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Evaluation of a Multi-disciplinary Approach for the Treatment of Hepatitis C in IDUs (HI-LO Study)

NCT00399672 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 370

Last updated 2016-11-30

No results posted yet for this study

Summary

Although injection drug users (IDUs) account for over 70% of new cases of HCV infection/year, there is no consensus on how to approach their medical care. In some Canadian centres, patients must be free of recreational drug use for as long as 6 months before being considered for HCV therapy. This is not consistent with current North American guidelines. Over the past 5 years, we have developed a successful program for the treatment of HIV infection in this population, based on a multi-disciplinary comprehensive program including directly observed therapy (DOT). Even though the duration of therapy for HCV is shorter than for HIV (as little as 6 months vs. life-long), we must address issues of administration of a weekly injection (interferon), twice daily pills (ribavirin) and the risk of significant side effects (including anxiety and depression) to successfully expand our program to treat this disease. Further, it may be that even if the program is successful, its benefits will be negated by HCV re-infection due to continued risk behaviors for its transmission.

Conditions

  • Hepatitis C Virus Infection

Interventions

DRUG

Interferon injections and ribavirin

Weekly pegylated interferon injections will be administered by clinic staff and ribavirin will be dispensed in weekly medication pack.

DRUG

Interferon injections and ribavirin

Patients will be offered the option of self or nurse administered pegylated interferon injections on an appointment basis. Ribavirin will be dispensed biweekly. The treatment medication cannot be stored at the clinic; it must be the subjects responsibility.

Sponsors & Collaborators

  • Canadian Institutes of Health Research (CIHR)

    collaborator OTHER_GOV

  • University of British Columbia

    lead OTHER

Principal Investigators

  • Brian Conway, MD · University of British Columbia

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
19 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-06-30
Primary Completion
2010-08-31
Completion
2012-12-31

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00399672 on ClinicalTrials.gov