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RECRUITING Phase 4 ClinicalTrials.gov

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

Sponsor: Gilead Sciences • ClinicalTrials.gov ID: NCT06337032

Registry updated: 2026-10-19
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Description

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.

Interventions

  • F/TAF (High Dose Tablet) (Drug)
    200/25 mg fixed-dose combination (FDC) tablet administered orally
  • F/TAF (Low Dose Tablet) (Drug)
    200/10 mg FDC tablet administered orally
  • F/TAF (Lowest Dose Tablet) (Drug)
    120/15 mg FDC tablet administered orally
  • F/TAF (High Dose TOS) (Drug)
    60/7.5 mg tablet for oral suspension (TOS) administered orally
  • F/TAF (Low Dose TOS) (Drug)
    30/3.75 mg TOS administered orally
  • F/TAF (Lowest Dose TOS) (Drug)
    15/1.88 mg TOS administered orally
  • E/C/F/TAF (Drug)
    150/150/200/10 mg tablet administered orally
  • E/C/F/TAF (Low Dose) (Drug)
    90/90/120/6 mg tablet administered orally
  • Cobicistat (High Dose) (Drug)
    150 mg tablet administered orally
  • Cobicistat (Low Dose) (Drug)
    90 mg tablet administered orally
  • Cobicistat (TOS) (Drug)
    30 mg TOS administered orally
  • B/F/TAF (High Dose) (Drug)
    50/200/25 mg FDC tablet administered orally
  • B/F/TAF (Low Dose) (Drug)
    30/120/15 mg FDC tablet administered orally
  • B/F/TAF (High Dose TOS) (Drug)
    15/60/7.52 mg TOS administered orally
  • B/F/TAF (Low Dose TOS) (Drug)
    7.5/30/3.76 mg TOS administered orally
  • B/F/TAF (Lowest Dose TOS) (Drug)
    3.76/15/1.88 mg TOS administered orally
  • 3rd ARV Agent (Drug)
    A 3rd antiretroviral (ARV) agent administered as defined by the investigator, according to the prescribing information. A 3rd ARV agent may include: boosted atazanavir (ATV), boosted lopinavir (LPV/r), boosted darunavir (DRV), unboosted efavirenz (EFV), unboosted nevirapine (NVP), unboosted raltegravir (RAL), or unboosted dolutegravir (DTG), or any other unspecified agent that is available in a participant's country
  • Nucleos(t)ide reverse transcriptase inhibitors (NRTI) (Drug)
    NRTIs administered as defined by the investigator, according to the prescribing information. NRTIs may include zidovudine (ZDV), stavudine (d4T), didanosine (ddI), abacavir (ABC), tenofovir disoproxil fumarate (TDF), tenofovir alafenamide (TAF), lamivudine (3TC), or emtricitabine (FTC)
  • ATV (Drug)
    Administered according to the prescribing information
  • DRV (Drug)
    Administered according to the prescribing information
  • Lopinavir Boosted with ritonavir (LPV/r) (Drug)
    Administered according to the prescribing information

Eligibility criteria

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.

Conditions

HIV-1-infection

Locations

  • Helios Salud — Buenos Aires, Argentina
  • Hospital del Niño — Panama City, Panama
  • University of Stellenbosch — Cape Town, South Africa
  • Enhancing Care Foundation — Durban, South Africa
  • WITS RHI Research Centre — Johannesburg, South Africa
  • Rahima Moosa Mother and Child Hospital — Johannesburg, South Africa
  • Be Part Yoluntu Centre — Paarl, South Africa
  • The Aurun Institute — Pretoria, South Africa
  • Perinatal HIV Research Unit — Soweto, South Africa
  • Faculty of Medicine - Mahidol University — Bangkok Noi, Thailand
  • Khon Kaen University — Khon Kaen, Thailand
  • Joint Clinical Research Centre — Kampala, Uganda
  • MU-JHU Research Collaboration/MU-JHU Care Ltd — Kampala, Uganda
  • Baylor College of Medicine — Kampala, Uganda
  • University of Zimbabwe Clinical Research Centre — Harare, Zimbabwe
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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record