Study to Evaluate the Pharmacokinetics, Safety, and Antiviral Activity of the Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Alafenamide (E/C/F/TAF) Single Tablet Regimen (STR) in HIV-1 Infected Antiretroviral Treatment-Naive Adolescents and Virologically Suppressed Children

Study Overview
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Brief Summary
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The primary objectives of Cohort 1 are to evaluate the steady state pharmacokinetics (PK) for elvitegravir (EVG) and tenofovir alafenamide (TAF) and confirm the dose of the elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (E/C/F/TAF) STR (Part A) and to evaluate the safety and tolerability of E/C/F/TAF STR through Week 24 (Part B) in human immunodeficiency virus - 1 (HIV-1) infected, antiretroviral (ARV) treatment-naive adolescents. The primary objectives of Cohort 2 are to evaluate the PK of EVG and TAF in virologically suppressed HIV-1 infected children 6 to < 12 years of age weighing ≥ 25 kg administered E/C/F/TAF STR (Part A) and to evaluate the safety and tolerability of E/C/F/TAF STR through Week 24 in virologically suppressed HIV-1 infected children 6 to < 12 years of age weighing ≥ 25 kg (Part B). The primary objectives of Cohort 3 are to evaluate the PK of EVG and TAF and confirm the dose of the STR, and to evaluate the safety and tolerability of E/C/F/TAF low dose (LD) STR in virologically suppressed HIV-1 infected children ≥ 2 years of age and weighing ≥ 14 to < 25 kg.

Official Title
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A Phase 2/3, Open-Label Study of the Pharmacokinetics, Safety, and Antiviral Activity of the Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Alafenamide (E/C/F/TAF) Single Tablet Regimen (STR) in HIV-1 Infected Antiretroviral Treatment-Naive Adolescents and Virologically Suppressed Children

Conditions
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Acquired Immune Deficiency Syndrome (AIDS), HIV Infections

Intervention / Treatment
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* Drug: E/C/F/TAF
* Drug: E/C/F/TAF (Low Dose)


Participation Criteria
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Eligibility Criteria
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Key Inclusion Criteria: Cohort 1 12 years to < 18 years of age at baseline Weight greater than or equal to 35 kg (77 lbs) Plasma HIV-1 ribonucleic acid (RNA) levels of ≥ 1,000 copies/mL at screening (Roche COBAS TaqMan v2.0) Screening genotype report shows sensitivity to EVG, FTC and tenofovir (TFV) No prior use of any approved or experimental anti-HIV-1 drug for any length of time Cohort 2 6 years to < 12 years of age at baseline Weight greater than or equal to 25 kg (55 lbs) Plasma HIV-1 RNA of < 50 copies/mL (or undetectable HIV-1 RNA level according to the local assay being used if the limit of detection is > 50 copies/mL) for ≥ 180 consecutive days (6 months) prior to screening on a stable antiretroviral regimen, without documented history of resistance to any component of E/C/F/TAF STR. Cohort 3 Age at baseline: ≥ 2 years old Weight at screening: ≥ 14 kg (31 lbs) to < 25 kg (55 lbs) Plasma HIV-1 RNA: < 50 copies/mL (or undetectable HIV-1 RNA level according to the local assay being used if the limit of detection is > 50 copies/mL) for ≥ 180 consecutive days (6 months) prior to screening on a stable antiretroviral regimen, without prior history of resistance to any component of E/C/F/TAF STR Key Exclusion Criteria: Hepatitis B or hepatitis C virus infection Evidence of active pulmonary or extra-pulmonary tuberculosis disease within 3 months of the screening visit. Individuals experiencing decompensated cirrhosis Pregnant or lactating females Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Ages Eligible for Study
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Minimum Age: 2 Years
