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
Status: Recruiting
Location: See all (12) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
SUMMARY
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 1 month
Healthy Volunteers: f
View:
• Completed an applicable parent study: GS-US-292-0106, GS-US-380-1474, GS-US-311-1269, GS-US-216-0128, or CO-US-380-5578 and gave consent to study participation.
Locations
Other Locations
Argentina
Helios Salud
RECRUITING
Buenos Aires
Panama
Hospital del Niño
RECRUITING
Panama City
South Africa
University of Stellenbosch
RECRUITING
Cape Town
Enhancing Care Foundation
RECRUITING
Durban
Rahima Moosa Mother and Child Hospital
RECRUITING
Johannesburg
Be Part Yoluntu Centre
RECRUITING
Paarl
The Aurun Institute
RECRUITING
Pretoria
Perinatal HIV Research Unit
RECRUITING
Soweto
Thailand
Faculty of Medicine - Mahidol University
RECRUITING
Bangkok Noi
Khon Kaen University
RECRUITING
Khon Kaen
Uganda
Joint Clinical Research Centre
RECRUITING
Kampala
Zimbabwe
University of Zimbabwe Clinical Research Centre
RECRUITING
Harare
Contact Information
Primary
Gilead Clinical Study Information Center
GileadClinicalTrials@gilead.com
1-833-445-3230 (GILEAD-0)
Time Frame
Start Date: 2024-08-27
Estimated Completion Date: 2034-03
Participants
Target number of participants: 350
Treatments
Experimental: Rollover from Parent Study: GS-US-311-1269: Parent Study Drug (F/TAF) or B/F/TAF
Participants will continue to take the study drug they were taking in the parent study, emtricitabine/tenofovir alafenamide (F/TAF) along with a 3rd antiretroviral (ARV) agent. The dose of F/TAF will be based on the weight of the participant, ranging between 120/15 mg to 200/25 mg. The dose of F/TAF will be different when given with the boosted and the unboosted 3rd ARV agent: F/TAF (High Dose Tablet) for unboosted 3rd ARV agent; F/TAF (Low Dose Tablet) for the boosted 3rd ARV agent.~Participants may switch to B/F/TAF, at a dose based on participant's weight.
Experimental: Rollover from Parent Study: GS-US-292-0106: Parent Study Drug (E/C/F/TAF) or B/F/TAF
Participants will continue to take the study drug they were taking in the parent study, elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (E/C/F/TAF). The dose of E/C/F/TAF will be based on the weight of the participant, ranging between 90/90/120/6 mg to 150/150/200/10 mg.~Participants may switch to B/F/TAF at a dose based on participant's weight.
Experimental: Rollover Parent Study GS-US-216-0128: Parent Study Drug (Combination Drugs) or B/F/TAF
Participants will continue to take the following study drugs they were taking in the parent study:~* Cobicistat (COBI) + DRV + NRTI backbone~* COBI + ATV + NRTI backbone~* F/TAF + DRV+ COBI~* F/TAF + ATV+ COBI~* F/TAF + LPV/r~* F/TAF + 3rd unboosted agent~The dose of F/TAF will be based on the weight of the participant, ranging between 15/1.88 mg and 200/25 mg, once daily. Additionally, the dose of COBI will be based on the weight of the participant, ranging between 30 mg and 150 mg, once or twice daily.~Participants may switch to B/F/TAF at a dose based on participant's weight.
Experimental: Rollover from Parent Studies: GS-US-380-1474 and CO-US-380-5578: Parent Study Drug (B/F/TAF)
Participants will continue to take the study drug they were taking in the parent study, B/F/TAF. Participants who are diagnosed with HIV-1 infection in parent study CO-US-380-5578 and complete the study drug will continue to take the study drug they were taking in the parent study, B/F/TAF. The dose of B/F/TAF will be based on the weight of the participant.
Related Therapeutic Areas
Sponsors
Leads: Gilead Sciences