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

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.

Study Overview

• Status: Recruiting
• Conditions: HIV-1-infection
• Intervention / Treatment: 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; Drug: E/C/F/TAF; Drug: E/C/F/TAF (Low Dose); 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 (Low Dose TOS); Drug: B/F/TAF (Lowest Dose TOS); Drug: Nucleos(t)ide reverse transcriptase inhibitors (NRTI); Drug: ATV; Drug: DRV; Drug: Lopinavir Boosted with ritonavir (LPV/r)

• Study Type: Interventional
• Enrollment (Estimated): 350
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Gilead Clinical Study Information Center; Phone Number: 1-833-445-3230 (GILEAD-0); Email: GileadClinicalTrials@gilead.com

Study Locations

• Argentina
  • Buenos Aires, Argentina, C1141 ACG
    • Recruiting
    • Helios Salud
• Panama
  • Panama City, Panama, 0816-00383
    • Recruiting
    • Hospital del Nino
• South Africa
  • Johannesburg, South Africa, 2112
    • Recruiting
    • Rahima Moosa Mother and Child Hospital
  • Paarl, South Africa, 7626
    • Recruiting
    • Be Part Yoluntu Centre
  • Soweto, South Africa, 2013
    • Recruiting
    • Perinatal HIV Research Unit
• Thailand
  • Khon Kaen, Thailand, 40002
    • Recruiting
    • Khon Kaen University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 study participation.

Key Exclusion Criteria:

• Individuals planning to switch to B/F/TAF on Day 1 cannot have 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 must not have 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Rollover from Parent Study: GS-US-311-1269: Parent Study Drug (F/TAF) or B/F/TAF; 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); 200/25 mg fixed-dose combination (FDC) tablet administered orally; Other Names: Descovy®; Drug: F/TAF (Low Dose Tablet); 200/10 mg FDC tablet administered orally; Drug: F/TAF (Lowest Dose Tablet); 120/15 mg FDC tablet administered orally; Drug: B/F/TAF (High Dose); 50/200/25 mg FDC tablet administered orally; Other Names: Biktarvy®; GS-9883/F/TAF; Drug: B/F/TAF (Low Dose); 30/120/15 mg FDC tablet administered orally; Other Names: GS-9883/F/TAF; Drug: B/F/TAF (High Dose TOS); 15/60/7.52 mg TOS administered orally; Other Names: GS-9883/F/TAF; Drug: 3rd ARV Agent; 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
Experimental: Rollover from Parent Study: GS-US-292-0106: Parent Study Drug (E/C/F/TAF) or B/F/TAF; 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: B/F/TAF (High Dose); 50/200/25 mg FDC tablet administered orally; Other Names: Biktarvy®; GS-9883/F/TAF; Drug: B/F/TAF (Low Dose); 30/120/15 mg FDC tablet administered orally; Other Names: GS-9883/F/TAF; Drug: E/C/F/TAF; 150/150/200/10 mg tablet administered orally; Other Names: Genvoya®; Drug: E/C/F/TAF (Low Dose); 90/90/120/6 mg tablet administered orally
Experimental: Rollover Parent Study GS-US-216-0128: Parent Study Drug (Combination Drugs) or B/F/TAF; 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); 200/25 mg fixed-dose combination (FDC) tablet administered orally; Other Names: Descovy®; Drug: F/TAF (Lowest Dose Tablet); 120/15 mg FDC tablet administered orally; Drug: B/F/TAF (High Dose); 50/200/25 mg FDC tablet administered orally; Other Names: Biktarvy®; GS-9883/F/TAF; Drug: B/F/TAF (Low Dose); 30/120/15 mg FDC tablet administered orally; Other Names: GS-9883/F/TAF; Drug: B/F/TAF (High Dose TOS); 15/60/7.52 mg TOS administered orally; Other Names: GS-9883/F/TAF; Drug: 3rd ARV Agent; 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; Drug: F/TAF (High Dose TOS); 60/7.5 mg tablet for oral suspension (TOS) administered orally; Drug: F/TAF (Low Dose TOS); 30/3.75 mg TOS administered orally; Drug: F/TAF (Lowest Dose TOS); 15/1.88 mg TOS administered orally; Drug: Cobicistat (High Dose); 150 mg tablet administered orally; Other Names: Tybost®; GS-9350; Drug: Cobicistat (Low Dose); 90 mg tablet administered orally; Other Names: GS-9350; Drug: Cobicistat (TOS); 30 mg TOS administered orally; Other Names: GS-9350; Drug: B/F/TAF (Low Dose TOS); 7.5/30/3.76 mg TOS administered orally; Other Names: GS-9883/F/TAF; Drug: B/F/TAF (Lowest Dose TOS); 3.76/15/1.88 mg TOS administered orally; Other Names: GS-9883/F/TAF; Drug: Nucleos(t)ide reverse transcriptase inhibitors (NRTI); 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); Drug: ATV; Administered according to the prescribing information; Drug: DRV; Administered according to the prescribing information; Drug: Lopinavir Boosted with ritonavir (LPV/r); Administered according to the prescribing information
Experimental: Rollover from Parent Studies: GS-US-380-1474 and CO-US-380-5578: Parent Study Drug (B/F/TAF); 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); 50/200/25 mg FDC tablet administered orally; Other Names: Biktarvy®; GS-9883/F/TAF; Drug: B/F/TAF (Low Dose); 30/120/15 mg FDC tablet administered orally; Other Names: GS-9883/F/TAF; Drug: B/F/TAF (High Dose TOS); 15/60/7.52 mg TOS administered orally; Other Names: GS-9883/F/TAF; Drug: B/F/TAF (Low Dose TOS); 7.5/30/3.76 mg TOS administered orally; Other Names: GS-9883/F/TAF; Drug: B/F/TAF (Lowest Dose TOS); 3.76/15/1.88 mg TOS administered orally; Other Names: GS-9883/F/TAF

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Number of Eligible Participants Who Have Received Access to the Study Drug(s) in the Study	Up to 9.5 Years

Secondary Outcome Measures

Outcome Measure	Time Frame
Percentage of Participants Experiencing Treatment-Emergent Adverse Events (TEAEs)	Up to 9.5 Years

Collaborators and Investigators

• Sponsor: Gilead Sciences
• Investigators: Study Director: Gilead Study Director, Gilead Sciences

Publications and helpful links

Helpful Links

• Gilead Clinical Trials Website

Study record dates

Study Major Dates

• Study Start (Actual): August 27, 2024
• Primary Completion (Estimated): March 1, 2034
• Study Completion (Estimated): March 1, 2034

Study Registration Dates

• First Submitted: March 22, 2024
• First Submitted That Met QC Criteria: March 22, 2024
• First Posted (Actual): March 29, 2024

Study Record Updates

• Last Update Posted (Estimated): November 8, 2024
• Last Update Submitted That Met QC Criteria: November 7, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Viral Protease Inhibitors; Anti-Infective Agents; Molecular Mechanisms of Pharmacological Action; Protease Inhibitors; Enzyme Inhibitors; Nucleic Acid Synthesis Inhibitors; Antiviral Agents; Cytochrome P-450 Enzyme Inhibitors; Anti-HIV Agents; Anti-Retroviral Agents; HIV Protease Inhibitors; Cytochrome P-450 CYP3A Inhibitors; Cobicistat; Ritonavir; Lopinavir; Reverse Transcriptase Inhibitors
• Other Study ID Numbers: GS-US-380-6684

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes