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

NCT03998176 | Completed Phase 4 Results FDA Drug

• 1 other identifier: 0471-19-FB
• Study Type: interventional
• Target: 43
• Locations: 1 country
• Sites: 1

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.

Conditions

HIV-1-infection

Keywords

Substance use

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Percentage of Participants With Grade 3 or Greater Adverse Events

  Week 24

• Percentage of Participants With Grade 3 or Greater Adverse Events

  Week 48

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

  Week 48

Study Arms (1)

B/F/TAF

EXPERIMENTAL

Participants will receive B/F/TAF for 48 weeks

Drug: Bictegravir/emtricitabine/tenofovir alafenamide

Interventions

Bictegravir/emtricitabine/tenofovir alafenamide DRUG

B/F/TAF single tablet formulation

Also known as: Biktarvy

B/F/TAF

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Nebraska: lead
• Gilead Sciences: collaborator

Study Sites (1)

Unversity of Nebraska Medical Center

Omaha, Nebraska, 68198, United States

Location

MeSH Terms

Conditions

Substance-Related Disorders

Interventions

bictegravir, emtricitabine, tenofovir alafenamide, drug combination

Condition Hierarchy (Ancestors)

Chemically-Induced Disorders; Mental Disorders

Results Point of Contact

• Title: Josh Havens
• Organization: University of Nebraska Medical Center

jhavens@unmc.edu

402-559-2674

Study Officials

• Joshua Havens, PharmD

  University of Nebraska

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 21, 2019
• First Posted: June 26, 2019
• Study Start: October 9, 2019
• Primary Completion: October 1, 2021
• Study Completion: April 1, 2022
• Last Updated: October 4, 2023
• Results First Posted: December 20, 2022

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)