 (0.00%)	0 / 25 (0.00%)	1 / 144 (0.69%)
occurrences all number	0	0	1
Ear pain
subjects affected / exposed	1 / 30 (3.33%)	0 / 25 (0.00%)	2 / 144 (1.39%)
occurrences all number	1	0	2
Ear pruritus
subjects affected / exposed	0 / 30 (0.00%)	2 / 25 (8.00%)	1 / 144 (0.69%)
occurrences all number	0	0	1
Middle ear effusion
subjects affected / exposed	0 / 30 (0.00%)	2 / 25 (8.00%)	1 / 144 (0.69%)
occurrences all number	0	2	1
Motion sickness
subjects affected / exposed	0 / 30 (0.00%)	0 / 25 (0.00%)	1 / 144 (0.69%)
occurrences all number	0	0	1
Noninfective myringitis
subjects affected / exposed	0 / 30 (0.00%)	0 / 25 (0.00%)	1 / 144 (0.69%)
occurrences all number	0	0	1
Otorrhoea
subjects affected / exposed	0 / 30 (0.00%)	1 / 25 (4.00%)	2 / 144 (1.39%)
occurrences all number	0	1	2
Tympanic membrane disorder
subjects affected / exposed	0 / 30 (0.00%)	0 / 25 (0.00%)	1 / 144 (0.69%)
occurrences all number	0	0	1
Vertigo positional
subjects affected / exposed	0 / 30 (0.00%)	0 / 25 (0.00%)	1 / 144 (0.69%)
occurrences all number	0	0	1
Eye disorders
Conjunctival pallor
subjects affected / exposed	1 / 30 (3.33%)	0 / 25 (0.00%)	4 / 144 (2.78%)
occurrences all number	1	0	4
Conjunctivitis allergic
subjects affected / exposed	0 / 30 (0.00%)	0 / 25 (0.00%)	2 / 144 (1.39%)
occurrences all number	0	0	1
Dry eye
subjects affected / exposed	0 / 30 (0.00%)	0 / 25 (0.00%)	1 / 144 (0.69%)
occurrences all number	0	0	1
Eye discharge
subjects affected / exposed	0 / 30 (0.00%)	0 / 25 (0.00%)	1 / 144 (0.69%)
occurrences all number	0	0	1
Eye pain
subjects affected / exposed	0 / 30 (0.00%)	1 / 25 (4.00%)	0 / 144 (0.00%)
occurrences all number	0	1	0
Eye pruritus
subjects affected / exposed	0 / 30 (0.00%)	1 / 25 (4.00%)	4 / 144 (2.78%)
occurrences all number	0	1	4
Eyelid oedema
subjects affected / exposed	0 / 30 (0.00%)	0 / 25 (0.00%)	1 / 144 (0.69%)
occurrences all number	0	0	1
Lacrimation increased
subjects affected / exposed	0 / 30 (0.00%)	1 / 25 (4.00%)	4 / 144 (2.78%)
occurrences all number	0	1	4
Ocular discomfort
subjects affected / exposed	0 / 30 (0.00%)	0 / 25 (0.00%)	1 / 144 (0.69%)
occurrences all number	0	0	1
Ocular hyperaemia
subjects affected / exposed	0 / 30 (0.00%)	0 / 25 (0.00%)	1 / 144 (0.69%)
occurrences all number	0	0	1
Photophobia
subjects affected / exposed	0 / 30 (0.00%)	0 / 25 (0.00%)	2 / 144 (1.39%)
occurrences all number	0	0	2
Visual impairment
subjects affected / exposed	0 / 30 (0.00%)	0 / 25 (0.00%)	2 / 144 (1.39%)
occurrences all number	0	0	2
Gastrointestinal disorders
Abdominal discomfort
subjects affected / exposed	0 / 30 (0.00%)	2 / 25 (8.00%)	0 / 144 (0.00%)
occurrences all number	0	2	0
Abdominal pain
subjects affected / exposed	0 / 30 (0.00%)	2 / 25 (8.00%)	9 / 144 (6.25%)
occurrences all number	0	2	9
Abdominal pain lower
subjects affected / exposed	0 / 30 (0.00%)	1 / 25 (4.00%)	2 / 144 (1.39%)
occurrences all number	0	1	2
Abdominal pain upper
subjects affected / exposed	1 / 30 (3.33%)	2 / 25 (8.00%)	6 / 144 (4.17%)
occurrences all number	1	2	6
Abdominal tenderness
subjects affected / exposed	0 / 30 (0.00%)	0 / 25 (0.00%)	1 / 144 (0.69%)
occurrences all number	0	0	1
Aphthous ulcer
subjects affected / exposed	0 / 30 (0.00%)	1 / 25 (4.00%)	2 / 144 (1.39%)
occurrences all number	0	1	2
Breath odour
subjects affected / exposed	0 / 30 (0.00%)	1 / 25 (4.00%)	1 / 144 (0.69%)
