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

NCT ID NCT02881320

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

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2/3

Runs two stages together: whether the treatment works, then large-scale confirmation.

Participants

177 people

The number who actually took part.

Started

Sep 2016

Expected to finish

Nov 2026

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

1 month to 17 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Key Inclusion Criteria: Cohort 1: HIV-1 infected adolescents (12 to \< 18 years of age and screening weight ≥ 35 kg) who are virologically suppressed for ≥ 6 months prior to screening. Cohort 2: HIV-1 infected children (6 to \< 12 years of age and screening weight ≥ 25 kg) who are virologically suppressed for ≥ 6 months prior to screening. Cohort 3: HIV-1 infected children (≥ 2 years of age and screening weight of ≥ 14 to \< 25 kg) who are virologically suppressed for ≥ 6 months prior to screening. Cohort 4 Group 1: HIV-1 infected children (≥ 2 years of age and screening weight of ≥ 14 to \< 25 kg) who are virologically suppressed for ≥ 6 months prior to screening and unable to swallow tablets. * Documented plasma HIV-1 ribonucleic acid (RNA) \< 50 copies/mL on a stable regimen (or undetectable HIV-1 RNA level according to the local assay being used if the limit of detection is ≥ 50 copies/mL) for ≥ 6 months preceding the Screening visit. Unconfirmed virologic elevations of ≥ 50 copies/mL (transient detectable viremia, or "blip") prior to screening are acceptable. If the lower limit of detection of the local HIV-1 RNA assay is \< 50 copies/mL (eg, \< 20 copies/mL), the plasma HIV-1 RNA level cannot exceed 50 copies/mL on two consecutive HIV-1 RNA tests. * Stable antiretroviral regimen of 2 nucleoside reverse transcriptase inhibitors (NRTIs) in combination with a third agent for a minimum of 6 months prior to the screening visit. Individuals undergoing dose modifications to their antiretroviral regimen for growth or who are switching medication formulation(s) are considered to be on a stable antiretroviral regimen. * Estimated glomerular filtration rate (eGFR) ≥ 90 mL/min/1.73 m\^2 according to the Schwartz Formula. * No documented or suspected resistance to emtricitabine (FTC), tenofovir (TFV), or integrase strand transfer inhibitors (INSTIs) including, but not limited to, the reverse transcriptase resistance mutations K65R and M184V/I. Cohort 4 Group 2-4: HIV-1 infected children (≥ 1 month of age and screening weight of ≥ 3 to \< 14 kg) who are treatment naive or on antiretroviral (ARV) treatment for ≥ 1 month prior to screening. * Positive confirmatory HIV test (confirmatory nucleic acid-based testing if \< 18 months of age). * On a stable ARV regimen for ≥ 1 month or treatment naive (Individual is considered treatment naive if ARVs were given for prevention of mother-to-child transmission but not for HIV treatment). * For \< 1 year of age, eGFR ≥ the minimum normal values for age according to the information below using the Schwartz Formula, * 30 mL/min/1.73 m\^2 for age \> 4 weeks to ≤ 95 days. * 39 mL/min/1.73 m\^2 for age ≥ 96 days to ≤ 6 months. * 49 mL/min/1.73 m\^2 for age \> 6 months to \< 12 months. * For ≥ 1 year of age, eGFR ≥ 90 mL/min/1.73 m\^2 using the Schwartz Formula. * No documented or suspected resistance to FTC, TFV, or INSTIs including, but not limited to, the reverse transcriptase resistance mutation K65R. * For individuals \< 14 kg, M184V/I AND HIV-1 RNA \< 50 copies/mL will be allowed. Individuals with HIV-1 RNA \> 50 copies/mL should not have FTC, TFV, or INSTI resistance mutations. * Last dose of nevirapine (NVP) or efavirenz (EFV), if applicable, ≥ 14 days prior to enrollment. Note: Other protocol defined Inclusion/Exclusion criteria may apply.

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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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