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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

43 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-10-09

Study Completion Date

2022-04-01

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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HIV-1-infection

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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B/F/TAF

Participants will receive B/F/TAF for 48 weeks

Group Type EXPERIMENTAL

Bictegravir/emtricitabine/tenofovir alafenamide

Intervention Type DRUG

B/F/TAF single tablet formulation

Interventions

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Bictegravir/emtricitabine/tenofovir alafenamide

B/F/TAF single tablet formulation

Intervention Type DRUG

Other Intervention Names

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Biktarvy

Eligibility Criteria

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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

Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No