B/F/TAF FDC in HIV-1 Infected Adolescents and Children
Status:
Active, not recruiting
Trial end date:
2026-07-01
Target enrollment:
Participant gender:
Summary
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