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

Study Overview
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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.

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.

Official Title
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A Phase 4, Single-Arm Study of the Efficacy and Safety of Bictegravir/Emtricitabine/Tenofovir Alafenamide in HIV-1 Infected Patients With Active Illicit Substance Use

Conditions
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HIV-1-infection

Intervention / Treatment
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* Drug: Bictegravir/emtricitabine/tenofovir alafenamide


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 19 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: B/F/TAF<br>Participants will receive B/F/TAF for 48 weeks | Drug: Bictegravir/emtricitabine/tenofovir alafenamide<br>* B/F/TAF single tablet formulation<br>* Other names: Biktarvy;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Week 24 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants With Grade 3 or Greater Adverse Events | The percentage of participants experiencing grade 3 or greater adverse events at Week 24 | 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 | 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. | Week 48 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Substance use