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Kids with HIV get continued access to lifesaving meds in new study

NCT ID NCT06337032

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 study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Sep 10, 2026 · Updated 2 times

Summary

This study offers continued access to HIV medications for children and adolescents who completed a previous Gilead HIV treatment study. About 350 participants will receive their study drug or switch to a standard HIV medication, and researchers will monitor for side effects. The goal is to ensure uninterrupted treatment and track safety.

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 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

About 350 people

The number the study aims to enrol. It can still change while the study runs.

Started

Aug 2024

Expected to finish

Mar 2034

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 and older

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: * Completed an applicable parent study: GS-US-292-0106, GS-US-380-1474, GS-US-311-1269, or GS-US-216-0128, and gave consent to study participation. Key Exclusion Criteria: * Individuals planning to switch to B/F/TAF on Day 1 with plasma HIV RNA ≥ 50 copies/mL during the last parent study visit prior to screening/Day 1 visit. * Note: individuals planning to switch after Day 1 must not have plasma HIV RNA ≥ 50 copies/mL (or detectable HIV-1 RNA level according to the local assay being used if the limit of detection is ≥ 50 copies/mL). * Individuals planning to switch to B/F/TAF with any ongoing Grade 3 or 4 drug-related AE or clinically relevant Grade 3 or 4 drug-related laboratory abnormality (confirmed on repeat) related to any component of B/F/TAF prior to treatment switch. * For those on B/F/TAF or planning to switch to B/F/TAF: previous treatment discontinuation of any component of B/F/TAF due to toxicity or intolerance. * For those planning to switch to B/F/TAF: known hypersensitivity to any component of the study drug, its metabolites, or formulation excipients. * Ongoing treatment with or prior use of any prohibited medications. 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

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    11 sites in 3 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Baylor College of Medicine

    RECRUITING

    Kampala, Uganda

  • Be Part Yoluntu Centre

    RECRUITING

    Paarl, 7626, South Africa

  • Enhancing Care Foundation

    RECRUITING

    Durban, 3629, South Africa

  • Faculty of Medicine - Mahidol University

    ACTIVE_NOT_RECRUITING

    Bangkok Noi, 10700, Thailand

  • Helios Salud

    COMPLETED

    Buenos Aires, C1141 ACG, Argentina

  • Hospital del Niño

    COMPLETED

    Panama City, 0816-00383, Panama

  • Joint Clinical Research Centre

    RECRUITING

    Kampala, 10005, Uganda

  • Khon Kaen University

    ACTIVE_NOT_RECRUITING

    Khon Kaen, 40002, Thailand

  • MU-JHU Research Collaboration/MU-JHU Care Ltd

    RECRUITING

    Kampala, 256, Uganda

  • Perinatal HIV Research Unit

    RECRUITING

    Soweto, 2013, South Africa

  • Rahima Moosa Mother and Child Hospital

    RECRUITING

    Johannesburg, 2112, South Africa

  • The Aurun Institute

    RECRUITING

    Pretoria, 0087, South Africa

  • University of Stellenbosch

    RECRUITING

    Cape Town, 7505, South Africa

  • University of Zimbabwe Clinical Research Centre

    RECRUITING

    Harare, Zimbabwe

  • WITS RHI Research Centre

    RECRUITING

    Johannesburg, 2038, South Africa

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Other studies related to the condition(s) this trial covers.