Prospective Observational Epidemiologic Study of Maraviroc's Safety

CompletedOBSERVATIONAL
Enrollment

2,500

Participants

Timeline

Start Date

March 31, 2008

Primary Completion Date

February 14, 2019

Study Completion Date

February 14, 2019

Conditions
Human Immunodeficiency Virus
Interventions
DRUG

Maraviroc along with an optimized background antiretroviral drug regimen

Maraviroc prescribed per approved local label.

DRUG

Optimized background antiretroviral drug regimen without maraviroc

Optimized background antiretroviral therapy prescribed per approved local label and treatment guidelines.

Trial Locations (269)

1000

CHU Saint Pierre, Brussels

1200

Cliniques Universitaires Saint-Luc, Brussels

4000

C.H.U. Sart-Tilman, Liège

10003

Beth Israel Medical Center, New York

Beth Israel Medical Clinic, New York

Mount Sinai Beth Israel Medical Center, New York

10011

HIV & Internal Medicine, New York

Mount Sinai Downtown Comprehensive Health Program, New York

10032

Columbia University Medical Center, New York

CUMC Research Pharmacy, New York

10100

Ospedale Amedeo di Savoia, Torino

10149

Ospedale Amedeo di Savoia, Clinica Universitaria di Malattie Infettive, Torino

10243

Praxis City Ost Medizinisches Zentrum, Berlin

10595

New York Medical College, Valhalla

Westchester Medical Center, Valhalla

11009

Unidad de Enfermedades Infecciosas, Cadiz

11030

North Shore University Hospital, Manhasset

13274

Hopital Sainte Marguerite, Marseille

14004

Hospital Universitario Reina Sofia, Córdoba

14215

Erie County Medical Center, HIV Services, Buffalo

14607

AIDS Care, Rochester

14850

Guthrie Medical Group, Ithaca

15006

Complejo Hospitalario Juan Canalejo, A Coruña

16128

Ente Ospedaliero Ospedali Galliera, Genova

17110

Pinnacle Health Medical Services, Harrisburg

18012

Hospital Clinico San Cecilio, Granada

18102

Lehigh Valley Hospital, Allentown

18840

Guthrie Clinic, Ltd., Sayre

19104

University of Pennsylvania, Philadelphia

19107

Philadelphia Fight, Philadelphia

20009

Dupont Circle Physician's Group, Washington D.C.

20014

Hospital Donostia, Donostia / San Sebastian

20020

Family Medical Counseling Service, Washington D.C.

20037

Division of Infectious Diseases, George Washington University Medical Center, Washington D.C.

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

Office of Mahmoud H. Mustafa, MD, FACP, Washington D.C.

20127

San Raffaele Hospital, Milan

20142

Clinic of Infectious and Tropical Diseases-University of Milan-San Paolo Hospital, Milan

20146

IPM - Study - Center, Hamburg

20157

1 Divisione di Malattive Infettive e Servizio di Allergologia, Ospedale L. Sacco, Milan

Universita' degli Studi di Milano, Dipartimento di scienza clinica Luigi Sacco, Milan

