NCT02016924Active, not recruitingPhase 2/3
Study of Cobicistat-Boosted Atazanavir (ATV/co), Cobicistat-Boosted Darunavir (DRV/co) and Emtricitabine/Tenofovir Alafenamide (F/TAF) in Children With HIV
A Phase 2/3, Multicenter, Open-label, Multicohort Study Evaluating Pharmacokinetics (PK), Safety, and Efficacy of Cobicistat-boosted Atazanavir (ATV/co) or Cobicistat-boosted Darunavir (DRV/co) and Emtricitabine/Tenofovir Alafenamide (F/TAF) in HIV-1 Infected, Virologically Suppressed Pediatric Participants
Source: ClinicalTrials.gov · Last updated 21 Apr 2026
Brief summary (registry, in English)
The goal of this clinical study is to learn more about the safety and dosing of study drugs, cobicistat-boosted Atazanavir (ATV/co), cobicistat-boosted darunavir (DRV/co) and emtricitabine/tenofovir alafenamide (F/TAF), in children (age ≥ 4 weeks to \< 18 years) with HIV.
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 2/3
- Study type
- Interventional
- Enrollment
- 133 (actual)
- First submitted
- 16 Dec 2013
- Start date
- 16 Jan 2014
- Primary completion date
- 13 Jun 2025
- Lead sponsor
- Gilead Sciences
- Diseases
- HIV
- NCT number
- NCT02016924
- EudraCT number
- 2013-001402-28
What you commit to
- Study type: Interventional · Phase 2/3
- Participants enrolled: 133
- From 16 Jan 2014 to the primary completion date, 13 Jun 2025
- 23 sites in 7 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Who the study is looking for
- HIV-1 infected, virologically suppressed males and females age ≥ 4 weeks to \< 18 years (according to requirements of enrolling Cohort).
- Body weight at screening ≥ 25 to \< 40 kg (Cohort 2); ≥ 14 to \< 25 kg (Cohort 3); ≥ 3 to \< 25 kg (Cohort 4); ≥ 3 to \< 14 kg (Cohort 5).
- Stable antiretroviral (ARV) regimen for a minimum of 3 months prior to the screening visit.
- Participants enrolled prior to implementation of Amendment 7: 2 nucleoside reverse transcriptase inhibitors (NRTIs) and ritonavir-boosted atazanavir (ATV/r) once daily or ritonavir-boosted darunavir (DRV/r) once daily or twice daily.
- Participants enrolled after the implementation of Amendment 9:
- Cohorts 2, 3 and 4 (Group 1): 2 NRTIs plus a third agent per local prescribing guidelines. Participants will switch from their current third agent to ATV or darunavir (DRV) at Day 1. Participants taking DRV must be on once-daily dosing or must switch to once daily at or prior to Day 1. Cohort 4 (Group 1), participants may also switch their current third agent to lopinavir boosted with ritonavir (LPV/r) at Day 1. Participants will switch their NRTI backbone to emtricitabine/tenofovir alafenamide (coformulated; Descovy®) (F/TAF).
- Cohort 4 (Groups 2 to 4) and Cohort 5 (Groups 1 to 3): 2 NRTIs plus a third agent per local prescribing guidelines or treatment naive. Participants on treatment will switch from their current third agent to ATV or LPV/r (Cohort 4 (Groups 2 to 4)), or to a third unboosted agent (Cohort 5 (Groups 1 to 3)). Participants will switch their NRTI backbone to F/TAF.
- Participants undergoing dose modifications to their ARV regimen for growth or switching medication formulations are considered to be on a stable ARV regimen.
- Documented plasma human immunodeficiency virus type 1 (HIV-1) ribonucleic acid (RNA) for ≥ 3 months preceding the screening visit:
- Participants enrolled after the implementation of Amendment 9:
- For Cohorts 2, 3, and 4 (Group 1), virologically suppressed ≥ 3 months preceding the screening visit: HIV-1 RNA \< 50 copies/mL on a stable regimen (or undetectable HIV-1 RNA level according to the local assay being used if the limit of detection is ≥ 50 copies/mL).
- For Cohorts 4 (Groups 2 to 4) and Cohort 5 (Groups 1 to 3), on an ARV regimen irrespective of plasma HIV-1 RNA copies or treatment naive; a participant is considered treatment naive, if ARVs were given for prevention of mother-to-child transmission but not for HIV treatment.
