NCT06337032RecruitingPhase 4
A Study to Provide Continued Access to Study Drug to Children and Adolescents Who Have Completed Clinical Studies Involving Gilead HIV Treatments
An Open-label, Single-arm Study to Provide Continued Access to Study Drug to Participants Who Have Completed Pediatric Clinical Studies Involving Gilead HIV Treatments
Source: ClinicalTrials.gov · Last updated 19 Oct 2026
Brief summary (registry, in English)
The goal of this clinical study is to provide continued access to the study drug(s) to children and adolescents with human immunodeficiency virus type 1 (HIV-1) who completed their participation in an applicable parent study and to monitor for adverse events. The primary objectives of this study are as follows: * To provide continued access to the study drug received in the parent protocol or switch to bictegravir/emtricitabine/tenofovir (B/F/TAF) for participants who completed a Gilead parent study evaluating drugs for HIV treatment. * To evaluate the safety of the study drug(s) in participants with HIV-1.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 350 (estimated)
- First submitted
- 22 Mar 2024
- Start date
- 27 Aug 2024
- Primary completion date
- 30 Jun 2027
- Lead sponsor
- Gilead Sciences
- Diseases
- HIV
- NCT number
- NCT06337032
- EudraCT number
- 2024-000521-40
What you commit to
- Study type: Interventional · Phase 4
- Planned participants: 350
- From 27 Aug 2024 to the primary completion date, 30 Jun 2027
- 15 sites in 6 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.
Prior treatment
- Individuals planning to switch to B/F/TAF on Day 1 with plasma HIV RNA ≥ 50 copies/mL during the last parent study visit prior to screening/Day 1 visit.
- Note: individuals planning to switch after Day 1 must not have plasma HIV RNA ≥ 50 copies/mL (or detectable HIV-1 RNA level according to the local assay being used if the limit of detection is ≥ 50 copies/mL).
- For those on B/F/TAF or planning to switch to B/F/TAF: previous treatment discontinuation of any component of B/F/TAF due to toxicity or intolerance.
- Ongoing treatment with or prior use of any prohibited medications.
- Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Other illness
- For those planning to switch to B/F/TAF: known hypersensitivity to any component of the study drug, its metabolites, or formulation excipients.
Lab values
- Individuals planning to switch to B/F/TAF with any ongoing Grade 3 or 4 drug-related AE or clinically relevant Grade 3 or 4 drug-related laboratory abnormality (confirmed on repeat) related to any component of B/F/TAF prior to treatment switch.
Who the study is looking for
- Completed an applicable parent study: GS-US-292-0106, GS-US-380-1474, GS-US-311-1269, or GS-US-216-0128, and gave consent to study participation.
Age in the registry: 1 month to - · Sex: All · Does not accept healthy volunteers
Sites (15)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Helios Salud Coordinator of this site? Confirm its status | Buenos Aires | Argentina | Completed |
| Hospital del Niño Coordinator of this site? Confirm its status | Panama City | Panama | Completed |
| Faculty of Medicine - Mahidol University Coordinator of this site? Confirm its status | Bangkok Noi | Thailand | Active, not recruiting |
| Khon Kaen University Coordinator of this site? Confirm its status | Khon Kaen | Thailand | Active, not recruiting |
| Baylor College of Medicine Coordinator of this site? Confirm its status | Kampala | Uganda | Recruiting |
| Joint Clinical Research Centre Coordinator of this site? Confirm its status | Kampala | Uganda | Recruiting |
| MU-JHU Research Collaboration/MU-JHU Care Ltd Coordinator of this site? Confirm its status | Kampala | Uganda | Recruiting |
| University of Stellenbosch Coordinator of this site? Confirm its status | Cape Town | South Africa | Recruiting |
| Enhancing Care Foundation Coordinator of this site? Confirm its status | Durban | South Africa | Recruiting |
| WITS RHI Research Centre Coordinator of this site? Confirm its status | Johannesburg | South Africa | Recruiting |
| Rahima Moosa Mother and Child Hospital Coordinator of this site? Confirm its status | Johannesburg | South Africa | Recruiting |
| Be Part Yoluntu Centre Coordinator of this site? Confirm its status | Paarl | South Africa | Recruiting |
| The Aurun Institute Coordinator of this site? Confirm its status | Pretoria | South Africa | Recruiting |
| Perinatal HIV Research Unit Coordinator of this site? Confirm its status | Soweto | South Africa | Recruiting |
| University of Zimbabwe Clinical Research Centre Coordinator of this site? Confirm its status | Harare | Zimbabwe | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.