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. The main purpose of this study is to investigate the effectiveness and safety of Pegasys plus amantadine, and Pegasys plus amantadine plus ribavirin, and comparison of rebetron with Pegasys plus CellCept, as initial treatment in patients with chronic HCV infection. The additional drugs in this study are approved by the Food and Drug Administration (FDA) to be used for the followoing purposes: (1) ribavirin has been marketed as Virazole for many years as an inhaler for the treatment of lower respiratory tract infections. More recently, ribavirin has been approved by the FDA as Rebetol, to be used with another medication called Intron A (interferon alfa-2b). The combination of Intron A and Rebetol is called Rebetron; (2) Rebetron is approved by the FDA for patients with hepatitis C infection; (3) CellCept has been approved by the FDA to help prevent organ rejection in patients receiving a kidney or heart transplant; and (4) amantadine is used for the prevention and treatment of respiratory tract infections caused by influenza A virus infections. Preliminary studies suggest that when used in combination, CellCept and amantadine may be useful against hepatitis C infections, although they are not yet approved by the FDA for this use.

Agency
National Institute of Health (NIH)
Institute
National Center for Research Resources (NCRR)
Type
General Clinical Research Centers Program (M01)
Project #
5M01RR000046-46
Application #
7377403
Study Section
National Center for Research Resources Initial Review Group (RIRG)
Project Start
2005-12-01
Project End
2006-11-30
Budget Start
2005-12-01
Budget End
2006-11-30
Support Year
46
Fiscal Year
2006
Total Cost
$248
Indirect Cost
Name
University of North Carolina Chapel Hill
Department
Internal Medicine/Medicine
Type
Schools of Medicine
DUNS #
608195277
City
Chapel Hill
State
NC
Country
United States
Zip Code
27599
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