724
Participants
Start Date
July 31, 2008
Primary Completion Date
December 31, 2010
Study Completion Date
April 30, 2015
Elvitegravir
Elvitegravir (EVG) tablet administered orally once daily with food
Raltegravir
Raltegravir tablet administered orally twice daily according to prescribing information
EVG placebo
Placebo to match elvitegravir administered orally once daily
RAL placebo
RAL placebo administered orally twice daily.
Background regimen
Background Regimen (administered according to prescribing information) contains 1 fully-active ritonavir-boosted protease inhibitor (PI/r) plus 1 or 2 additional agents. The ritonavir-boosted PIs include either ATV, darunavir, fosamprenavir, LPV (Kaletra®), or tipranavir; the additional agents include abacavir (ABC), Combivir® (lamivudine (LAM)/zidovudine (ZDV) coformulated), didanosine, emtricitabine (FTC), enfuvirtide, Epzicom® (ABC/LAM coformulated), etravirine, LAM, maraviroc, tenofovir disoproxil fumarate (TDF), Truvada®, (FTC/TDF coformulated), and/or ZDV.
C.H.U. St Pierre, Brussels
Hôpital Erasme, Brussels
Institute of Tropical Medicine, Antwerp
Ground Zero Medical Centre, Darlinghurst
Holdsworth House Medical Practice, Darlinghurst
St. Vincent's Hospital, Sydney, Darlinghurst
Albion Street Centre, Sydney
East Sidney Doctors, Sydney
Royal Prince Alfred Hospital, Camperdown
Westmead Hospital, Wentworthville
St George Hospital, Kogarah
Centre Hospitalier Universitaire de Liège, Liège
CHU de Charleroi-Hopital civil, Charleroi
Beth Israel Medical Center, New York
Chelsea Village Medical, PC, New York
Ricky K. Hsu, MD, PC, New York
Mount Sinai School of Medicine, New York
Greiger Clinic, Mount Vernon
Montefiore Medical Center, The Bronx
STAR Health Care Center, Brooklyn
Albany Medical College, Albany
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran (INCMYNSZ), México
Hospital Reina Sofia, Córdoba
AIDS Community HealthCenter, Rochester
Hospital Clinico San Cecilio, Granada
University of Pennsylvania, Philadelphia
Philadelphia FIGHT, Philadelphia
Thomas Jefferson University Jefferson Alumni Hall, Philadelphia
Whitman-Walker Clinic, Washington D.C.
The George Washington University Medical Center, Washington D.C.
IFI-Institute, Hamburg
Fondazione Centro San Raffaele del Monte Tabor, Milan
Ospedale L. Sacco, Milan
Ospedale Luigi Sacco, Milan
Ambulanzzentrum am Universitatsklinikum Hamburg Eppendorf, Hamburg
University of Maryland, Institute of Human Virology, Baltimore
Clinical Alliance for Research & Education - Infectious Diseases, LLC (CARE-ID), Annandale
Medizinische Universitatsklinik Kiel, Kiel
Ospedali Riuniti Di Bergamo, Bergamo
Spedali Civili di Brescia, Brescia
Wake Forest University Health Sciences, Winston-Salem
University of North Carolina/ School of Medicine Division of Infectious Diseases/ AIDS Clinical Trials Unit, Chapel Hill
Duke University, Durham
Brody School of Medicine at East Carolina University, Greenville
Hospital La Princesa, Madrid
Hospital General Universitario Gregorio Maranon, Madrid
Hospital Ramon y Cajal, Madrid
Hospital Doce De Octubre, Madrid
Hospital Universitario La Paz, Madrid
Rosedale Infectious Diseases, Huntersville
Carolinas Medical Center, Charlotte
Hospital Virgen de la Victoria, Málaga
Infectious Disease Specialists of Atlanta (IDSA), Decatur
AIDS Research Consortium of Atlanta, Atlanta
The Emory Clinic, Inc., Division of Infectious Diseases, Atlanta
Atlanta ID Group, Atlanta
Hopital Purpan - Service of Infectious Diseases, Toulouse
Mercer Univ. School of Medicine, Macon
Hospital Regional de Leon Guanajuato, León
Chatham County Health Department, Savannah
Orlando Immunology Center, Orlando
Infectious Disease of Central Florida, Orlando
Treasure Coast Infectious Disease Consultants, Vero Beach
The Kinder Medical Group, Miami
University of Miami, Miami
Wohlfeiler, Piperato and Associates, LLC, North Miami Beach
Lifeway , Inc., Fort Lauderdale
NorthPoint Medical, Fort Lauderdale
Therafirst Medical Centers, Fort Lauderdale
Broward Health CCC, Fort Lauderdale
Gary Richmond, MD, PA, Inc., Fort Lauderdale
South Florida Clinical Research, Atlantis
CHU Bordeaux, Pessac
St. Joseph's Comprehensive Research Institute, Tampa
University Hospital of Montpellier - Gui de Chauliac, Montpellier
Barry M. Rodwick, M. D., Safety Harbor
Associates In Infectious Diseases, Ft. Pierce
Complexo Hospitalario Xeral-Cies (Chuvi) Vigo, Vigo
Hospital Universitario de Canarias, Santa Cruz de Tenerife
Universitatsklinikum Dusseldorf, Düsseldorf