occurrences all number	0	1	1
Constipation
subjects affected / exposed	0 / 30 (0.00%)	3 / 25 (12.00%)	4 / 144 (2.78%)
occurrences all number	0	3	4
Dental caries
subjects affected / exposed	0 / 30 (0.00%)	0 / 25 (0.00%)	1 / 144 (0.69%)
occurrences all number	0	0	1
Diarrhoea
subjects affected / exposed	2 / 30 (6.67%)	3 / 25 (12.00%)	9 / 144 (6.25%)
occurrences all number	2	3	9
Duodenal ulcer
subjects affected / exposed	0 / 30 (0.00%)	0 / 25 (0.00%)	1 / 144 (0.69%)
occurrences all number	0	0	1
Dyspepsia
subjects affected / exposed	1 / 30 (3.33%)	2 / 25 (8.00%)	2 / 144 (1.39%)
occurrences all number	1	2	2
Enlarged uvula
subjects affected / exposed	1 / 30 (3.33%)	0 / 25 (0.00%)	1 / 144 (0.69%)
occurrences all number	1	0	1
Flatulence
subjects affected / exposed	0 / 30 (0.00%)	0 / 25 (0.00%)	2 / 144 (1.39%)
occurrences all number	0	0	2
Gastrooesophageal reflux disease
subjects affected / exposed	0 / 30 (0.00%)	0 / 25 (0.00%)	3 / 144 (2.08%)
occurrences all number	0	0	3
Gingival pain
subjects affected / exposed	0 / 30 (0.00%)	0 / 25 (0.00%)	1 / 144 (0.69%)
occurrences all number	0	0	1
Hypoaesthesia oral
subjects affected / exposed	0 / 30 (0.00%)	0 / 25 (0.00%)	1 / 144 (0.69%)
occurrences all number	0	0	1
Lip dry
subjects affected / exposed	0 / 30 (0.00%)	0 / 25 (0.00%)	1 / 144 (0.69%)
occurrences all number	0	0	1
Malpositioned teeth
subjects affected / exposed	0 / 30 (0.00%)	0 / 25 (0.00%)	1 / 144 (0.69%)
occurrences all number	0	0	1
Melaena
subjects affected / exposed	1 / 30 (3.33%)	0 / 25 (0.00%)	1 / 144 (0.69%)
occurrences all number	1	0	1
Nausea
subjects affected / exposed	1 / 30 (3.33%)	5 / 25 (20.00%)	11 / 144 (7.64%)
occurrences all number	1	5	11
Oral mucosal erythema
subjects affected / exposed	1 / 30 (3.33%)	0 / 25 (0.00%)	1 / 144 (0.69%)
occurrences all number	1	0	1
Stomatitis
subjects affected / exposed	0 / 30 (0.00%)	0 / 25 (0.00%)	2 / 144 (1.39%)
occurrences all number	0	0	2
Tongue ulceration
subjects affected / exposed	0 / 30 (0.00%)	1 / 25 (4.00%)	2 / 144 (1.39%)
occurrences all number	0	1	2
Tooth impacted
subjects affected / exposed	0 / 30 (0.00%)	1 / 25 (4.00%)	1 / 144 (0.69%)
occurrences all number	0	1	1
Toothache
subjects affected / exposed	0 / 30 (0.00%)	1 / 25 (4.00%)	6 / 144 (4.17%)
occurrences all number	0	1	6
Vomiting
subjects affected / exposed	1 / 30 (3.33%)	4 / 25 (16.00%)	12 / 144 (8.33%)
occurrences all number	1	4	12
Hepatobiliary disorders
Hepatic steatosis
subjects affected / exposed	0 / 30 (0.00%)	0 / 25 (0.00%)	1 / 144 (0.69%)
occurrences all number	0	0	1
Ocular icterus
subjects affected / exposed	0 / 30 (0.00%)	1 / 25 (4.00%)	1 / 144 (0.69%)
occurrences all number	0	1	1
Skin and subcutaneous tissue disorders
Acne
subjects affected / exposed	0 / 30 (0.00%)	2 / 25 (8.00%)	4 / 144 (2.78%)
occurrences all number	0	2	4
Blister
subjects affected / exposed	0 / 30 (0.00%)	0 / 25 (0.00%)	1 / 144 (0.69%)
occurrences all number	0	0	1
Dermatitis
subjects affected / exposed	1 / 30 (3.33%)	0 / 25 (0.00%)	1 / 144 (0.69%)
occurrences all number	1	0	1
Dermatitis allergic
subjects affected / exposed	0 / 30 (0.00%)	0 / 25 (0.00%)	1 / 144 (0.69%)
occurrences all number	0	0	1
Dermatitis atopic
subjects affected / exposed	0 / 30 (0.00%)	0 / 25 (0.00%)	1 / 144 (0.69%)
occurrences all number	0	0	1
Dilated pores
