At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 62 enrolled
Drug / intervention
B/F/TAFdrug
Likely dose
B/F/TAF 25 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase 1b, Open-label Study to Evaluate the PK, Safety and Efficacy of B/F/TAF in HIV-1 Infected, Virologically Suppressed, Pregnant Women in Their Second and Third Trimesters
In Brief
A Phase 1 clinical trial evaluating B/F/TAF for HIV-1-infection. Completed, enrolled 62 participants across 8 sites in 3 countries.
Detailed Summary
The primary objective of this study is to evaluate the steady state PK of bictegravir (BIC) and confirm the dose of BIC/emtricitabine/tenofovir alafenamide (B/F/TAF) 50/200/25 mg fixed dose combination (FDC) in HIV-1 infected, virologically suppressed pregnant women in their second and third trimesters.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHIV-1-infection
CountriesDominican Republic, Thailand, United States
Collaborators--
Timeline
Phase 1CompletedFinished
2020202120222023202420252026
First PostedMay 2019
Enrollment StartJun 2019
Primary CompletionJul 2022
Study CompletionAug 2022
TodayJul 2026
First PostedMay 23, 2019
Enrollment StartJun 28, 2019
Primary CompletionJul 21, 2022
Study CompletionAug 18, 2022
TodayJul 2, 2026
Enrollment to primary: 3.1 yearsPosted 7.1 years ago
Interventions
B/F/TAFdrug
50/200/25 mg FDC tablet administered orally once daily without regard to food.