Expanded Access Program for Maraviroc At Multiple Centers

PHASE3CompletedINTERVENTIONAL
Enrollment

1,047

Participants

Timeline

Start Date

February 28, 2007

Primary Completion Date

June 30, 2010

Study Completion Date

June 30, 2010

Conditions
HIV Infections
Interventions
DRUG

maraviroc

The nominal dose for maraviroc is 300 mg twice a day (BID). However, the dosage of maraviroc should be adjusted based on optimal background therapy (OBT) patient is taking. If OBT includes CYP3A4 inhibitor (with or without inducers) maraviroc dose should be 150 mg BID and if OBT includes CYP3A4 inducer (without inhibitors) maraviroc dose should be 600mg BID. If OBT does not include any CYP3A4 inducers or inhibitors maraviroc dose should be 300 mg BID.

Trial Locations (361)

7

Catherine McAuley Centre, Dublin

8

St. James's Hospital, Dublin

824

Department of Infectious Disease, E-Da Hospital, Kaohsiung County

1000

Centre Hospitalier Universitaire Saint-Pierre, Maladies Infectieuses, Brussels

1070

Hôpital Erasme, Médecine Interne, Brussels

1200

Cliniques Universitaires Saint-Luc, Maladies Infectieuses, Brussels

2000

Instituut voor Tropische Geneeskunde, Inwendige Geneeskunde, Antwerp

2010

Holdsworth House Medical Practice, Darlinghurst

St. Vincent's Hospital, Darlinghurst

Albion Street Centre, Surry Hills

2145

Westmead Hospital, Wentworthville

3000

Universitair Ziekenhuis Gasthuisberg, Inwendige Geneeskunde, Leuven

3004

Clinical Research Unit, Infectious Diseases, Melbourne

3053

Melbourne Sexual Health Centre, Carlton

3068

Northside Clinic, Fitzroy North

3141

Prahran Market Clinic, South Yarra

4000

AIDS Medical Centre, Brisbane

CHU Sart-Tilman, Medecine Interne, Liège

4029

Infectious Diseases Unit, Herston

5000

Infectious Diseases Unit, Adelaide

6000

Centre Hospitalier Universitaire de Charleroi, Médecine Interne, Charleroi

8091

Universitätsspital Zürich, Zurich

9000

Universitair Ziekenhuis Gent, Inwendige Geneeskunde, Ghent

10003

Astor Medical Group, LLP, New York

Beth Israel Medical Center, New York

Paul Bellman, MD, New York

Sidney Hillman Family Health Center, New York

10011

Ricky Hsu, New York

10016

Bellevue Hospital, New York

NYU School of Medicine, New York

10018

Perion Smith, New York

10024

Sharon Lewin MD and Michael Rendel MD, New York

10026

Lenox Ave Clinic, New York

10029

Harlem Medical Associates, New York

Mount Sinai Medical Center, New York

Mount Sinai School of Medicine, New York

10032

New York-Presbyterian Hospital, New York

10149

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

10243

Praxisgemeinschaft Bieniek & Cordes, Berlin

10304

Jordon Glaser, MD, Stanton Island

10454

Allmed Medical and Rehabilitaion of NY, The Bronx

10457

Bronx Lebanon Hospital Center, The Bronx

10676

Evagelismos Hospital, Athens

11009

Hospital Puerta Del Mar, Cadiz

11030

North Shore University Hospital, Department of Infectious Disease, Manhasset

11042

Schneider Children's Hospital, Great Neck

11206

Woodhull Medical Center, Brooklyn

11215

New York Methodist Hospital, Brooklyn

NYM Medical Pavilion, Brooklyn

11367

NYHQ, Flushing

12208

Upstate Infectious Disease Associates, Albany

13210

SUNY Upstate Medical University, Syracuse

13274

Hopital Sainte Marguerite, Marseille

14012

Hospital Universitario Reina Sofia, Córdoba

14033

Centre Hospitalier Universitaire de Caen, Caen

14215

Chiu-Bin Hsiao, MD, Buffalo

The Office of Dr. Zale P. Bernstein, MD., Buffalo

14605

Dr. Steven Fine, Rochester

15586

Physician Clinic, Kota Bharu

15706

Hospital Clinico Universitario de Santiago de Compostela, Santiago de Compostela

16132

Unita' Operativa Clinica Malattie Infettive, Dipartimento di Medicina Interna e Malattie Infettive, Genova