subjects affected / exposed	1 / 30 (3.33%)	0 / 25 (0.00%)	0 / 144 (0.00%)
occurrences all number	1	0	0
Dry skin
subjects affected / exposed	0 / 30 (0.00%)	1 / 25 (4.00%)	3 / 144 (2.08%)
occurrences all number	0	1	3
Erythema
subjects affected / exposed	0 / 30 (0.00%)	1 / 25 (4.00%)	1 / 144 (0.69%)
occurrences all number	0	1	1
Hyperhidrosis
subjects affected / exposed	0 / 30 (0.00%)	0 / 25 (0.00%)	1 / 144 (0.69%)
occurrences all number	0	0	1
Ingrowing nail
subjects affected / exposed	0 / 30 (0.00%)	0 / 25 (0.00%)	1 / 144 (0.69%)
occurrences all number	0	0	1
Night sweats
subjects affected / exposed	0 / 30 (0.00%)	1 / 25 (4.00%)	1 / 144 (0.69%)
occurrences all number	0	1	1
Papule
subjects affected / exposed	0 / 30 (0.00%)	1 / 25 (4.00%)	6 / 144 (4.17%)
occurrences all number	0	1	6
Photosensitivity reaction
subjects affected / exposed	0 / 30 (0.00%)	0 / 25 (0.00%)	1 / 144 (0.69%)
occurrences all number	0	0	1
Pruritus
subjects affected / exposed	1 / 30 (3.33%)	1 / 25 (4.00%)	5 / 144 (3.47%)
occurrences all number	1	1	5
Psoriasis
subjects affected / exposed	0 / 30 (0.00%)	0 / 25 (0.00%)	1 / 144 (0.69%)
occurrences all number	0	0	1
Rash
subjects affected / exposed	2 / 30 (6.67%)	2 / 25 (8.00%)	7 / 144 (4.86%)
occurrences all number	2	2	7
Rash maculo-papular
subjects affected / exposed	0 / 30 (0.00%)	1 / 25 (4.00%)	3 / 144 (2.08%)
occurrences all number	0	1	3
Rash papular
subjects affected / exposed	0 / 30 (0.00%)	1 / 25 (4.00%)	3 / 144 (2.08%)
occurrences all number	0	1	3
Rash pruritic
subjects affected / exposed	1 / 30 (3.33%)	0 / 25 (0.00%)	4 / 144 (2.78%)
occurrences all number	1	0	4
Skin discolouration
subjects affected / exposed	0 / 30 (0.00%)	1 / 25 (4.00%)	1 / 144 (0.69%)
occurrences all number	0	1	1
Skin fissures
subjects affected / exposed	0 / 30 (0.00%)	0 / 25 (0.00%)	1 / 144 (0.69%)
occurrences all number	0	0	1
Skin hyperpigmentation
subjects affected / exposed	0 / 30 (0.00%)	1 / 25 (4.00%)	1 / 144 (0.69%)
occurrences all number	0	1	1
Skin ulcer
subjects affected / exposed	0 / 30 (0.00%)	0 / 25 (0.00%)	1 / 144 (0.69%)
occurrences all number	0	0	1
Urticaria
subjects affected / exposed	0 / 30 (0.00%)	1 / 25 (4.00%)	4 / 144 (2.78%)
occurrences all number	0	1	4
Renal and urinary disorders
Chronic kidney disease
subjects affected / exposed	0 / 30 (0.00%)	0 / 25 (0.00%)	1 / 144 (0.69%)
occurrences all number	0	0	1
Glycosuria
subjects affected / exposed	0 / 30 (0.00%)	0 / 25 (0.00%)	1 / 144 (0.69%)
occurrences all number	0	0	1
Proteinuria
subjects affected / exposed	0 / 30 (0.00%)	0 / 25 (0.00%)	1 / 144 (0.69%)
occurrences all number	0	0	1
Endocrine disorders
Autoimmune thyroiditis
subjects affected / exposed	0 / 30 (0.00%)	0 / 25 (0.00%)	1 / 144 (0.69%)
occurrences all number	0	0	1
Hypothyroidism
subjects affected / exposed	0 / 30 (0.00%)	0 / 25 (0.00%)	1 / 144 (0.69%)
occurrences all number	0	0	1
Musculoskeletal and connective tissue disorders
Arthralgia
subjects affected / exposed	0 / 30 (0.00%)	1 / 25 (4.00%)	6 / 144 (4.17%)
occurrences all number	0	1	6
Back pain
subjects affected / exposed	1 / 30 (3.33%)	3 / 25 (12.00%)	9 / 144 (6.25%)
occurrences all number	1	3	9
Coccydynia
subjects affected / exposed	0 / 30 (0.00%)	0 / 25 (0.00%)	1 / 144 (0.69%)
occurrences all number	0	0	1
Flank pain
subjects affected / exposed	0 / 30 (0.00%)	0 / 25 (0.00%)	2 / 144 (1.39%)