- For virologically suppressed participants, unconfirmed virologic elevations of HIV-1 RNA ≥ 50 copies/mL (transient detectable viremia, or "blip") prior to screening are acceptable. If the lower limit of detection of the local HIV-1 RNA assay is \< 50 copies/mL (eg, \< 20 copies/mL), the plasma HIV-1 RNA level cannot exceed 50 copies/mL on 2 consecutive HIV-1 RNA tests.
- Adequate renal function: Estimated glomerular filtration rate (eGFR) ≥ 90 mL/min/1.73m2 using the Schwartz formula. If ≥ 1 year old, eGFR greater than or equal to the minimum normal value for age using the Schwartz formula. If \< 1 year old as follows:
- Age minimum value for eGFR (mL/min/1.73 m2) \> 28 days to ≤ 95 days is 30, ≥ 96 days to ≤ 6 months is 39, \> 6 to \< 12 months is 49.
- Participants must not have documented or suspected resistance to applicable study drugs including emtricitabine (Emtriva®) (FTC), TFV, ATV, DRV, or LPV. Participants \< 14 kg (Cohorts 4 (Groups 2 to 4) and 5 (Groups 1 to 3)) with M184V/I AND HIV-1 RNA \< 50 copies/mL will be allowed.
- Positive confirmatory HIV test (confirmatory nucleic acid-based testing if \< 18 months of age).
- Cohort 4 (Groups 2 to 4) and Cohort 5 (Groups 1 to 3): Last dose of nevirapine or efavirenz, if applicable, ≥ 14 days prior to enrollment.
- Note: Other protocol defined Inclusion/Exclusion criteria do apply.
Age in the registry: 4 weeks to 17 years · Sex: All · Does not accept healthy volunteers
Sites (23)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Helios Salud Coordinator of this site? Confirm its status | Buenos Aires | Argentina | Unknown status |
| Hospital General de Agudos Cosme Argerich Coordinator of this site? Confirm its status | Buenos Aires | Argentina | Unknown status |
| Imperial College Healthcare NHS Trust Coordinator of this site? Confirm its status | London | United Kingdom | Unknown status |
| Siriraj Hospital Coordinator of this site? Confirm its status | Bangkok | Thailand | Unknown status |
| HIV-NAT Coordinator of this site? Confirm its status | Bangkok | Thailand | Unknown status |
| Srinagarind Hospital Coordinator of this site? Confirm its status | Khon Kaen | Thailand | Unknown status |
| SICRA-TASO Mulago National Referral Hospital Coordinator of this site? Confirm its status | Kampala | Uganda | Unknown status |
| MU-JHU Research Collaboration/MU-JHU Care Ltd Coordinator of this site? Confirm its status | Kampala | Uganda | Unknown status |
| - Coordinator of this site? Confirm its status | Masaka | Uganda | Unknown status |
| University of Colorado Denver Coordinator of this site? Confirm its status | Aurora | United States | Unknown status |
| University of Texas Health Science Center of Houston Coordinator of this site? Confirm its status | Houston | United States | Unknown status |
| Pediatric Infectious Disease Associates Coordinator of this site? Confirm its status | Long Beach | United States | Unknown status |
| Peter Morton Medical Building Coordinator of this site? Confirm its status | Los Angeles | United States | Unknown status |
| St. Jude Children's Research Hospital Coordinator of this site? Confirm its status | Memphis | United States | Unknown status |
| University of South Florida Coordinator of this site? Confirm its status | Tampa | United States | Unknown status |
| The George Washington University Coordinator of this site? Confirm its status | Washington D.C. | United States | Unknown status |
| University of the Free State Coordinator of this site? Confirm its status | Bloemfontein | South Africa | Unknown status |
| University of Stellenbosch Coordinator of this site? Confirm its status | Cape Town | South Africa | Unknown status |
| King Edward VIII Hospital Coordinator of this site? Confirm its status | Durban | South Africa | Unknown status |
| Rahima Clinical Trials, a Division of Wits Health Consortium (Pty) Ltd Coordinator of this site? Confirm its status | Johannesburg | South Africa | Unknown status |
| The Aurum Institute: Pretoria Clinical Research Centre Coordinator of this site? Confirm its status | Pretoria | South Africa | Unknown status |
| Perinatal HIV Research Unit Coordinator of this site? Confirm its status | Soweto | South Africa | Unknown status |
| University of Zimbabwe Clinical Research Centre Coordinator of this site? Confirm its status | Harare | Zimbabwe | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.