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HIV-1-infectionPhase 4NCT06337032

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

A Phase 4 study testing F/TAF (High Dose Tablet), F/TAF (Low Dose Tablet) and F/TAF (Lowest Dose Tablet) in people with HIV-1-infection, run by Gilead Sciences at 15 sites in 6 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 1 month and older
Conditions the study is for
HIV-1-infection
What is being tested?
F/TAF (High Dose Tablet), F/TAF (Low Dose Tablet) and F/TAF (Lowest Dose Tablet)
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
350 participants
Where
15 sitesin 6 countries
Study dates
27 Aug 2024to Mar 2034
Phase
Phase 4
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 1 month and older
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

15 sites in 6 countries. Contact the study team or a site near you to ask about taking part.

Gilead Clinical Study Information Center contact

1-833-445-3230 (GILEAD-0)

GileadClinicalTrials@gilead.com

15 sites in 6 countries

South Africa7 sites, 7 recruiting

  • University of Stellenbosch

    Cape Town, 7505

    Recruiting

  • Enhancing Care Foundation

    Durban, 3629

    Recruiting

  • WITS RHI Research Centre

    Johannesburg, 2038

    Recruiting

  • Rahima Moosa Mother and Child Hospital

    Johannesburg, 2112

    Recruiting

  • Be Part Yoluntu Centre

    Paarl, 7626

    Recruiting

  • The Aurun Institute

    Pretoria, 0087

    Recruiting

  • Perinatal HIV Research Unit

    Soweto, 2013

    Recruiting

Other trials in South Africa

Uganda3 sites, 3 recruiting

  • Joint Clinical Research Centre

    Kampala, 10005

    Recruiting

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

    Kampala, 256

    Recruiting

  • Baylor College of Medicine

    Kampala

    Recruiting

Other trials in Uganda

Thailand2 sites

  • Faculty of Medicine - Mahidol University

    Bangkok Noi, 10700

    Active, not recruiting

  • Khon Kaen University

    Khon Kaen, 40002

    Active, not recruiting

Other trials in Thailand

Argentina1 site

  • Helios Salud

    Buenos Aires, C1141 ACG

    Completed

Other trials in Argentina

Panama1 site

  • Hospital del Niño

    Panama City, 0816-00383

    Completed

Other trials in Panama

Zimbabwe1 site, 1 recruiting

  • University of Zimbabwe Clinical Research Centre

    Harare

    Recruiting

Other trials in Zimbabwe

About this study

Official title: An Open-label, Single-arm Study to Provide Continued Access to Study Drug to Participants Who Have Completed Pediatric Clinical Studies Involving Gilead HIV Treatments

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.
Conditions
HIV-1-infection
Being tested
F/TAF (High Dose Tablet), F/TAF (Low Dose Tablet), F/TAF (Lowest Dose Tablet), F/TAF (High Dose TOS), F/TAF (Low Dose TOS)

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • F/TAF (High Dose Tablet)Drug

    Also called Descovy®

    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/TAFDrug

    Also called Genvoya®

    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

    Also called GS-9350, Tybost®

    150 mg tablet administered orally

  • Cobicistat (Low Dose)Drug

    Also called GS-9350

    90 mg tablet administered orally

  • Cobicistat (TOS)Drug

    Also called GS-9350

    30 mg TOS administered orally

  • B/F/TAF (High Dose)Drug

    Also called Biktarvy®, GS-9883/F/TAF

    50/200/25 mg FDC tablet administered orally

  • B/F/TAF (Low Dose)Drug

    Also called GS-9883/F/TAF

    30/120/15 mg FDC tablet administered orally

  • B/F/TAF (High Dose TOS)Drug

    Also called GS-9883/F/TAF

    15/60/7.52 mg TOS administered orally

  • B/F/TAF (Low Dose TOS)Drug

    Also called GS-9883/F/TAF

    7.5/30/3.76 mg TOS administered orally

  • B/F/TAF (Lowest Dose TOS)Drug

    Also called GS-9883/F/TAF

    3.76/15/1.88 mg TOS administered orally

  • 3rd ARV AgentDrug

    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)