occurrences all number	0	0	2
Joint stiffness
subjects affected / exposed	0 / 30 (0.00%)	0 / 25 (0.00%)	1 / 144 (0.69%)
occurrences all number	0	0	1
Joint swelling
subjects affected / exposed	0 / 30 (0.00%)	0 / 25 (0.00%)	2 / 144 (1.39%)
occurrences all number	0	0	2
Muscle spasms
subjects affected / exposed	0 / 30 (0.00%)	0 / 25 (0.00%)	2 / 144 (1.39%)
occurrences all number	0	0	2
Myalgia
subjects affected / exposed	1 / 30 (3.33%)	2 / 25 (8.00%)	12 / 144 (8.33%)
occurrences all number	1	2	12
Neck pain
subjects affected / exposed	0 / 30 (0.00%)	0 / 25 (0.00%)	1 / 144 (0.69%)
occurrences all number	0	0	1
Pain in extremity
subjects affected / exposed	1 / 30 (3.33%)	3 / 25 (12.00%)	8 / 144 (5.56%)
occurrences all number	1	3	8
Pain in jaw
subjects affected / exposed	0 / 30 (0.00%)	0 / 25 (0.00%)	2 / 144 (1.39%)
occurrences all number	0	0	2
Tendon pain
subjects affected / exposed	0 / 30 (0.00%)	0 / 25 (0.00%)	1 / 144 (0.69%)
occurrences all number	0	0	1
Torticollis
subjects affected / exposed	0 / 30 (0.00%)	1 / 25 (4.00%)	1 / 144 (0.69%)
occurrences all number	0	1	1
Infections and infestations
Abscess limb
subjects affected / exposed	0 / 30 (0.00%)	0 / 25 (0.00%)	2 / 144 (1.39%)
occurrences all number	0	0	2
Acute sinusitis
subjects affected / exposed	0 / 30 (0.00%)	1 / 25 (4.00%)	2 / 144 (1.39%)
occurrences all number	0	1	2
Bacteraemia
subjects affected / exposed	0 / 30 (0.00%)	0 / 25 (0.00%)	1 / 144 (0.69%)
occurrences all number	0	0	1
Body tinea
subjects affected / exposed	0 / 30 (0.00%)	0 / 25 (0.00%)	1 / 144 (0.69%)
occurrences all number	0	0	1
Bronchitis
subjects affected / exposed	0 / 30 (0.00%)	0 / 25 (0.00%)	1 / 144 (0.69%)
occurrences all number	0	0	1
COVID-19
subjects affected / exposed	2 / 30 (6.67%)	0 / 25 (0.00%)	11 / 144 (7.64%)
occurrences all number	2	0	11
Conjunctivitis
subjects affected / exposed	0 / 30 (0.00%)	0 / 25 (0.00%)	3 / 144 (2.08%)
occurrences all number	0	0	3
Cystitis
subjects affected / exposed	0 / 30 (0.00%)	0 / 25 (0.00%)	1 / 144 (0.69%)
occurrences all number	0	0	1
Dermatophytosis
subjects affected / exposed	0 / 30 (0.00%)	0 / 25 (0.00%)	1 / 144 (0.69%)
occurrences all number	0	0	1
Diarrhoea infectious
subjects affected / exposed	0 / 30 (0.00%)	0 / 25 (0.00%)	1 / 144 (0.69%)
occurrences all number	0	0	1
Enterocolitis viral
subjects affected / exposed	0 / 30 (0.00%)	1 / 25 (4.00%)	1 / 144 (0.69%)
occurrences all number	0	1	1
Folliculitis
subjects affected / exposed	0 / 30 (0.00%)	0 / 25 (0.00%)	1 / 144 (0.69%)
occurrences all number	0	0	1
Furuncle
subjects affected / exposed	0 / 30 (0.00%)	0 / 25 (0.00%)	2 / 144 (1.39%)
occurrences all number	0	0	2
Gastroenteritis
subjects affected / exposed	0 / 30 (0.00%)	0 / 25 (0.00%)	4 / 144 (2.78%)
occurrences all number	0	0	4
Gastroenteritis viral
subjects affected / exposed	0 / 30 (0.00%)	1 / 25 (4.00%)	1 / 144 (0.69%)
occurrences all number	0	1	1
Genital herpes
subjects affected / exposed	0 / 30 (0.00%)	0 / 25 (0.00%)	1 / 144 (0.69%)
occurrences all number	0	0	1
Herpes simplex pharyngitis
subjects affected / exposed	0 / 30 (0.00%)	0 / 25 (0.00%)	1 / 144 (0.69%)
occurrences all number	0	0	1
Herpes zoster
subjects affected / exposed	0 / 30 (0.00%)	0 / 25 (0.00%)	1 / 144 (0.69%)
occurrences all number	0	0	1
Hordeolum
subjects affected / exposed	0 / 30 (0.00%)	0 / 25 (0.00%)	1 / 144 (0.69%)