18012

Hospital Universitario San Cecilio, Granada

18014

Hospital Universitario Virgen de Las Nieves, Granada

18102

Lehigh Valley Hospital, Allentown

19107

Philadelphia FIGHT, Philadelphia

19611

RPS Infectious Diseases, West Reading

20009

Dupont Circle Physicians Group, Washington D.C.

20014

Hospital Donostia-Donostia Ospitalea, Donostia / San Sebastian

20127

Fondazione Centro San Raffaele del Monte Tabor, Milan

20157

Dipartimento di Scienze Cliniche, Divisione Clinicizzata Malattie Infettive, Milan

20910

Dr.'s Alpert, Trinh, and Posorske, Silver Spring

21201

Chase Brexton Health Services Inc, Baltimore

22003

Clinical Alliance for Research & Education - Infectious Diseases, Annandale

22030

Infectious Disease Consultants, Fairfax

23224

Crossover Ministry, Richmond

23666

Hampton Roads Medical Specialists, Hampton

24501

Barbara Cassie, Lynchburg

24541

Infectious Diseases Associates of Central Virginia, Danville

25030

Hôpital Saint Jacques, Besançon

25123

Istituto di Malattie Infettive e Tropicali, Brescia

25304

CAMC Memorial Hospital, Charleston

Clinical Trials Center, Charleston

25701

University Physicians Internal Medicine, Huntington

27100

Fondazione IRCCS Policlinico S. Matteo, Pavia

28006

Hospital Universitario de La Princesa, Madrid

28007

Hospital General Gregorio Marañon, Madrid

28029

Hospital Carlos Iii, Madrid

28034

Hospital Ramon Y Cajal, Madrid

28040

Fundacion Jimenez Diaz, Madrid

28041

Hospital 12 de Octubre, Madrid

28046

Hospital Universitario La Paz, Madrid

28054

ID Associates, Gastonia

28078

Rosedale Infectious Diseases, Huntersville

29010

Complejo Hospitalario Carlos Haya, Málaga

Hospital Virgen de La Victoria, Málaga

29401

Investigational Drug Services, Charleston

29403

Medical University of South Carolina, Charleston

29425

Medical University of South Carolina, Charleston

29600

Hospital Costa Del Sol, Málaga

30033

Atlanta VA Medical Center, Decatur

Infectious Disease Specialists of Atlanta, Decatur

30122

Unita' Operativa di Malattie Infettive, Venezia

30236

Kaiser Permanente, Jonesboro

30274

Infectious Diseases Associates, PC, Riverdale

30309

Philip Brachman MD, Atlanta

30318

Midtown West Medical, Atlanta

30329

Absolute CARE, Atlanta

30339

Kaiser Permanente, Atlanta

30625

Medizinische Hochschule Hannover, Klinische Immunologie, Zentrum Innere Medizin, Hanover

31059

Hôpital de Purpan, Toulouse

31405

Chatham County Health Department, Savannah

32117

Daniel Warner M.D., P.A. Consultive Medicine, Daytona Beach

32308

Eric Nicholson, M.D., P.A., Tallahassee

32803

Orlando Immunology Center, Orlando

32806

Infectious Diseases of Central Florida, Orlando

32901

Osler Medical Inc., Melbourne

33021

Sunshine Medical Institute, Hollywood

33075

Hôpital Saint-andré, Bordeaux

33076

Hopital Pellegrin - Service des Maladies Infectieuses et Medecine Interne, Bordeaux

