Treatment of Acute Hepatitis C Virus Infection With Pegylated Interferon in Injection Drug Users

• Status: Completed
• Trial end date: 2007-06-01
• Target enrollment: 0
• Participant gender: All

Summary

Injection drug use accounts for transmission of a high proportion of Hepatitis C Virus (HCV) infections. The purpose of this trial is to investigate the effectiveness of pegylated interferon in treating injection drug users (IDUs) with acute HCV.

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

Details

• Lead Sponsor: National Institute on Drug Abuse (NIDA)
• Collaborator: University of Washington
• Treatments: Interferons

Criteria

Inclusion Criteria:

• Documented HCV antibody seroconversion within the 12 months prior to study entry

• Serum positive for HCV

• Meets hematologic, biochemical, and serologic criteria at entry visit

• Thyroid stimulating hormone within normal limits

• Hepatitis B surface antigen negative

• Reads at an eighth grade reading level

• Willing to use adequate contraception for the duration of the study

• Plans to remain in the study area for 12 months

Exclusion Criteria:

• Positive test for Hepatitis A antibodies, Hepatitis B antibodies, or HIV antibodies

• Suspected hypersensitivity to pegylated interferon

• Liver disease

• Hemoglobinopathies

• Immune mediated disease

• Significant cardiac or pulmonary disease

• Uncontrolled seizure disorder

• Renal insufficiency with serum creatinine levels greater than 11.5 mb/ml or less than 60 mb/ml

• History of thyroid disease

• Active gout

• Any medical condition requiring or likely to require steroids during the course of study

• Untreated severe psychiatric disorder, as determined by study psychiatrist

• Any condition, which in the opinion of the investigator, would preclude successful completion of the study

• Pregnant or breastfeeding