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

Primary Purpose

HIV-1-infection

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Bictegravir/emtricitabine/tenofovir alafenamide
Sponsored by
University of Nebraska
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for HIV-1-infection focused on measuring Substance use

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Unversity of Nebraska Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

B/F/TAF

Arm Description

Participants will receive B/F/TAF for 48 weeks

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Percentage of Participants With Grade 3 or Greater Adverse Events
The percentage of participants experiencing grade 3 or greater adverse events at 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
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.

Full Information

First Posted
June 21, 2019
Last Updated
September 26, 2023
Sponsor
University of Nebraska
Collaborators
Gilead Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT03998176
Brief Title
Bictegravir/Emtricitabine/Tenofovir Alafenamide (B/F/TAF) in HIV-1 Infected Patients With Active Illicit Substance usE
Acronym
BASE
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Completed
Study Start Date
October 9, 2019 (Actual)
Primary Completion Date
October 1, 2021 (Actual)
Study Completion Date
April 1, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Nebraska
Collaborators
Gilead Sciences

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV-1-infection
Keywords
Substance use

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
43 (Actual)

8. Arms, Groups, and Interventions

Arm Title
B/F/TAF
Arm Type
Experimental
Arm Description
Participants will receive B/F/TAF for 48 weeks
Intervention Type
Drug
Intervention Name(s)
Bictegravir/emtricitabine/tenofovir alafenamide
Other Intervention Name(s)
Biktarvy
Intervention Description
B/F/TAF single tablet formulation
Primary Outcome Measure Information:
Title
Percentage of Participants With HIV-1 RNA < 50 Copies/mL as Determined by the FDA-defined Snapshot Algorithm
Description
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.
Time Frame
Week 24
Secondary Outcome Measure Information:
Title
Percentage of Participants With Grade 3 or Greater Adverse Events
Description
The percentage of participants experiencing grade 3 or greater adverse events at Week 24
Time Frame
Week 24
Title
Percentage of Participants With Grade 3 or Greater Adverse Events
Description
The percentage of participants experiencing grade 3 or greater adverse events at Week 48
Time Frame
Week 48
Title
Percentage of Participants With HIV-1 RNA < 50 Copies/mL as Determined by the FDA-defined Snapshot Algorithm
Description
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.
Time Frame
Week 48

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joshua Havens, PharmD
Organizational Affiliation
University of Nebraska
Official's Role
Principal Investigator
Facility Information:
Facility Name
Unversity of Nebraska Medical Center
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68198
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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