Study of Bictegravir/Emtricitabine/Tenofovir Alafenamide Fixed Dose Combination in Adolescents and Children With Human Immunodeficiency Virus-1
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Phase
Phase 2/3
Status
Active, not recruiting
Study type
Interventional
Design
Non randomized · None · Treatment
Enrollment
177actual
Sites
25
Countries
South Africa, Thailand, Uganda +1
Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →
Source: ClinicalTrials.gov, retrieved 2026-08-19
Dates
each axis at the precision it was filed, with the registry's own basis| Date | Filed | Basis | What it is |
|---|---|---|---|
| Start | 2016-09-21 | actual | When the study began enrolling |
| Primary completion | 2025-03-24 | actual | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | Nov 2026 | estimated | The whole study's end, after follow-up |
| First posted | 2016-08-26 | estimated | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2026-03-24 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Condition
- HIV-1 Infection
Interventions
- Drug: B/F/TAF (Adult Strength) — also filed as Biktarvy®, GS-9883/F/TAF
- Drug: B/F/TAF (Low Dose) — also filed as GS-9883/F/TAF
- Drug: B/F/TAF (TOS) — also filed as GS-9883/F/TAF
- Drug: B/F/TAF (TOS) — also filed as GS-9883/F/TAF
- Drug: B/F/TAF (TOS) — also filed as GS-9883/F/TAF
- Drug: B/F/TAF (TOS) — also filed as GS-9883/F/TAF
Primary outcomes
what the primary-completion date above is the date OFPK Parameter: AUCtau of Bictegravir
measured 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
measured 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)
measured Week 2 for Cohort 4: 0 (predose) 0.5, 1, 2, 4, & 8 hours postdose
PK Parameter: AUC0-24 of Bictegravir (Cohort 4)
measured Week 2 for Cohort 4: 0 (predose) 0.5, 1, 2, 4, & 8 hours postdose
PK Parameter: Cmax of TAF (Cohort 4)
measured 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
measured Up to 24 weeks
Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities Through Week 24
measured Up to 24 weeks
Publications
- PMID 38621393 — linked by the registry
- PMID 34302760 — linked by the registry
Linked on the registry record. A “linked by the registry” entry is NLM's own automated PubMed match, not a claim by the sponsor that the paper reports this study.
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