20910

Montgomery Infectious Disease Associates, P.A. (Private Practice), Silver Spring

21052

Busto Arsizio Hospital, Busto Arsizio

24501

Infectious Diseases Associates of Central Virginia, Lynchburg

24541

Infectious Diseases Associates of Central Virginia, Danville

25701

Marshall University Joan C. Edwards School of Medicine, Huntington

26006

Hospital San Pedro, Logroño

27100

Fondazione IRCCS Policlinico San Matteo, Pavia

27157

Wake Forest University Health Sciences, Winston-Salem

27834

East Carolina University, Greenville

28006

Hospital Universitario de La Princesa, Madrid

28029

Hospital Carlos Iii, Madrid

28034

Hospital Ramon Y Cajal, Madrid

28040

Hospital Clinico San Carlos, Madrid

28041

Hospital Universitario 12 de Octubre, Madrid

28046

Hospital Univ. La Paz, Madrid

28054

ID Associates, Gastonia

28078

Rosedale Infectious Diseases, Huntersville

28935

Hospital de Mostoles, Madrid

29010

Complejo Hospitalario Carlos Haya, Málaga

29203

MCC Clinic, Columbia

University of South Carolina School of Medicine, Columbia

University Speciality Clinics, Columbia

29414

Low Country Infectious Diseases, P.A., Charleston

29425

Medical University of South Carolina, Charleston

30033

Atlanta VA Medical Center, Decatur

30060

WellStar Clinical Trials Office, Marietta

WellStar Infectious Disease, Marietta

WellStar Kennestone Hospital, Marietta

30274

Infectious Diseases Associates, Riverdale

30309

Atlanta Infectious Disease Group, Atlanta

30312

Atlanta Primary Care, Atlanta

PMI Health Research Group, Atlanta

30318

Family Health Care of Atlanta, PC, Atlanta

30329

Absolute Care Medical Center, Atlanta

30342

Atlanta Specialty Research, Atlanta

30912

Georgia Health Sciences University, Augusta

31401

Chatham County Health Department, Savannah

32114

Daniel A. Warner/Consultive Medicine, Daytona Beach

32206

Duval County Health Department, Jacksonville

33075

Hopital Saint-andre CHU de Bordeaux, Bordeaux

33076

Hopital Pellegrin, Bordeaux

33136

University of Miami, Miami

33137

Care Resource, Miami

33139

Office of Albert Canas, MD, Miami Beach

33176

South Florida Infectious Deisease and Tropical Medicine Center, Miami

33305

Rowan Tree Medical, PA, Wilton Manors

33426

ID Consultants Inc & Infectious Disease Research Corp., Boynton Beach

33604

Hôpital Haut - Leveque - Centre Francois Magendie, Pessac

33614

Infectious Disease Research Institute, Inc, Tampa

Midtown Medical Center, Tampa

St. Joseph's Hospital Comprehensive Research Institute, Tampa

Tampa Care Clinic, Tampa

33713

Pinellas Care Clinic, St. Petersburg

33901

The McGregor Clinic, Fort Myers

34695

Health Positive, Safety Harbor

34982

Associates in Infectious Disease, Ft. Pierce

35801

AAC/Davis Clinic, Huntsville

Alabama Infectious Diseases Center, Huntsville

36201

Health Services Center, Hobson City

38320

Hospital Universitario de Canarias, Santa Cruz de Tenerife

40133

Ambulatorio Day Hospital Malattie Infettive, Bologna

40138

Dipartimento di Medicina Clinica Specialistica e Sperimentale, Bologna

40536

Blue Grass Care Clinic, Lexington

University of Kentucky Medical Center, Lexington

University of Kentucky, Lexington

41009

Hospital Universitario Virgen de La Macarena, Seville

41013

Hospital Universitario Virgen Del Rocio, Seville

41100

Azienda Ospedaliero Universitaria Policlinico di Modena, Modena

43210

The Ohio State University Medical Center, Columbus

43500

Hospital de Tortosa Verge de La Cinta, Tortosa

43614

University of Toledo: Health Sciences Campus, Toledo

44137

Klinikum Dortmund, Dortmund

45267

University of Cincinnati Medical Center, Cincinnati

46010

Hospital Clinico Universitario, Valencia

48075

Newland Medical Associates, Southfield

48109

University Of Michigan Health Systems, Ann Arbor

48143

Centrum fuer interdisziplinaere Medizin Muenster GmbH, Münster

48202

Henry Ford Hospital, Detroit

48236

St. John hospital and Medical Center, Grosse Pointe Woods

48910

Ingham County Health Department, Lansing

Michigan State University College of Osteopathic Medicine, Lansing

50139

SOD Malattie Infettive, La Piastra dei Servizi, Florence

52062

Arztpraxis fuer Innere Medizin Dr. Knechten, Aachen

52242

University of Iowa Hospitals and Clinics, Iowa City

55904

Federal Medical Center Rochester, Rochester

55905

Mayo Medical Clinic, Rochester

59208

Centre Hospitalier de Tourcoing, Tourcoing

60461

Office of William Johnson, M.D., Olympia Fields

Southside Health Association, Olympia Fields

60612

Ruth M. Rothstein CORE Center, Chicago

60613

Howard Brown Health Center, Chicago

60637

University of Chicago, Chicago

62702

Southern Illinois University School of Medicine, Springfield

63108

Central West Clinical Research, St Louis

65100

Azienda Sanitaria Locale Ospedale Civile dello Spirito Santo Presidio Ospedaliero, Pescara

