Expanded Access Program for Maraviroc At Multiple Centers

May 23, 2016 updated by: ViiV Healthcare

A Multicenter, Open Label, Expanded Access Trial Of Maraviroc

To provide access to maraviroc to patients who have limited or no therapeutic treatment options and to collect more safety data in a broader patient population.

Study Overview

Status

Completed

Conditions

HIV Infections

Intervention / Treatment

Drug: maraviroc

Study Type

Interventional

Enrollment (Actual)

1047

Phase

Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Argentina
- - Buenos Aires, Argentina, C1202ABB
    - Fundacion Huesped, Departamento de Investigacion Clinica
  - Buenos Aires, Argentina, C1425AWK
    - FUNCEI
Australia
- New South Wales
  - Darlinghurst, New South Wales, Australia, 2010
    - Holdsworth House Medical Practice
  - Darlinghurst, New South Wales, Australia, 2010
    - St. Vincent's Hospital
  - Surry Hills, New South Wales, Australia, 2010
    - Albion Street Centre
  - Wentworthville, New South Wales, Australia, 2145
    - Westmead Hospital
- Queensland
  - Brisbane, Queensland, Australia, 4000
    - AIDS Medical Centre
  - Herston, Queensland, Australia, 4029
    - Infectious Diseases Unit
- South Australia
  - Adelaide, South Australia, Australia, 5000
    - Infectious Diseases Unit
- Victoria
  - Carlton, Victoria, Australia, 3053
    - Melbourne Sexual Health Centre
  - Melbourne, Victoria, Australia, 3004
    - Clinical Research Unit, Infectious Diseases
  - North Fitzroy, Victoria, Australia, 3068
    - Northside Clinic
  - South Yarra, Victoria, Australia, 3141
    - Prahran Market Clinic
Austria
- - A-1090, Austria
    - Allgemeines Krankenhaus Wien
  - Graz, Austria, A-8020
    - Landeskrankenhaus Graz West / Abteilung fuer Innere Medizin 1
  - Wien, Austria, A-1140
    - Sozialmedizinisches Zentrum Baumgartner Hoehe / 2. Interne Lungenabteilung
Belgium
- - Antwerpen, Belgium, 2000
    - Instituut voor Tropische Geneeskunde, Inwendige Geneeskunde
  - Bruxelles, Belgium, 1000
    - Centre Hospitalier Universitaire Saint-Pierre, Maladies Infectieuses
  - Bruxelles, Belgium, 1070
    - Hôpital Erasme, Médecine Interne
  - Bruxelles, Belgium, 1200
    - Cliniques Universitaires Saint-Luc, Maladies Infectieuses
  - Charleroi, Belgium, 6000
    - Centre Hospitalier Universitaire de Charleroi, Médecine Interne
  - Gent, Belgium, 9000
    - Universitair Ziekenhuis Gent, Inwendige Geneeskunde
  - Jette, Belgium, B-1090
    - Academisch Ziekenhuis VUB
  - Leuven, Belgium, 3000
    - Universitair Ziekenhuis Gasthuisberg, Inwendige Geneeskunde
  - Liège, Belgium, 4000
    - CHU Sart-Tilman, Medecine Interne
Canada
- Nova Scotia
  - Halifax, Nova Scotia, Canada, B3H 1V7
    - Queen Elizabeth II Health Sciences Center
- Ontario
  - Hamilton, Ontario, Canada, L8N 3Z5
    - Hamilton Health Sciences - McMaster University Medical Centre
  - Toronto, Ontario, Canada, M4N 3M5
    - Sunnybrook Health Sciences Centre
  - Toronto, Ontario, Canada, M5B 1L6
    - Canadian Immunodeficiency Research Collaborative
- Quebec
  - Montreal, Quebec, Canada, H2L 5B1
    - Clinique Medicale du Quartier Latin
  - Montreal, Quebec, Canada, H2L 4P9
