Multicenter, Randomized, Double-Blind, Double-Dummy, Phase 3 Study of the Safety and Efficacy of Elvitegravir Versus Raltegravir

PHASE3CompletedINTERVENTIONAL
Enrollment

724

Participants

Timeline

Start Date

July 31, 2008

Primary Completion Date

December 31, 2010

Study Completion Date

April 30, 2015

Conditions
HIV Infection
Interventions
DRUG

Elvitegravir

Elvitegravir (EVG) tablet administered orally once daily with food

DRUG

Raltegravir

Raltegravir tablet administered orally twice daily according to prescribing information

DRUG

EVG placebo

Placebo to match elvitegravir administered orally once daily

DRUG

RAL placebo

RAL placebo administered orally twice daily.

DRUG

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.

Trial Locations (180)

1000

C.H.U. St Pierre, Brussels

1070

Hôpital Erasme, Brussels

2000

Institute of Tropical Medicine, Antwerp

2010

Ground Zero Medical Centre, Darlinghurst

Holdsworth House Medical Practice, Darlinghurst

St. Vincent's Hospital, Sydney, Darlinghurst

Albion Street Centre, Sydney

East Sidney Doctors, Sydney

2050

Royal Prince Alfred Hospital, Camperdown

2145

Westmead Hospital, Wentworthville

2217

St George Hospital, Kogarah

4000

Centre Hospitalier Universitaire de Liège, Liège

6000

CHU de Charleroi-Hopital civil, Charleroi

10003

Beth Israel Medical Center, New York

10011

Chelsea Village Medical, PC, New York

Ricky K. Hsu, MD, PC, New York

10029

Mount Sinai School of Medicine, New York

10550

Greiger Clinic, Mount Vernon

10573

Montefiore Medical Center, The Bronx

11203

STAR Health Care Center, Brooklyn

12208

Albany Medical College, Albany

14000

Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran (INCMYNSZ), México

14004

Hospital Reina Sofia, Córdoba

14604

AIDS Community HealthCenter, Rochester

18014

Hospital Clinico San Cecilio, Granada

19104

University of Pennsylvania, Philadelphia

19107

Philadelphia FIGHT, Philadelphia

Thomas Jefferson University Jefferson Alumni Hall, Philadelphia

20009

Whitman-Walker Clinic, Washington D.C.

20037

The George Washington University Medical Center, Washington D.C.

20099

IFI-Institute, Hamburg

20127

Fondazione Centro San Raffaele del Monte Tabor, Milan

20157

Ospedale L. Sacco, Milan

Ospedale Luigi Sacco, Milan

20251

Ambulanzzentrum am Universitatsklinikum Hamburg Eppendorf, Hamburg

21201

University of Maryland, Institute of Human Virology, Baltimore

22003

Clinical Alliance for Research & Education - Infectious Diseases, LLC (CARE-ID), Annandale

24116

Medizinische Universitatsklinik Kiel, Kiel

24128

Ospedali Riuniti Di Bergamo, Bergamo

25137

Spedali Civili di Brescia, Brescia

27157

Wake Forest University Health Sciences, Winston-Salem

27514

University of North Carolina/ School of Medicine Division of Infectious Diseases/ AIDS Clinical Trials Unit, Chapel Hill

