CLINICAL STUDY · NCT06337032

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

RecruitingPhase 4Interventional

Condition: HIV-1-infection
Study locations: 15 reported sites
Study updated: 19 Oct 2026
Source: ClinicalTrials.gov

Overall study status is shown above. Individual hospitals may have a different recruitment status.

THE STUDY

About this study

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.

Full 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

PARTICIPATION

Who may participate

Minimum age: 1 Month
Maximum age: Not reported
Sex eligibility: All sexes
Healthy volunteers: Not accepted

Only the study team can confirm eligibility. The registry criteria below are not a medical recommendation.

Full inclusion and exclusion 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.

NEAR YOU

Study locations worldwide

15 sites

Check the individual site’s status and contact the listed study team for current availability.

Helios Salud

Completed

Buenos Aires, C1141 ACG, Argentina

Study team contact · shared across sites

Email study team ↗View all study contacts ↓

Hospital del Niño

Completed

Panama City, 0816-00383, Panama

Study team contact · shared across sites

Email study team ↗View all study contacts ↓

University of Stellenbosch

Recruiting

Cape Town, 7505, South Africa

Study team contact · shared across sites

Email study team ↗View all study contacts ↓

Enhancing Care Foundation

Recruiting

Durban, 3629, South Africa

Study team contact · shared across sites

Email study team ↗View all study contacts ↓

WITS RHI Research Centre

Recruiting

Johannesburg, 2038, South Africa

Study team contact · shared across sites

Email study team ↗View all study contacts ↓

Rahima Moosa Mother and Child Hospital

Recruiting

Johannesburg, 2112, South Africa

Study team contact · shared across sites

Email study team ↗View all study contacts ↓

Be Part Yoluntu Centre

Recruiting

Paarl, 7626, South Africa

Study team contact · shared across sites

Email study team ↗View all study contacts ↓

The Aurun Institute

Recruiting

Pretoria, 0087, South Africa

Study team contact · shared across sites

Email study team ↗View all study contacts ↓

Perinatal HIV Research Unit

Recruiting

Soweto, 2013, South Africa

Study team contact · shared across sites

Email study team ↗View all study contacts ↓

Faculty of Medicine - Mahidol University

Active, not recruiting

Bangkok Noi, 10700, Thailand

Study team contact · shared across sites

Email study team ↗View all study contacts ↓

Khon Kaen University

Active, not recruiting

Khon Kaen, 40002, Thailand

Study team contact · shared across sites

Email study team ↗View all study contacts ↓

Joint Clinical Research Centre

Recruiting

Kampala, 10005, Uganda

Study team contact · shared across sites

Email study team ↗View all study contacts ↓

MU-JHU Research Collaboration/MU-JHU Care Ltd

Recruiting

Kampala, 256, Uganda

Study team contact · shared across sites

Email study team ↗View all study contacts ↓

Baylor College of Medicine

Recruiting

Kampala, Uganda

Study team contact · shared across sites

Email study team ↗View all study contacts ↓

University of Zimbabwe Clinical Research Centre

Recruiting

Harare, Zimbabwe

Study team contact · shared across sites

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WHAT IS BEING STUDIED

Treatments and study groups

Interventions

F/TAF (High Dose Tablet)Drug

200/25 mg fixed-dose combination (FDC) tablet administered orally

Study groups: Rollover Parent Study GS-US-216-0128: Parent Study Drug (Combination Drugs) or B/F/TAF, Rollover from Parent Study: GS-US-311-1269: Parent Study Drug (F/TAF) or B/F/TAF

Other names: Descovy®

F/TAF (Low Dose Tablet)Drug

200/10 mg FDC tablet administered orally

Study groups: Rollover from Parent Study: GS-US-311-1269: Parent Study Drug (F/TAF) or B/F/TAF

F/TAF (Lowest Dose Tablet)Drug

120/15 mg FDC tablet administered orally

Study groups: Rollover Parent Study GS-US-216-0128: Parent Study Drug (Combination Drugs) or B/F/TAF, Rollover from Parent Study: GS-US-311-1269: Parent Study Drug (F/TAF) or B/F/TAF

F/TAF (High Dose TOS)Drug

60/7.5 mg tablet for oral suspension (TOS) administered orally

Study groups: Rollover Parent Study GS-US-216-0128: Parent Study Drug (Combination Drugs) or B/F/TAF

F/TAF (Low Dose TOS)Drug

30/3.75 mg TOS administered orally

Study groups: Rollover Parent Study GS-US-216-0128: Parent Study Drug (Combination Drugs) or B/F/TAF

F/TAF (Lowest Dose TOS)Drug

15/1.88 mg TOS administered orally

Study groups: Rollover Parent Study GS-US-216-0128: Parent Study Drug (Combination Drugs) or B/F/TAF

E/C/F/TAFDrug

150/150/200/10 mg tablet administered orally

Study groups: Rollover from Parent Study: GS-US-292-0106: Parent Study Drug (E/C/F/TAF) or B/F/TAF

Other names: Genvoya®

E/C/F/TAF (Low Dose)Drug

90/90/120/6 mg tablet administered orally

Study groups: Rollover from Parent Study: GS-US-292-0106: Parent Study Drug (E/C/F/TAF) or B/F/TAF

Cobicistat (High Dose)Drug

150 mg tablet administered orally

Study groups: Rollover Parent Study GS-US-216-0128: Parent Study Drug (Combination Drugs) or B/F/TAF

Other names: GS-9350, Tybost®

Cobicistat (Low Dose)Drug

90 mg tablet administered orally

Study groups: Rollover Parent Study GS-US-216-0128: Parent Study Drug (Combination Drugs) or B/F/TAF