Maximum Age: 17 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cohort 1: Age 12 to < 18 Years and Weight ≥ 35 kg<br>HIV-infected, ARV treatment-naive adolescents (12 to < 18 years of age weighing ≥ 35 kg) will receive E/C/F/TAF (150/150/200/10 mg) fixed-dose combination (FDC) once daily for 48 weeks. Participants who complete 48 weeks of study treatment will have the option to receive E/C/F/TAF in an extension phase of the study until: a) the participant turns 18 years old and E/C/F/TAF is commercially available for adults in the country in which the participant is enrolled; b) age-appropriate E/C/F/TAF become commercially available in the country in which the participant is enrolled; or c) Gilead elects to terminate development of E/C/F/TAF in that country. | Drug: E/C/F/TAF<br>* Tablets administered orally with food.<br>* Other names: Genvoya®;|
| Experimental: Cohort 2: Age 6 to < 12 Years and Weight ≥ 25 kg<br>Virologically suppressed HIV-infected children (6 to < 12 years of age weighing ≥ 25 kg) will receive E/C/F/TAF (150/150/200/10 mg) FDC once daily for 48 weeks. Participants who complete 48 weeks of study treatment will have the option to receive E/C/F/TAF in an extension phase of the study until: a) the participant turns 18 years old and E/C/F/TAF is commercially available for adults in the country in which the participant is enrolled; b) age-appropriate E/C/F/TAF become commercially available in the country in which the participant is enrolled; or c) Gilead elects to terminate development of E/C/F/TAF in that country. | Drug: E/C/F/TAF<br>* Tablets administered orally with food.<br>* Other names: Genvoya®;|
| Experimental: Cohort 3: Age ≥2 Years and Weight ≥ 14 to <25 kg<br>Virologically suppressed HIV-infected children (≥ 2 years of age weighing ≥ 14 to < 25 kg) will receive E/C/F/TAF (90/90/120/6 mg) FDC once daily for 48 weeks. Participants who attain a weight of ≥ 25 kg during the course of the study will switch to adult E/C/F/TAF (150/150/200/10 mg) tablets. Participants who complete 48 weeks of study treatment will have the option to receive E/C/F/TAF in an extension phase of the study until: a) the participant turns 18 years old and E/C/F/TAF is commercially available for adults in the country in which the participant is enrolled; b) age-appropriate E/C/F/TAF became commercially available in the country in which the participant is enrolled; or c) Gilead elects to terminate development of E/C/F/TAF in that country. | Drug: E/C/F/TAF<br>* Tablets administered orally with food.<br>* Other names: Genvoya®;Drug: E/C/F/TAF (Low Dose)<br>* 90/90/120/6 mg STR administered once daily orally with food.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetic (PK) Parameter: AUCtau of Elvitegravir (EVG) (Cohort 1) | AUCtau is defined as concentration of drug over time (the area under the concentration verses time curve over the dosing interval). | 0 (pre-dose, ≤ 30 minutes prior to dosing), 5 minutes, 0.25, 0.5, 1, 1.5, 2, 4, 5, 8 and 24 hours post-dose at Week 4 | 
| PK Parameter: AUCtau of EVG (Cohort 2) | AUCtau is defined as concentration of drug over time (the area under the concentration verses time curve over the dosing interval). | 0 (pre-dose, ≤ 30 minutes prior to dosing), 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 8, and 24 hours post-dose at Week 4 | 
| PK Parameter: AUCtau of EVG (Cohort 3) | AUCtau is defined as concentration of drug over time (the area under the concentration verses time curve over the dosing interval). | 0 (pre-dose, ≤ 30 minutes prior to dosing), 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, and 8 hours post-dose at Week 2 | 
| PK Parameter: AUClast of Tenofovir Alafenamide (TAF) (Cohort 1) | AUClast is defined as the concentration of drug from time zero to the last observable concentration. | 0 (pre-dose, ≤ 30 minutes prior to dosing), 5 minutes, 0.25, 0.5, 1, 1.5, 2, 4, 5, 8 and 24 hours post-dose at Week 4 | 
| PK Parameter: AUClast of TAF (Cohort 2) | AUClast is defined as the concentration of drug from time zero to the last observable concentration. | 0 (pre-dose, ≤ 30 minutes prior to dosing), 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 8, and 24 hours post-dose at Week 4 | 
