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
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT01854775 |
Recruitment Status :
Active, not recruiting
First Posted : May 16, 2013
Results First Posted : May 24, 2021
Last Update Posted : June 30, 2022
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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.
Condition or disease | Intervention/treatment | Phase |
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Acquired Immune Deficiency Syndrome (AIDS) HIV Infections | Drug: E/C/F/TAF Drug: E/C/F/TAF (Low Dose) | Phase 2 Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 129 participants |
Allocation: | Non-Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | 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 |
Actual Study Start Date : | May 6, 2013 |
Actual Primary Completion Date : | May 11, 2020 |
Estimated Study Completion Date : | December 2023 |
Arm | Intervention/treatment |
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Experimental: Cohort 1: Age 12 to < 18 Years and Weight ≥ 35 kg
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.
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Drug: E/C/F/TAF
Tablets administered orally with food.
Other Name: Genvoya® |
Experimental: Cohort 2: Age 6 to < 12 Years and Weight ≥ 25 kg
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.
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Drug: E/C/F/TAF
Tablets administered orally with food.
Other Name: Genvoya® |
Experimental: Cohort 3: Age ≥2 Years and Weight ≥ 14 to <25 kg
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.
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Drug: E/C/F/TAF
Tablets administered orally with food.
Other Name: Genvoya® Drug: E/C/F/TAF (Low Dose) 90/90/120/6 mg STR administered once daily orally with food. |
- Pharmacokinetic (PK) Parameter: AUCtau of Elvitegravir (EVG) (Cohort 1) [ Time Frame: 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 ]AUCtau is defined as concentration of drug over time (the area under the concentration verses time curve over the dosing interval).
- PK Parameter: AUCtau of EVG (Cohort 2) [ Time Frame: 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 ]AUCtau is defined as concentration of drug over time (the area under the concentration verses time curve over the dosing interval).
- PK Parameter: AUCtau of EVG (Cohort 3) [ Time Frame: 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 ]AUCtau is defined as concentration of drug over time (the area under the concentration verses time curve over the dosing interval).
- PK Parameter: AUClast of Tenofovir Alafenamide (TAF) (Cohort 1) [ Time Frame: 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 ]AUClast is defined as the concentration of drug from time zero to the last observable concentration.
- PK Parameter: AUClast of TAF (Cohort 2) [ Time Frame: 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 ]AUClast is defined as the concentration of drug from time zero to the last observable concentration.
- PK Parameter: AUCtau of TAF (Cohort 3) [ Time Frame: 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 ]AUCtau is defined as concentration of drug over time (the area under the concentration verses time curve over the dosing interval).
- Cohort 1: Percentage of Participants With All Treatment-Emergent Adverse Events (AEs) and Treatment-Emergent Serious Adverse Events (SAEs) [ Time Frame: From first dose date up to Week 24 ]
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.
- Cohort 2: Percentage of Participants With All Treatment-Emergent AEs and Treatment-Emergent SAEs [ Time Frame: From first dose date up to Week 24 ]
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.
- Cohort 3: Percentage of Participants With All Treatment-Emergent AEs and Treatment-Emergent SAEs [ Time Frame: From first dose date up to Week 24 ]
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.
- PK Parameter: Ctau of EVG, FTC, TFV, and COBI (Cohort 1) [ Time Frame: 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 ]Ctau is defined as the observed drug concentration at the end of the dosing interval.
- PK Parameter: Ctau of EVG, FTC, TFV, and COBI (Cohort 2) [ Time Frame: (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 ]Ctau is defined as the observed drug concentration at the end of the dosing interval.
- PK Parameter: Ctau of EVG, FTC, TFV, and COBI (Cohort 3) [ Time Frame: 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 ]Ctau is defined as the observed drug concentration at the end of the dosing interval.
- PK Parameter: Cmax of EVG, TAF, FTC, TFV, and COBI (Cohort 1) [ Time Frame: 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 ]Cmax is defined as the maximum concentration of drug.
- PK Parameter: Cmax of EVG, TAF, FTC, TFV, and COBI (Cohort 2) [ Time Frame: 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 ]Cmax is defined as the maximum concentration of drug.
- PK Parameter: Cmax of EVG, TAF, FTC, TFV, and COBI (Cohort 3) [ Time Frame: 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 ]Cmax is defined as the maximum concentration of drug.
- PK Parameter: CL of EVG and TAF (Cohort 1) [ Time Frame: 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 ]Clearance (CL) is defined as the systemic clearance of the drug following intravenous administration.
- PK Parameter: CL of EVG and TAF (Cohort 2) [ Time Frame: 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 ]Clearance (CL) is defined as the systemic clearance of the drug following intravenous administration.
