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
- Conditions
- Acquired Immune Deficiency Syndrome (AIDS)HIV Infections
- Interventions
- Drug: E/C/F/TAFDrug: E/C/F/TAF (Low Dose)
- Registration Number
- NCT01854775
- Lead Sponsor
- Gilead Sciences
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 129
-
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
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Cohort 1: Age 12 to < 18 Years and Weight ≥ 35 kg E/C/F/TAF 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. Cohort 2: Age 6 to < 12 Years and Weight ≥ 25 kg E/C/F/TAF 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. Cohort 3: Age ≥2 Years and Weight ≥ 14 to <25 kg E/C/F/TAF 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. Cohort 3: Age ≥2 Years and Weight ≥ 14 to <25 kg E/C/F/TAF (Low Dose) 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.
- Primary Outcome Measures
Name Time Method PK Parameter: AUCtau of EVG (Cohort 3) 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).
Pharmacokinetic (PK) Parameter: AUCtau of Elvitegravir (EVG) (Cohort 1) 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) 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: AUClast of Tenofovir Alafenamide (TAF) (Cohort 1) 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.
Cohort 3: Percentage of Participants With All Treatment-Emergent AEs and Treatment-Emergent SAEs 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: AUClast of TAF (Cohort 2) 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.
Cohort 1: Percentage of Participants With All Treatment-Emergent Adverse Events (AEs) and Treatment-Emergent Serious Adverse Events (SAEs) 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 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: AUCtau of TAF (Cohort 3) 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).
- Secondary Outcome Measures
Name Time Method 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 PK Parameter: Ctau of EVG, FTC, TFV, and COBI (Cohort 1) 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: Vz of EVG and TAF (Cohort 3) 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) 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: Ctau of EVG, FTC, TFV, and COBI (Cohort 3) 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) 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) 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: Ctau of EVG, FTC, TFV, and COBI (Cohort 2) (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: Cmax of EVG, TAF, FTC, TFV, and COBI (Cohort 3) 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) 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) 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) 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) 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) 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: AUCtau of FTC, TFV, and COBI (Cohort 2) 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) 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 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 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 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 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 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 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 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 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: Change From Baseline in CD4+ Cell Count at Week 24 Baseline, Week 24 Cohort 1: Percentage of Participants With Plasma HIV-1 RNA < 50 Copies/mL at Week 24, Based on Missing = Failure Analyses 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 Baseline, Week 24 Cohort 1: Change From Baseline in Plasma log10 HIV-1 RNA at Week 48 Baseline, Week 48 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
Trial Locations
- Locations (16)
Emory University School of Medicine
🇺🇸Atlanta, Georgia, United States
Seattle Children's Hospital
🇺🇸Seattle, Washington, United States
Desmond Tutu HIV Foundation
🇿🇦Cape Town, South Africa
Department of Pediatrics, Faculty of Medicine, Khon Kaen University
🇹🇭Khon Kaen, Thailand
The HIV Netherlands Australia Thailand Research collaboration (HIV-NAT)
🇹🇭Bangkok, Thailand
University of Zimbabwe - Clinical Research Centre
🇿🇼Belgravia, Zimbabwe
KIDCRU Ward J8
🇿🇦Cape Town, South Africa
Joint Clinical Research Centre
🇺🇬Kampala, Uganda
Clinical HIV Research Unit
🇿🇦Johannesburg, South Africa
Miller's Children Hospital
🇺🇸Long Beach, California, United States
St. Jude Children's Research Hospital
🇺🇸Memphis, Tennessee, United States
Children's Research Institute
🇺🇸Washington, District of Columbia, United States
Be Part Yoluntu Centre
🇿🇦Cape Town, South Africa
Perinatal HIV Research Unit Baragwanath Hospital
🇿🇦Johannesburg, South Africa
Empilweni Services and Research Unit (ESRU)
🇿🇦Johannesburg, South Africa
Queen Savang Vadhana Memorial Hospital
🇹🇭Chon Buri, Thailand