At a glance
ClinicalIndex Comparison RecordPhase 4Completed· 43 enrolled
Drug / intervention
Bictegravir/emtricitabine/tenofovir alafenamidedrug
Likely dose
Not stated in 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 4, Single-Arm Study of the Efficacy and Safety of Bictegravir/Emtricitabine/Tenofovir Alafenamide in HIV-1 Infected Patients With Active Illicit Substance Use
In Brief
A Phase 4 clinical trial evaluating Bictegravir/emtricitabine/tenofovir alafenamide for HIV-1-infection. Completed, enrolled 43 participants across 1 site.
Detailed Summary
This study will evaluate the efficacy and safety of bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) in HIV-1 infected patients who actively use illicit substances. The study will also evaluate retention in care and adherence to B/F/TAF by self-report and pharmacokinetic analysis.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHIV-1-infection
CountriesUnited States
CollaboratorsGilead Sciences
Timeline
Phase 4CompletedFinished
2020202120222023202420252026
First PostedJun 2019
Enrollment StartOct 2019
Primary CompletionOct 2021
Study CompletionApr 2022
TodayJul 2026
First PostedJun 26, 2019
Enrollment StartOct 9, 2019
Primary CompletionOct 1, 2021
Study CompletionApr 1, 2022
TodayJul 2, 2026
Enrollment to primary: 2.0 yearsPosted 7.0 years ago
Interventions
Bictegravir/emtricitabine/tenofovir alafenamidedrug
B/F/TAF single tablet formulation