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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

Full criteria on ClinicalTrials.gov

Sites (15)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Helios Salud
Coordinator of this site? Confirm its status
Buenos AiresArgentinaCompleted
Hospital del Niño
Coordinator of this site? Confirm its status
Panama CityPanamaCompleted
Faculty of Medicine - Mahidol University
Coordinator of this site? Confirm its status
Bangkok NoiThailandActive, not recruiting
Khon Kaen University
Coordinator of this site? Confirm its status
Khon KaenThailandActive, not recruiting
Baylor College of Medicine
Coordinator of this site? Confirm its status
KampalaUgandaRecruiting
Joint Clinical Research Centre
Coordinator of this site? Confirm its status
KampalaUgandaRecruiting
MU-JHU Research Collaboration/MU-JHU Care Ltd
Coordinator of this site? Confirm its status
KampalaUgandaRecruiting
University of Stellenbosch
Coordinator of this site? Confirm its status
Cape TownSouth AfricaRecruiting
Enhancing Care Foundation
Coordinator of this site? Confirm its status
DurbanSouth AfricaRecruiting
WITS RHI Research Centre
Coordinator of this site? Confirm its status
JohannesburgSouth AfricaRecruiting
Rahima Moosa Mother and Child Hospital
Coordinator of this site? Confirm its status
JohannesburgSouth AfricaRecruiting
Be Part Yoluntu Centre
Coordinator of this site? Confirm its status
PaarlSouth AfricaRecruiting
The Aurun Institute
Coordinator of this site? Confirm its status
PretoriaSouth AfricaRecruiting
Perinatal HIV Research Unit
Coordinator of this site? Confirm its status
SowetoSouth AfricaRecruiting
University of Zimbabwe Clinical Research Centre
Coordinator of this site? Confirm its status
HarareZimbabweRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.