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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03998176
Recruitment Status : Recruiting
First Posted : June 26, 2019
Last Update Posted : November 12, 2019
Sponsor:
Collaborator:
Gilead Sciences
Information provided by (Responsible Party):
Josh Havens, University of Nebraska

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
HIV-1-infection Drug: Bictegravir/emtricitabine/tenofovir alafenamide Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 45 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official 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
Actual Study Start Date : October 9, 2019
Estimated Primary Completion Date : March 2021
Estimated Study Completion Date : October 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Arm Intervention/treatment
Experimental: B/F/TAF
Participants will receive B/F/TAF for 48 weeks
Drug: Bictegravir/emtricitabine/tenofovir alafenamide
B/F/TAF single tablet formulation
Other Name: Biktarvy




Primary Outcome Measures :
  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 Outcome Measures :
  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.



Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03998176


Contacts
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Contact: Jen O'Neill, RN 402-559-4312 jloneill@unmc.edu
Contact: Mo Kubat, RN 402559-4408 mo.kubat@unmc.edu

Locations
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United States, Nebraska
Specialty Care Center Recruiting
Omaha, Nebraska, United States, 68198-8106
Contact: Joshua Havens, PharmD    402-559-2674    jhavens@unmc.edu   
Sponsors and Collaborators
University of Nebraska
Gilead Sciences
Investigators
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Principal Investigator: Joshua Havens, PharmD University of Nebraska Medical Center, HIV Program
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Responsible Party: Josh Havens, Clinical Pharmacist, HIV Program, University of Nebraska
ClinicalTrials.gov Identifier: NCT03998176    
Other Study ID Numbers: 471-19-FB
First Posted: June 26, 2019    Key Record Dates
Last Update Posted: November 12, 2019
Last Verified: November 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by Josh Havens, University of Nebraska:
Substance use
Additional relevant MeSH terms:
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Tenofovir
Emtricitabine
Antiviral Agents
Anti-Infective Agents
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Retroviral Agents
Anti-HIV Agents