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

Phase 4

Completed

• Conditions: HIV-1-infection
• Interventions: Drug: Bictegravir/emtricitabine/tenofovir alafenamide

• Registration Number: NCT03998176
• Lead Sponsor: 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.

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 Timeline

• Study First Submitted: 2019-06-21
• Study First Submitted QC: 2019-06-21
• Study First Posted: 2019-06-26
• Study Start: 2019-10-09
• Primary Completion: 2021-10-01
• Study Completion: 2022-04-01
• Results First Submitted: 2022-11-04
• Results First Submitted QC: 2022-11-29
• Results First Posted: 2022-12-20
• Status Verified: 2023-09
• Last Update Submitted: 2023-09-26
• Last Update Posted: 2023-10-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 43

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
B/F/TAF	Bictegravir/emtricitabine/tenofovir alafenamide	Participants will receive B/F/TAF for 48 weeks

Primary Outcome Measures

Name	Time	Method
Percentage of Participants With HIV-1 RNA < 50 Copies/mL as Determined by the FDA-defined Snapshot Algorithm	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

Name	Time	Method
Percentage of Participants With HIV-1 RNA < 50 Copies/mL as Determined by the FDA-defined Snapshot Algorithm	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.
Percentage of Participants With Grade 3 or Greater Adverse Events	Week 48	The percentage of participants experiencing grade 3 or greater adverse events at Week 48

Trial Locations

Locations (1)

Unversity of Nebraska Medical Center; 🇺🇸 Omaha, Nebraska, United States