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

HIV-1-infection Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03998176
• Other study ID #: 0471-19-FB
• Status: Completed
• Phase: Phase 4
• Start date: October 9, 2019
• Est. completion date: April 1, 2022

Study information

• Verified date: September 2023
• Source: University of Nebraska
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 43
• Est. completion date: April 1, 2022
• Est. primary completion date: October 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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

Related Conditions & MeSH terms

• HIV-1-infection
• Substance-Related Disorders

Intervention

Drug:
• Bictegravir/emtricitabine/tenofovir alafenamide
B/F/TAF single tablet formulation

Locations

Country	Name	City	State
United States	Unversity of Nebraska Medical Center	Omaha	Nebraska

Sponsors (2)

Lead Sponsor	Collaborator
University of Nebraska	Gilead Sciences

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Week 24
Secondary	Percentage of Participants With Grade 3 or Greater Adverse Events	The percentage of participants experiencing grade 3 or greater adverse events at Week 24	Week 24
Secondary	Percentage of Participants With Grade 3 or Greater Adverse Events	The percentage of participants experiencing grade 3 or greater adverse events at Week 48	Week 48
Secondary	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.	Week 48