- PK Parameter: CL of EVG and TAF (Cohort 3) [ Time Frame: 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 ]Clearance (CL) is defined as the systemic clearance of the drug following intravenous administration.
- PK Parameter: Vz of EVG and TAF (Cohort 1) [ Time Frame: 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 ]Vz is defined as the volume of distribution of the drug after intravenous administration.
- PK Parameter: Vz of EVG and TAF (Cohort 2) [ Time Frame: 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 ]Vz is defined as the volume of distribution of the drug after intravenous administration.
- PK Parameter: Vz of EVG and TAF (Cohort 3) [ Time Frame: 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 ]Vz is defined as the volume of distribution of the drug after intravenous administration.
- PK Parameter: AUCtau of FTC, TFV, and COBI (Cohort 1) [ Time Frame: 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 ]AUCtau is defined as concentration of drug over time (the area under the concentration verses time curve over the dosing interval).
- PK Parameter: AUCtau of FTC, TFV, and COBI (Cohort 2) [ Time Frame: 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 ]AUCtau is defined as concentration of drug over time (the area under the concentration verses time curve over the dosing interval).
- PK Parameter: AUCtau of FTC, TFV, and COBI (Cohort 3) [ Time Frame: 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 ]AUCtau is defined as concentration of drug over time (the area under the concentration verses time curve over the dosing interval).
- Cohort 1: Percentage of Participants With Plasma HIV-1 RNA < 50 Copies/mL at Week 24, as Defined by the FDA Snapshot Analysis [ Time Frame: Week 24 ]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.
- Cohort 1: Percentage of Participants With Plasma HIV-1 RNA < 50 Copies/mL at Week 48, as Defined by the FDA Snapshot Analysis [ Time Frame: Week 48 ]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.
- Cohort 1: Percentage of Participants With Plasma HIV-1 RNA < 400 Copies/mL at Week 24, as Defined by the FDA Snapshot Analysis [ Time Frame: Week 24 ]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.
- Cohort 1: Percentage of Participants With Plasma HIV-1 RNA < 400 Copies/mL at Week 48, as Defined by the FDA Snapshot Analysis [ Time Frame: Week 48 ]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.
- Cohort 2: Percentage of Participants With Plasma HIV-1 RNA < 50 Copies/mL at Week 24, as Defined by the FDA Snapshot Analysis [ Time Frame: Week 24 ]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.
- Cohort 2: Percentage of Participants With Plasma HIV-1 RNA < 50 Copies/mL at Week 48, as Defined by the FDA Snapshot Analysis [ Time Frame: Week 48 ]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.
- Cohort 3: Percentage of Participants With Plasma HIV-1 RNA < 50 Copies/mL at Week 24, as Defined by the FDA Snapshot Analysis [ Time Frame: Week 24 ]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.
- Cohort 3: Percentage of Participants With Plasma HIV-1 RNA < 50 Copies/mL at Week 48, as Defined by the FDA Snapshot Analysis [ Time Frame: Week 48 ]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.
- Cohort 1: Percentage of Participants With Plasma HIV-1 RNA < 50 Copies/mL at Week 24, Based on Missing = Failure Analyses [ Time Frame: Week 24 ]The percentage of participants with HIV-1 RNA < 50 copies/mL at Week 24 was analyzed based on missing = failure analyses.
- Cohort 1: Percentage of Participants With Plasma HIV-1 RNA < 50 Copies/mL at Week 48, Based on Missing = Failure Analyses [ Time Frame: Week 48 ]The percentage of participants with HIV-1 RNA < 50 copies/mL at Week 48 was analyzed based on missing = failure analyses.
- Cohort 1: Percentage of Participants With Plasma HIV-1 RNA < 400 Copies/mL at Week 24, Based on Missing = Failure Analyses [ Time Frame: Week 24 ]The percentage of participants with HIV-1 RNA < 50 copies/mL at Week 24 was analyzed based on missing = failure analyses.
- Cohort 1: Percentage of Participants With Plasma HIV-1 RNA < 400 Copies/mL at Week 48, Based on Missing = Failure Analyses [ Time Frame: Week 48 ]The percentage of participants with HIV-1 RNA < 400 copies/mL at Week 48 was analyzed based on missing = failure analyses.
- Cohort 2: Percentage of Participants With Plasma HIV-1 RNA < 50 Copies/mL at Week 24, Based on Missing = Failure Analyses [ Time Frame: Week 24 ]The percentage of participants with HIV-1 RNA < 50 copies/mL at Week 24 was analyzed based on missing = failure analyses.
- Cohort 2: Percentage of Participants With Plasma HIV-1 RNA < 50 Copies/mL at Week 48, Based on Missing = Failure Analyses [ Time Frame: Week 24 ]The percentage of participants with HIV-1 RNA < 50 copies/mL at Week 48 was analyzed based on missing = failure analyses.