occurrences all number	0	0	1
Impetigo
subjects affected / exposed	0 / 30 (0.00%)	0 / 25 (0.00%)	2 / 144 (1.39%)
occurrences all number	0	0	2
Injection site abscess
subjects affected / exposed	0 / 30 (0.00%)	0 / 25 (0.00%)	2 / 144 (1.39%)
occurrences all number	0	0	2
Influenza
subjects affected / exposed	0 / 30 (0.00%)	1 / 25 (4.00%)	3 / 144 (2.08%)
occurrences all number	0	1	3
Laryngitis
subjects affected / exposed	0 / 30 (0.00%)	0 / 25 (0.00%)	1 / 144 (0.69%)
occurrences all number	0	0	1
Latent syphilis
subjects affected / exposed	0 / 30 (0.00%)	0 / 25 (0.00%)	1 / 144 (0.69%)
occurrences all number	0	0	1
Lower respiratory tract infection
subjects affected / exposed	0 / 30 (0.00%)	0 / 25 (0.00%)	2 / 144 (1.39%)
occurrences all number	0	0	2
Malaria
subjects affected / exposed	0 / 30 (0.00%)	0 / 25 (0.00%)	7 / 144 (4.86%)
occurrences all number	0	0	7
Mumps
subjects affected / exposed	0 / 30 (0.00%)	0 / 25 (0.00%)	1 / 144 (0.69%)
occurrences all number	0	0	1
Nasopharyngitis
subjects affected / exposed	1 / 30 (3.33%)	0 / 25 (0.00%)	14 / 144 (9.72%)
occurrences all number	1	0	14
Onychomycosis
subjects affected / exposed	0 / 30 (0.00%)	0 / 25 (0.00%)	1 / 144 (0.69%)
occurrences all number	0	0	1
Oral herpes
subjects affected / exposed	1 / 30 (3.33%)	0 / 25 (0.00%)	6 / 144 (4.17%)
occurrences all number	1	0	6
Otitis media
subjects affected / exposed	0 / 30 (0.00%)	0 / 25 (0.00%)	2 / 144 (1.39%)
occurrences all number	0	0	2
Otitis media acute
subjects affected / exposed	0 / 30 (0.00%)	0 / 25 (0.00%)	2 / 144 (1.39%)
occurrences all number	0	0	2
Paronychia
subjects affected / exposed	0 / 30 (0.00%)	1 / 25 (4.00%)	1 / 144 (0.69%)
occurrences all number	0	1	1
Pelvic inflammatory disease
subjects affected / exposed	0 / 30 (0.00%)	0 / 25 (0.00%)	1 / 144 (0.69%)
occurrences all number	0	0	1
Pharyngitis
subjects affected / exposed	1 / 30 (3.33%)	0 / 25 (0.00%)	2 / 144 (1.39%)
occurrences all number	1	0	2
Pharyngitis streptococcal
subjects affected / exposed	0 / 30 (0.00%)	0 / 25 (0.00%)	3 / 144 (2.08%)
occurrences all number	0	0	3
Plasmodium falciparum infection
subjects affected / exposed	0 / 30 (0.00%)	0 / 25 (0.00%)	2 / 144 (1.39%)
occurrences all number	0	0	2
Pneumonia
subjects affected / exposed	0 / 30 (0.00%)	0 / 25 (0.00%)	1 / 144 (0.69%)
occurrences all number	0	0	1
Proctitis gonococcal
subjects affected / exposed	0 / 30 (0.00%)	0 / 25 (0.00%)	1 / 144 (0.69%)
occurrences all number	0	0	1
Respiratory tract infection
subjects affected / exposed	0 / 30 (0.00%)	0 / 25 (0.00%)	3 / 144 (2.08%)
occurrences all number	0	0	3
Respiratory tract infection viral
subjects affected / exposed	0 / 30 (0.00%)	0 / 25 (0.00%)	2 / 144 (1.39%)
occurrences all number	0	0	2
Rhinitis
subjects affected / exposed	0 / 30 (0.00%)	0 / 25 (0.00%)	1 / 144 (0.69%)
occurrences all number	0	0	1
Scabies
subjects affected / exposed	0 / 30 (0.00%)	0 / 25 (0.00%)	1 / 144 (0.69%)
occurrences all number	0	0	1
Secondary syphilis
subjects affected / exposed	0 / 30 (0.00%)	1 / 25 (4.00%)	1 / 144 (0.69%)
occurrences all number	0	1	1
Sinusitis
subjects affected / exposed	1 / 30 (3.33%)	0 / 25 (0.00%)	3 / 144 (2.08%)
occurrences all number	1	0	3
Skin bacterial infection
subjects affected / exposed	0 / 30 (0.00%)	0 / 25 (0.00%)	1 / 144 (0.69%)
occurrences all number	0	0	1
Skin candida
