HIV pill biktarvy tested in kids: a step toward better treatment?

NCT ID NCT02881320

Ongoing Disease control Sponsor: Gilead Sciences Source: ClinicalTrials.gov ↗

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study is testing the HIV medication Biktarvy (a combination of three drugs) in adolescents and children who have HIV-1. The goal is to see how the drug works in younger bodies, confirm the right dose, and check for side effects. About 177 participants will take the pill once daily, and researchers will monitor virus levels and safety over several weeks.

What this could mean

Our plain-language read of the trial. This is informational only — not medical advice or a prediction.

Active substance: Bictegravir/Emtricitabine/Tenofovir Alafenamide (Biktarvy)
What this could lead to: If successful, this study could confirm that Biktarvy is a safe and effective once-daily treatment option for children and teens living with HIV.
What could go wrong: This is an open-label study without a placebo group, so results may be less definitive. Side effects are possible, and long-term effects in younger populations are still being studied.

This is an AI summary of the original study and may miss details. Read our disclaimer.

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Conditions

The condition(s) this trial relates to.

HIV infectious disease

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

HIV-1-INFECTION

Contacts and locations

Locations

Baylor College of Medicine Children's Foundation - Uganda

Kampala, Uganda
Be Part Ypluntu Centre

Cape Town, 7646, South Africa
Bellevue Hospital

New York, New York, 10016, United States
Children's National Health System

Washington D.C., District of Columbia, 20010, United States
Department of Paediatrics and Child Health

Bloemfontein, 9301, South Africa
Dr. J Fourie Medical Centre

Dundee, 3000, South Africa
Duke Children's Health Center, Pediatric Infectious Diseases

Durham, North Carolina, 27710, United States
Empilweni Service and Research Unit (ESRU)

Johannesburg, 2112, South Africa
Enhancing Care Foundation, Durban International Clinical Research Site

Durban, 4302, South Africa
FAMCRU, Ward J8

CapeTown, 7505, South Africa
Faculty of Medicine Siriraj Hospital, Mahidol University

Bangkok, 10700, Thailand
Faculty of Medicine, Khon Kaen University

Khon Kaen, 40002, Thailand
Grady Health System Ponce Center Family and Youth Clinic

Atlanta, Georgia, 30322, United States
Joint Clinical Research Centre

Kampala, 10005, Uganda
Makerere University, Johns Hopkins (MU-JHU) Research Collaboration

Kampala, 0000, Uganda
Midway Immunology and Research Center

Ft. Pierce, Florida, 34982, United States
Perinatal HIV Research Unit

Soweto, 2013, South Africa
St. Christopher's Hospital for Children/Section of Immunology

Philadelphia, Pennsylvania, 19134, United States
St. Jude Children's Research Hospital

Memphis, Tennessee, 38105, United States
The HIV Netherlands Australia Thailand Research Collaboration

Bangkok, 10330, Thailand
USF Clinic at Children's Medical Services (study visits and drug storage)

Tampa, Florida, 33606, United States
University of Florida Health

Gainesville, Florida, 32209, United States
VX Pharma(Pty) Ltd

Pretoria, 0087, South Africa
Wayne Pediatric Clinic

Detroit, Michigan, 48201, United States
Wits RHI Shandukani Research Centre, Wits Reproductive Health & HIV Institute

Johannesburg, 2038, South Africa

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