B/F/TAF FDC in HIV-1 Infected Adolescents and Children

A Phase 2/3, Open-Label Study of the Pharmacokinetics, Safety, and Antiviral Activity of the GS-9883/Emtricitabine/Tenofovir Alafenamide (GS-9883/F/TAF) Fixed Dose Combination (FDC) in HIV-1 Infected Adolescents and Children

Cohort 1 and 2: The primary objectives of this study are: Part A: To evaluate the steady state pharmacokinetics (PK) of bictegravir (BIC) and confirm the dose of the bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) 50/200/25 mg fixed dose combination (FDC) in HIV-1 infected, virologically suppressed adolescents (12 to < 18 years of age) and children (6 to < 12 years of age) Parts A and B: To evaluate the safety and tolerability of the adult strength B/F/TAF FDC through Week 24 in HIV-1 infected, virologically suppressed adolescents (12 to <18 years of age) and children (6 to <12 years of age) Cohort 3: The primary objectives of this study are: Part A: To evaluate the steady state PK of BIC and confirm the dose of B/F/TAF 30/120/15 mg FDC in HIV-1 infected, virologically suppressed children ? 2 years of age weighing ? 14 to < 25 kg Parts A and B: To evaluate the safety and tolerability of the low dose B/F/TAF FDC tablet through Week 24 in HIV-1 infected, virologically suppressed children ? 2 years of age weighing ? 14 to < 25 kg Cohort 4: Group 1: The primary objective of this study is: To evaluate the safety and tolerability of B/F/TAF 30/120/15 mg FDC TOS (administration of 2 B/F/TAF 15/60/7.5 mg FDC tablets for oral suspension (TOS)) through Week 24 in HIV-1 infected, virologically suppressed children ? 2 years of age weighing ? 14 to < 25 kg who are unable to swallow tablets Group 2: The primary objectives of this study are: To evaluate the steady state PK of BIC and TAF and confirm the dose of B/F/TAF 15/60/7.5 mg FDC TOS in HIV-1 infected children ? 1 month of age, on antiretroviral (ARV) treatment or treatment naive, weighing ? 10 to < 14 kg To evaluate the safety and tolerability of the B/F/TAF 15/60/7.5 mg FDC TOS through Week 24 in HIV-1 infected children ? 1 month of age, on ARV treatment or treatment naive, weighing ? 10 to < 14 kg Group 3: The primary objectives of this study are: To evaluate the steady state PK of BIC and TAF and confirm the dose of B/F/TAF 7.5/30/3.75 mg FDC TOS (administration of 2 B/F/TAF 3.75/15/1.88 mg FDC TOS) in HIV-1 infected children ? 1 month of age, on ARV treatment or treatment naive, weighing ? 6 to < 10 kg To evaluate the safety and tolerability of B/F/TAF 7.5/30/3.75 mg FDC TOS (administration of 2 B/F/TAF 3.75/15/1.88 mg FDC TOS) through Week 24 in HIV-1 infected children ? 1 month of age, on ARV treatment or treatment naive, weighing ? 6 to < 10 kg Group 4: The primary objectives of this study are: To evaluate the steady state PK of BIC and TAF and confirm the dose of B/F/TAF 3.75/15/1.88 mg FDC TOS in HIV-1 infected children ? 1 month of age, on ARV treatment or treatment naive, weighing ? 3 to < 6 kg To evaluate the safety and tolerability of the B/F/TAF 3.75/15/1.88 mg FDC TOS through Week 24 in HIV-1 infected children ? 1 month of age, on ARV treatment or treatment naive, weighing ? 3 to < 6 kg

B/F/TAF FDC in HIV-1 Infected Adolescents and Children

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