Actively Recruiting
A Study to Provide Continued Access to Study Drug to Children and Adolescents Who Have Completed Clinical Studies Involving Gilead HIV Treatments
Led by Gilead Sciences · Updated on 2026-03-16
350
Participants Needed
14
Research Sites
496 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
A Study to Provide Continued Access to Study Drug to Children and Adolescents Who Have Completed Clinical Studies Involving Gilead HIV Treatments
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Completed an applicable parent study: GS-US-292-0106, GS-US-380-1474, GS-US-311-1269, or GS-US-216-0128
- Provided consent to participate in this study
You will not qualify if you...
- Planning to switch to B/F/TAF on Day 1 with plasma HIV RNA 60 50 copies/mL during the last parent study visit prior to screening/Day 1
- Planning to switch after Day 1 with plasma HIV RNA 60 50 copies/mL or detectable HIV-1 RNA level according to local assay
- Planning to switch to B/F/TAF with ongoing Grade 3 or 4 drug-related adverse events or clinically relevant laboratory abnormalities related to B/F/TAF prior to treatment switch
- Previous discontinuation of any component of B/F/TAF due to toxicity or intolerance
- Known hypersensitivity to any component of the study drug, its metabolites, or formulation excipients
- Ongoing treatment with or prior use of any prohibited medications
- Other protocol-defined inclusion/exclusion criteria may apply
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 14 locations
1
Helios Salud
Buenos Aires, Argentina, C1141 ACG
Active, Not Recruiting
2
Hospital del Niño
Panama City, Panama, 0816-00383
Active, Not Recruiting
3
University of Stellenbosch
Cape Town, South Africa, 7505
Actively Recruiting
4
Enhancing Care Foundation
Durban, South Africa, 3629
Actively Recruiting
5
WITS RHI Research Centre
Johannesburg, South Africa, 2038
Actively Recruiting
6
Rahima Moosa Mother and Child Hospital
Johannesburg, South Africa, 2112
Actively Recruiting
7
Be Part Yoluntu Centre
Paarl, South Africa, 7626
Actively Recruiting
8
The Aurun Institute
Pretoria, South Africa, 0087
Actively Recruiting
9
Perinatal HIV Research Unit
Soweto, South Africa, 2013
Actively Recruiting
10
Faculty of Medicine - Mahidol University
Bangkok Noi, Thailand, 10700
Active, Not Recruiting
11
Khon Kaen University
Khon Kaen, Thailand, 40002
Active, Not Recruiting
12
Joint Clinical Research Centre
Kampala, Uganda, 10005
Actively Recruiting
13
Baylor College of Medicine
Kampala, Uganda
Actively Recruiting
14
University of Zimbabwe Clinical Research Centre
Harare, Zimbabwe
Actively Recruiting
Research Team
G
Gilead Clinical Study Information Center
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
4
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