- Cohort 2: Percentage of Participants With Plasma HIV-1 RNA < 400 Copies/mL at Week 24, Based on Missing = Failure Analyses [ Time Frame: Week 24 ]The percentage of participants with HIV-1 RNA < 400 copies/mL at Week 24 was analyzed based on missing = failure analyses.
- Cohort 2: Percentage of Participants With Plasma HIV-1 RNA < 400 Copies/mL at Week 48, Based on Missing = Failure Analyses [ Time Frame: Week 48 ]The percentage of participants with HIV-1 RNA < 400 copies/mL at Week 48 was analyzed based on missing = failure analyses.
- Cohort 3: Percentage of Participants With Plasma HIV-1 RNA < 50 Copies/mL at Week 24, Based on Missing = Failure Analyses [ Time Frame: Week 24 ]The percentage of participants with HIV-1 RNA < 50 copies/mL at Week 24 was analyzed based on missing = failure analyses.
- Cohort 3: Percentage of Participants With Plasma HIV-1 RNA < 50 Copies/mL at Week 48, Based on Missing = Failure Analyses [ Time Frame: Week 48 ]The percentage of participants with HIV-1 RNA < 50 copies/mL at Week 48 was analyzed based on missing = failure analyses.
- Cohort 1: Percentage of Participants With Plasma HIV-1 RNA < 50 Copies/mL at Week 24, Based on Missing = Excluded Analyses [ Time Frame: Week 24 ]The percentage of participants with HIV-1 RNA < 50 copies/mL at Week 24 was analyzed based on missing = excluded analyses.
- Cohort 1: Percentage of Participants With Plasma HIV-1 RNA < 50 Copies/mL at Week 48, Based on Missing = Excluded Analyses [ Time Frame: Week 48 ]The percentage of participants with HIV-1 RNA < 50 copies/mL at Week 48 was analyzed based on missing = excluded analyses.
- Cohort 1: Percentage of Participants With Plasma HIV-1 RNA < 400 Copies/mL at Week 24, Based on Missing = Excluded Analyses [ Time Frame: Week 24 ]The percentage of participants with HIV-1 RNA < 400 copies/mL at Week 24 was analyzed based on missing = excluded analyses.
- Cohort 1: Percentage of Participants With Plasma HIV-1 RNA < 400 Copies/mL at Week 48, Based on Missing = Excluded Analyses [ Time Frame: Week 48 ]The percentage of participants with HIV-1 RNA < 400 copies/mL at Week 48 was analyzed based on missing = excluded analyses.
- Cohort 2: Percentage of Participants With Plasma HIV-1 RNA < 50 Copies/mL at Week 24, Based on Missing = Excluded Analyses [ Time Frame: Week 24 ]The percentage of participants with HIV-1 RNA < 50 copies/mL at Week 24 was analyzed based on missing = excluded analyses.
- Cohort 2: Percentage of Participants With Plasma HIV-1 RNA < 50 Copies/mL at Week 48, Based on Missing = Excluded Analyses [ Time Frame: Week 48 ]The percentage of participants with HIV-1 RNA < 50 copies/mL at Week 48 was analyzed based on missing = excluded analyses.
- Cohort 2: Percentage of Participants With Plasma HIV-1 RNA < 400 Copies/mL at Week 24, Based on Missing = Excluded Analyses [ Time Frame: Week 24 ]The percentage of participants with HIV-1 RNA < 400 copies/mL at Week 24 was analyzed based on missing = excluded analyses.
- Cohort 2: Percentage of Participants With Plasma HIV-1 RNA < 400 Copies/mL at Week 48, Based on Missing = Excluded Analyses [ Time Frame: Week 48 ]The percentage of participants with HIV-1 RNA < 400 copies/mL at Week 48 was analyzed based on missing = excluded analyses.
- Cohort 3: Percentage of Participants With Plasma HIV-1 RNA < 50 Copies/mL at Week 24, Based on Missing = Excluded Analyses [ Time Frame: Week 24 ]The percentage of participants with HIV-1 RNA < 50 copies/mL at Week 24 was analyzed based on missing = excluded analyses.
- Cohort 3: Percentage of Participants With Plasma HIV-1 RNA < 50 Copies/mL at Week 48, Based on Missing = Excluded Analyses [ Time Frame: Week 48 ]The percentage of participants with HIV-1 RNA < 50 copies/mL at Week 48 was analyzed based on missing = excluded analyses.