| PK Parameter: AUCtau of TAF (Cohort 3) | AUCtau is defined as concentration of drug over time (the area under the concentration verses time curve over the dosing interval). | 0 (pre-dose, ≤ 30 minutes prior to dosing), 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, and 8 hours post-dose at Week 2 | 
| Cohort 1: Percentage of Participants With All Treatment-Emergent Adverse Events (AEs) and Treatment-Emergent Serious Adverse Events (SAEs) | Treatment-emergent adverse events (TEAEs) were defined as any AEs that begin or worsen on or after the start of study drug through 30 days after the last dose of study drug. The severity was graded based on the Gilead Sciences Grading Scale for Severity of Adverse Events. An AE that met one or more of the following outcomes was classified as serious: Fatal Life-threatening Disabling/incapacitating Results in hospitalization or prolongs a hospital stay A congenital abnormality Other important medical events may also be considered serious AEs if they may require medical or surgical intervention to prevent one of the outcomes listed above. | From first dose date up to Week 24 | 
| Cohort 2: Percentage of Participants With All Treatment-Emergent AEs and Treatment-Emergent SAEs | TEAEs were defined as any AEs that begin or worsen on or after the start of study drug through 30 days after the last dose of study drug. The severity was graded based on the Gilead Sciences Grading Scale for Severity of Adverse Events. An AE that met one or more of the following outcomes was classified as serious: Fatal Life-threatening Disabling/incapacitating Results in hospitalization or prolongs a hospital stay A congenital abnormality Other important medical events may also be considered serious AEs if they may require medical or surgical intervention to prevent one of the outcomes listed above. | From first dose date up to Week 24 | 
| Cohort 3: Percentage of Participants With All Treatment-Emergent AEs and Treatment-Emergent SAEs | TEAEs were defined as any AEs that begin or worsen on or after the start of study drug through 30 days after the last dose of study drug. The severity was graded based on the Gilead Sciences Grading Scale for Severity of Adverse Events. An AE that met one or more of the following outcomes was classified as serious: Fatal Life-threatening Disabling/incapacitating Results in hospitalization or prolongs a hospital stay A congenital abnormality Other important medical events may also be considered serious AEs if they may require medical or surgical intervention to prevent one of the outcomes listed above. | From first dose date up to Week 24 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PK Parameter: Ctau of EVG, FTC, TFV, and COBI (Cohort 1) | Ctau is defined as the observed drug concentration at the end of the dosing interval. | 0 (pre-dose, ≤ 30 minutes prior to dosing), 5 minutes, 0.25, 0.5, 1, 1.5, 2, 4, 5, 8 and 24 hours post-dose at Week 4 | 
| PK Parameter: Ctau of EVG, FTC, TFV, and COBI (Cohort 2) | Ctau is defined as the observed drug concentration at the end of the dosing interval. | (pre-dose, ≤ 30 minutes prior to dosing), 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 8, and 24 hours post-dose at Week 4 | 
| PK Parameter: Ctau of EVG, FTC, TFV, and COBI (Cohort 3) | Ctau is defined as the observed drug concentration at the end of the dosing interval. | 0 (pre-dose, ≤ 30 minutes prior to dosing), 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, and 8 hours post-dose at Week 2 | 
| PK Parameter: Cmax of EVG, TAF, FTC, TFV, and COBI (Cohort 1) | Cmax is defined as the maximum concentration of drug. | 0 (pre-dose, ≤ 30 minutes prior to dosing), 5 minutes, 0.25, 0.5, 1, 1.5, 2, 4, 5, 8 and 24 hours post-dose at Week 4 | 
| PK Parameter: Cmax of EVG, TAF, FTC, TFV, and COBI (Cohort 2) | Cmax is defined as the maximum concentration of drug. | 0 (pre-dose, ≤ 30 minutes prior to dosing), 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 8, and 24 hours post-dose at Week 4 | 
