At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 86 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 3b, Multicenter, Open-Label Study to Evaluate Switching From an Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Alafenamide Fixed-Dose Combination Regimen or a Tenofovir Disoproxil Fumarate Containing Regimen to Fixed-Dose Combination of Bictegravir/Emtricitabine/Tenofovir Alafenamide in Elderly, Virologically-Suppressed, HIV-1 Infected Subjects Aged ≥ 65 Years
In Brief
A Phase 3 clinical trial evaluating B/F/TAF for HIV-1 Infection. Completed, enrolled 86 participants across 25 sites in 5 countries.
Detailed Summary
The primary objective of this study is to characterize the virologic efficacy of switching virologically suppressed participants on an elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (E/C/F/TAF) fixed-dose combination (FDC) regimen or a tenofovir disoproxil fumarate (TDF) containing regimen to bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) FDC.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHIV-1 Infection
CountriesBelgium, France, Italy, Spain, United Kingdom
Collaborators--
Timeline
Phase 3CompletedFinished
201820192020202120222023202420252026
First PostedJan 2018
Enrollment StartMar 2018
Primary CompletionNov 2018
Study CompletionMay 2020
TodayJul 2026
First PostedJan 23, 2018
Enrollment StartMar 1, 2018
Primary CompletionNov 20, 2018
Study CompletionMay 29, 2020
TodayJul 2, 2026
Enrollment to primary: 9 monthsPosted 8.4 years ago
Interventions
B/F/TAFdrug
50/200/25 mg FDC tablet administered orally once daily without regard to food.