Study of Bictegravir/Emtricitabine/Tenofovir Alafenamide Fixed Dose Combination in Adolescents and Children With Human Immunodeficiency Virus-1
Running, not enrolling · Phase 2/Phase 3
Conditions studied: HIV-1 Infection
In brief
The goals of this clinical study are to learn how Bictegravir/Emtricitabine/Tenofovir Alafenamide fixed dose combination (FDC) interacts with the body, confirm the dose, and also to learn more about the safety and tolerability of Bictegravir/Emtricitabine/Tenofovir Alafenamide FDC in adolescents and children with HIV-1.
Key facts
- Study ID
- NCT02881320
- Run by
- Gilead Sciences
- People needed
- 177
- Starts
- 2016-09-21
- Expected to finish
- 2026-11-01
- Last updated by the study team
- 2026-03-24
Who can join
Age: 0 and older, up to 17. Sex: any. Healthy volunteers: not accepted.
Where it is running
- Children's National Health System — Washington D.C., District of Columbia, United States
- Midway Immunology and Research Center — Ft. Pierce, Florida, United States
- University of Florida Health — Gainesville, Florida, United States
- USF Clinic at Children's Medical Services (study visits and drug storage) — Tampa, Florida, United States
- Grady Health System Ponce Center Family and Youth Clinic — Atlanta, Georgia, United States
- Wayne Pediatric Clinic — Detroit, Michigan, United States
- Bellevue Hospital — New York, New York, United States
- Duke Children's Health Center, Pediatric Infectious Diseases — Durham, North Carolina, United States
- St. Christopher's Hospital for Children/Section of Immunology — Philadelphia, Pennsylvania, United States
- St. Jude Children's Research Hospital — Memphis, Tennessee, United States
- Department of Paediatrics and Child Health — Bloemfontein, South Africa
- Be Part Ypluntu Centre — Cape Town, South Africa
- FAMCRU, Ward J8 — CapeTown, South Africa
- Dr. J Fourie Medical Centre — Dundee, South Africa
- Enhancing Care Foundation, Durban International Clinical Research Site — Durban, South Africa
- Wits RHI Shandukani Research Centre, Wits Reproductive Health & HIV Institute — Johannesburg, South Africa
- Empilweni Service and Research Unit (ESRU) — Johannesburg, South Africa
- VX Pharma(Pty) Ltd — Pretoria, South Africa
- Perinatal HIV Research Unit — Soweto, South Africa
- The HIV Netherlands Australia Thailand Research Collaboration — Bangkok, Thailand
- Faculty of Medicine Siriraj Hospital, Mahidol University — Bangkok, Thailand
- Faculty of Medicine, Khon Kaen University — Khon Kaen, Thailand
- Makerere University, Johns Hopkins (MU-JHU) Research Collaboration — Kampala, Uganda
- Joint Clinical Research Centre — Kampala, Uganda
- Baylor College of Medicine Children's Foundation - Uganda — Kampala, Uganda
Full record on ClinicalTrials.gov
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