    - Clinique Médicale L'Actuel
  - Montreal, Quebec, Canada, H2W 1T8
    - CHUM Hôtel-Dieu
  - Montreal, Quebec, Canada, H3H 1V1
    - Projet L.O.R.I.
Chile
- RM
  - Santiago, RM, Chile, 8330023
    - Hospital Clínica Universidad Católica
  - Santiago, RM, Chile, 8360160
    - Hospital Clinico San Borja Arriaran
Costa Rica
- San Jose
  - Barrio Aranjuez, San Jose, Costa Rica
    - Fundación para el Desarrollo de la Lucha contra el SIDA
Dominican Republic
- - Santo Domingo, Dominican Republic
    - Instituto Dominicano de Estudios Virologicos
France
- - Besancon, France, 25030
    - Hopital Saint Jacques
  - Bobigny Cedex, France, 93009
    - Hôpital Avicenne
  - Bordeaux, France, 33076
    - Hopital Pellegrin - Service des Maladies Infectieuses et Medecine Interne
  - Bordeaux Cedex, France, 33075
    - Hôpital Saint-André
  - Clermont Ferrand, France, 63000
    - Hôpital Gabriel Montpied
  - Grenoble Cedex 09, France, 38043
    - CHU Michallon
  - La Source, France, 45100
    - Hopital La Source
  - Le Kremlin Bicêtre, France, 94270
    - Hopital de Bicetre
  - Lyon Cedex 02, France, 69288
    - Hopital de l'Hotel-Dieu, Service d'Hepato-Gastroenterologie
  - Lyon Cedex 04, France, 690317
    - Hôpital de la Croix Rousse
  - Montpellier, France, 34295
    - Hopital Gui de Chauliac
  - Nantes, France, 44093
    - CHU de Nantes - Hôpital Hôtel Dieu
  - Nice Cedex 3, 06, France, 06202
    - Hopital de l Archet 1
  - Paris, France, 75013
    - Hopital de la Pitie Salpetriere
  - Paris, France, 75015
    - Hôpital Européen George Pompidou
  - Paris, France, 75020
    - Hopital Tenon, Service des Maladies Infectieuses
  - Paris, France, 75018
    - Hopital Bichat-Claude Bernard, Service des Maladies Infectieuses
  - Paris CEDEX 14, France, 75679
    - Centre Hospitalier Cochin Saint Vincent de Paul
  - Paris Cedex 10, France, 75475
    - Hopital Saint-Louis
  - Paris cedex 15, France, 75743
    - Hôpital Necker-Service des Maladies Infectieuses et Tropicales
  - Rennes, France, 35033
    - Chu Pontchaillou, Service des maladies infectieuses
  - Toulouse, France, 31059
    - Hôpital de Purpan
  - Tourcoing, France, 59208
    - CHU de Tourcoing
  - Villejuif, France, 94800
    - Hopital Paul Brousse
- Cedex
  - Caen, Cedex, France, 14033
    - Centre Hospitalier Universitaire de Caen
- Cedex 09
  - Marseille, Cedex 09, France, 13274
    - Hôpital Sainte Marguerite
- Cedex 12
  - Paris, Cedex 12, France, 75571
    - Hopital Saint Antoine
Germany
- - Berlin, Germany, 10243
    - Praxisgemeinschaft Bieniek & Cordes
  - Dresden, Germany, 01307
    - Universitaetsklinikum Carl Gustav Carus, Klinik und Poliklinik fuer Dermatologie
  - Essen, Germany, 45122
    - Universitaetsklinikum Essen, HIV-Ambulanz, Hautklinik
  - Freiburg, Germany, 79098
    - Gemeinschaftspraxis Dres. Rump und Usadel
  - Hannover, Germany, 30625
    - Medizinische Hochschule Hannover, Klinische Immunologie, Zentrum Innere Medizin
  - Koeln, Germany, 50937
    - Universitaetsklinikum Koeln, Klinik I fuer Innere Medizin,
Greece
- - Athens, Greece, 115 27
    - General Hospital of Athens G. Gennimatas
  - Athens, Greece, 161 21
    - Andreas Sygros Hospital