66000

CH Perpignan, Perpignan

69288

Hopital de L'Hotel Dieu, Lyon

70112

Louisiana State University Health Sciences Center, New Orleans

70119

Louisiana State University Health Sciences Center, New Orleans

70124

Clinica Malattie Infettive, Bari

73104

University of Oklahoma Health Sciences Center, Oklahoma City

75010

Saint-Louis Hospital, Paris

75014

Cochin Hospital Saint Vincent de Paul, Paris

75020

Hopital Tenon, Paris

75075

Dr. Howard Kussman, MD, Plano

75216

Dallas VA Medical Center, Dallas

75219

Southwest Infectious Disease Clinical Research, Inc., Dallas

75235

UT Southwestern Medical Center HIV/AIDS Research Unit, Dallas

75243

Pillar Clinical Research LLC, Dallas

75651

Hopital Pitie Salpetriere, Paris

75908

Hopital Europeen Georges Pompidou, Paris

76104

Office of Allan Rowan Kelly MD, Fort Worth

Tarrant County Infectious Disease Assocciates, Fort Worth

Tarrant County Infectious Disease Associates, Fort Worth

77030

Michael E. DeBakey Veterans Affairs Medical Center, Houston

77057

Diversified Medical Practices, PA, Houston

77401

Saint Hope Foundation, Bellaire

78207

University Health Care System, San Antonio

78229

South Texas Veterans Health Care System, San Antonio

78550

Garcias' Family Health Group, Harlingen

Valley Aids Council, Harlingen

78705

Central Texas Clinical Research, Austin

80026

Kaiser Permanete of Colorado Rock Creek Medical Offices, Lafayette

80135

Azienda Ospedal Universitaria II Univ degli Studi di Napoli Servizio di Diagnosi e Terapia, Naples

