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Completed

NCT Number: NCT03998176

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

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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Key information

Conditions

HIV-1-infection Chemically-Induced Disorders Mental Disorders Substance-Related Disorders

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Unversity of Nebraska Medical Center

Omaha, Nebraska, 68198, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

bictegravir/emtricitabine/tenofovir alafenamide

Drug

B/F/TAF single tablet formulation

Other names: Biktarvy

Primary outcomes

  1. 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 outcomes

  1. 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

  2. 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

  3. 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.

Sponsors and collaborators

Lead sponsor

University of Nebraska

Other

Collaborators

  • Gilead Sciences

Registry information

Official study title

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

Acronym: BASE

Important dates

Study start
2019
Primary completion
2021
Study completion
2022
First posted
Jun 26, 2019
Registry last updated
Oct 4, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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