  - Patras, Greece, 265 00
    - University Hospital of Patras
  - Piraeus, Greece, 185 36
    - Regional General Hospital Tzaneio
  - Thessaloniki, Greece, 54636
    - AHEPA Hospital
- Attiki
  - Athens, Attiki, Greece, 10676
    - Evagelismos hospital
  - Athens, Attiki, Greece, 115 26
    - Greek Red Cross Hospital
Hong Kong
- - Kowloon, Hong Kong
    - Department of Medicine Queen Elizabeth Hospital
India
- Karnataka
  - Bangalore, Karnataka, India, 560 034
    - Department of Medicine, St. John's Medical College Hospital
- Maharashtra
  - Mumbai, Maharashtra, India, 400 026
    - Department of HIV Medicine (I D Clinic), Jaslok Hospital & Research Centre
- Tamil Nadu
  - Chennai, Tamil Nadu, India, 600 113
    - YR Gaitonde Centre for AIDS Research and Education (YRG CARE)
Ireland
- - Dublin, Ireland, 8
    - St. James's Hospital
  - Dublin, Ireland, 7
    - Catherine McAuley Centre
Italy
- - Bari, Italy, 70124
    - Universita' degli Studi di Bari, Clinica Malattie Infettive, Policlinico
  - Bologna, Italy, 40138
    - Unita' Operativa Malattie Infettive
  - Brescia, Italy, 25123
    - Istituto di Malattie Infettive e Tropicali
  - Catania, Italy, 95126
    - Unita' Operativa di Malattie Infettive
  - Chieti Scalo, Italy, 66100
    - Presidio Ospedaliero SS Annunziata
  - Ferrara, Italy, 44100
    - Arcispedale S. Anna Azienda Ospedaliera Universitaria di Ferrara
  - Firenze, Italy, 50100
    - SOD Malattie Infettive, La Piastra dei Servizi
  - Genova, Italy, 16132
    - Unita' Operativa Clinica Malattie Infettive, Dipartimento di Medicina Interna e Malattie Infettive
  - Milano, Italy, 20127
    - Fondazione Centro San Raffaele del Monte Tabor
  - Milano, Italy, 20157
    - Dipartimento di Scienze Cliniche, Divisione Clinicizzata Malattie Infettive
  - Modena, Italy, 41100
    - Clinica Malattie Infettive e Tropicali, Universita' degli Studi di Modena Reggio Emilia
  - Padova, Italy, 35128
    - Unita Operativa di Malattie Infettive e Tropicali
  - Pavia, Italy, 27100
    - Fondazione IRCCS Policlinico S. Matteo
  - Pescara, Italy, 65124
    - Reparto di Malattie Infettive, Azienda Sanitaria Locale
  - Roma, Italy, 00184
    - Azienda Ospedaliera San Giovanni Addolorata
  - Roma, Italy, 00168
    - Universita'Cattolica del Sacro Cuore Policlinico Gemelli
  - Roma, Italy, 00133
    - Policlinico Tor Vergata, Divisione Malattie Infettive
  - Roma, Italy, 00149
    - IRCCS Lazzaro Spallanzani Istituto Nazionale per la Malattie Infettive
  - Roma, Italy, 00149
    - IRCCS Lazzaro Spallanzani Istituto Nazionale per le Malattie Infettive
  - Roma, Italy, 00149
    - IRCCS Lazzaro Spallanzani, Istituto Nazionale per le Malattie Infettive
  - Roma, Italy, 00161
    - Dipartimento di Malattie Infettive e Tropicali, Universita' di Roma La Sapienza
  - Torino, Italy, 10149
    - Clinica Universitaria di Malattie Infettive, Ospedale Amedeo di Savoia
  - Torrette di Ancona, Italy, 60121
    - Uni. Politecnica delle Marche, Ist. Malattie Infettive e Medicina P.
  - Venezia, Italy, 30122
    - Unita' Operativa di Malattie Infettive
Malaysia
- Kelantan
  - Kota Bharu, Kelantan, Malaysia, 15586
    - Physician Clinic
