Substance-Related Disorders Clinical Trial
Official title:
Treatment of Acute Hepatitis C Virus Infection in Injection Drug Users With Pegylated Interferon for 24 Weeks
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.
IDUs are at high risk for developing HCV. Pegylated interferon is a man-made form of
interferon, a chemical naturally produced by the body that works to fight viruses.
Interferon helps to stop HCV from replicating, and helps the immune system to kill HCV. The
purpose of this trial is to determine the effectiveness of pegylated interferon in IDUs with
HCV.
This trial will last 24 weeks. Participants will be randomly assigned to one of two groups.
Group 1 will receive pegylated interferon while group 2 will receive an active control.
Injection with either pegylated interferon or control will occur weekly. During each
injection visit, participants will be asked about adverse events, including common side
effects to interferon such as injection site reactions, headache, myalgias, arthralgias,
insomnia, and hair loss. At Weeks 2, 4, and then every 4 weeks thereafter, participants will
complete depression self-reports. Laboratory assessments will occur at Week 2, and then on a
monthly basis for the remainder of the study. Follow-up assessments will occur every 4 weeks
after Week 24.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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