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

Last updated: February 26, 2025
Sponsor: Gilead Sciences
Overall Status: Active - Recruiting

Phase

4

Condition

N/A

Treatment

Lopinavir Boosted with ritonavir (LPV/r)

F/TAF (Lowest Dose TOS)

Cobicistat (High Dose)

Clinical Study ID

NCT06337032
GS-US-380-6684
  • 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, GS-US-216-0128, or CO-US-380-5578 and gave consent to studyparticipation.

Exclusion

Key Exclusion Criteria:

  • Individuals planning to switch to B/F/TAF on Day 1 cannot have 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 must not have any ongoing Grade 3 or 4drug-related AE or clinically relevant Grade 3 or 4 drug-related laboratoryabnormality (confirmed on repeat) related to any component of B/F/TAF prior totreatment 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: Lopinavir Boosted with ritonavir (LPV/r)
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

    Active - Recruiting

  • Hospital del Niño

    Panama City, 0816-00383
    Panama

    Active - Recruiting

  • University of Stellenbosch

    Cape Town, 7505
    South Africa

    Active - Recruiting

  • Enhancing Care Foundation

    Durban, 3629
    South Africa

    Active - Recruiting

  • Rahima Moosa Mother and Child Hospital

    Johannesburg, 2112
    South Africa

    Active - Recruiting

  • Be Part Yoluntu Centre

    Paarl, 7626
    South Africa

    Active - Recruiting

  • The Aurun Institute

    Pretoria, 0087
    South Africa

    Active - Recruiting

  • Perinatal HIV Research Unit

    Soweto, 2013
    South Africa

    Active - Recruiting

  • Faculty of Medicine - Mahidol University

    Bangkok Noi, 10700
    Thailand

    Active - Recruiting

  • Khon Kaen University

    Khon Kaen, 40002
    Thailand

    Active - Recruiting

  • Joint Clinical Research Centre

    Kampala, 10005
    Uganda

    Active - Recruiting

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