80137

"Azienda Ospedaliera Domenico Cotugno", Napoli

80205

Kaiser Permanente, Denver

80206

National Jewish Health, Denver

81371

Gemeinschaftspraxis Untersendling, München

90028

LA Gay and Lesbian Center, Los Angeles

90036

Office of Peter J. Ruane, MD, Los Angeles

90048

Cedars Sinai Medical Group, Los Angeles

90127

AOUP Paolo Giaccone, UOC Malattie Infettive, Palermo

90762

Praxis Dr. Lothar Schneider Interne Medizin, HIV Schwerpunkt, Fürth

90806

Bickerstaff Pediatric Family HIV Center, Long Beach

91505

Providence Clinical Research, Burbank

92211

A Professional Corporation, Research Department, Palm Desert

92380

Raymond Poincare Hospital, Garches

92395

Bipin Bhagat MD Inc., Victorville

92708

Lalla-Reddy Medical Corporation, Fountain Valley

92868

University of California Irvine Medical Center, Orange

93140

Hopital Jean Verdier, Unite de maladies infectieuses, Bondy

93301

Office of Franco Antonio Felizarta MD, Bakersfield

94118

Kaiser Permanente Medical Center, San Francisco

94121

San Francisco Veterans Affairs Medical Center, San Francisco

94305

Statnford University Medical Center, Stanford

95035

Alta Bates Summit Medical Center East Bay AIDS Center, Oakland

95817

University of California, Sacramento

97210

The Research and Education Group, Portland

97227

Kaiser Permanente Northwest Region, Immune Deficiency Clinic, Portland

98112

Group Health Cooperative, Seattle

94304-5350

Stanford ACTG, Palo Alto

06510

Yale University School of Medicine Aids Program, New Haven

06511

Clinical AIDS & HIV, New Haven

Hospital of Saint Raphael, New Haven

06851

Circle Medical, LLC, Norwalk

30339-3915

Kaiser Permanente, Atlanta

02135

St. Elizabeth's Medical Center, Brighton

01107

The Research Institute, Springfield

01199

Baystate Infectious Diseases Clinical Research, Springfield

64111-2610

Nemechek Health Renewal, Kansas City

07740

Monmouth Medical Center, Long Branch

07754

Jersey Shore Medical Center, Neptune City

Meridian Medical Associates, Neptune City

07102

Saint Michael's Medical Center, Newark

19104-6073

University of Pennsylvania, Philadelphia

B-2000

Institute of Tropical Medicine, Antwerp

B-3000

Universitair Ziekenhuis Gasthuisberg, Inwendige Geneeskunde, Leuven

70351-580

Hospital Dia, Brasília

80240-280

Instituto A.Z. de Pesquisa e Ensino, Curitiba

26030-380

Hospital Geral de Nova Iguacu, Nova Iguaçu

09060-650

Faculdade de Medicina do ABC, Santo André

04121-000

Centro de Referencia e Treinamento DST/AIDS, São Paulo

04231-030

Hospital Heliopolis, São Paulo

V6Z 2C7

University of British Columbia/ Downtown Infectious Diseases Clinic, Vancouver

B3H 1V7

Queen Elizabeth II Health Sciences Center, Halifax

M4N 3M5

Sunnybrook Health Sciences Centre, Toronto

M5G 2N2

University Health Network, Toronto

H2L 5B1

Clinique Medicale du Quartier Latin, Montreal

H2W 1T8

CHUM, Hotel-Dieu Hospital, Montreal

G1V 4X7

Recherche Clinique Médicale des Campus, Québec

35033 Cedex 09

Centre Hospitalier Universitaire de Rennes, Rennes

D-10243

Praxis Dr. Christiane Cordes, Berlin

D-50937

Klinik I fuer Innere Medizin der Uni-Klinik Koeln, Cologne

D-01307

Universitaetsklinikum Carl Gustav Carus, Klinik und Poliklinik fuer Dermatologie, Dresden

D-60590

Hospital of the J.W. Goethe University, Medical Clinic II, Frankfurt am Main

D-20099

ifi-Institut am Allgemeines Krankenhaus St.Georg, Hamburg

D-20246

Universitaetsklinikum Hamburg-Eppendorf, Ambulanzzentrum des UKE GmbH, Bereich Infektiologie, Hamburg

D-55131

Universitaetsklinikum Mainz, I. Medizinische Klinik und Poliklinik,, Mainz

D-68161

Mannheimer Onkologie Praxis, Mannheim

D 80335

Medizinisches Versorgungszentrum, München

D-80336

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

D-49090

Klinikum Osnabruck, Osnabrück

D-70197

Infectomed GbR Zentrum für medizinische Studien, Stuttgart

Privatpraxis Ulmer, Frietsch, Müller, Stuttgart

26 500

University Hospital of Patras, Pátrai

161 21

Andreas Syngros Hospital, Athens

185 36

Tzaneion General Hospital of Piraeus, Piraeus

00149

"Istituto Nazionale Malattie Infettive L.Spallanzani-IRCCS", Roma

"Istituto Nazionale Malattie Infettive INMI- L. Spallanzani- I.R.C.C.S.", Roma

00161

Universita' di Roma La Sapienza, Dipartimento di Malattie Infettive e Tropicali, Roma

00168

Universita'Cattolica del Sacro Cuore Policlinico Gemelli, Roma

00184

Azienda Ospedaliera San Giovanni Addolorata Presidia Santa Maria, Rome

00717-1567

Ararat Research Center, Ponce

00909

HOPE Clinical Research, San Juan

08221

Clinica Mutua de Terrassa, Terrassa

03010

Hospital General Universitário de Alicante, Alicante

08003

Hospital Del Mar, Barcelona

08036

Hospital Clinic I Provincial de Barcelona, Barcelona

08916

Hospital Universitario Germans Tias I Pujol, Barcelona

03203

Hospital General Universitario de Elche, Elche

08304

Mataro Hospital, Mataró

HU16 5JQ

Hull & East Yorkshire Hospitals NHS Trust, Cottingham

NE1 4LP

Clinical Resource Building, Level 7, Newcastle upon Tyne

Royal Victoria Infirmary Hospital, Newcastle upon Tyne

Royal Victoria Infirmary, Newcastle upon Tyne

BT12 6BA

Royal Victoria Hospital, Belfast

B4 6DH

Selly Oak Hospital, Birmingham

BN2 1ES

Brighton and Sussex University Hospitals NHS Trust, Brighton

M8 5RB

North Manchester General Hospital, Crumpsall

DL36HX

Darlington Memorial Hospital, Darlington

EH4 2XU

Regional Infectious Diseases Unit, Edinburgh

E1 1BB

Grahame Hayton Unit, London

N18 1QX

North Middlesex Hospital, London

NW3 2QG

Royal Free Hospital, Ian Charleson Day Centre, London

SW10 9NH

1st Floor St Stephens Centre, London

BN43 6TQ

Warren browne Unit, Southlands Hospital, Shoreham-by-Sea

ST6 2JW

Cobridge Community Health Centre, Stoke-on-Trent

SW17 0QT

St. George's Hospital, Tooting

Sponsors

Lead Sponsor

Collaborators (1)

All Listed Sponsors
collaborator

Pfizer

INDUSTRY

lead

ViiV Healthcare

INDUSTRY

NCT00665561 - Prospective Observational Epidemiologic Study of Maraviroc's Safety | Biotech Hunter | Biotech Hunter