33133

Steinhart Medical Associates, Miami

33137

Care Resource, Miami

33139

Office of Albert Canas, MD, Miami Beach

33162

Donald Johnson, MD, North Miami Beach

33169

Wohlfeiler, Piperato & Associates, LLC, North Miami Beach

33308

Northpoint Medical, PA, Fort Lauderdale

Therafirst Medical Centers, Fort Lauderdale

33311

Comprehensive Care Center, Fort Lauderdale

33316

Office of Gary J. Richmond, MD, Fort Lauderdale

33394

Hospital de Cabueñes, Cabueñes

33401

Donald Watren MD, West Palm Beach

33426

Infectious Disease Research Corp, Boynton Beach

33606

University of South Florida, Tampa

33612

University of Sout Florida, Tampa

33614

Midtown Medical Center, Tampa

33701

All Children's Hospital, St. Petersburg

33912

Internal Medicine Associates of Lee County, Fort Myers

33990

Internal Medicine Associates of Lee County, Cape Coral

34134

Internal Medicine Associates of Lee County, Bonita Springs

34239

Infectious Diseases Associates, Sarasota

34243

University Hepatitis Center at Bach & Godofsky, MD,PA, Sarasota

34295

Hopital Gui de Chauliac, Montpellier

34695

Barry Rodwick, MD, Safety Harbor

34952

Associates in Infectious Diseases, Port Saint Lucie

35033

Chu Pontchaillou, Service des maladies infectieuses, Rennes

35128

Unita Operativa di Malattie Infettive e Tropicali, Padua

36201

Health Services Center, Hobson City

36204

Complejo Hospitalario Xeral-Cies, Vigo

38043

CHU Michallon, Grenoble

38119

Infectious Disease Associates of Memphis, Memphis

38320

Hospital Universitario de Canarias, San Cristóbal de La Laguna

39008

Hospital Universitario Marques de Valdecilla, Santander

40138

Unita' Operativa Malattie Infettive, Bologna

41013

Hospital Virgen Del Rocio, Seville

41014

Complejo Hospitalario Nuestra Señora de Valme, Seville

41071

Hospital Universitario Virgen de La Macarena, Seville

41100

Clinica Malattie Infettive e Tropicali, Universita' degli Studi di Modena Reggio Emilia, Modena

43500

Hospital de Tortosa Verge de La Cinta, Tortosa

44093

CHU de Nantes - Hopital Hotel Dieu, Nantes

44100

Arcispedale S. Anna Azienda Ospedaliera Universitaria di Ferrara, Ferrara

44109

Metro Health Systems, Cleveland

44280

"Antiguo Hospital Civil de Guadalajara Fray Antonio Alcalde", Guadalajara

45100

Hopital La Source, La Source

45122

Universitaetsklinikum Essen, HIV-Ambulanz, Hautklinik, Essen

45429

South Dayton Acute Care Consultants Inc., Dayton

46009

Hospital Universitario La Fe, Valencia

46010

Hospital Clinico Universitario, Valencia

46014

Consorcio Hospital General Universitario de Valencia, Valencia

46015

Hospital Arnau de Vilanova, Valencia

47000

Hospital Sungai Buloh, Sungai Buloh

48072

The Office of Dr. Paul A. Benson, DO, Berkley

48078

Hospital de Basurto, Basurto

48236

St. John hospital and Medical Center, Grosse Pointe Woods

48320

Private Practice, Keego Harbor

48903

Hospital de Cruces, Barakaldo

48910

MSU Adult Medicine, 10, Lansing

49546

Private Practice (Dr. Gregory Kuldanek), Grand Rapids

50100

SOD Malattie Infettive, La Piastra dei Servizi, Florence

50937

Universitaetsklinikum Koeln, Klinik I fuer Innere Medizin,, Cologne

54636

AHEPA Hospital, Thessaloniki

55415

Hennepin County Medical Center, Minneapolis

59208

CHU de Tourcoing, Tourcoing

59802

Partnership Health Center, Missoula

60121

Uni. Politecnica delle Marche, Ist. Malattie Infettive e Medicina P., Torrette Di Ancona

