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

University of Nebraska

Status and phase

Completed

Phase 4

Conditions

HIV-1-infection

Treatments

Drug: Bictegravir/emtricitabine/tenofovir alafenamide

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT03998176

0471-19-FB

Details and patient eligibility

About

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.

Full 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.

Enrollment

43 patients

Sex

All

Ages

19+ years old

Volunteers

No Healthy Volunteers

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