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A Study to Provide Continued Access to Study Drug to Children and Adolescents Who Have Completed Clinical Studies Involving Gilead HIV Treatments
Sponsor: Gilead Sciences
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.
Official title: 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
Key Details
Gender
All
Age Range
1 Month - Any
Study Type
INTERVENTIONAL
Enrollment
350
Start Date
2024-08-27
Completion Date
2034-03
Last Updated
2026-03-16
Healthy Volunteers
No
Conditions
Interventions
F/TAF (High Dose Tablet)
200/25 mg fixed-dose combination (FDC) tablet administered orally
F/TAF (Low Dose Tablet)
200/10 mg FDC tablet administered orally
F/TAF (Lowest Dose Tablet)
120/15 mg FDC tablet administered orally
F/TAF (High Dose TOS)
60/7.5 mg tablet for oral suspension (TOS) administered orally
F/TAF (Low Dose TOS)
30/3.75 mg TOS administered orally
F/TAF (Lowest Dose TOS)
15/1.88 mg TOS administered orally
E/C/F/TAF
150/150/200/10 mg tablet administered orally
E/C/F/TAF (Low Dose)
90/90/120/6 mg tablet administered orally
Cobicistat (High Dose)
150 mg tablet administered orally
Cobicistat (Low Dose)
90 mg tablet administered orally
Cobicistat (TOS)
30 mg TOS administered orally
B/F/TAF (High Dose)
50/200/25 mg FDC tablet administered orally
B/F/TAF (Low Dose)
30/120/15 mg FDC tablet administered orally
B/F/TAF (High Dose TOS)
15/60/7.52 mg TOS administered orally
B/F/TAF (Low Dose TOS)
7.5/30/3.76 mg TOS administered orally
B/F/TAF (Lowest Dose TOS)
3.76/15/1.88 mg TOS administered orally
3rd ARV Agent
A 3rd antiretroviral (ARV) agent administered as defined by the investigator, according to the prescribing information. A 3rd ARV agent may include: boosted atazanavir (ATV), boosted lopinavir (LPV/r), boosted darunavir (DRV), unboosted efavirenz (EFV), unboosted nevirapine (NVP), unboosted raltegravir (RAL), or unboosted dolutegravir (DTG), or any other unspecified agent that is available in a participant's country
Nucleos(t)ide reverse transcriptase inhibitors (NRTI)
NRTIs administered as defined by the investigator, according to the prescribing information. NRTIs may include zidovudine (ZDV), stavudine (d4T), didanosine (ddI), abacavir (ABC), tenofovir disoproxil fumarate (TDF), tenofovir alafenamide (TAF), lamivudine (3TC), or emtricitabine (FTC)
ATV
Administered according to the prescribing information
DRV
Administered according to the prescribing information
Lopinavir Boosted with ritonavir (LPV/r)
Administered according to the prescribing information
Locations (14)
Helios Salud
Buenos Aires, Argentina
Hospital del Niño
Panama City, Panama
University of Stellenbosch
Cape Town, South Africa
Enhancing Care Foundation
Durban, South Africa
WITS RHI Research Centre
Johannesburg, South Africa
Rahima Moosa Mother and Child Hospital
Johannesburg, South Africa
Be Part Yoluntu Centre
Paarl, South Africa
The Aurun Institute
Pretoria, South Africa
Perinatal HIV Research Unit
Soweto, South Africa
Faculty of Medicine - Mahidol University
Bangkok Noi, Thailand
Khon Kaen University
Khon Kaen, Thailand
Joint Clinical Research Centre
Kampala, Uganda
Baylor College of Medicine
Kampala, Uganda
University of Zimbabwe Clinical Research Centre
Harare, Zimbabwe