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

NCT06337032 | Recruiting Phase 4 FDA Drug

• 2 other identifiers: GS-US-380-66842024-000521-40
• Study Type: interventional
• Target: 350
• Locations: 6 countries
• Sites: 14

Brief 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.

Conditions

HIV-1-infection

Outcome Measures

Primary Outcomes (1)

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

  Up to 9.5 Years

Secondary Outcomes (1)

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

  Up to 9.5 Years

Study Arms (4)

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

EXPERIMENTAL

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.

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/TAF

EXPERIMENTAL

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.

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/TAF

EXPERIMENTAL

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.

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.

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)

Interventions

F/TAF (Lowest Dose TOS) DRUG

15/1.88 mg TOS administered orally

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

E/C/F/TAF DRUG

150/150/200/10 mg tablet administered orally

Also known as: Genvoya®

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

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

90/90/120/6 mg tablet administered orally

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

Also known as: GS-9350, Tybost®

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

Cobicistat (Low Dose) DRUG

90 mg tablet administered orally

Also known as: GS-9350

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

Cobicistat (TOS) DRUG

30 mg TOS administered orally

Also known as: GS-9350

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

F/TAF (High Dose Tablet) DRUG

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

Also known as: Descovy®

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 (Low Dose Tablet) DRUG

200/10 mg FDC tablet administered orally

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

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

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

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

B/F/TAF (High Dose) DRUG

50/200/25 mg FDC tablet administered orally

Also known as: Biktarvy®, GS-9883/F/TAF

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

B/F/TAF (Low Dose) DRUG

30/120/15 mg FDC tablet administered orally

Also known as: GS-9883/F/TAF

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

B/F/TAF (High Dose TOS) DRUG

15/60/7.52 mg TOS administered orally

Also known as: GS-9883/F/TAF

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

B/F/TAF (Low Dose TOS) DRUG

7.5/30/3.76 mg TOS administered orally

Also known as: GS-9883/F/TAF

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)

B/F/TAF (Lowest Dose TOS) DRUG

3.76/15/1.88 mg TOS administered orally

Also known as: GS-9883/F/TAF

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)

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

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)

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

ATV DRUG

Administered according to the prescribing information

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

DRV DRUG

Administered according to the prescribing information

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

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

Eligibility Criteria

• Age: 1 Month+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Gilead Sciences: lead

Study Sites (14)

Helios Salud

Buenos Aires, C1141 ACG, Argentina

ACTIVE NOT RECRUITING

Hospital del Niño

Panama City, 0816-00383, Panama

ACTIVE NOT RECRUITING

University of Stellenbosch

Cape Town, 7505, South Africa

RECRUITING

Enhancing Care Foundation

Durban, 3629, South Africa

RECRUITING

WITS RHI Research Centre

Johannesburg, 2038, South Africa

RECRUITING

Rahima Moosa Mother and Child Hospital

Johannesburg, 2112, South Africa

RECRUITING

Be Part Yoluntu Centre

Paarl, 7626, South Africa

RECRUITING

The Aurun Institute

Pretoria, 0087, South Africa

RECRUITING

Perinatal HIV Research Unit

Soweto, 2013, South Africa

RECRUITING

Faculty of Medicine - Mahidol University

Bangkok Noi, 10700, Thailand

ACTIVE NOT RECRUITING

Khon Kaen University

Khon Kaen, 40002, Thailand

ACTIVE NOT RECRUITING

Joint Clinical Research Centre

Kampala, 10005, Uganda

RECRUITING

Baylor College of Medicine

Kampala, Uganda

RECRUITING

University of Zimbabwe Clinical Research Centre

Harare, Zimbabwe

RECRUITING

Related Links

• Gilead Clinical Trials Website

MeSH Terms

Interventions

Tablets; emtricitabine tenofovir alafenamide; Elvitegravir, Cobicistat, Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination; Cobicistat; bictegravir, emtricitabine, tenofovir alafenamide, drug combination; Ritonavir

Intervention Hierarchy (Ancestors)

Dosage Forms; Pharmaceutical Preparations; Carbamates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Tenofovir; Organophosphonates; Organophosphorus Compounds; Thiazoles; Sulfur Compounds; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Emtricitabine; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Adenine; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Drug Combinations

Study Officials

• Gilead Study Director

  Gilead Sciences

  STUDY DIRECTOR

Central Study Contacts

Gilead Clinical Study Information Center

CONTACT

1-833-445-3230 (GILEAD-0); GileadClinicalTrials@gilead.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 22, 2024
• First Posted: March 29, 2024
• Study Start: August 27, 2024
• Primary Completion (Estimated): March 1, 2034
• Study Completion (Estimated): March 1, 2034
• Last Updated: March 16, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1); UG (2); ZI (1); ZA (7); AR (1); TH (2)