This study is not yet accepting patients

Rapid HCV Treatment Access for Persons Who Use Drugs

a study on Hepatitis C

Summary

Eligibility
for people ages 18-70 (full criteria)
Location
at San Francisco, California and other locations
Dates
study started
estimated completion

Description

Summary

This study is being done to compare two strategies to deliver HCV treatment to persons with hepatitis C virus (HCV) who also use drugs and are participating in an outpatient opioid treatment program (OTP). Participants will be randomized into one of two treatment groups: 1. Test and treat plus peer-mentors: This treatment group will be offered 8 weeks of glecaprevir/pibrentasvir (an FDA approved HCV treatment) within days of HCV diagnosis at the OTP. Participants in this group will receive treatment adherence support from a peer-mentor who is someone who has been cured of HCV infection. 2. Standard of care HCV treatment referral: This treatment group will be referred to an offsite HCV treatment location. This is the usual care for anyone who tests positive for HCV at the OTP who is not participating in this study.

Official Title

Rapid HCV Test and Treat to Increase HCV Treatment Uptake Among People Who Use Drugs

Keywords

Hepatitis C Virus Infection, Response to Therapy of Hepatitis C Test and treat plus peer mentors

Eligibility

You can join if…

Open to people ages 18-70

  • Ability and willingness of participant to provide written informed consent
  • Men and women age ≥18 to ≤70 years at study entry
  • HCV antibody positive
  • HCV treatment naïve (no prior treatment with an approved or investigational anti HCV medication)
  • Negative pregnancy test at screening or at the day of treatment initiation (females of childbearing potential only)
  • If co-infection with Human Immunodeficiency Virus (HIV) is documented, the subject must be anti-retroviral treatment (ART) naïve with CD4 T cell count >500 cells/mm3 OR on a stable ART regimen (containing only permissible ART - Raltegravir; dolutegravir; Rilpivirine; Elvitegravir/cobicistat; Tenofovir disoproxil fumarate; Tenofovir alafenamide; Emtricitabine; Lamivudine and/or Abacavir, bictegravir)

You CAN'T join if...

  • Women who are pregnant or breastfeeding, or considering becoming pregnant during the study and for 30 days after the last dose of study drug
  • Known allergy/sensitivity or any hypersensitivity to components of study drugs or their formulation
  • Current or history of decompensated liver disease (including but not limited to encephalopathy, variceal bleeding, or ascites) prior to study entry
  • History of hepatocellular carcinoma (HCC)
  • Any history of active Hepatitis B or positive HBsAg test
  • Platelet count < 150,000/mm3
  • HCV RNA undetectable
  • History of clinically significant abnormalities or co-morbidities that make the subject an unsuitable candidate for this study, in the opinion of the investigator.
  • Women of childbearing potential that are not practicing at least one specified method of birth control that is effective from Study Day 1 through at least 30 days after the last dose of study drug.
  • Subject is not able or not willing to safely discontinue the prohibited medications or supplements at least 14 days prior to the first dose of GLE/PIB.

Locations

  • University of California, San Francisco
    San Francisco California 94143 United States
  • University of Alabama
    Birmingham Alabama 35294 United States

Details

Status
not yet accepting patients
Start Date
Completion Date
(estimated)
Sponsor
Johns Hopkins University
ID
NCT04677153
Study Type
Interventional
Last Updated