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

University of Nebraska43 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

HIV-1-infection

Interventions

Bictegravir/emtricitabine/tenofovir alafenamideDRUG

B/F/TAF single tablet formulation

Eligibility

Sex: ALLMin age: 19 Years

Medical Language ↔ Plain English

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

Locations (1)

Unversity of Nebraska Medical Center

Omaha, Nebraska, United States

Outcomes

Primary Outcomes

Percentage of Participants With HIV-1 RNA < 50 Copies/mL as Determined by the FDA-defined Snapshot Algorithm

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.

Time frame: Week 24

Secondary Outcomes

Percentage of Participants With Grade 3 or Greater Adverse Events

The percentage of participants experiencing grade 3 or greater adverse events at Week 24

Time frame: Week 24

Percentage of Participants With Grade 3 or Greater Adverse Events

The percentage of participants experiencing grade 3 or greater adverse events at Week 48

Time frame: Week 48

Percentage of Participants With HIV-1 RNA < 50 Copies/mL as Determined by the FDA-defined Snapshot Algorithm

The percentage of participants achieving HIV-1 RNA \< 50 copies/mL at Week 48 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.

Time frame: Week 48

Data from ClinicalTrials.gov

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