119
Participants
Start Date
May 31, 2004
Primary Completion Date
December 31, 2005
Study Completion Date
January 31, 2011
SCH-D (vicriviroc)
Group 2 will receive 5 mg vicriviroc daily; Group 3 will receive 10 mg vicriviroc daily; and Group 4 will receive 15 mg vicriviroc daily. If at or after Week 16 a participant's viral load has not met certain criteria, a dose increase of vicriviroc may occur and the participant will enter Step 2. As of 10/12/05, patients in Group 2 and any patients who entered Step 2 following virologic failure in Step 1 will be unblinded and offered either 15 mg vicriviroc daily through this study or the option of seeking alternative treatment.
Placebo
Patients in Group 1 will receive placebo.
Beth Israel Med. Ctr., ACTU, New York
Weill Cornell Chelsea CRS, New York
NY Univ. HIV/AIDS CRS, New York
Weill Cornell Uptown CRS, New York
Trillium Health ACTG CRS, Rochester
Univ. of Rochester ACTG CRS, Rochester
Penn Therapeutics, CRS, Philadelphia
Georgetown University CRS (GU CRS), Washington D.C.
Chapel Hill CRS, Chapel Hill
Vanderbilt Therapeutics (VT) CRS, Nashville
Ohio State University CRS, Columbus
Case CRS, Cleveland
MetroHealth CRS, Cleveland
Indiana Univ. School of Medicine, Infectious Disease Research Clinic, Indianapolis
Rush University CRS, Chicago
Washington University Therapeutics (WT) CRS, St Louis
University of Colorado Hospital CRS, Aurora
UCLA CARE Center CRS, Los Angeles
UCSD Antiviral Research Center CRS, San Diego
Ucsf Hiv/Aids Crs, San Francisco
Santa Clara Valley Med. Ctr., San Jose
University of Washington AIDS CRS, Seattle
Stanford AIDS Clinical Trials Unit CRS, Palo Alto
The Ponce de Leon Center CRS, Atlanta
Massachusetts General Hospital CRS (MGH CRS), Boston
Brigham and Women's Hospital Therapeutics Clinical Research Site (BWH TCRS) CRS, Boston
Bmc Actg Crs, Boston
University of Pittsburgh CRS, Pittsburgh
The Miriam Hospital Clinical Research Site (TMH CRS) CRS, Providence
Univ. of Texas Medical Branch, ACTU, Galveston
Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections
NETWORK
National Institute of Allergy and Infectious Diseases (NIAID)
NIH