A Study to Provide Continued Access to Study Drug to Children and Adolescents Who Have Completed Clinical Studies Involving Gilead HIV Treatments

Last updated: March 13, 2026
Sponsor: Gilead Sciences
Overall Status: Active - Recruiting

Phase

4

Condition

N/A

Treatment

F/TAF (Low Dose Tablet)

DRV

E/C/F/TAF (Low Dose)

Clinical Study ID

NCT06337032
GS-US-380-6684
2024-000521-40
  • Ages > 1
  • All Genders

Study Summary

The goal of this clinical study is to provide continued access to the study drug(s) to children and adolescents with human immunodeficiency virus type 1 (HIV-1) who completed their participation in an applicable parent study and to monitor for adverse events.

The primary objectives of this study are as follows:

  • To provide continued access to the study drug received in the parent protocol or switch to bictegravir/emtricitabine/tenofovir (B/F/TAF) for participants who completed a Gilead parent study evaluating drugs for HIV treatment.

  • To evaluate the safety of the study drug(s) in participants with HIV-1.

Eligibility Criteria

Inclusion

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.

Exclusion

Key Exclusion Criteria:

  • Individuals planning to switch to B/F/TAF on Day 1 with plasma HIV RNA ≥ 50copies/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 beingused 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-relatedAE 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 treatmentdiscontinuation 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 ofthe 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.

Study Design

Total Participants: 350
Treatment Group(s): 21
Primary Treatment: F/TAF (Low Dose Tablet)
Phase: 4
Study Start date:
August 27, 2024
Estimated Completion Date:
March 31, 2034

Connect with a study center

  • Helios Salud

    Buenos Aires, C1141 ACG
    Argentina

    Site Not Available

  • Helios Salud

    Buenos Aires 3435910, C1141 ACG
    Argentina

    Site Not Available

  • Hospital del Niño

    Panama City, 0816-00383
    Panama

    Site Not Available

  • Hospital del Niño

    Panama City 3703443, 0816-00383
    Panama

    Site Not Available

  • University of Stellenbosch

    Cape Town, 7505
    South Africa

    Active - Recruiting

  • University of Stellenbosch

    Cape Town 3369157, 7505
    South Africa

    Site Not Available

  • Enhancing Care Foundation

    Durban, 3629
    South Africa

    Active - Recruiting

  • Enhancing Care Foundation

    Durban 1007311, 3629
    South Africa

    Site Not Available

  • Rahima Moosa Mother and Child Hospital

    Johannesburg, 2112
    South Africa

    Active - Recruiting

  • WITS RHI Research Centre

    Johannesburg, 2038
    South Africa

    Active - Recruiting

  • Rahima Moosa Mother and Child Hospital

    Johannesburg 993800, 2112
    South Africa

    Site Not Available

  • WITS RHI Research Centre

    Johannesburg 993800, 2038
    South Africa

    Active - Recruiting

  • Be Part Yoluntu Centre

    Paarl, 7626
    South Africa

    Active - Recruiting

  • Be Part Yoluntu Centre

    Paarl 3363094, 7626
    South Africa

    Site Not Available

  • The Aurun Institute

    Pretoria, 0087
    South Africa

    Active - Recruiting

  • The Aurun Institute

    Pretoria 964137, 0087
    South Africa

    Site Not Available

  • Perinatal HIV Research Unit

    Soweto, 2013
    South Africa

    Active - Recruiting

  • Perinatal HIV Research Unit

    Soweto 953781, 2013
    South Africa

    Site Not Available

  • Faculty of Medicine - Mahidol University

    Bangkok Noi, 10700
    Thailand

    Site Not Available

  • Faculty of Medicine - Mahidol University

    Bangkok Noi 1619460, 10700
    Thailand

    Site Not Available

  • Khon Kaen University

    Khon Kaen, 40002
    Thailand

    Site Not Available

  • Khon Kaen University

    Khon Kaen 1609776, 40002
    Thailand

    Site Not Available

  • Baylor College of Medicine

    Kampala,
    Uganda

    Active - Recruiting

  • Joint Clinical Research Centre

    Kampala, 10005
    Uganda

    Active - Recruiting

  • Baylor College of Medicine

    Kampala 232422,
    Uganda

    Active - Recruiting

  • Joint Clinical Research Centre

    Kampala 232422, 10005
    Uganda

    Site Not Available

  • University of Zimbabwe Clinical Research Centre

    Harare,
    Zimbabwe

    Active - Recruiting

  • University of Zimbabwe Clinical Research Centre

    Harare 890299,
    Zimbabwe

    Site Not Available

Map preview placeholder

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.