Other names: GS-9350

Cobicistat (TOS)Drug

30 mg TOS administered orally

Study groups: Rollover Parent Study GS-US-216-0128: Parent Study Drug (Combination Drugs) or B/F/TAF

Other names: GS-9350

B/F/TAF (High Dose)Drug

50/200/25 mg FDC tablet administered orally

Study groups: Rollover Parent Study GS-US-216-0128: Parent Study Drug (Combination Drugs) or B/F/TAF, Rollover from Parent Studies: GS-US-380-1474 and CO-US-380-5578: Parent Study Drug (B/F/TAF), Rollover from Parent Study: GS-US-292-0106: Parent Study Drug (E/C/F/TAF) or B/F/TAF, Rollover from Parent Study: GS-US-311-1269: Parent Study Drug (F/TAF) or B/F/TAF

Other names: Biktarvy®, GS-9883/F/TAF

B/F/TAF (Low Dose)Drug

30/120/15 mg FDC tablet administered orally

Study groups: Rollover Parent Study GS-US-216-0128: Parent Study Drug (Combination Drugs) or B/F/TAF, Rollover from Parent Studies: GS-US-380-1474 and CO-US-380-5578: Parent Study Drug (B/F/TAF), Rollover from Parent Study: GS-US-292-0106: Parent Study Drug (E/C/F/TAF) or B/F/TAF, Rollover from Parent Study: GS-US-311-1269: Parent Study Drug (F/TAF) or B/F/TAF

Other names: GS-9883/F/TAF

B/F/TAF (High Dose TOS)Drug

15/60/7.52 mg TOS administered orally

Study groups: Rollover Parent Study GS-US-216-0128: Parent Study Drug (Combination Drugs) or B/F/TAF, Rollover from Parent Studies: GS-US-380-1474 and CO-US-380-5578: Parent Study Drug (B/F/TAF), Rollover from Parent Study: GS-US-311-1269: Parent Study Drug (F/TAF) or B/F/TAF

Other names: GS-9883/F/TAF

B/F/TAF (Low Dose TOS)Drug

7.5/30/3.76 mg TOS administered orally

Study groups: Rollover Parent Study GS-US-216-0128: Parent Study Drug (Combination Drugs) or B/F/TAF, Rollover from Parent Studies: GS-US-380-1474 and CO-US-380-5578: Parent Study Drug (B/F/TAF)

Other names: GS-9883/F/TAF

B/F/TAF (Lowest Dose TOS)Drug

3.76/15/1.88 mg TOS administered orally

Study groups: Rollover Parent Study GS-US-216-0128: Parent Study Drug (Combination Drugs) or B/F/TAF, Rollover from Parent Studies: GS-US-380-1474 and CO-US-380-5578: Parent Study Drug (B/F/TAF)

Other names: GS-9883/F/TAF

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

Study groups: Rollover Parent Study GS-US-216-0128: Parent Study Drug (Combination Drugs) or B/F/TAF, Rollover from Parent Study: GS-US-311-1269: Parent Study Drug (F/TAF) or B/F/TAF

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)

Study groups: Rollover Parent Study GS-US-216-0128: Parent Study Drug (Combination Drugs) or B/F/TAF

ATVDrug

Administered according to the prescribing information

Study groups: Rollover Parent Study GS-US-216-0128: Parent Study Drug (Combination Drugs) or B/F/TAF

DRVDrug

Administered according to the prescribing information

Study groups: Rollover Parent Study GS-US-216-0128: Parent Study Drug (Combination Drugs) or B/F/TAF

Lopinavir Boosted with ritonavir (LPV/r)Drug

Administered according to the prescribing information

Study groups: Rollover Parent Study GS-US-216-0128: Parent Study Drug (Combination Drugs) or B/F/TAF

Study groups

Rollover from Parent Study: GS-US-311-1269: Parent Study Drug (F/TAF) or B/F/TAFExperimental

Participants 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.

Interventions: 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/TAFExperimental

Participants 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.

Interventions: 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/TAFExperimental

Participants 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.

Interventions: 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)Experimental

Participants 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.

Interventions: 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)

RESEARCH DETAILS

Study design

Study type: Interventional
Phase: Phase 4
Primary purpose: Treatment
Allocation: Non randomized
Study model: Parallel
Masking: None (open label)
Enrolment: 350 participants · Estimated

TIMELINE & MEASURES

Dates and outcomes

Study started: 27 Aug 2024 · Actual
Primary completion: Jun 2027 · Estimated
Study completion: Mar 2034 · Estimated
First registered: 29 Mar 2024 · Actual
Last registry update: 19 Oct 2026 · Actual
Status last verified: Oct 2026

Primary outcomes (1)

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

Not reported.

Time frame: Up to 2.8 Years

Secondary outcomes (1)

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

Not reported.

Time frame: Up to 9.5 Years

STUDY TEAM

Sponsor and contacts

Lead sponsor: Gilead Sciences
Sponsor type: Industry
Collaborators: Not reported
Organisation study ID: GS-US-380-6684

Central study contacts

Gilead Clinical Study Information CenterContactPhone: 1-833-445-3230 (GILEAD-0)Email: GileadClinicalTrials@gilead.com

Study officials

Gilead Study DirectorStudy director · Gilead Sciences

Contacts are provided by the registry for study enquiries. Do not use these details for marketing or promotions.

FURTHER READING

Results, documents and references

No results are posted in this registry record

This does not mean the study has no findings. Results may not yet have been submitted or published here.

No study documents are listed in this record.

Related information

Gilead Clinical Trials Website ↗