| PK Parameter: Cmax of EVG, TAF, FTC, TFV, and COBI (Cohort 3) | Cmax is defined as the maximum concentration of drug. | 0 (pre-dose, ≤ 30 minutes prior to dosing), 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, and 8 hours post-dose at Week 2 | 
| PK Parameter: CL of EVG and TAF (Cohort 1) | Clearance (CL) is defined as the systemic clearance of the drug following intravenous administration. | 0 (pre-dose, ≤ 30 minutes prior to dosing), 5 minutes, 0.25, 0.5, 1, 1.5, 2, 4, 5, 8 and 24 hours post-dose at Week 4 | 
| PK Parameter: CL of EVG and TAF (Cohort 2) | Clearance (CL) is defined as the systemic clearance of the drug following intravenous administration. | 0 (pre-dose, ≤ 30 minutes prior to dosing), 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 8, and 24 hours post-dose at Week 4 | 
| PK Parameter: CL of EVG and TAF (Cohort 3) | Clearance (CL) is defined as the systemic clearance of the drug following intravenous administration. | 0 (pre-dose, ≤ 30 minutes prior to dosing), 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, and 8 hours post-dose at Week 2 | 
| PK Parameter: Vz of EVG and TAF (Cohort 1) | Vz is defined as the volume of distribution of the drug after intravenous administration. | 0 (pre-dose, ≤ 30 minutes prior to dosing), 5 minutes, 0.25, 0.5, 1, 1.5, 2, 4, 5, 8 and 24 hours post-dose at Week 4 | 
| PK Parameter: Vz of EVG and TAF (Cohort 2) | Vz is defined as the volume of distribution of the drug after intravenous administration. | 0 (pre-dose, ≤ 30 minutes prior to dosing), 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 8, and 24 hours post-dose at Week 4 | 
| PK Parameter: Vz of EVG and TAF (Cohort 3) | Vz is defined as the volume of distribution of the drug after intravenous administration. | 0 (pre-dose, ≤ 30 minutes prior to dosing), 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, and 8 hours post-dose at Week 2 | 
| PK Parameter: AUCtau of FTC, TFV, and COBI (Cohort 1) | AUCtau is defined as concentration of drug over time (the area under the concentration verses time curve over the dosing interval). | 0 (pre-dose, ≤ 30 minutes prior to dosing), 5 minutes, 0.25, 0.5, 1, 1.5, 2, 4, 5, 8 and 24 hours post-dose at Week 4 | 
| PK Parameter: AUCtau of FTC, TFV, and COBI (Cohort 2) | AUCtau is defined as concentration of drug over time (the area under the concentration verses time curve over the dosing interval). | 0 (pre-dose, ≤ 30 minutes prior to dosing), 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 8, and 24 hours post-dose at Week 4 | 
| PK Parameter: AUCtau of FTC, TFV, and COBI (Cohort 3) | AUCtau is defined as concentration of drug over time (the area under the concentration verses time curve over the dosing interval). | 0 (pre-dose, ≤ 30 minutes prior to dosing), 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, and 8 hours post-dose at Week 2 | 
| Cohort 1: Percentage of Participants With Plasma HIV-1 RNA < 50 Copies/mL at Week 24, as Defined by the FDA Snapshot Analysis | The percentage of participants with HIV-1 RNA < 50 copies/mL at Week 24 was analyzed using the snapshot algorithm, which defines a participant's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status. | Week 24 | 
| Cohort 1: Percentage of Participants With Plasma HIV-1 RNA < 50 Copies/mL at Week 48, as Defined by the FDA Snapshot Analysis | The percentage of participants with HIV-1 RNA < 50 copies/mL at Week 48 was analyzed using the snapshot algorithm, which defines a participant's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status. | Week 48 | 
| Cohort 1: Percentage of Participants With Plasma HIV-1 RNA < 400 Copies/mL at Week 24, as Defined by the FDA Snapshot Analysis | The percentage of participants with HIV-1 RNA < 400 Copies/mL at Week 24 was analyzed using the snapshot algorithm, which defines a participant's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status. | Week 24 | 
| Cohort 1: Percentage of Participants With Plasma HIV-1 RNA < 400 Copies/mL at Week 48, as Defined by the FDA Snapshot Analysis | The percentage of participants with HIV-1 RNA < 400 Copies/mL at Weeks 24 and 48 was analyzed using the snapshot algorithm, which defines a participant's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status. | Week 48 | 
