NCT00247884|Completed
Pender Assisted Therapy (PATh) - Prospective Study of the Treatment of HCV
Directly Observed Therapy for the Treatment of Hepatitis C Virus Infection in Injection Drug Users
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Directly Observed Therapy for the Treatment of Hepatitis C Virus Infection in Injection Drug Users
Sponsor study identifier
observational
50
1 country
2
Study Start
June 2005
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
Not reported
Date not reportedStudy Completion
October 2009
Actual (reported)The treatment of HCV-infected IDUs presents multiple challenges, such as adherence to therapy, relapse of substance use, re-infection, and co-morbid psychiatric disease. Some guidelines recommended that IDUs not be offered HCV treatment until they had stopped all such use for \> 6 months, raising some questions about fairness and discrimination. Little published data exist on HCV therapy in active IDUs. However, extensive evidence exists that, when specific programs are developed, IDUs can be successfully engaged in care. In IDUs, strategies shown to improve adherence include directly-observed therapy (DOT), cash incentives, and comprehensive case management. Weekly interferon dosing now provides a means of improving HCV treatment adherence, and makes a DOT approach more practical. Within an observational, prospective clinical cohort, we will be able to identify a group of IDUs infected with HCV genotype 2 or 3 who would most benefit from treatment for their infection. We will design a systematic approach to the determination of their appropriateness for treatment, refine the approach to their treatment within a directly observed therapy (DOT) setting, and evaluate the success of the approach (defined as the achievement of Sustained Virologic Response (SVR)). Taken together, this project will help define a systematic approach to HCV infection in the inner city. The hypothesis is that the development of a systematic approach for the diagnosis of HCV and the establishment of a directly observed therapy (DOT) program for the treatment of HCV infection in IDUs will constitute an effective means of controlling the epidemic of this infection within this population.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
October 2009
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
June 2005
Date type not reportedThis date has not been verified as actual or estimated.
October 31, 2005
Actual (reported)November 2, 2005
Actual (reported)October 2009
Actual (reported)Injection drug users
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Pender Community Health Centre
Vancouver, British Columbia, Canada
Cool-Aid Community Health Centre
Victoria, British Columbia, Canada
Brian Conway, MD
University of British Columbia
First Submitted
October 31, 2005
First Posted
November 2, 2005
Study Start
June 2005
Date type not reportedThis date has not been verified as actual or estimated.
Study Completion
October 2009
Actual (reported)Safety and Efficacy of Ledipasvir/Sofosbuvir (LDV/SOF) Fixed Dose Combination Tablet With Ribavirin for 12 Weeks in Treatment-naive Adults With Chronic HCV Genotype 3 Infection
Last Updated
October 14, 2009
Record last verified: 2009-10
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