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ACTIVE NOT RECRUITING
NCT02881320
PHASE2/PHASE3

Study of Bictegravir/Emtricitabine/Tenofovir Alafenamide Fixed Dose Combination in Adolescents and Children With Human Immunodeficiency Virus-1

Sponsor: Gilead Sciences

View on ClinicalTrials.gov

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

DRUG

B/F/TAF (Adult Strength)

50/200/25 mg FDC tablets administered orally once daily without regard to food.

DRUG

B/F/TAF (Low Dose)

30/120/15 mg FDC tablets administered orally once daily without regard to food.

DRUG

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.

DRUG

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.

DRUG

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.

DRUG

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