This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. VIRAHEP-C is a multicenter, collaborative clinical trial, sponsored by NIDDK-NIH, designed to test the hypothesis that African Americans respond less well to antiviral therapy than Caucasian patients. A total of 400 patients, equally divided between African American and Caucasians, will be enrolled at eight clinical centers throughout the United States. All participants will be HCV genotype 1. Participants will be treated for 48 weeks with pegylated interferon alfa-2a 180 mcg/week plus ribaviirin 1000-1200 mg/day. Participants will be followed for an additional 48 weeks after cessation of therapy. Sustained virological response rates (undetectable HCV RNA in serum 24 weeks post-treatment) and durable sustained virological response rates (undetectable HCV RNA in serum 48 weeks post-treatment) between the two cohorts will be compared to determine differences in treatment response between the two racial graoups. Clinical and virological data from these treatment cohorts will be used to evaluate factors associated with resistance to antiviral therapy in African Americans and Caucasians with chronic hepatitis C. Ancillary virology, immunology, genetics, and interferon signaling studies will be performed on samples obtained from participants will investigate potential mechanisms of antiviral resistance. Thus, viral kinetics (the rate at which HCV RNA is cleared from serum during therapy), immunological responses, measures of, and host and viral genetics will be evaluated in releationship to treatment respo

Agency
National Institute of Health (NIH)
Institute
National Center for Research Resources (NCRR)
Type
General Clinical Research Centers Program (M01)
Project #
5M01RR016500-05
Application #
7376926
Study Section
National Center for Research Resources Initial Review Group (RIRG)
Project Start
2006-03-01
Project End
2007-02-28
Budget Start
2006-03-01
Budget End
2007-02-28
Support Year
5
Fiscal Year
2006
Total Cost
$23,766
Indirect Cost
Name
University of Maryland Baltimore
Department
Internal Medicine/Medicine
Type
Schools of Medicine
DUNS #
188435911
City
Baltimore
State
MD
Country
United States
Zip Code
21201
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