Comparative Trial Of Maraviroc Versus Emtricitabine/Tenofovir Both With Darunavir/Ritonavir In Antiretroviral-Naive Patients Infected With CCR5 Tropic HIV 1

PHASE3TerminatedINTERVENTIONAL
Enrollment

813

Participants

Timeline

Start Date

September 30, 2011

Primary Completion Date

August 31, 2013

Study Completion Date

January 31, 2014

Conditions
HIV-1
Interventions
DRUG

Maraviroc

Maraviroc tablet 150 mg once daily for 96 weeks.

DRUG

Emtricitabine/tenofovir

Emtricitabine/tenofovir tablet 200/300 mg once daily for 96 weeks.

DRUG

darunavir/ritonavir 800/100 mg

darunavir/ritonavir 800/100 mg

DRUG

placebo for emtricitabine/tenofovir

placebo for emtricitabine/tenofovir

DRUG

placebo for maraviroc

placebo for maraviroc

Trial Locations (177)

1000

C.H.U. St-Pierre, Brussels

1070

Hôpital Universitaire Erasme, Brussels

1090

AKH Wien Universitaetsklinik fuer Dermatologie, Vienna

1097

Egyesitett Szent Istvan és Szent Laszlo Korhaz-Rendelointezet, Budapest

1200

Cliniques Universitaires St-Luc, Brussels

2010

East Sydney Doctors, Darlinghurst

Holdsworth House General Practice, Darlinghurst

St Vincent's Hospital, Darlinghurst

Taylor Square Private Clinic, Surry Hills

2100

Rigshospitalet, Epidemiklinikken, Koebenhavn OE

2650

Hvidovre Hospital, Infektionsmedicinsk afd., Hvidovre

3004

Clinical Research Unit, Infectious Diseases, Melbourne

3010

Inselspital Universitaetsklinik fuer Infektiologie, Bern

3053

Melbourne Sexual Health Centre, Carlton

4000

Brisbane Sexual Health and HIV Service, Brisbane

C.H.U. Sart-Tilman, Liège

4031

Universitaetsspital Basel Infektiologie und Spitalhygiene, Basel

5000

Odense Universitetshospital, Odense

8091

Universitatsspital Zurich, Zurich

9007

Kantonsspital St. Gallen, Sankt Gallen

10003

Beth Israel Medical Center - AIDS Clinical Trials Unit, New York

10018

AIDS Community Research Initiative of America (ACRIA), New York

10022

Research Across America, New York

10107

Dr. Howard A. Grossman, M.D., New York

10243

Praxis Christiane Cordes, Berlin

Studiengesellschaft mbH Gubener 37, Berlin

10595

New York Medical College, Valhalla

12157

EPIMED - Gesellschaft fuer epidemiologische und klinische Forschung in der Medizin mbH, Berlin

14004

Hospital Universitario Reina Sofia - Hospital Provincial, Córdoba

14215

Erie County Medical Center, Buffalo

14607

AIDS Care, Rochester

20036

Capital Medical Associates, PC, Washington D.C.

20037

George Washington University Medical Faculty Associates, Washington D.C.

20099

ifi - Studien und Projekte GmbH, Hamburg

20127

Ospedale San Raffaele, Milan

20146

ICH - Study - Center GmbH & Co. KG, Hamburg

20246

Universitaetsklinikum Hamburg-Eppendorf, Hamburg

27834

(DEXA Scan Facility) East Carolina University Brody Outpatient Center, Greenville

East Carolina University Division of Infectious Diseases, Greenville

28007

Hospital General Universitario Gregorio Marañon, Madrid

28046

Hospital Universitario de La Paz, Madrid

28209

I.D. Consultants, P.A., Charlotte

30033

DeKalb Medical Diagnostic Breast Center, Decatur

Infectious Disease Specialists of Atlanta, Decatur

30312

AIDS Research Consortium of Atlanta, Atlanta

32504

Infectious Diseases Associates of Northwest Florida, PA, Pensacola

33067

St. Joseph's Hospital Diagnostic Center, Tampa

33075

Hopital Saint-andre, Bordeaux

33133

The Kinder Medical Group, Miami

33136

UMHC/Sylvester Comprehensive Cancer Center, Miami

University of Miami AIDS Clinical Research Unit, Miami

University of Miami, Miami

33137

Community AIDS Resource Inc dba Care Resource, Miami

33139

Wohlfeiler, Piperato and Associates, LLC, Miami Beach

33143

Miami Research Associates, Miami

33305

Rowan Tree Medical, PA, Wilton Manors

33311

Broward Health - Comprehensive Care Center, Fort Lauderdale

33316

Broward General Medical Center, Fort Lauderdale

33602

University of South Florida Health-HIV Clinical Research Unit, Tampa

33614

Infectious Disease Research Institute, Inc., Tampa

Osteoporosis Care Center, Tampa

Quest Diagnostic Laboratory, Tampa

34295

Hopital Gui de Chauliac, Montpellier

35294

University of Alabama at Birmingham - 1917 Research Clinic, Birmingham

36201

Health Services Center, Hobson City

41007

Hospital Universitario Virgen de la Macarena, Seville

43614

The University of Toledo Medical Center, Toledo

44035

CHU de Nantes - Hotel Dieu, Nantes

45067

CHR d'Orleans la Source, Orléans

45267

University of Cincinnati - Department of Internal Medicine, Cincinnati

48072

Be Well Medical Center, PC, Berkley

48201

University Physicians Group, Detroit

Wayne State University, Detroit

48202

Henry Ford Health System, Detroit

48824

Michigan State University College of Osteopathic Medicine - Department of Internal Medicine, East Lansing

48825

Biomedical and Health Institutional Review Board, East Lansing

48911

Ingham County Health Department, Lansing

50937

Klinikum der Universitaet zu Koeln, Klinik I fuer Innere Medizin, Cologne

52242

University of Iowa, University of Hospitals and Clinics - Division of Infectious Disease, Iowa City

53127

Universitaetsklinikum Bonn, Immunologische Ambulanz HIV, Bonn

55415

Hennepin County Medical Center, Minneapolis

59208

Centre Hospitalier de Tourcoing, Tourcoing

60590

Klinikum der J.W. Goethe-Universitaet, Medizinische Klinik II, Frankfurt am Main

60596

InfektioResearch GmbH & Co. KG, Frankfurt am Main

60611

Northwestern University/NMH, Chicago

Northwestern University, Chicago

60613

Howard Brown Health Center, Chicago

64111

Kansas City Free Health Clinic, Kansas City

67091

Nouvel Hopital Civil, Strasbourg

68106

University of Nebraska Medical Center, Omaha

69317

Hopital de la Croix Rousse, Lyon

70112

Tulane University School of Medicine, New Orleans

70121

Ochsner Clinic Foundation, New Orleans

75013

Hôpital de la Pitié Salpétrière, Paris

75020

Hopital Tenon, Service des Maladies Infectieuses, Paris

75230

Dallas Diabetes and Endocrine Center, Dallas

75235

Parkland Memorial Hospital, Dallas

University of Texas Southwestern Medical Center at Dallas, Dallas

75246

North Texas Infectious Diseases Consultants, PA, Dallas

75475

Hopital Saint-Louis, Paris

75571

Hopital Saint Antoine, Paris

75877

Hopital Bichat, Paris

77004

Therapeutic Concepts, PA, Houston

77098

Research Access Network, Houston

The Office of Dr. Gordon E. Crofoot, M.D., PA, Houston

78705

Central Texas Clinical Research, Austin

80045

University of Colorado Denver - University of Colorado Hospital, Aurora

80205

Kaiser Permanente of Colorado, Denver

80335

MUC Research Group GbR, München

80336

Ludwig-Maximilians-Universitaet, Medizinische Poliklinik - Klinikum Innenstadt, München

