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Drug users account for a disproportionately large burden of hepatitis C virus (HCV) infection. However, HCV treatment adherence rates in drug users may be suboptimal in patients who use drugs regularly during HCV treatment. Because HCV treatment is most effective when patients adhere to at least 80% of the prescribed treatment regimen, interventions to improve HCV treatment adherence need to be developed and evaluated. The investigators designed the HCV DOT trial to test the efficacy of two versions of modified directly observed HCV therapy provided on-site at a methadone clinic. The primary objective of this trial is to determine whether enhanced DOT with both pegylated interferon alfa-2a plus ribavirin (PEG/RBV-DOT) is more efficacious than standard DOT with weekly provider-administered pegylated interferon (PEG-DOT) and self-administered ribavirin for increasing adherence and improving HCV treatment outcomes. The investigators hypothesize that PEG/RBV-DOT is associated with increased adherence and rates of sustained viral response compared with PEG-DOT.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
Albert Einstein College of Medicine Division of Substance Abuse
The Bronx, New York, United States
Start Date
October 1, 2007
Primary Completion Date
March 1, 2013
Completion Date
March 1, 2013
Last Updated
June 26, 2015
80
ACTUAL participants
enhanced DOT (both pegylated interferon alfa-2a and ribavirin)
OTHER
standard DOT (PEG-DOT control arm)
OTHER
Lead Sponsor
Albert Einstein College of Medicine
Collaborators
Data Source & Attribution
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