subjects affected / exposed	0 / 30 (0.00%)	0 / 25 (0.00%)	1 / 144 (0.69%)
occurrences all number	0	0	1
Subcutaneous abscess
subjects affected / exposed	0 / 30 (0.00%)	0 / 25 (0.00%)	1 / 144 (0.69%)
occurrences all number	0	0	1
Syphilis genital
subjects affected / exposed	0 / 30 (0.00%)	1 / 25 (4.00%)	1 / 144 (0.69%)
occurrences all number	0	1	1
Tinea infection
subjects affected / exposed	0 / 30 (0.00%)	0 / 25 (0.00%)	1 / 144 (0.69%)
occurrences all number	0	0	1
Tinea pedis
subjects affected / exposed	0 / 30 (0.00%)	0 / 25 (0.00%)	1 / 144 (0.69%)
occurrences all number	0	0	1
Tinea versicolour
subjects affected / exposed	0 / 30 (0.00%)	0 / 25 (0.00%)	1 / 144 (0.69%)
occurrences all number	0	0	1
Tonsillitis
subjects affected / exposed	0 / 30 (0.00%)	0 / 25 (0.00%)	2 / 144 (1.39%)
occurrences all number	0	0	2
Tooth infection
subjects affected / exposed	0 / 30 (0.00%)	0 / 25 (0.00%)	2 / 144 (1.39%)
occurrences all number	0	0	2
Typhoid fever
subjects affected / exposed	0 / 30 (0.00%)	0 / 25 (0.00%)	1 / 144 (0.69%)
occurrences all number	0	0	1
Upper respiratory tract infection
subjects affected / exposed	4 / 30 (13.33%)	2 / 25 (8.00%)	30 / 144 (20.83%)
occurrences all number	4	2	30
Urethritis
subjects affected / exposed	0 / 30 (0.00%)	0 / 25 (0.00%)	1 / 144 (0.69%)
occurrences all number	0	0	1
Urethritis gonococcal
subjects affected / exposed	0 / 30 (0.00%)	0 / 25 (0.00%)	1 / 144 (0.69%)
occurrences all number	0	0	1
Urinary tract infection
subjects affected / exposed	0 / 30 (0.00%)	0 / 25 (0.00%)	7 / 144 (4.86%)
occurrences all number	0	0	7
Viral infection
subjects affected / exposed	0 / 30 (0.00%)	1 / 25 (4.00%)	1 / 144 (0.69%)
occurrences all number	0	1	1
Viral pharyngitis
subjects affected / exposed	0 / 30 (0.00%)	1 / 25 (4.00%)	2 / 144 (1.39%)
occurrences all number	0	1	2
Viral upper respiratory tract infection
subjects affected / exposed	1 / 30 (3.33%)	3 / 25 (12.00%)	10 / 144 (6.94%)
occurrences all number	1	3	10
Vulvovaginal candidiasis
subjects affected / exposed	0 / 30 (0.00%)	0 / 25 (0.00%)	3 / 144 (2.08%)
occurrences all number	0	0	3
Metabolism and nutrition disorders
Abnormal loss of weight
subjects affected / exposed	0 / 30 (0.00%)	0 / 25 (0.00%)	2 / 144 (1.39%)
occurrences all number	0	0	2
Decreased appetite
subjects affected / exposed	1 / 30 (3.33%)	1 / 25 (4.00%)	4 / 144 (2.78%)
occurrences all number	1	1	4
Dehydration
subjects affected / exposed	1 / 30 (3.33%)	0 / 25 (0.00%)	3 / 144 (2.08%)
occurrences all number	1	0	3
Hypercholesterolaemia
subjects affected / exposed	0 / 30 (0.00%)	0 / 25 (0.00%)	1 / 144 (0.69%)
occurrences all number	0	0	1
Hypoglycaemia
subjects affected / exposed	0 / 30 (0.00%)	0 / 25 (0.00%)	1 / 144 (0.69%)
occurrences all number	0	0	1
Hypokalaemia
subjects affected / exposed	0 / 30 (0.00%)	0 / 25 (0.00%)	1 / 144 (0.69%)
occurrences all number	0	0	1
Obesity
subjects affected / exposed	0 / 30 (0.00%)	0 / 25 (0.00%)	1 / 144 (0.69%)
occurrences all number	0	0	1
Overweight
subjects affected / exposed	0 / 30 (0.00%)	0 / 25 (0.00%)	2 / 144 (1.39%)
occurrences all number	0	0	2
Underweight
subjects affected / exposed	2 / 30 (6.67%)	0 / 25 (0.00%)	5 / 144 (3.47%)
occurrences all number	2	0	5
Vitamin D deficiency
subjects affected / exposed	0 / 30 (0.00%)	1 / 25 (4.00%)	2 / 144 (1.39%)
occurrences all number	0	1	2

