79
Participants
Start Date
March 31, 2016
Primary Completion Date
November 30, 2018
Study Completion Date
November 30, 2018
ibalizumab
Intravenous infusion of humanized monoclonal antibody binding with a region of Domain 2 of CD4 receptor, blocking post-attachment conformational changes necessary for HIV cell entry
Optimized Background Regimen
An investigator-selected, standard-of-care combination regimen of antiretroviral agents for treating HIV-1 infection, selected based upon patient treatment history and the results of previous viral resistance testing. The combination must contain at least one agent other than ibalizumab to which the patient's virus is sensitive (susceptible).
AIDS Healthcare Foundation - Manhattan Midtown HCC, New York
Chelsea Village Medical, New York
Jacobi Medical Center, The Bronx
Philadelphia FIGHT, Philadelphia
Georgetown University School of Medicine, Washington D.C.
National Institute of Allergy & Infectious Diseases, Bethesda
East Carolina University, Greenville
AIDS Research Consortium of Atlanta, Atlanta
Orlando Immunology Center, Orlando
AIDS Healthcare Foundation - Kinder Medical Group, Miami
AIDS Healthcare Foundation - South Beach, Miami
Gary Richmond, MD, PA, Fort Lauderdale
Triple O Research Institute, West Palm Beach
St. Jude's Children's Research Hospital, Memphis
Howard Brown Health Center, Chicago
Central West Clinical Research, St Louis
North Texas Infectious Disease Consultants, Dallas
Crofoot Research Center, Houston
Research Access Network, Houston
St. Hope Foundation Community Health Center, Bellaire
Southern California Permanente Medical Group, Los Angeles
Ruane Clinical Research Institute Inc., Los Angeles
Charles R. Drew University of Medicine and Science, Clinical and Translational Research Center, Los Angeles
Anthony Mills MD Inc., Los Angeles
Long Beach Education and Research Consultants, Long Beach
Palmtree Clinical Research, Inc., Palm Springs
eStudy Site, San Francisco
Kaiser Foundation Research Institute, San Francisco
University of Hawaii - John A. Burns School of Medicine, Honolulu
Yale University, New Haven
ID Research Institute, Springfield
Clinical Research PR, Inc., San Juan
Collaborators (1)
Westat
OTHER
TaiMed Biologics Inc.
INDUSTRY