60612

Ruth M. Rothstein CORE Center, Chicago

60613

Roger Trinh, Chicago

60657

Northstar Medical Center, Chicago

63000

Hopital Gabriel Montpied, Clermont-Ferrand

63117

Private Practice (Dr. Mark Scheperle), St Louis

64111

Nemechek Health Renewal, Kansas City

65124

Reparto di Malattie Infettive, Azienda Sanitaria Locale, Pescara

66100

Presidio Ospedaliero SS Annunziata, Chieti Scalo

67214

Kansas University Internal Medicine Midtown Clinic, Wichita

Via Christi Research, Inc., Wichita

69288

Hopital de l'Hotel-Dieu, Service d'Hepato-Gastroenterologie, Lyon

70124

Universita' degli Studi di Bari, Clinica Malattie Infettive, Policlinico, Bari

72207

Health for Life Clinic PLLC, Little Rock

Thomas T Jefferson, MD, Little Rock

74135

University of Oklahoma - Schusterman Clinic, Tulsa

75013

Hôpital de la Pitié Salpétrière, Paris

75015

Hopital Europeen George Pompidou, Paris

75018

Hopital Bichat-Claude Bernard, Service des Maladies Infectieuses, Paris

75020

Hopital Tenon, Service des Maladies Infectieuses, Paris

75204

The Office of Dr. Nicholaos C. Bellos, MD, Dallas

75219

The Office of Dr. Patrick W. Daly, MD., Dallas

75231

The Office of Dr. Susan M. Diamond, MD., Dallas

75475

Hopital Saint-Louis, Paris

75571

Hopital Saint Antoine, Paris

75605

DCOL Center for Clinical Research, Longview

Diagnostic Clinic of Longview, PA, Longview

75679

Centre Hospitalier Cochin Saint Vincent de Paul, Paris

75743

Hôpital Necker-Service des Maladies Infectieuses et Tropicales, Paris

76104

Tarrant County Infectious Disease Associates, Fort Worth

77009

Harris County Hospital District, Houston

Thomas Street Clinic, Houston

77027

Diversified Medical Practices, PA, Houston

77030

Baylor College of Medicine, Houston

The University of Texas Health Sciences Center at Houston, Houston

77098

Research Access Network, Houston

The Office of Dr. Gordon E. Crofoot, MD., Houston

78212

Dr. James Bromley, San Antonio

78258

Responsive ID Solutions, San Antonio

78550

Fernando Garcia, MD, Harlingen

79098

Gemeinschaftspraxis Dres. Rump und Usadel, Freiburg im Breisgau

79925

La Fe CARE Center Clinic, El Paso

80026

Kaiser Permanente of Colorado, Lafayette

80205

Kaiser Permanente Colorado, Denver

Kaiser Permanente of Colorado, Denver

80220

Denver Infectious Disease Consultants, PLLC, Denver

85745

El Rio, Special Immunology Associates, Tucson

90022

AltaMed Health Services Corporation, Los Angeles

90027

Kaiser Permanente Medical Center, Los Angeles

90028

Robert Bolan, MD, Los Angeles

90033

Maternal-Child and Adolescent Clinic of Infectious Diseases and Virology, Los Angeles

