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.
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PK Parameter: AUCtau of Bictegravir
Timeframe: 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
PK Parameter: Ctau of Bictegravir
Timeframe: 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
PK Parameter: AUC0-24 of TAF (Cohort 4)
Timeframe: Week 2 for Cohort 4: 0 (predose) 0.5, 1, 2, 4, & 8 hours postdose
PK Parameter: AUC0-24 of Bictegravir (Cohort 4)
Timeframe: Week 2 for Cohort 4: 0 (predose) 0.5, 1, 2, 4, & 8 hours postdose
PK Parameter: Cmax of TAF (Cohort 4)
Timeframe: Week 2 for Cohort 4: 0 (predose) 0.5, 1, 2, 4, & 8 hours postdose
Percentage of Participants Experiencing Treatment-Emergent Adverse Events (AEs) Through Week 24
Timeframe: Up to 24 weeks
Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities Through Week 24
Timeframe: Up to 24 weeks