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

0471-19-FB

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.

2019-10-09

2021-10-01

2022-04-01

Completed

Early phase I

43

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

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 43, 'type': 'ACTUAL'}}

2023-10-04