B/F/TAF for HIV

Recruiting in Palo Alto (17 mi)

+26 other locations

Age: < 18

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2 & 3

Waitlist Available

Sponsor: Gilead Sciences

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?The goals of this clinical study are to learn how Bictegravir/Emtricitabine/Tenofovir Alafenamide fixed dose combination (FDC) interacts with the body, confirm the dose, and also to learn more about the safety and tolerability of Bictegravir/Emtricitabine/Tenofovir Alafenamide FDC in adolescents and children with HIV-1.

Eligibility Criteria

This trial is for children and adolescents with HIV-1 who have been virologically suppressed for at least 6 months. It includes different age groups: those aged 12 to <18 years weighing ≥35 kg, those aged 6 to <12 years weighing ≥25 kg, and younger children down to infants of ≥1 month old with varying weight requirements. Participants must have a stable antiretroviral regimen, good kidney function (eGFR ≥90 mL/min/1.73 m^2), and no resistance to certain HIV medications.

Inclusion Criteria

I have been on a stable HIV medication regimen for at least 6 months.

My HIV does not resist common medications like FTC, TFV, or INSTIs.

I am a child with HIV, either new to treatment or have been on ARV for at least a month.

+12 more

Exclusion Criteria

Other protocol defined Inclusion/Exclusion criteria may apply

Participant Groups

The study tests various doses of Bictegravir/Emtricitabine/Tenofovir Alafenamide (B/F/TAF) in fixed dose combinations for safety and how the body processes them. The goal is also to confirm the appropriate dosing for these age groups while monitoring their response to this combination therapy.

8Treatment groups

Experimental Treatment

Group I: Open-Label ExtensionExperimental Treatment3 Interventions

Following Week 48, participants in countries where B/F/TAF is not available may have the option to receive adult strength B/F/TAF FDC, low dose B/F/TAF FDC, or B/F/TAF FDC TOS (based on age and weight) until it becomes available for use according to the participant's age and weight or the product becomes accessible to participants through an access program.

Group II: Cohort 4 Group 4 (≥ 1 month of age and weight ≥ 3 to < 6 kg)Experimental Treatment1 Intervention

Participants will participate in an Intensive PK evaluation at Week 2 after which they will continue to receive B/F/TAF FDC TOS twice daily through Week 48.

Group III: Cohort 4 Group 3 (≥ 1 month of age and weight ≥ 6 to < 10 kg)Experimental Treatment1 Intervention

Participants will participate in an Intensive PK evaluation at Week 2 after which they will continue to receive B/F/TAF FDC TOS twice daily through Week 48.

Group IV: Cohort 4 Group 2 (≥ 1 month of age and weight ≥ 10 to < 14 kg)Experimental Treatment1 Intervention

Participants will participate in an Intensive PK evaluation at Week 2 after which they will continue to receive B/F/TAF FDC TOS twice daily through Week 48.

Group V: Cohort 4 Group 1 (≥ 2 years of age and weight ≥ 14 to < 25 kg)Experimental Treatment1 Intervention

Due to Cohort 3 Part A Intensive PK evaluation at Week 2 with the low dose B/F/TAF FDC tablet, participants will not participate in an Intensive PK evaluation at Week 2. Participants will receive B/F/TAF FDC tablets for oral suspension (TOS) once daily through Week 48.

Group VI: Cohort 3 (≥ 2 years of age and weight ≥ 14 to < 25 kg)Experimental Treatment1 Intervention

* Part A: Participants will participate in an Intensive PK evaluation at Week 2 after which they will continue to receive the low dose B/F/TAF FDC tablet through Week 48. * Part B: Following confirmation of BIC PK data from Cohort 3 Part A, participants will receive the low dose B/F/TAF FDC tablet through Week 48.

Group VII: Cohort 2 (6 to < 12 years of age and weight ≥ 25 kg)Experimental Treatment1 Intervention

* Part A: Participants will participate in an Intensive PK evaluation at Week 2 or Week 4 and continue to receive the adult strength B/F/TAF FDC through Week 48. * Part B: Following confirmation of BIC PK data from Cohort 2 Part A, participants will receive the adult strength B/F/TAF FDC through Week 48.

Group VIII: Cohort 1 (12 to < 18 years of age and weight ≥ 35 kg)Experimental Treatment1 Intervention

* Part A: Participants will participate in an Intensive PK evaluation at Week 2 or Week 4 and continue to receive the adult strength B/F/TAF FDC through Week 48. * Part B: Following confirmation of BIC PK data from Cohort 1 Part A, participants will receive the adult strength B/F/TAF through Week 48.