Actively Recruiting
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
Led by Gilead Sciences · Updated on 2026-03-16
350
Participants Needed
14
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to provide ongoing access to HIV treatment drugs for children and adolescents who have finished participating in previous Gilead clinical studies for HIV-1 infection. The main goals are to allow these participants to continue their study medication or switch to a specific combination drug called bictegravir/emtricitabine/tenofovir (B/F/TAF) and to monitor the safety of these drugs in young people living with HIV-1. Participants will either continue taking the study drug they used in their previous parent study or switch to B/F/TAF based on their weight. The study drugs include various doses of emtricitabine/tenofovir alafenamide (F/TAF), elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (E/C/F/TAF), combinations including cobicistat, darunavir, atazanavir, lopinavir, and other third antiretroviral agents. Dosing varies according to the participant's weight and the combination of drugs used. During the study, participants will be closely monitored for adverse events and safety concerns over up to 9.5 years. The research team will track how many eligible participants receive access to the study drugs and the percentage experiencing treatment-emergent adverse events. Participants will have regular assessments to ensure continued safety while on the study medication, supporting long-term monitoring of treatment effects and tolerability.
CONDITIONS
Brief 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
- Age 1 month or older
You will not qualify if you...
- Planning to switch to B/F/TAF on Day 1 with plasma HIV RNA 65 50 copies/mL during the last parent study visit before screening/Day 1
- Planning to switch to B/F/TAF after Day 1 with plasma HIV RNA 65 50 copies/mL or detectable HIV-1 RNA if detection limit is 65 50 copies/mL
- Planning to switch to B/F/TAF with ongoing Grade 3 or 4 drug-related adverse events or clinically relevant Grade 3 or 4 drug-related lab abnormalities
- Previous treatment discontinuation of any B/F/TAF component due to toxicity or intolerance
- Known hypersensitivity to any component of the study drug or its ingredients
- Ongoing treatment with or prior use of any prohibited medications
AI-Screening
AI-Powered Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 9.5 years
Participants continue to take the study drug from their parent study, which may include various dosages of F/TAF, E/C/F/TAF, B/F/TAF, or combination drugs along with a 3rd antiretroviral agent as prescribed by their investigator. Participants may switch to B/F/TAF at a dose based on their weight.
Visits occur regularly throughout treatment as per study protocol
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
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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