| Cohort 2: Percentage of Participants With Plasma HIV-1 RNA < 50 Copies/mL at Week 24, as Defined by the FDA Snapshot Analysis | The percentage of participants with HIV-1 RNA < 50 copies/mL at Week 24 was analyzed using the snapshot algorithm, which defines a participant's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status. | Week 24 | 
| Cohort 2: Percentage of Participants With Plasma HIV-1 RNA < 50 Copies/mL at Week 48, as Defined by the FDA Snapshot Analysis | The percentage of participants with HIV-1 RNA < 50 copies/mL at Week 48 was analyzed using the snapshot algorithm, which defines a participant's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status. | Week 48 | 
| Cohort 3: Percentage of Participants With Plasma HIV-1 RNA < 50 Copies/mL at Week 24, as Defined by the FDA Snapshot Analysis | The percentage of participants with HIV-1 RNA < 50 copies/mL at Week 24 was analyzed using the snapshot algorithm, which defines a participant's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status. | Week 24 | 
| Cohort 3: Percentage of Participants With Plasma HIV-1 RNA < 50 Copies/mL at Week 48, as Defined by the FDA Snapshot Analysis | The percentage of participants with HIV-1 RNA < 50 copies/mL at Week 48 was analyzed using the snapshot algorithm, which defines a participant's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status. | Week 48 | 
| Cohort 1: Percentage of Participants With Plasma HIV-1 RNA < 50 Copies/mL at Week 24, Based on Missing = Failure Analyses | The percentage of participants with HIV-1 RNA < 50 copies/mL at Week 24 was analyzed based on missing = failure analyses. | Week 24 | 
| Cohort 1: Percentage of Participants With Plasma HIV-1 RNA < 50 Copies/mL at Week 48, Based on Missing = Failure Analyses | The percentage of participants with HIV-1 RNA < 50 copies/mL at Week 48 was analyzed based on missing = failure analyses. | Week 48 | 
| Cohort 1: Percentage of Participants With Plasma HIV-1 RNA < 400 Copies/mL at Week 24, Based on Missing = Failure Analyses | The percentage of participants with HIV-1 RNA < 50 copies/mL at Week 24 was analyzed based on missing = failure analyses. | Week 24 | 
| Cohort 1: Percentage of Participants With Plasma HIV-1 RNA < 400 Copies/mL at Week 48, Based on Missing = Failure Analyses | The percentage of participants with HIV-1 RNA < 400 copies/mL at Week 48 was analyzed based on missing = failure analyses. | Week 48 | 
| Cohort 2: Percentage of Participants With Plasma HIV-1 RNA < 50 Copies/mL at Week 24, Based on Missing = Failure Analyses | The percentage of participants with HIV-1 RNA < 50 copies/mL at Week 24 was analyzed based on missing = failure analyses. | Week 24 | 
| Cohort 2: Percentage of Participants With Plasma HIV-1 RNA < 50 Copies/mL at Week 48, Based on Missing = Failure Analyses | The percentage of participants with HIV-1 RNA < 50 copies/mL at Week 48 was analyzed based on missing = failure analyses. | Week 24 | 
| Cohort 2: Percentage of Participants With Plasma HIV-1 RNA < 400 Copies/mL at Week 24, Based on Missing = Failure Analyses | The percentage of participants with HIV-1 RNA < 400 copies/mL at Week 24 was analyzed based on missing = failure analyses. | Week 24 | 
| Cohort 2: Percentage of Participants With Plasma HIV-1 RNA < 400 Copies/mL at Week 48, Based on Missing = Failure Analyses | The percentage of participants with HIV-1 RNA < 400 copies/mL at Week 48 was analyzed based on missing = failure analyses. | Week 48 | 
| Cohort 3: Percentage of Participants With Plasma HIV-1 RNA < 50 Copies/mL at Week 24, Based on Missing = Failure Analyses | The percentage of participants with HIV-1 RNA < 50 copies/mL at Week 24 was analyzed based on missing = failure analyses. | Week 24 | 
| Cohort 3: Percentage of Participants With Plasma HIV-1 RNA < 50 Copies/mL at Week 48, Based on Missing = Failure Analyses | The percentage of participants with HIV-1 RNA < 50 copies/mL at Week 48 was analyzed based on missing = failure analyses. | Week 48 | 
