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

Gilead Sciences

Status and phase: Enrolling; Phase 4

Conditions: HIV-1-infection

Treatments: Drug: E/C/F/TAF; Drug: ATV; Drug: F/TAF (Lowest Dose TOS); Drug: F/TAF (High Dose Tablet); Drug: Nucleos(t)ide reverse transcriptase inhibitors (NRTI); Drug: B/F/TAF (High Dose); Drug: 3rd ARV Agent; Drug: F/TAF (Low Dose TOS); Drug: B/F/TAF (Lowest Dose TOS); Drug: Lopinavir Boosted with ritonavir (LPV/r); Drug: F/TAF (Low Dose Tablet); Drug: B/F/TAF (Low Dose TOS); Drug: F/TAF (High Dose TOS); Drug: DRV; Drug: Cobicistat (High Dose); Drug: E/C/F/TAF (Low Dose); Drug: B/F/TAF (Low Dose); Drug: B/F/TAF (High Dose TOS); Drug: Cobicistat (TOS); Drug: Cobicistat (Low Dose); Drug: F/TAF (Lowest Dose Tablet)

Study type: Interventional

Funder types: Industry

Identifiers

NCT06337032

2024-000521-40 (Other Identifier)

GS-US-380-6684

Details and patient eligibility

About

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.

Enrollment: 350 estimated patients

Sex: All

Ages: 1 month to 18 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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350 participants in 4 patient groups

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

Experimental group

Description:

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.

Treatment:

Drug: F/TAF (Lowest Dose Tablet)

Drug: B/F/TAF (High Dose TOS)

Drug: B/F/TAF (Low Dose)

Drug: F/TAF (Low Dose Tablet)

Drug: 3rd ARV Agent

Drug: B/F/TAF (High Dose)

Drug: F/TAF (High Dose Tablet)

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

Experimental group

Description:

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.

Treatment:

Drug: B/F/TAF (Low Dose)

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

Drug: B/F/TAF (High Dose)

Drug: E/C/F/TAF

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

Experimental group

Description:

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.

Treatment:

Drug: F/TAF (Lowest Dose Tablet)

Drug: B/F/TAF (High Dose TOS)

Drug: Cobicistat (TOS)

Drug: Cobicistat (Low Dose)

Drug: B/F/TAF (Low Dose)

Drug: DRV

Drug: Cobicistat (High Dose)

Drug: F/TAF (High Dose TOS)

Drug: B/F/TAF (Low Dose TOS)

Drug: Lopinavir Boosted with ritonavir (LPV/r)

Drug: B/F/TAF (Lowest Dose TOS)

Drug: F/TAF (Low Dose TOS)

Drug: 3rd ARV Agent

Drug: Nucleos(t)ide reverse transcriptase inhibitors (NRTI)

Drug: B/F/TAF (High Dose)

Drug: F/TAF (High Dose Tablet)

Drug: F/TAF (Lowest Dose TOS)

Drug: ATV

Rollover from Parent Studies: GS-US-380-1474 and CO-US-380-5578: Parent Study Drug (B/F/TAF)

Experimental group

Description:

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.

Treatment:

Drug: B/F/TAF (High Dose TOS)

Drug: B/F/TAF (Low Dose)

Drug: B/F/TAF (Low Dose TOS)

Drug: B/F/TAF (Lowest Dose TOS)

Drug: B/F/TAF (High Dose)