- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03998176
Bictegravir/Emtricitabine/Tenofovir Alafenamide (B/F/TAF) in HIV-1 Infected Patients With Active Illicit Substance usE (BASE)
September 26, 2023 updated by: University of Nebraska
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
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
43
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Nebraska
-
Omaha, Nebraska, United States, 68198
- Unversity of Nebraska Medical Center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
17 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: B/F/TAF
Participants will receive B/F/TAF for 48 weeks
|
B/F/TAF single tablet formulation
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
Week 24
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
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
|
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.
|
Week 48
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Joshua Havens, PharmD, University of Nebraska
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
October 9, 2019
Primary Completion (Actual)
October 1, 2021
Study Completion (Actual)
April 1, 2022
Study Registration Dates
First Submitted
June 21, 2019
First Submitted That Met QC Criteria
June 21, 2019
First Posted (Actual)
June 26, 2019
Study Record Updates
Last Update Posted (Actual)
October 4, 2023
Last Update Submitted That Met QC Criteria
September 26, 2023
Last Verified
September 1, 2023
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Mental Disorders
- Chemically-Induced Disorders
- Substance-Related Disorders
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Antiviral Agents
- Reverse Transcriptase Inhibitors
- Nucleic Acid Synthesis Inhibitors
- Enzyme Inhibitors
- Anti-HIV Agents
- Anti-Retroviral Agents
- Tenofovir
- Emtricitabine
- Emtricitabine tenofovir alafenamide
Other Study ID Numbers
- 0471-19-FB
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
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
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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