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Study of Bictegravir/Emtricitabine/Tenofovir Alafenamide Fixed Dose Combination in Adolescents and Children With Human Immunodeficiency Virus-1
Sponsor: Gilead Sciences
Summary
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.
Official title: A Phase 2/3, Open-Label Study of the Pharmacokinetics, Safety, and Antiviral Activity of the GS-9883/Emtricitabine/Tenofovir Alafenamide (GS-9883/F/TAF) Fixed Dose Combination (FDC) in HIV-1 Infected Adolescents and Children
Key Details
Gender
All
Age Range
1 Month - 17 Years
Study Type
INTERVENTIONAL
Enrollment
177
Start Date
2016-09-21
Completion Date
2026-11
Last Updated
2026-03-24
Healthy Volunteers
No
Conditions
Interventions
B/F/TAF (Adult Strength)
50/200/25 mg FDC tablets administered orally once daily without regard to food.
B/F/TAF (Low Dose)
30/120/15 mg FDC tablets administered orally once daily without regard to food.
B/F/TAF (TOS)
2 x B/F/TAF 15/60/7.5 mg (total daily dose 30/120/15 mg) FDC tablets administered orally as TOS, once daily.
B/F/TAF (TOS)
2 x B/F/TAF 3.75/15/1.88 mg (total daily dose 15/60/7.52 mg) FDC tablets administered orally as TOS, twice daily.
B/F/TAF (TOS)
1 x B/F/TAF 3.75/15/1.88 mg (total daily dose 7.5/30/3.76 mg) FDC tablets administered orally as TOS, twice daily.
B/F/TAF (TOS)
1 x B/F/TAF 1.88/7.5/0.94 mg (total daily dose 3.76/15/1.88 mg) FDC tablets administered orally as TOS, twice daily
Locations (25)
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