- Selangor
  - Sungai Buloh, Selangor, Malaysia, 47000
    - Hospital Sungai Buloh
Mexico
- DF
  - Mexico, DF, Mexico, 01030
    - Hospital Regional Lic. Adolfo López Mateos
- Jalisco
  - Guadalajara, Jalisco, Mexico, 44280
    - Antiguo Hospital Civil de Guadalajara "Fray Antonio Alcalde"
- Mexico Df
  - Tlalpan, Mexico Df, Mexico, CP 14000
    - Instituto Nacional de Ciencias Medicas Y Nutricion Dr Salvador Zubiran
Netherlands
- - Utrecht, Netherlands, NL 3584 CX
    - Academisch Ziekenhuis Utrecht
Portugal
- - Cascais, Portugal, 2750-349
    - Centro Hospitalar de Cascais
  - Lisboa, Portugal, 1169-050
    - Centro Hospitalar de Lisboa - Zona Central - Hospital Santo António Capuchos
  - Lisbon, Portugal, 1649-035
    - Hospital Sta. Maria
  - Porto, Portugal, 4200-319
    - Hospital Sao Joao
Puerto Rico
- - Ponce, Puerto Rico, 00717-1563
    - Centro Ararat Inc
  - San Juan, Puerto Rico, 00909
    - HOPE Clinical Research
Romania
- - Bucharest, Romania, 030303
    - Spitalul de Boli Infectioase si Tropicale Victor Babes
  - Constanta, Romania, 900709
    - Spitalul Clinic de Boli Infectioase Constanta
  - Iasi, Romania, 700116
    - Spitalul Clinic de Boli Infectioase Sf. Parascheva
- Sector 2
  - Bucuresti, Sector 2, Romania, 021105
    - Institutul de Boli Infectioase "Prof. Matei Bals"
Spain
- - Alicante, Spain, 03010
    - Hospital General Universitario de Alicante
  - Barcelona, Spain, 08003
    - Hospital Del Mar
  - Barcelona, Spain, 08035
    - Hospital Universitari Vall d'Hebron
  - Barcelona, Spain, 08036
    - Hospital Clinic i Provincial de Barcelona
  - Barcelona, Spain, 08025
    - Fund. de Gest. Sanitaria de L' Hospital de La Sta. Creu I Sant Pau
  - Cadiz, Spain, 11009
    - Hospital Puerta del Mar
  - Cordoba, Spain, 14012
    - Hospital Universitario Reina Sofia
  - Granada, Spain, 18012
    - Hospital Universitario San Cecilio
  - Granada, Spain, 18014
    - Hospital Universitario Virgen de las Nieves
  - Madrid, Spain, 28040
    - Fundacion Jimenez Diaz
  - Madrid, Spain, 28046
    - Hospital Universitario La Paz
  - Madrid, Spain, 28006
    - Hospital Universitario de la Princesa
  - Madrid, Spain, 28034
    - Hospital Ramon y Cajal
  - Madrid, Spain, 28041
    - Hospital 12 de Octubre
  - Madrid, Spain, 28007
    - Hospital General Gregorio Marañón
  - Madrid, Spain, 28029
    - Hospital Carlos III
  - Malaga, Spain, 29010
    - Hospital Virgen de la Victoria
  - Malaga, Spain, 29010
    - Complejo Hospitalario Carlos Haya
  - Malaga, Spain, 29600
    - Hospital Costa del Sol
  - Sevilla, Spain, 41013
    - Hospital Virgen del Rocío
  - Sevilla, Spain, 41014
    - Complejo Hospitalario Nuestra Senora de Valme
  - Sevilla, Spain, 41071
    - Hospital Universitario Virgen de la Macarena
  - Valencia, Spain, 46009
    - Hospital Universitario la Fe
  - Valencia, Spain, 46015
    - Hospital Arnau de Vilanova
  - Valencia, Spain, 46014
    - Consorcio Hospital General Universitario de Valencia
  - Valencia, Spain, 46010
    - Hospital Clínico Universitario
- Alicante
  - Elche, Alicante, Spain, 03202
    - Hospital General Universitario de Elche
- Barcelona
  - Badalona, Barcelona, Spain, 08916
