527
Participants
Start Date
December 31, 2011
Primary Completion Date
January 31, 2013
Study Completion Date
April 30, 2013
Sofosbuvir
Sofosbuvir 400 mg (2 × 200 mg tablets) administered orally once daily
PEG
Pegylated interferon alfa-2a (PEG) 180 μg administered once weekly by subcutaneous injection
RBV
"Ribavirin (RBV) administered as 200 mg tablets up to 1200 mg in a divided daily dose~* Dose of sofosbuvir+RBV group based on baseline weight: \< 75kg = 1000 mg and ≥ 75 kg = 1200 mg~* Dose of PEG+RBV group: 800 mg"
Royal Prince Alfred Hospital, Camperdown
Concord Repatriation General Hospital, Concord
St. George Hospital, Kogarah
Canberra Hospital, Garran
The Alfred, Melbourne
Austin Hospital, Heidelberg
Tauranga Hospital, Tauranga
Monash Medical Centre, Clayton
Waikato Hospital (District Health Board), Hamilton
Royal Brisbane Hospital Research Foundation, Herston
Princess Alexandria, Woollongabba
Gallipoli MRF, Greenslopes
Royal Adelaide Hospital, Adelaide
Royal Perth Hospital, Perth
Sir Charles Gairdner, Nedlands
Wellington Hospital, Newtown
Fremantle Hospital, Fremantle
Christchurch Hospital, Chrischurch
Mercy Hospital, Dunedin
Weill Cornell Medical College, New York
Mount Sinai School of Medicine, New York
North Shore University Hospital, Manhasset
University of Rochester, Rochester
UPMC Center For Liver Diseases, Pittsburgh
Regional Gastroenterology Associates of Lancaster, Ltd., Lancaster
Digestive Disease Associates, P.A., Baltimore
Metropolitan Research, Fairfax
Digestive and Liver Disease Specialist, Ltd., Norfolk
Digestive and Liver Disease Specialists, Norfolk
Digestive Health Specialists, PA, Winston-Salem
Duke University Medical Center, Durham
Carolinas Center for Liver Disease, Statesville
Asheville Gastroenterology Associates, P.A., Asheville
Gastrointestinal Specialists of Georgia, PC, Marietta
AIDS Research Consortium of Atlanta, Inc., Atlanta
Atlanta Gastroenterology Associates, Atlanta
Borland-Groover Clinic Baptist, Jacksonville
University of Florida College of Medicine, Gainesville
Orlando Immunology Center, Orlando
Internal Medicine Specialists, Orlando
University of Miami, School of Medicine, Miami
South Florida Center of Gastroenterology, Wellington
Pointe West Infectious Diseases, Bradenton
Advanced Research Institute, Trinity
Midway Immunology & Research Center, LLC, Ft. Pierce
University of Alabama at Birmingham, Birmingham
Alabama Liver & Digestive Specialist, Montgomery
Nashville Gastrointestinal Specialists Inc., Nashville
Gastro One, Germantown
Digestive Health Specialists, PA, Tupelo
Sahlgrenska Universitetssjukhuset, Östra Sjukhus, Gothenburg
University of Cincinnati, Cincinnati
Indianapolis Gastroenterology Research Foundation, Indianapolis
Henry Ford Health System, Detroit
University of Chicago, Chicago
Casa Sollievo della Sofferenza Hospital, San Giovanni Rotondo
Gastroenterology United of Tulsa, Tulsa
Baylor University Medical Center, Dallas
Texas Clinical Research Institute, LLC, Arlington
Kelsey-Seybold Clinic PA, Houston
Research Specialists of Texas, Houston
VAMC & Baylor College, Houston
Alamo Medical Research, San Antonio
South Denver Gastroenterology, PC, Englewood
Southwest C.A.R.E. Center, Santa Fe
Peter J. Ruane, M.D. Inc., Los Angeles
California Liver Institute, Beverly Hills
eStudy Site, La Mesa
eStudySite, Oceanside
University of California San Diego Medical Center, San Diego
Research and Education, Inc., San Diego
SCTI Research Foundation, Coronado
Medical Associates Research Group, Inc., San Diego
Arrowhead Regional Medical Center, Colton
Franco Felizarta, MD, Bakersfield
Quest Clinical Research, San Francisco
University of California, Davis - Health System, Sacramento
Schleinitz Research and Gastroenterology LLC, Medford
Virginia Mason Medical Center, Seattle
Beth Israel Deaconess Medical Center, Boston
The Research Institute, Springfield
Partners in Internal Medicine, PC, Worcester
University of Massachusetts, Worcester, Worcester
Veterans Affairs Medical Center, East Orange
AGA Clinical Research Associates, LLC, Egg Harbor
ID Care, Hillsborough
Atlantic Research Affiliates, LLC, Morristown
University Gastroenterology, Warwick
(G.I.R.I.) Gastrointestinal Research Institute, Vancouver
Mount Sinai Hospital, Toronto
University Health Network-Toronto Western Hospital, Toronto
Toronto Liver Centre, Toronto
Toronto Digestive Disease Associates, Inc., Vaughan
Academish Medisch Centrum, Amsterdam
Auckland City Hospital, Grafton
Fundacion de Investigacion de Diego, San Juan
Karolinska Universitetssjukhuset, Solna, Stockholm
Lead Sponsor
Gilead Sciences
INDUSTRY