| Cohort 1: Percentage of Participants With Plasma HIV-1 RNA < 50 Copies/mL at Week 24, Based on Missing = Excluded Analyses | The percentage of participants with HIV-1 RNA < 50 copies/mL at Week 24 was analyzed based on missing = excluded analyses. | Week 24 | 
| Cohort 1: Percentage of Participants With Plasma HIV-1 RNA < 50 Copies/mL at Week 48, Based on Missing = Excluded Analyses | The percentage of participants with HIV-1 RNA < 50 copies/mL at Week 48 was analyzed based on missing = excluded analyses. | Week 48 | 
| Cohort 1: Percentage of Participants With Plasma HIV-1 RNA < 400 Copies/mL at Week 24, Based on Missing = Excluded Analyses | The percentage of participants with HIV-1 RNA < 400 copies/mL at Week 24 was analyzed based on missing = excluded analyses. | Week 24 | 
| Cohort 1: Percentage of Participants With Plasma HIV-1 RNA < 400 Copies/mL at Week 48, Based on Missing = Excluded Analyses | The percentage of participants with HIV-1 RNA < 400 copies/mL at Week 48 was analyzed based on missing = excluded analyses. | Week 48 | 
| Cohort 2: Percentage of Participants With Plasma HIV-1 RNA < 50 Copies/mL at Week 24, Based on Missing = Excluded Analyses | The percentage of participants with HIV-1 RNA < 50 copies/mL at Week 24 was analyzed based on missing = excluded analyses. | Week 24 | 
| Cohort 2: Percentage of Participants With Plasma HIV-1 RNA < 50 Copies/mL at Week 48, Based on Missing = Excluded Analyses | The percentage of participants with HIV-1 RNA < 50 copies/mL at Week 48 was analyzed based on missing = excluded analyses. | Week 48 | 
| Cohort 2: Percentage of Participants With Plasma HIV-1 RNA < 400 Copies/mL at Week 24, Based on Missing = Excluded Analyses | The percentage of participants with HIV-1 RNA < 400 copies/mL at Week 24 was analyzed based on missing = excluded analyses. | Week 24 | 
| Cohort 2: Percentage of Participants With Plasma HIV-1 RNA < 400 Copies/mL at Week 48, Based on Missing = Excluded Analyses | The percentage of participants with HIV-1 RNA < 400 copies/mL at Week 48 was analyzed based on missing = excluded analyses. | Week 48 | 
| Cohort 3: Percentage of Participants With Plasma HIV-1 RNA < 50 Copies/mL at Week 24, Based on Missing = Excluded Analyses | The percentage of participants with HIV-1 RNA < 50 copies/mL at Week 24 was analyzed based on missing = excluded analyses. | Week 24 | 
| Cohort 3: Percentage of Participants With Plasma HIV-1 RNA < 50 Copies/mL at Week 48, Based on Missing = Excluded Analyses | The percentage of participants with HIV-1 RNA < 50 copies/mL at Week 48 was analyzed based on missing = excluded analyses. | Week 48 | 
| Cohort 1: Change From Baseline in Plasma log10 HIV-1 RNA at Week 24 |  | Baseline, Week 24 | 
| Cohort 1: Change From Baseline in Plasma log10 HIV-1 RNA at Week 48 |  | Baseline, Week 48 | 
| Cohort 1: Change From Baseline in CD4+ Cell Count at Week 24 |  | Baseline, Week 24 | 
| Cohort 1: Change From Baseline in CD4+ Cell Count at Week 48 |  | Baseline, Week 48 | 
| Cohort 2: Change From Baseline in CD4+ Cell Count at Week 24 |  | Baseline, Week 24 | 
| Cohort 2: Change From Baseline in CD4+ Cell Count at Week 48 |  | Baseline, Week 48 | 
| Cohort 3: Change From Baseline in CD4+ Cell Count at Week 24 |  | Baseline, Week 24 | 
| Cohort 3: Change From Baseline in CD4+ Cell Count at Week 48 |  | Baseline, Week 48 | 
| Cohort 1: Change From Baseline in CD4+ Cell Percentage at Week 24 |  | Baseline, Week 24 | 
| Cohort 1: Change From Baseline in CD4+ Cell Percentage at Week 48 |  | Baseline, Week 48 | 
| Cohort 2: Change From Baseline in CD4+ Cell Percentage at Week 24 |  | Baseline, Week 24 | 
| Cohort 2: Change From Baseline in CD4+ Cell Percentage at Week 48 |  | Baseline, Week 48 | 
| Cohort 3: Change From Baseline in CD4+ Cell Percentage at Week 24 |  | Baseline, Week 24 | 
| Cohort 3: Change From Baseline in CD4+ Cell Percentage at Week 48 |  | Baseline, Week 48 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Adolescents, HIV-1, HIV, Treatment-naive, Virologically suppressed