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

Completed · Phase 4

Conditions studied: HIV-1-infection

In brief

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.

Key facts

Study ID

NCT03998176

Run by

University of Nebraska

People needed

43

Starts

2019-10-09

Expected to finish

2022-04-01

Last updated by the study team

2023-10-04

Who can join

Age: 19 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Unversity of Nebraska Medical Center — Omaha, Nebraska, United States

Full record on ClinicalTrials.gov

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