NCT03998176

Bictegravir/Emtricitabine/Tenofovir Alafenamide (B/F/TAF) in HIV-1 Infected Patients With Active Illicit Substance usE

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 43 (actual)
• Sponsor: University of Nebraska · Academic / Other
• Sex: All
• Age: 19 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This is a single-center, single-arm, prospective, pilot study to evaluate the effectiveness and safety of B/F/TAF in viremic HIV-1 infected treatment naive or experienced patients with active illicit substance use outside of nicotine, alcohol, and marijuana use.

Conditions

• HIV-1-infection

Interventions

Type	Name	Description
DRUG	Bictegravir/emtricitabine/tenofovir alafenamide	B/F/TAF single tablet formulation

Timeline

• Start date: 2019-10-09
• Primary completion: 2021-10-01
• Completion: 2022-04-01
• First posted: 2019-06-26
• Last updated: 2023-10-04
• Results posted: 2022-12-20

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study