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Were there any global substantial amendments to the protocol? No

Were there any global interruptions to the trial? No

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

None reported

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Clinical trials

Clinical Trial Results: Phase I/II Study of the Safety, Acceptability, Tolerability, and Pharmacokinetics of Oral and Long-Acting Injectable Cabotegravir and Long-Acting Injectable Rilpivirine in Virologically Suppressed HIV-Infected Children and Adolescents

Trial information

Trial information

Subject disposition

Subject disposition

Baseline characteristics

Baseline characteristics

End points

End points

Primary: Proportion of Participants Who Had Grade 3 or Higher Adverse Events (AEs) (Cohort 1)

Primary: Proportion of Participants Who Had Grade 3 or Higher Adverse Events (AEs) (Cohort 1)

Primary: Proportion of Participants Who Had Grade 3 or Higher AEs Assessed as Related to Study Product/s (Cohort 1)

Primary: Proportion of Participants Who Had Grade 3 or Higher AEs Assessed as Related to Study Product/s (Cohort 1)

Primary: Proportion of Participants Who Had Serious AEs Meeting International Conference on Harmonisation (ICH) Criteria Assessed as Related to the Study Product/s (Cohort 1)

Primary: Proportion of Participants Who Had Serious AEs Meeting International Conference on Harmonisation (ICH) Criteria Assessed as Related to the Study Product/s (Cohort 1)

Primary: Proportion of Participants Who Permanently Discontinued Study Products Due to AEs Assessed as Related to Study Product/s (Cohort 1)

Primary: Proportion of Participants Who Permanently Discontinued Study Products Due to AEs Assessed as Related to Study Product/s (Cohort 1)

Primary: Proportion of Participants Who Died Due to AEs Assessed as Related to Study Product/s (Cohort 1)

Primary: Proportion of Participants Who Died Due to AEs Assessed as Related to Study Product/s (Cohort 1)

Primary: Proportion of Participants Who Had Grade 3 or Higher AEs (Cohort 1)

Primary: Proportion of Participants Who Had Grade 3 or Higher AEs (Cohort 1)

Primary: Proportion of Participants Who Had Grade 3 or Higher AEs Assessed as Related to Study Product/s (Cohort 1)

Primary: Proportion of Participants Who Had Grade 3 or Higher AEs Assessed as Related to Study Product/s (Cohort 1)

Primary: Proportion of Participants Who Had Serious AEs Meeting ICH Criteria Assessed as Related to the Study Product/s (Cohort 1)

Primary: Proportion of Participants Who Had Serious AEs Meeting ICH Criteria Assessed as Related to the Study Product/s (Cohort 1)

Primary: Proportion of Participants Who Permanently Discontinued Study Products Due to AEs Assessed as Related to Study Product/s (Cohort 1)

Primary: Proportion of Participants Who Permanently Discontinued Study Products Due to AEs Assessed as Related to Study Product/s (Cohort 1)

Primary: Proportion of Participants Who Died Due to AEs Assessed as Related to Study Product/s (Cohort 1)

Primary: Proportion of Participants Who Died Due to AEs Assessed as Related to Study Product/s (Cohort 1)

Primary: Proportion of Participants Who Had Grade 3 or Higher AEs (Cohort 2)

Primary: Proportion of Participants Who Had Grade 3 or Higher AEs (Cohort 2)

Primary: Proportion of Participants Who Had Grade 3 or Higher AEs Assessed as Related to Study Product/s (Cohort 2)

Primary: Proportion of Participants Who Had Grade 3 or Higher AEs Assessed as Related to Study Product/s (Cohort 2)

Primary: Proportion of Participants Who Had Serious AEs Meeting ICH Criteria Assessed as Related to the Study Product/s (Cohort 2)

Primary: Proportion of Participants Who Had Serious AEs Meeting ICH Criteria Assessed as Related to the Study Product/s (Cohort 2)

Primary: Proportion of Participants Who Permanently Discontinued Study Products Due to AEs Assessed as Related to Study Product/s (Cohort 2)

Primary: Proportion of Participants Who Permanently Discontinued Study Products Due to AEs Assessed as Related to Study Product/s (Cohort 2)

Primary: Proportion of Participants Who Died Due to AEs Assessed as Related to Study Product/s (Cohort 2)

Primary: Proportion of Participants Who Died Due to AEs Assessed as Related to Study Product/s (Cohort 2)

Primary: Geometric Mean Area Under the Plasma Concentration-time Curve (AUC) for Step 1 Oral CAB (Cohort 1C)

