Improving Hepatitis C Treatment in Injection Drug Users

• Status: Completed
• Trial end date: 2007-03-01
• Target enrollment: 0
• Participant gender: All

Summary

The overall goal of the research project is to improve the outcome of medical care for injection drug users (IDUs) with Hepatitis C viral (HCV) infection.

Hypothesis: An intervention designed to improve the rate of HCV treatment completion and sustained virologic response (SVR) in IDUs will increase access by integrating HCV medical care into a substance abuse treatment program.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: State University of New York - Upstate Medical University
• Treatments: Interferons; Ribavirin

Criteria

Inclusion Criteria:

1. 18-65 years of age.

2. Enrolled in outpatient methadone maintenance treatment for greater than 3 months.

3. Hepatitis C RNA positive.

4. Willingness to accept HCV treatment.

5. Subject has non-VA (Veteran's Administration) medical insurance or is willing to bear any and all expenses associated with Hepatitis C medical treatment.

Exclusion Criteria:

1. In need of inpatient drug or alcohol detoxification.

2. Currently receiving the standard Hepatitis C treatment

3. Unable to give adequate informed consent.

4. Pregnant, nursing, or planning to become pregnant during HCV treatment or within 6 months following completion of treatment.

5. Male subject who has a female sexual partner who is pregnant or planning to become pregnant at any time during HCV treatment or within 6 months following completion of treatment.

6. Female subject or male subject who has a female sexual partner who is of child bearing years and not using two medically approved forms of contraception.

7. Subject has made a commitment to attend residential care psychiatric or drug/alcohol rehabilitation, which would lead to unavailability to attend regularly scheduled medical care and research visits.

8. Subject did not attend all required screening appointments.

9. Subject has a legal proceeding whose outcome may lead to incarceration within 3 months of intake.