- Cohort 1: Change From Baseline in Plasma log10 HIV-1 RNA at Week 24 [ Time Frame: Baseline, Week 24 ]
- Cohort 1: Change From Baseline in Plasma log10 HIV-1 RNA at Week 48 [ Time Frame: Baseline, Week 48 ]
- Cohort 1: Change From Baseline in CD4+ Cell Count at Week 24 [ Time Frame: Baseline, Week 24 ]
- Cohort 1: Change From Baseline in CD4+ Cell Count at Week 48 [ Time Frame: Baseline, Week 48 ]
- Cohort 2: Change From Baseline in CD4+ Cell Count at Week 24 [ Time Frame: Baseline, Week 24 ]
- Cohort 2: Change From Baseline in CD4+ Cell Count at Week 48 [ Time Frame: Baseline, Week 48 ]
- Cohort 3: Change From Baseline in CD4+ Cell Count at Week 24 [ Time Frame: Baseline, Week 24 ]
- Cohort 3: Change From Baseline in CD4+ Cell Count at Week 48 [ Time Frame: Baseline, Week 48 ]
- Cohort 1: Change From Baseline in CD4+ Cell Percentage at Week 24 [ Time Frame: Baseline, Week 24 ]
- Cohort 1: Change From Baseline in CD4+ Cell Percentage at Week 48 [ Time Frame: Baseline, Week 48 ]
- Cohort 2: Change From Baseline in CD4+ Cell Percentage at Week 24 [ Time Frame: Baseline, Week 24 ]
- Cohort 2: Change From Baseline in CD4+ Cell Percentage at Week 48 [ Time Frame: Baseline, Week 48 ]
- Cohort 3: Change From Baseline in CD4+ Cell Percentage at Week 24 [ Time Frame: Baseline, Week 24 ]
- Cohort 3: Change From Baseline in CD4+ Cell Percentage at Week 48 [ Time Frame: Baseline, Week 48 ]

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 2 Years to 17 Years (Child) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Key Inclusion Criteria:
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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
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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.
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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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01854775
United States, California | |
Miller's Children Hospital | |
Long Beach, California, United States, 90806 | |
United States, District of Columbia | |
Children's Research Institute | |
Washington, District of Columbia, United States, 20010 | |
United States, Georgia | |
Emory University School of Medicine | |
Atlanta, Georgia, United States, 30322 | |
United States, Tennessee | |
St. Jude Children's Research Hospital | |
Memphis, Tennessee, United States, 38105 | |
United States, Washington | |
Seattle Children's Hospital | |
Seattle, Washington, United States, 98105-0371 | |
South Africa | |
KIDCRU Ward J8 | |
Cape Town, South Africa, 7505 | |
Be Part Yoluntu Centre | |
Cape Town, South Africa, 7646 | |
Desmond Tutu HIV Foundation | |
Cape Town, South Africa, 7705 | |
Perinatal HIV Research Unit Baragwanath Hospital | |
Johannesburg, South Africa, 1862 | |
Clinical HIV Research Unit | |
Johannesburg, South Africa, 2041 | |
Empilweni Services and Research Unit (ESRU) | |
Johannesburg, South Africa, 2092 | |
Thailand | |
The HIV Netherlands Australia Thailand Research collaboration (HIV-NAT) | |
Bangkok, Thailand, 10330 | |
Queen Savang Vadhana Memorial Hospital | |
Chon Buri, Thailand, 20110 | |
Department of Pediatrics, Faculty of Medicine, Khon Kaen University | |
Khon Kaen, Thailand, 40002 | |
Uganda | |
Joint Clinical Research Centre | |
Kampala, Uganda, PO Box 10005 | |
Zimbabwe | |
University of Zimbabwe - Clinical Research Centre | |
Belgravia, Zimbabwe, 263 |
Study Director: | Gilead Study Director | Gilead Sciences |
Documents provided by Gilead Sciences:
Publications of Results:
Other Publications:
Responsible Party: | Gilead Sciences |
ClinicalTrials.gov Identifier: | NCT01854775 |
Other Study ID Numbers: |
GS-US-292-0106 2013-002780-26 ( EudraCT Number ) |
First Posted: | May 16, 2013 Key Record Dates |
Results First Posted: | May 24, 2021 |
Last Update Posted: | June 30, 2022 |
Last Verified: | June 2022 |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
Adolescents HIV-1 HIV Treatment-naive Virologically suppressed |
Elvitegravir, Cobicistat, Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination HIV Infections Acquired Immunodeficiency Syndrome Immunologic Deficiency Syndromes Blood-Borne Infections Communicable Diseases Infections Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Lentivirus Infections |
Retroviridae Infections RNA Virus Infections Virus Diseases Immune System Diseases Slow Virus Diseases Anti-HIV Agents Anti-Retroviral Agents Antiviral Agents Anti-Infective Agents |