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
Overview
- Phase
- Phase 4
- Intervention
- Bictegravir/emtricitabine/tenofovir alafenamide
- Conditions
- HIV-1-infection
- Sponsor
- University of Nebraska
- Enrollment
- 43
- Locations
- 1
- Primary Endpoint
- Percentage of Participants With HIV-1 RNA < 50 Copies/mL as Determined by the FDA-defined Snapshot Algorithm
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief 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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Documented HIV-1 infection
- •Treatment naive or experienced
- •Self-reported illicit substance use or confirmed urine drug screen within past 6 months of any of the following: cocaine, heroin, methamphetamine, MDMA, phencyclidine, ketamine, gamma hydroxybutyrate, cathiniones, or inappropriate prescription opiate, benzodiazepine or stimulant use (excluding nicotine, alcohol, marijuana for criteria)
- •HIV RNA \>1000 copies/mL
- •Creatinine clearance \> 30 mL/min (Cockroft-Gault)
- •ALT and AST \< 5 times the upper limit of normal
- •Willing and able to provide written informed consent
Exclusion Criteria
- •History of integrase or tenofovir related HIV resistance mutations
- •Pregnancy
- •Serious illness requiring systemic treatment and/or hospitalization within 30 days prior to study entry
Arms & Interventions
B/F/TAF
Participants will receive B/F/TAF for 48 weeks
Intervention: Bictegravir/emtricitabine/tenofovir alafenamide
Outcomes
Primary Outcomes
Percentage of Participants With HIV-1 RNA < 50 Copies/mL as Determined by the FDA-defined Snapshot Algorithm
Time Frame: Week 24
The percentage of participants achieving HIV-1 RNA \< 50 copies/mL at Week 24 analyzed by the snapshot algorithm, which defines a participants virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status.
Secondary Outcomes
- Percentage of Participants With HIV-1 RNA < 50 Copies/mL as Determined by the FDA-defined Snapshot Algorithm(Week 48)
- Percentage of Participants With Grade 3 or Greater Adverse Events(Week 48)