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

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.

Full Title of Study: “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”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: March 2021

Detailed Description

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.

Interventions

  • Drug: Bictegravir/emtricitabine/tenofovir alafenamide
    • B/F/TAF single tablet formulation

Arms, Groups and Cohorts

  • Experimental: B/F/TAF
    • Participants will receive B/F/TAF for 48 weeks

Clinical Trial Outcome Measures

Primary Measures

  • Percentage of Participants with HIV-1 RNA < 50 copies/mL as Determined by the FDA-defined Snapshot Algorithm
    • Time Frame: Week 24
    • 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.

Secondary Measures

  • Percentage of Participants with Grade 3 or Greater Adverse Events
    • Time Frame: Week 24
    • The percentage of participants experiencing grade 3 or greater adverse events at Week 24
  • Percentage of Participants with Grade 3 or Greater Adverse Events
    • Time Frame: Week 48
    • The percentage of participants experiencing grade 3 or greater adverse events at Week 48
  • Percentage of Participants with HIV-1 RNA < 50 copies/mL as Determined by the FDA-defined Snapshot Algorithm
    • Time Frame: Week 48
    • 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.

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 19 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • University of Nebraska
  • Collaborator
    • Gilead Sciences
  • Provider of Information About this Clinical Study
    • Principal Investigator: Josh Havens, Clinical Pharmacist, HIV Program – University of Nebraska
  • Overall Official(s)
    • Joshua Havens, PharmD, Principal Investigator, University of Nebraska Medical Center, HIV Program
  • Overall Contact(s)
    • Jen O’Neill, RN, 402-559-4312, jloneill@unmc.edu

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