Pender Assisted Therapy (PATh) - Prospective Study of the Treatment of HCV

NCT00247884 | Completed

• 1 other identifier: C05-0219
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 2

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 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.

Conditions

Hepatitis C Virus Infection

Keywords

Injection drug users; pegylated interferon; ribavirin,; HCV

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Injection drug users

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of British Columbia: lead
• Canadian Institutes of Health Research (CIHR): collaborator

Study Sites (2)

Pender Community Health Centre

Vancouver, British Columbia, Canada

Location

Cool-Aid Community Health Centre

Victoria, British Columbia, Canada

Location

MeSH Terms

Conditions

Hepatitis C

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections; Hepatitis; Liver Diseases; Digestive System Diseases

Study Officials

• Brian Conway, MD

  University of British Columbia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: October 31, 2005
• First Posted: November 2, 2005
• Study Start: June 1, 2005
• Study Completion: October 1, 2009
• Last Updated: October 14, 2009

Record last verified: 2009-10

Locations

CA (2)