27710

Duke University, Durham

27834

Brody School of Medicine at East Carolina University, Greenville

28006

Hospital La Princesa, Madrid

28007

Hospital General Universitario Gregorio Maranon, Madrid

28034

Hospital Ramon y Cajal, Madrid

28041

Hospital Doce De Octubre, Madrid

28046

Hospital Universitario La Paz, Madrid

28078

Rosedale Infectious Diseases, Huntersville

28207

Carolinas Medical Center, Charlotte

29010

Hospital Virgen de la Victoria, Málaga

30033

Infectious Disease Specialists of Atlanta (IDSA), Decatur

30308

AIDS Research Consortium of Atlanta, Atlanta

The Emory Clinic, Inc., Division of Infectious Diseases, Atlanta

30309

Atlanta ID Group, Atlanta

31059

Hopital Purpan - Service of Infectious Diseases, Toulouse

31201

Mercer Univ. School of Medicine, Macon

31320

Hospital Regional de Leon Guanajuato, León

31401

Chatham County Health Department, Savannah

32803

Orlando Immunology Center, Orlando

32806

Infectious Disease of Central Florida, Orlando

32960

Treasure Coast Infectious Disease Consultants, Vero Beach

33133

The Kinder Medical Group, Miami

33136

University of Miami, Miami

33169

Wohlfeiler, Piperato and Associates, LLC, North Miami Beach

33308

Lifeway , Inc., Fort Lauderdale

NorthPoint Medical, Fort Lauderdale

Therafirst Medical Centers, Fort Lauderdale

33311

Broward Health CCC, Fort Lauderdale

33316

Gary Richmond, MD, PA, Inc., Fort Lauderdale

33462

South Florida Clinical Research, Atlantis

33604

CHU Bordeaux, Pessac

33614

St. Joseph's Comprehensive Research Institute, Tampa

34295

University Hospital of Montpellier - Gui de Chauliac, Montpellier

34695

Barry M. Rodwick, M. D., Safety Harbor

34952

Associates In Infectious Diseases, Ft. Pierce

36204

Complexo Hospitalario Xeral-Cies (Chuvi) Vigo, Vigo

38320

Hospital Universitario de Canarias, Santa Cruz de Tenerife

40225

Universitatsklinikum Dusseldorf, Düsseldorf

40536

University of Kentucky Healthcare/Bluegrass Care Clinic, Lexington

41013

Hospital Virgen del Rocio, Seville

44093

CHU Nantes, Nantes

44280

Hospital Civil de Guadalajara, Guadalajara

44304

Summa Health CARE Center, Akron

45122

Universitatklinikum Essen, Essen

48072

Be Well Medical Center, Berkley

48201

Wayne State University, Detroit

48202

Henry Ford Hospital Div of Infectious Disease, Detroit

50937

Klinikum der Universitat zu Koln, Cologne

53125

Universitatsklinikum Bonn, Bonn

60590

Klinikum der J.W. Goethe-Universitat, Frankfurt

60612

The Ruth M. Rothstein CORE Center, Chicago

60613

Howard Brown Health Center, Chicago

60657

Northstar Medical Center, Chicago

63110

Washington University School of Medicine, St Louis

63139

Southampton Healthcare, Inc., St Louis

72207

Health for Life Clinic, PLLC, Little Rock

75010

Hopital Saint Louis, Paris

75012

Hopital Saint Antoine - Infectious Desease Department, Paris

75013

Hopital Pitie Salpetriere - Infectious Deseases Department, Paris

75018

APHP Hopital Bichat-Claude Bernard, Paris

75020

Hopital Tenon, Paris

75215

AIDS Arms/ Peabody Health Center, Dallas

75219

Southwest Infectious Disease Clinical Research, Dallas

75231

Presbyterian Hospital of Dallas, Dallas

75246

North Texas Infectious Disease Consultants, Dallas

75605

DCOL Center for Clinical Research, Longview

76104

Tarrant County Infectious Disease Associates, Fort Worth

77030

University of Texas Health Science Center at Houston, Houston

77098

Gordon E. Crofoot, MD, PA, Houston

The Schrader Clinic, Houston

77478

Joseph C. Gathe, JR. MD, F.A.C.P., Houston

78240

Hospital Central Morones Prieto, San Luis Potosí City

78550

Garcia Family Health Group, Harlingen