90036

Peter J. Ruane, M.D. Inc., Los Angeles

Synergy Hematology-Oncology Associates, Los Angeles

90048

Cedars-Sinai Medical Center, Los Angeles

Erlmed Corp ABA Lim-Keith Muiltispecialty Clinic Inc., Los Angeles

90069

Office of Anthony Mills, MD, Los Angeles

90211

AHF Research Center, Beverly Hills

90813

Living Hope Clinical Trials, Long Beach

91356

Shared Medical Research Foundation, Tarzana

Tarzana Treatment Center, Tarzana

92262

Desert Medical Group, Clinical Research Center, Palm Springs

92395

Bipin Bhagat MD Inc., Victorville

92506

Riverside Medical Clinic, Riverside

92663

Bonnie V Bock MD, Newport Beach

92708

Orange County Center for Special Immunology, Fountain Valley

93009

Hopital Avicenne, Bobigny

94118

Kaiser Permanente Medical Center, San Francisco

94270

Hopital de Bicêtre, Le Kremlin-Bicêtre

94545

Kaiser Permanente, Hayward

94609

Alta Bates Summit Medical Center, Oakland

94800

Hopital Paul Brousse, Villejuif

95051

Kaiser Permanente Santa Clara, Santa Clara

95126

Unita' Operativa di Malattie Infettive, Catania

95350

Office of Dr. Salah Bibi, MD, Modesto

95816

Fort Sutter Medical Complex, Sacramento

Sutter Institute for Medical Research, Sacramento

Sutter Medical Group, Sacramento

97210

The Research & Education Group, Portland

97227

Kaiser Permanente-Northwest Region, Immune Deficiency Clinic, Portland

98026

William F. Ehni, MD, Edmonds

98109

Emerald City Medical Arts, Seattle

98112

Group Health Cooperative, Seattle

98664

The Vancouver Clinic, Inc., P.S., Vancouver

99204

The Office of Dr. Daniel R. Coulston, MD, Spokane

690317

Hôpital de la Croix Rousse, Lyon

700116

Spitalul Clinic de Boli Infectioase Sf. Parascheva, Iași

900709

Spitalul Clinic de Boli Infectioase Constanta, Constanța

8330023

Hospital Clínica Universidad Católica, Santiago

8360160

Hospital Clínico San Borja Arriarán, Santiago

35294-2050

The University of Alabama, Birmingham

90210-4212

Vista Medical, Beverly Hills

94115-3029

Quest Clinical Research, San Francisco

06033

Connecticut Health Care Group, Glastonbury

06360

Infectious Disease Clinic, Norwich

30318-2513

Family Health Care of Atlanta, Atlanta

30084-8128

Infectious Disease Consultants, Tucker

66606-1670

Cotton-O'Neil Clinic, Topeka

20770-3525

Metro Health Care, Greenbelt

02111

Tufts - New England Medical Center, Boston

02115

Fenway Community Health, Boston

02215-3318

Community Research Initiative of New England, Boston

01107

Community Research Initiative of New England, Springfield

07631

CPMC Research Pharmacy, Englewood

Leonia Medical Associates, Englewood

07601

Center for Infectious Diseaes, Hackensack

Hackensack University Medical Center, Hackensack

07103

UMDNJ, Newark

University Hospital, Newark

07114

Newark Community Health Center, Newark

08244

South Jersey Infectious Disease, Somers Point

08755

Premier Medical Research Group, Toms River

08043

Garden State Infectious Disease Associates, PA, Voorhees Township

10019-1819

James I Jones Jr, MD, New York

43614-5812

University of Toledo - Health Science Campus, Toledo

02906

The Miriam Hospital, Providence

76104-3048

Kelly, Allan Rowman MD, Fort Worth

77098-2807

Brewton, Gary W MD, Houston

22205-3633

Infectious Diseases, Arlington

C1202ABB

Fundacion Huesped, Departamento de Investigacion Clinica, Buenos Aires

C1425AWK

FUNCEI, Buenos Aires

Unknown

Allgemeines Krankenhaus Wien, A-1090

Fundación para el Desarrollo de la Lucha contra el SIDA, Barrio Aranjuez

Instituto Dominicano de Estudios Virologicos, Santo Domingo

Department of Medicine Queen Elizabeth Hospital, Kowloon

A-8020

Landeskrankenhaus Graz West / Abteilung fuer Innere Medizin 1, Graz

A-1140

Sozialmedizinisches Zentrum Baumgartner Hoehe / 2. Interne Lungenabteilung, Vienna

