Status:
COMPLETED
Rapid HCV Treatment Access for Persons Who Use Drugs
Lead Sponsor:
Johns Hopkins University
Collaborating Sponsors:
AbbVie
Conditions:
Hepatitis C Virus Infection, Response to Therapy of
Eligibility:
All Genders
18-70 years
Phase:
NA
Brief 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 (...
Eligibility Criteria
Inclusion
- Ability and willingness of participant to provide written informed consent
- Men and women age ≥18 to ≤70 years at study entry
- HCV antibody positive/detectable HCV RNA
- HCV treatment naïve (no prior treatment with an approved or investigational oral Direct-Acting Antivirals (DAA) therapy
- 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)
Exclusion
- 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 currently taking any of the following prohibited medications: red yeast rice (monacolin K), St. John's Wort, carbamazepine, dabigatran, efavirenz, phenytoin, pentobarbital, phenobarbital, primidone, rifabutin, rifampin.
- Subject is not able or willing to safely discontinue the prohibited medications or supplements listed below at least 14 days prior to the first dose of GLE/PIB: some HMG-CoA reductase inhibitors, astemizole, cisapride, terfenadine, ethinyl estradiol.
Key Trial Info
Start Date :
August 6 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 23 2024
Estimated Enrollment :
124 Patients enrolled
Trial Details
Trial ID
NCT04677153
Start Date
August 6 2021
End Date
September 23 2024
Last Update
December 3 2025
Active Locations (4)
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1
University of Alabama
Birmingham, Alabama, United States, 35294
2
University of California, San Francisco
San Francisco, California, United States, 94143
3
Johns Hopkins University
Baltimore, Maryland, United States, 21287
4
University Health Network Toronto
Toronto, Ontario, Canada, M5G 2C4