Directly Observed Hepatitis C Treatment in Methadone Clinics

Status Completed

Clinical Trial Summary

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.

Clinical Trial Description

n/a

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT01442311
Study type	Interventional
Source	Albert Einstein College of Medicine of Yeshiva University
Contact
Status	Completed
Phase	N/A
Start date	October 2007
Completion date	March 2013

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