B-1090

Academisch Ziekenhuis VUB, Jette

B3H 1V7

Queen Elizabeth II Health Sciences Center, Halifax

L8N 3Z5

Hamilton Health Sciences - McMaster University Medical Centre, Hamilton

M4N 3M5

Sunnybrook Health Sciences Centre, Toronto

M5B 1L6

Canadian Immunodeficiency Research Collaborative, Toronto

H2L 4P9

Clinique médicale l'Actuel, Montreal

H2L 5B1

Clinique Medicale du Quartier Latin, Montreal

H2W 1T8

CHUM Hôtel-Dieu, Montreal

H3H 1V1

Projet L.O.R.I., Montreal

06202

Hopital de l Archet 1, Nice Cedex 3, 06

01307

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

115 26

Greek Red Cross Hospital, Athens

115 27

General Hospital of Athens G. Gennimatas, Athens

161 21

Andreas Sygros Hospital, Athens

265 00

University Hospital of Patras, Pátrai

185 36

Regional General Hospital Tzaneio, Piraeus

560 034

Department of Medicine, St. John's Medical College Hospital, Bangalore

400 026

Department of HIV Medicine (I D Clinic), Jaslok Hospital & Research Centre, Mumbai

600 113

YR Gaitonde Centre for AIDS Research and Education (YRG CARE), Chennai

00133

Policlinico Tor Vergata, Divisione Malattie Infettive, Roma

00149

IRCCS Lazzaro Spallanzani Istituto Nazionale per la Malattie Infettive, Roma

IRCCS Lazzaro Spallanzani Istituto Nazionale per le Malattie Infettive, Roma

IRCCS Lazzaro Spallanzani, Istituto Nazionale per le Malattie Infettive, Roma

00161

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

00168

Universita'Cattolica del Sacro Cuore Policlinico Gemelli, Roma

00184

Azienda Ospedaliera San Giovanni Addolorata, Roma

01030

Hospital Regional Lic. Adolfo Lopez Mateos, Mexico City

CP 14000

Instituto Nacional de Ciencias Medicas Y Nutricion Dr Salvador Zubiran, Tlalpan

NL 3584 CX

Academisch Ziekenhuis Utrecht, Utrecht

2750-349

Centro Hospitalar de Cascais, Cascais

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

00717-1563

Centro Ararat Inc, Ponce

00909

HOPE Clinical Research, San Juan

021105

"Institutul de Boli Infectioase Prof. Matei Bals", Bucharest

030303

Spitalul de Boli Infectioase si Tropicale Victor Babes, Bucharest

03010

Hospital General Universitario de Alicante, Alicante

03202

Hospital General Universitario de Elche, Elche

08916

H. Universitari Germans Trias I Pujol, Badalona

08003

Hospital Del Mar, Barcelona

08025

Fund. de Gest. Sanitaria de L' Hospital de La Sta. Creu I Sant Pau, Barcelona

08035

Hospital Universitari Vall D'Hebron, Barcelona

08036

Hospital Clinic I Provincial de Barcelona, Barcelona

08400

Hospital General de Granollers, Granollers

08907

Hospital Universitari de Bellvitge, L'Hospitalet de Llobregat

BN2 1ES

Brighton and Sussex University Hospitals NHS Trust, The Elton John Centre, Brighton

M8 6RB

North Manchester General Hospital, Crumpsall, Manchester

EH4 2XU

Regional Infectious Diseases Unit, Edinburgh

NW3 2QG

Ian Charleson Centre, London

SE5 9RS

Department of Sexual Health, London

SW10 9NH

St Stephens Research Ltd, London

W2 1NY

Imperial College, London

Sponsors

Lead Sponsor

All Listed Sponsors
lead

ViiV Healthcare

INDUSTRY