202
Participants
Start Date
June 30, 2012
Primary Completion Date
February 28, 2013
Study Completion Date
May 31, 2013
SOF
Sofosbuvir (SOF) 400 mg tablet was administered orally once daily.
RBV
Ribavirin (RBV) tablets was administered orally in a divided daily dose according to package insert weight-based dosing recommendations (\< 75kg = 1000 mg and ≥ 75 kg = 1200 mg).
Placebo to match SOF
Placebo to match SOF was administered orally once daily.
Placebo to match RBV
Placebo to match RBV was administered orally twice daily.
Auckland Clinical Studies Limited, Auckland
Christchurch Hospital, Christchurch
Mount Sinai School of Medicine, New York
Binghamton Gastroenterology Associates, Binghamton
University of Pennsylvania, Philadelphia
Whitman Walker Clinic, Washington D.C.
Johns Hopkins University, Lutherville
Metropolitan Research, Fairfax
Inova Fairfax Hospital Center for Liver Diseases, Falls Church
Bon Secours St. Mary's Hospital of Richmond, Inc., Richmond
Digestive and Liver Disease Specialists, Norfolk
Digestive Health Specialists, PA, Winston-Salem
Duke University Medical Center, Durham
Asheville Gastroenterology Associates, P.A., Asheville
Gastrointestinal Specialists of Georgia, PC, Marietta
Digestive Healthcare of Georgia, Atlanta
Borland-Groover Clinic Baptist, Jacksonville
Internal Medicine Specialists, Orlando
University of Miami, Miami
South Florida Center of Gastroenterology, P.A., Wellington
Advanced Research Institute, New Port Richey
Nashville Gastrointestinal Specialists, Inc, Nashville
Gastro One, Germantown
Graves-Gilbert Clinic, Bowling Green
Indianapolis Gastroenterology Research Foundation, Indianapolis
Henry Ford Health System, Novi
Minnesota Gastroenterology, P.A., Minneapolis
Kansas City Gastroenterology and Hepatology, Kansas City
Gastroenterology Associates, LLC, Baton Rouge
Southwest Infectious Disease Clinical Research, Inc., Dallas
Texas Clinical Research Institute, LLC, Arlington
Alamo Medical Research, San Antonio
University of Colorado, Aurora
South Denver Gastroenterology, PC, Englewood
Southwest C.A.R.E. Center, Santa Fe
Kaiser Permanente, Los Angeles
Peter J. Ruane, MD, Inc., Los Angeles
Anthony Mills MD, Inc., Los Angeles
UCSD Antiviral Research Center, San Diego
SCTI Research Foundation, Coronado
Medical Associates Research Group, Inc., San Diego
Kaiser Permanente, San Diego
Quest Clinical Research, San Francisco
Virginia Mason Medical Center, Seattle
University of Florida, Gainesville
Orlando Immunology Center (ACH), Orlando
Massachusetts General Hospital, Boston
Beth Israel Deaconess Medical Center, Boston
The Research Institute, Springfield
Comprehensive Clinical Research, Berlin
ID Care, Hillsborough
University Gastroenterology, Providence
The Miriam Hospital, Providence
University of Calgary, Calgary
University of Alberta Hospital, Edmonton
University of Alberta Hospital, Edmonton
Gordon & Leslie Diamond Health Care Centre, Vancouver
University of British Columbia, Vancouver
(G.I.R.I.) Gastrointestinal Research Institute, Vancouver
University of Manitoba Health Sciences Center, Winnipeg
The Ottawa Hospital, Ottawa
Mount Sinai Hospital, Toronto
Toronto Western Hospital, Toronto
Toronto Liver Centre, Toronto
Hopital St. Luc, Montreal
Clinical Research Puerto Rico Inc, San Juan
Fundacion De Investigacion De Diego, San Juan
Lead Sponsor
Gilead Sciences
INDUSTRY