Status:
COMPLETED
Effective Treatment of Hepatitis C in Substance Users
Lead Sponsor:
Yale University
Collaborating Sponsors:
National Institute on Drug Abuse (NIDA)
Conditions:
Hepatitis C
Opiate Dependence
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
We hypothesize that integrating Hepatitis C into methadone and buprenorphine treatment will improve Hepatitis C outcomes as well as drug treatment outcomes in patients who are addicted to opiates. We ...
Eligibility Criteria
Inclusion
- Subjects with a DSM IV diagnosis of opioid dependence who are currently enrolled in methadone or buprenorphine maintenance at South Central Rehabilitation Center in good standing (opiate free urine with positive methadone or buprenorphine, respectively) for at least 30 days.
- Hepatitis C infection as evidenced by a positive HCV antibody and a detectable HCV RNA.
Exclusion
- Suicidal or homicidal ideation
- Psychiatric condition that is not stable
- Pregnancy (RBV is a Class C drug during pregnancy)
- Pending court case or warrant which would interrupt treatment
- Decompensated cirrhosis (Child's Class B or C) or presence of hepatocellular carcinoma
- HIV+ with CD4\<200 or CD4\>200 and VL\>5,000 copies/mL
- Platelet count \< 75,000 /mL
- Hemoglobin \< 10 mg/dL
- Absolute neutrophil count \<1500 cells/mL
Key Trial Info
Start Date :
April 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2011
Estimated Enrollment :
21 Patients enrolled
Trial Details
Trial ID
NCT00633243
Start Date
April 1 2007
End Date
September 1 2011
Last Update
January 3 2013
Active Locations (1)
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1
South Central Rehabilitation Agency
New Haven, Connecticut, United States, 06519