Last updated on November 2019

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

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Brief description of study

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