78705

Central Texas Clinical Research, Austin

80335

MUC Research, Munich

85006

Southwest Center for HIV/AIDS, Phoenix

87505

Southwest C.A.R.E. Center, Santa Fe

90027

Kaiser Permanente, Los Angeles

90028

Jeffrey Goodman Special Care Clinic, Los Angeles

90033

University of Southern California, AIDS Clinical Trials Unit, Los Angeles

90036

Peter J. Ruane, MD, Inc., Los Angeles

90069

Tony Mills, MD Internal Medicine, Los Angeles

90211

Pacific Oaks Medical Group, Beverly Hills

90804

AIDS Healthcare Foundation-Research Center, Beverly Hills

90813

The Living Hope Foundation, Long Beach

92103

David J. Shamblaw, MD Inc., San Diego

92663

Orange Coast Medical Group, Newport Beach

92708

Center for Special Immunology, Fountain Valley

94115

Metropolis Medical, San Francisco

94121

San Francisco VA Medical Center/UCSF, San Francisco

94270

Hopital de Bicentre - Service de medecine Interne et Immunologie, Le Kremlin-Bicêtre

94602

Alameda County Medical Center, Oakland

94609

East Bay AIDS Center, Oakland

95825

Kaiser Permanente, Sacramento

96316

Hawaii AIDS Clinical Research Program HACRP, Honolulu

99204

EHS Pulmonary and Critical Care, Spokane

06033

Connecticut Health Care Group, Glastonbury

06851

Circle Medical LLC, Norwalk

06902

The Stamford Hospital - Stamford ID, Stamford

02215

Community Research Initiative of New England, Boston

08844

ID Care, Hillsborough

07102

Saint Michael's Medical Center, Newark

07103

University of Medicine and Dentistry of New Jersey; University Hospital Infectious Disease Practice, Newark

08244

South Jersey Infectious Disease, Somer Point

V35 4N9

Downtown Infectious Diseases Clinic, Vancouver

B3H 1V7

Queen Elizabeth II Health Sciences Centre, Halifax

M4N 3M5

Sunnybrook Health Sciences Centre, Toronto

M4T 3A7

CascAids Research, Toronto

M5B 1L6

Canadian Immunodeficiency Research Collaborative (CIRC) Inc., Toronto

M5G 2N2

University Health Network, Toronto General Hospital, Toronto

H2L 4P9

Clinique medicale l'Actuel, Montreal

H2X 2P4

Immunodeficiency Service, McGill University Health Centre (MUHC), Montreal

R3A 1R9

University of Manitoba - Health Sciences Centre, Winnipeg

06202

C.H.U. de Nice - Hopital de l'Archet 1, Nice

00149

Istituto Nazionale per le Malattie Infettive Lazzaro Spallanzani I.R.C.C.S., Rome

00161

Universita La Sapienza Policlinico Umberto I, Rome

00168

Universita' Cattolica Del Sacro Cuore, Rome

3000CA

Erasmus Medisch Centrum, Rotterdam

2720-276

Hospital Fernando Fonseca, Amadora

1150-069

Hospital Santo Antonio dos Capuchos, Lisbon

1649-035

Hospital de Santa Maria, Lisbon

1769-001

Hospital Pulido Valente, Lisbon

42020-451

Hospital de Sao Joao, Porto

00731

Instituto de Investigacion Cientifica del Sur, Ponce

00909

Clinical Research Puerto Rico, Inc., San Juan

HOPE Clinical Research, San Juan

00921

VA Caribbean healthcare System, San Juan

00936

University of Puerto Rico, School of Medicine, Proyecto ACTU, San Juan

03010

Hospital General Universitario de Alicante, Alicante

08025

Hospital de la Santa Creu i Sant Pau, Barcelona

08036

Hospital Clinic i Provincial de Barcelona, Barcelona

08916

Hospital Universitario Germans Trias i Pujol, Barcelona

03203

Hospital General Universitario del Elche, Elche

CH-8091

Universitatsspital Zurich, Zurich

EH4 2XU

RIDU, Western General Hospital, Edinburgh

W2 1NY

Imperial College Healthcare NHS Trust, St. Mary's Campus, London

WC1E 6JB

Royal Free and University College Medical School, London

M8 6RB

North Manchester General Hospital, Manchester

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Gilead Sciences

INDUSTRY