Primary: Geometric Mean Area Under the Plasma Concentration-time Curve (AUC) for Step 1 Oral CAB (Cohort 1C)

Primary: Apparent Body Clearance (CL/F) of Step 1 Oral CAB (Cohort 1C)

Primary: Apparent Body Clearance (CL/F) of Step 1 Oral CAB (Cohort 1C)

Primary: Geometric Mean Maximum Plasma Concentration (Cmax) of Oral CAB (Cohort 1C)

Primary: Geometric Mean Maximum Plasma Concentration (Cmax) of Oral CAB (Cohort 1C)

Primary: Time of Maximum Concentration (Tmax) of Oral CAB (Cohort 1C)

Primary: Time of Maximum Concentration (Tmax) of Oral CAB (Cohort 1C)

Primary: Geometric Mean Pre-Dose Concentration (C0) of Oral CAB (Cohort 1C)

Primary: Geometric Mean Pre-Dose Concentration (C0) of Oral CAB (Cohort 1C)

Primary: Geometric Mean Concentration of LA CAB/LA RPV at Week 16 (Cohort 1 Q4W)

Primary: Geometric Mean Concentration of LA CAB/LA RPV at Week 16 (Cohort 1 Q4W)

Primary: Geometric Mean Cmax of LA CAB/LA RPV (Cohort 1 Q4W)

Primary: Geometric Mean Cmax of LA CAB/LA RPV (Cohort 1 Q4W)

Primary: Tmax of LA CAB/LA RPV (Cohort 1 Q4W)

Primary: Tmax of LA CAB/LA RPV (Cohort 1 Q4W)

Primary: Geometric Mean Pre-Dose Concentration (C0) of LA CAB/LA RPV (Cohort 1 Q4W)

Primary: Geometric Mean Pre-Dose Concentration (C0) of LA CAB/LA RPV (Cohort 1 Q4W)

Primary: Geometric Mean Concentration of LA CAB/LA RPV at Week 16 (Cohort 1 Q8W)

Primary: Geometric Mean Concentration of LA CAB/LA RPV at Week 16 (Cohort 1 Q8W)

Primary: Geometric Mean Cmax of LA CAB/LA RPV (Cohort 1 Q8W)

Primary: Geometric Mean Cmax of LA CAB/LA RPV (Cohort 1 Q8W)

Primary: Tmax of LA CAB/LA RPV (Cohort 1 Q8W)

Primary: Tmax of LA CAB/LA RPV (Cohort 1 Q8W)

Primary: Geometric Mean Pre-Dose Concentration (C0) of LA CAB/LA RPV (Cohort 1 Q8W)

Primary: Geometric Mean Pre-Dose Concentration (C0) of LA CAB/LA RPV (Cohort 1 Q8W)

Secondary: Proportion of Participants With HIV-1 RNA <50 Copies/mL (Cohort 1)

Secondary: Proportion of Participants With HIV-1 RNA <50 Copies/mL (Cohort 1)

Secondary: Proportion of Participants Who Reported "Hurts Whole Lot" or "Hurts Worst" in Regards to Being Bothered by Pain During Injection of CAB LA of RPV LA (Cohort 1)

Secondary: Proportion of Participants Who Reported "Hurts Whole Lot" or "Hurts Worst" in Regards to Being Bothered by Pain During Injection of CAB LA of RPV LA (Cohort 1)

Secondary: Median Dimension of Quality of Life Scores

Secondary: Median Dimension of Quality of Life Scores

Secondary: Proportion of Participants Who Had Grade 3 or Higher AEs (Cohort 2)

Secondary: Proportion of Participants Who Had Grade 3 or Higher AEs (Cohort 2)

Secondary: Proportion of Participants Who Had Grade 3 or Higher AEs Assessed as Related to Study Product/s (Cohort 2)

Secondary: Proportion of Participants Who Had Grade 3 or Higher AEs Assessed as Related to Study Product/s (Cohort 2)

Secondary: Proportion of Participants Who Had Serious (S) AEs Meeting ICH Criteria Assessed as Related to the Study Product/s (Cohort 2)

Secondary: Proportion of Participants Who Had Serious (S) AEs Meeting ICH Criteria Assessed as Related to the Study Product/s (Cohort 2)

Secondary: Proportion of Participants Who Permanently Discontinued Study Products Due to AEs Assessed as Related to Study Product/s (Cohort 2)

Secondary: Proportion of Participants Who Permanently Discontinued Study Products Due to AEs Assessed as Related to Study Product/s (Cohort 2)

Clinical Trial Results:
Phase I/II Study of the Safety, Acceptability, Tolerability, and Pharmacokinetics of Oral and Long-Acting Injectable Cabotegravir and Long-Acting Injectable Rilpivirine in Virologically Suppressed HIV-Infected Children and Adolescents