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Antiretroviral

B/F/TAF for HIV

Phase 2 & 3

Waitlist Available

Research Sponsored by Gilead Sciences

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

No documented or suspected resistance to emtricitabine (FTC), tenofovir (TFV), or integrase strand transfer inhibitors (INSTIs) including, but not limited to, the reverse transcriptase resistance mutations K65R and M184V/I

Last dose of nevirapine (NVP) or efavirenz (EFV), if applicable, ≥ 14 days prior to enrollment

Timeline

Screening 3 weeks

Treatment Varies

Follow Up week 2 or week 4 for cohorts 1 & 2: 0 (pre-dose), 0.5, 1, 2, 3, 4, 6, 8, & 24 hours postdose; week 2 for cohort 3: 0 (pre-dose), 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 8, & 24 hours post-dose; week 2 for cohort 4: 0 (predose) 0.5, 1, 2, 4, & 8 hours postdose

Awards & highlights

No Placebo-Only Group

Summary

This trial is studying a 3-drug combination pill (bictegravir/emtricitabine/tenofovir alafenamide) to treat HIV in children and adolescents.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Potential side effects may include gastrointestinal issues like nausea or diarrhea, headaches, fatigue, allergic reactions, and changes in liver or kidney function tests. Specific side effects will be monitored closely due to the young age of participants.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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

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I last took nevirapine or efavirenz 14 days ago or more.

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I have been on the same HIV medication for at least a month or have not started treatment.

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My baby's kidney function is normal for their age.

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My HIV does not have resistance to certain HIV medications.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ week 2 or week 4 for cohorts 1 & 2: 0 (pre-dose), 0.5, 1, 2, 3, 4, 6, 8, & 24 hours postdose; week 2 for cohort 3: 0 (pre-dose), 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 8, & 24 hours post-dose; week 2 for cohort 4: 0 (predose) 0.5, 1, 2, 4, & 8 hours postdose

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~week 2 or week 4 for cohorts 1 & 2: 0 (pre-dose), 0.5, 1, 2, 3, 4, 6, 8, & 24 hours postdose; week 2 for cohort 3: 0 (pre-dose), 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 8, & 24 hours post-dose; week 2 for cohort 4: 0 (predose) 0.5, 1, 2, 4, & 8 hours postdose

This trial's timeline: 3 weeks for screening, Varies for treatment, and week 2 or week 4 for cohorts 1 & 2: 0 (pre-dose), 0.5, 1, 2, 3, 4, 6, 8, & 24 hours postdose; week 2 for cohort 3: 0 (pre-dose), 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 8, & 24 hours post-dose; week 2 for cohort 4: 0 (predose) 0.5, 1, 2, 4, & 8 hours postdose for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

PK Parameter: AUClast of TAF (Cohort 4)

PK Parameter: AUCtau of Bictegravir

PK Parameter: Cmax of TAF (Cohort 4)

+1 more

Secondary study objectives

Acceptability of B/F/TAF Formulation at Day 1 (All Cohorts)

Acceptability of B/F/TAF Formulation at Week 1 (Cohort 4)

Acceptability of B/F/TAF Formulation at Week 2 (Cohort 4)

+25 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

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.

0 / 5Eligibility criteria met