University of Kentucky Healthcare/Bluegrass Care Clinic, Lexington
Hospital Virgen del Rocio, Seville
CHU Nantes, Nantes
Hospital Civil de Guadalajara, Guadalajara
Summa Health CARE Center, Akron
Universitatklinikum Essen, Essen
Be Well Medical Center, Berkley
Wayne State University, Detroit
Henry Ford Hospital Div of Infectious Disease, Detroit
Klinikum der Universitat zu Koln, Cologne
Universitatsklinikum Bonn, Bonn
Klinikum der J.W. Goethe-Universitat, Frankfurt
The Ruth M. Rothstein CORE Center, Chicago
Howard Brown Health Center, Chicago
Northstar Medical Center, Chicago
Washington University School of Medicine, St Louis
Southampton Healthcare, Inc., St Louis
Health for Life Clinic, PLLC, Little Rock
Hopital Saint Louis, Paris
Hopital Saint Antoine - Infectious Desease Department, Paris
Hopital Pitie Salpetriere - Infectious Deseases Department, Paris
APHP Hopital Bichat-Claude Bernard, Paris
Hopital Tenon, Paris
AIDS Arms/ Peabody Health Center, Dallas
Southwest Infectious Disease Clinical Research, Dallas
Presbyterian Hospital of Dallas, Dallas
North Texas Infectious Disease Consultants, Dallas
DCOL Center for Clinical Research, Longview
Tarrant County Infectious Disease Associates, Fort Worth
University of Texas Health Science Center at Houston, Houston
Gordon E. Crofoot, MD, PA, Houston
The Schrader Clinic, Houston
Joseph C. Gathe, JR. MD, F.A.C.P., Houston
Hospital Central Morones Prieto, San Luis Potosí City
Garcia Family Health Group, Harlingen
Central Texas Clinical Research, Austin
MUC Research, Munich
Southwest Center for HIV/AIDS, Phoenix
Southwest C.A.R.E. Center, Santa Fe
Kaiser Permanente, Los Angeles
Jeffrey Goodman Special Care Clinic, Los Angeles
University of Southern California, AIDS Clinical Trials Unit, Los Angeles
Peter J. Ruane, MD, Inc., Los Angeles
Tony Mills, MD Internal Medicine, Los Angeles
Pacific Oaks Medical Group, Beverly Hills
AIDS Healthcare Foundation-Research Center, Beverly Hills
The Living Hope Foundation, Long Beach
David J. Shamblaw, MD Inc., San Diego
Orange Coast Medical Group, Newport Beach
Center for Special Immunology, Fountain Valley
Metropolis Medical, San Francisco
San Francisco VA Medical Center/UCSF, San Francisco
Hopital de Bicentre - Service de medecine Interne et Immunologie, Le Kremlin-Bicêtre
Alameda County Medical Center, Oakland
East Bay AIDS Center, Oakland
Kaiser Permanente, Sacramento
Hawaii AIDS Clinical Research Program HACRP, Honolulu
EHS Pulmonary and Critical Care, Spokane
Connecticut Health Care Group, Glastonbury
Circle Medical LLC, Norwalk
The Stamford Hospital - Stamford ID, Stamford
Community Research Initiative of New England, Boston
ID Care, Hillsborough
Saint Michael's Medical Center, Newark
University of Medicine and Dentistry of New Jersey; University Hospital Infectious Disease Practice, Newark
South Jersey Infectious Disease, Somer Point
Downtown Infectious Diseases Clinic, Vancouver
Queen Elizabeth II Health Sciences Centre, Halifax
Sunnybrook Health Sciences Centre, Toronto
CascAids Research, Toronto
Canadian Immunodeficiency Research Collaborative (CIRC) Inc., Toronto
University Health Network, Toronto General Hospital, Toronto
Clinique medicale l'Actuel, Montreal
Immunodeficiency Service, McGill University Health Centre (MUHC), Montreal
University of Manitoba - Health Sciences Centre, Winnipeg
C.H.U. de Nice - Hopital de l'Archet 1, Nice
Istituto Nazionale per le Malattie Infettive Lazzaro Spallanzani I.R.C.C.S., Rome
Universita La Sapienza Policlinico Umberto I, Rome
Universita' Cattolica Del Sacro Cuore, Rome
Erasmus Medisch Centrum, Rotterdam
Hospital Fernando Fonseca, Amadora
Hospital Santo Antonio dos Capuchos, Lisbon
Hospital de Santa Maria, Lisbon
Hospital Pulido Valente, Lisbon
Hospital de Sao Joao, Porto
Instituto de Investigacion Cientifica del Sur, Ponce
Clinical Research Puerto Rico, Inc., San Juan
HOPE Clinical Research, San Juan
VA Caribbean healthcare System, San Juan
University of Puerto Rico, School of Medicine, Proyecto ACTU, San Juan
Hospital General Universitario de Alicante, Alicante
Hospital de la Santa Creu i Sant Pau, Barcelona
Hospital Clinic i Provincial de Barcelona, Barcelona
Hospital Universitario Germans Trias i Pujol, Barcelona
Hospital General Universitario del Elche, Elche
Universitatsspital Zurich, Zurich
RIDU, Western General Hospital, Edinburgh
Imperial College Healthcare NHS Trust, St. Mary's Campus, London
Royal Free and University College Medical School, London
North Manchester General Hospital, Manchester
Lead Sponsor
Gilead Sciences
INDUSTRY