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

  • STATUS
    Recruiting
  • End date
    Oct 23, 2021
  • participants needed
    45
  • sponsor
    University of Nebraska
Updated on 23 January 2021

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.

Details
Condition HIV-1-infection, HIV-1-infection
Treatment bictegravir/emtricitabine/tenofovir alafenamide
Clinical Study IdentifierNCT03998176
SponsorUniversity of Nebraska
Last Modified on23 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age greater than or equal to 19 yrs?
Gender: Male or Female
Do you have HIV-1-infection?
Do you have any of these conditions: Do you have HIV-1-infection??
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
Clear my responses

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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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