90048

Cedars-Sinai Medical Center, Los Angeles

90069

Dr. Anthony Mills, MD, Inc., Los Angeles

92262

Desert Oasis Healthcare Medical Group, Palm Springs

92663

Orange Coast Medical Group, Newport Beach

94000

Hopital Henri Mondor, Créteil

94105

Synarc Inc., San Francisco

94118

Investigational Drugs Pharmacy, San Francisco

Kaiser Permanente - Clinical Trials Unit, San Francisco

94275

Hopital Bicetre, Le Kremlin-Bicêtre

94545

Kaiser Permanente, Hayward

94587

Kaiser Permanente, Union City

95051

Kaiser Permanente Santa Clara, Santa Clara

95814

University of California Davis Research, Sacramento

95817

TICON I Research Clinic (DEXA Scan only), Sacramento

95825

Kaiser Hospital Sacramento, Sacramento

98104

Swedish Medical Center, Seattle

98122

Swedish Medical Center, Seattle

06504

Yale - New Haven Hospital Nathan Smith Clinic, New Haven

06510

Yale University, New Haven

06851

Circle CARE Center, Norwalk

01199

Baystate Infectious Diseases Clinical Research, Springfield

07753

Jersey Shore University Medical Center, Neptune City

07754

Brandywine Common, Neptune City

Jersey Shore University Medical Center, Neptune City

07102

Saint Michael's Medical Center, Newark

B-2000

Instituut voor Tropische Geneeskunde, Antwerp

B-9000

Universitair Ziekenhuis Gent, Ghent

V6Z 2C7

Vancouver ID Research and Care Centre Society, Vancouver

K1H 7W9

The Ottawa Hospital-Riverside Campus, Ottawa

K1H 8L6

The Ottawa Hospital, Ottawa

M5G 1K2

Maple Leaf Research / Maple Leaf Medical Clinic, Toronto

M5G 2N2

University Health Network / Toronto General Hospital, Toronto

H2L 4P9

Clinique Medicale L'Actuel, Montreal

H2L 5B1

Clinique Medicale du Quartier Latin, Montreal

00250

Infektiosairauksien poliklinikka,HUS Auroran sairaala, rakennus 5, 1. krs, Helsinki

3584 CX

University Medical Center Utrecht, Utrecht

85-030

Wojewodzki Szpital Obserwacyjno - Zakazny im. Tadeusza Browicza, Bydgoszcz

01-201

SPZOZ Wojewodzki Szpital Zakazny, Warsaw

50-220

EMC Instytut Medyczny S.A. Przychodnia przy ul. Lowieckiej, Wroclaw

2720-276

Hospital Prof. Doutor Fernando Fonseca E.P.E., Amadora

1169-050

Centro Hospitalar de Lisboa - Zona Central - Hospital Santo António Capuchos, Lisbon

1649-035

Hospital Sta. Maria, Lisbon

4200-319

Hospital São João, Porto

00959

Innovative Care PSC, Bayamón

00717

Ararat Research Center, Ponce

00935

Medical Center University Hospital, Rio Piedras

University of Puerto Rico Medical Sciences Campus, Rio Piedras

00909

Clinical Research Puerto Rico, San Juan

HOPE Clinical Research, San Juan

03010

Hospital General Universitario de Alicante, Alicante

08003

Hospital del Mar, Barcelona

08025

Hospital de la Santa Creu i Sant Pau, Barcelona

08036

Hospital Clinic I Provincial de Barcelona, Barcelona

08907

Hospital Universitari de Bellvitge, L'Hospitalet de Llobregat

416 85

SU Ostra sjukhuset, Infektionsmottagningen, Gothenburg

205 02

Skanes Universitetssjukhus, Malmo

118 83

Sodersjukhuset, Venhalsan, Stockholm

141 86

Karolinska Universitetssjukhuset Huddinge, Stockholm

B9 5SS

Dept of Sexual Health & HIV Medicine, Birmingham

BN2 1ES

HIV Research Department, Elton John Centre, Brighton

EH4 2XU

Regional Infectious Diseases Unit, Edinburgh

E1 1BB

Grahame Hayton Unit, Ambrose King Centre, Royal London Hospital,, London

NW3 2QG

Ian Charleson Day Centre, Royal Free Hospital, London

SE18 4QH

Queen Elizabeth Hospital, London

SW10 9NH

St Stephen's Centre, Chelsea and Westminster Hospital NHS Foundation Trust, London

WC1E 6AU

Centre for Sexual Health & HIV Research, University College London, London

M8 5RB

Department of Infectious Diseases & Tropical Medicine, Pennine Acute Trust Hospitals, Manchester

Sponsors

Lead Sponsor

Collaborators (1)

All Listed Sponsors
collaborator

Pfizer

INDUSTRY

lead

ViiV Healthcare

INDUSTRY