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

• Status: Active, not recruiting
• Trial end date: 2022-04-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Nebraska
• Collaborator: Gilead Sciences
• Treatments: Emtricitabine; Emtricitabine tenofovir alafenamide; Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination; Tenofovir

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