Clinical Trials

MainTitle

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

This study is currently recruiting participants. (see Contacts and Locations)

Verified November 2019 by Josh Havens, University of Nebraska

Sponsor
University of Nebraska

Collaborator
Gilead Sciences

Information provided by (Responsible Party)
Josh Havens, University of Nebraska

ClinicalTrials.gov Identifier
NCT03998176

First received: June 21, 2019
Last updated: November 7, 2019
Last Verified: November 2019
History of Changes
Purpose

Purpose

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 Intervention Phase
HIV-1-infection

Drug : Bictegravir/emtricitabine/tenofovir alafenamide
Phase 4

Study Type: Interventional
Study Design: 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

Further study details as provided by Josh Havens, University of Nebraska:

Primary Outcome 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 Outcome 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.

Estimated Enrollment: 45
Study Start Date: October 9, 2019
Estimated Study Completion Date: October 2021
Estimated Primary Completion Date: March 2021 (Final data collection date for primary outcome measure)

Arms Assigned Interventions
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

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.

Eligibility

Eligibility

Ages Eligible for Study: 19 Years and older  
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

contacts and locations

Contacts and Locations

Choosing to participate in a study is an important personal decision.Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT03998176

Contacts

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

Locations

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

Principal Investigator: Joshua Havens, PharmD University of Nebraska Medical Center, HIV Program
More Information

More Information


Responsible Party: Josh Havens, Clinical Pharmacist, HIV Program, University of Nebraska  
ClinicalTrials.gov Identifier: NCT03998176   History of Changes  
Other Study ID Numbers: 471-19-FB  
Study First Received: June 21, 2019  
Last Updated: November 7, 2019  
Individual Participant Data    
Plan to Share IPD: No  

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:
Tenofovir
Emtricitabine

ClinicalTrials.gov processed this data on June 01, 2020
This information is provided by ClinicalTrials.gov.