  • ATVDrug

    Administered according to the prescribing information

  • DRVDrug

    Administered according to the prescribing information

  • Lopinavir Boosted with ritonavir (LPV/r)Drug

    Administered according to the prescribing information

Study groups in NCT06337032
Study groupRoleWhat they receive
Rollover from Parent Study: GS-US-311-1269: Parent Study Drug (F/TAF) or B/F/TAFExperimentalParticipants will continue to take the study drug they were taking in the parent study, emtricitabine/tenofovir alafenamide (F/TAF) along with a 3rd antiretroviral (ARV) agent. The dose of F/TAF will be based on the weight of the participant, ranging between 120/15 mg to 200/25 mg. The dose of F/TAF will be different when given with the boosted and the unboosted 3rd ARV agent: F/TAF (High Dose Tablet) for unboosted 3rd ARV agent; F/TAF (Low Dose Tablet) for the boosted 3rd ARV agent. Participants may switch to B/F/TAF, at a dose based on participant's weight.
Receives: Drug: F/TAF (High Dose Tablet); Drug: F/TAF (Low Dose Tablet); Drug: F/TAF (Lowest Dose Tablet); Drug: B/F/TAF (High Dose); Drug: B/F/TAF (Low Dose); Drug: B/F/TAF (High Dose TOS); Drug: 3rd ARV Agent
Rollover from Parent Study: GS-US-292-0106: Parent Study Drug (E/C/F/TAF) or B/F/TAFExperimentalParticipants will continue to take the study drug they were taking in the parent study, elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (E/C/F/TAF). The dose of E/C/F/TAF will be based on the weight of the participant, ranging between 90/90/120/6 mg to 150/150/200/10 mg. Participants may switch to B/F/TAF at a dose based on participant's weight.
Receives: Drug: E/C/F/TAF; Drug: E/C/F/TAF (Low Dose); Drug: B/F/TAF (High Dose); Drug: B/F/TAF (Low Dose)
Rollover Parent Study GS-US-216-0128: Parent Study Drug (Combination Drugs) or B/F/TAFExperimentalParticipants will continue to take the following study drugs they were taking in the parent study: * Cobicistat (COBI) + DRV + NRTI backbone * COBI + ATV + NRTI backbone * F/TAF + DRV+ COBI * F/TAF + ATV+ COBI * F/TAF + LPV/r * F/TAF + 3rd unboosted agent The dose of F/TAF will be based on the weight of the participant, ranging between 15/1.88 mg and 200/25 mg, once daily. Additionally, the dose of COBI will be based on the weight of the participant, ranging between 30 mg and 150 mg, once or twice daily. Participants may switch to B/F/TAF at a dose based on participant's weight.
Receives: Drug: F/TAF (High Dose Tablet); Drug: F/TAF (Lowest Dose Tablet); Drug: F/TAF (High Dose TOS); Drug: F/TAF (Low Dose TOS); Drug: F/TAF (Lowest Dose TOS); Drug: Cobicistat (High Dose); Drug: Cobicistat (Low Dose); Drug: Cobicistat (TOS); Drug: B/F/TAF (High Dose); Drug: B/F/TAF (Low Dose); Drug: B/F/TAF (High Dose TOS); Drug: B/F/TAF (Low Dose TOS); Drug: B/F/TAF (Lowest Dose TOS); Drug: 3rd ARV Agent; Drug: Nucleos(t)ide reverse transcriptase inhibitors (NRTI); Drug: ATV; Drug: DRV; Drug: Lopinavir Boosted with ritonavir (LPV/r)
Rollover from Parent Studies: GS-US-380-1474 and CO-US-380-5578: Parent Study Drug (B/F/TAF)ExperimentalParticipants will continue to take the study drug they were taking in the parent study, B/F/TAF. Participants who are diagnosed with HIV-1 infection in parent study CO-US-380-5578 and complete the study drug will continue to take the study drug they were taking in the parent study, B/F/TAF. The dose of B/F/TAF will be based on the weight of the participant.
Receives: Drug: B/F/TAF (High Dose); Drug: B/F/TAF (Low Dose); Drug: B/F/TAF (High Dose TOS); Drug: B/F/TAF (Low Dose TOS); Drug: B/F/TAF (Lowest Dose TOS)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of Eligible Participants Who Have Received Access to the Study Drug(s) in the Study

    Measured: Up to 2.8 Years

Secondary outcomes (1)

  1. Percentage of Participants Experiencing Treatment-Emergent Adverse Events (TEAEs)

    Measured: Up to 9.5 Years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Mar 2024
  2. Study start27 Aug 2024
  3. Primary completionJun 2027 (estimated)
  4. Study completionMar 2034 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
350 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06337032
Sponsor's protocol ID
GS-US-380-6684
Other IDs
2024-000521-40
Status last verified
Oct 2026
First submitted
22 Mar 2024
Last updated
19 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing F/TAF (High Dose Tablet), F/TAF (Low Dose Tablet) and F/TAF (Lowest Dose Tablet) in people with HIV-1-infection, run by Gilead Sciences at 15 sites in 6 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 19 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 15 sites in South Africa, Uganda, Thailand, Argentina, Panama and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Gilead Clinical Study Information Center (1-833-445-3230 (GILEAD-0), GileadClinicalTrials@gilead.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Eligible Participants Who Have Received Access to the Study Drug(s) in the Study (time frame: Up to 2.8 Years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06337032.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Oct 2026.

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Clinical Trial NCT06337032 | AzTrials