Status:
COMPLETED
Pender Assisted Therapy (PATh) - Prospective Study of the Treatment of HCV
Lead Sponsor:
University of British Columbia
Collaborating Sponsors:
Canadian Institutes of Health Research (CIHR)
Conditions:
Hepatitis C Virus Infection
Eligibility:
All Genders
19+ years
Brief Summary
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 th...
Detailed Description
We will evaluate up to 200 IDUs receiving care in our clinics. For those found to carry genotype 2 or 3 and be eligible for treatment on medical grounds, we will evaluate the patients in a bi-weekly c...
Eligibility Criteria
Inclusion
- Age greater than 18 years; Serum HCV-RNA positive; HCV genotype 2 or 3; HBsAg negative; serum ALT greater than 1.5x upper limit normal greater than 3 months; Agreement from each participant of childbearing age to practice contraception; Ability to provide informed consent; judged to be appropriate for immediate treatment by case conference.
Exclusion
- Any cause for chronic liver disease other than HCV (including alcohol use greater than 350 g/wk); Pregnant or breastfeeding women; Active HBV infection; Hemolytic anemia; Decompensated cirrhosis or portal hypertension; Active suicidal ideation, psychosis, mania or hypomania; Serum creatinine greater than 180 µg/mL; Hemoglobin less than 120 g/L in men or 110 g/L in women; Platelets \< 90 x 109/L; Neutrophils less than 1.5 x 109/L; Active autoimmune disease; NYHA disease \> grade 2; Psoriasis requiring systemic therapy; Active malignancy apart from non melanoma skin cancer; Use of systemic immunosuppressant agents; Weight greater than 105 kg ; Prior treatment of HCV with interferon or ribavirin; HIV positive with CD4 count less than 250 cells/mm3 or receiving didanosine (due to interaction with ribavirin); Life expectancy less than 2 years; judged to be inappropriate for immediate treatment by case conference
Key Trial Info
Start Date :
June 1 2005
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
October 1 2009
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT00247884
Start Date
June 1 2005
End Date
October 1 2009
Last Update
October 14 2009
Active Locations (2)
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1
Pender Community Health Centre
Vancouver, British Columbia, Canada
2
Cool-Aid Community Health Centre
Victoria, British Columbia, Canada