    - H. Universitari Germans Trias i Pujol
  - Granollers, Barcelona, Spain, 08400
    - Hospital General de Granollers
  - Hospitalet de Llobregat, Barcelona, Spain, 08907
    - Hospital Universitari de Bellvitge
- Bilbao
  - Basurto, Bilbao, Spain, 48078
    - Hospital de Basurto
- Cantabria
  - Santander, Cantabria, Spain, 39008
    - Hospital Universitario Marqués de Valdecilla
- Gijon
  - Cabueñes, Gijon, Spain, 33394
    - Hospital de Cabuenes
- La Coruña
  - Santiago de Compostela, La Coruña, Spain, 15706
    - Hospital Clínico Universitario de Santiago de Compostela
- Pontevedra
  - Vigo, Pontevedra, Spain, 36204
    - Complejo Hospitalario Xeral-Cies
- San Sebastian
  - Donostia, San Sebastian, Spain, 20014
    - Hospital Donostia-Donostia Ospitalea
- Santa Cruz de Tenerife
  - La Laguna, Santa Cruz de Tenerife, Spain, 38320
    - Hospital Universitario de Canarias
- Tarragona
  - Tortosa, Tarragona, Spain, 43500
    - Hospital de Tortosa Verge de la Cinta
- Vizcaya
  - Barakaldo, Vizcaya, Spain, 48903
    - Hospital de Cruces
Switzerland
- - Zürich, Switzerland, 8091
    - Universitatsspital Zurich
Taiwan
- - Kaohsiung County, Taiwan, 824
    - Department of Infectious Disease, E-Da Hospital
United Kingdom
- - Crumpsall, Manchester, United Kingdom, M8 6RB
    - North Manchester General Hospital
  - Edinburgh, United Kingdom, EH4 2XU
    - Regional Infectious Diseases Unit
  - London, United Kingdom, NW3 2QG
    - Ian Charleson Centre
  - London, United Kingdom, SE5 9RS
    - Department of Sexual Health
  - London, United Kingdom, SW10 9NH
    - St Stephens Research Ltd
  - London, United Kingdom, W2 1NY
    - Imperial College
- Sussex
  - Brighton, Sussex, United Kingdom, BN2 1ES
    - Brighton and Sussex University Hospitals NHS Trust, The Elton John Centre
United States
- Alabama
  - Birmingham, Alabama, United States, 35294-2050
    - The University of Alabama
  - Hobson City, Alabama, United States, 36201
    - Health Services Center
- Arizona
  - Tucson, Arizona, United States, 85745
    - El Rio, Special Immunology Associates
- Arkansas
  - Little Rock, Arkansas, United States, 72207
    - Health For Life Clinic Pllc
  - Little Rock, Arkansas, United States, 72207
    - Thomas T Jefferson, MD
- California
  - Beverly Hills, California, United States, 90211
    - AHF Research Center
  - Beverly Hills, California, United States, 90210-4212
    - Vista Medical
  - Fountain Valley, California, United States, 92708
    - Orange County Center for Special Immunology
  - Hayward, California, United States, 94545
    - Kaiser Permanente
  - Long Beach, California, United States, 90813
    - Living Hope Clinical Trials
  - Los Angeles, California, United States, 90048
    - Cedars-Sinai Medical Center
  - Los Angeles, California, United States, 90027
    - Kaiser Permanente Medical Center
  - Los Angeles, California, United States, 90022
    - AltaMed Health Services Corporation
  - Los Angeles, California, United States, 90028
    - Robert Bolan, MD
  - Los Angeles, California, United States, 90033
    - Maternal-Child and Adolescent Clinic of Infectious Diseases and Virology
  - Los Angeles, California, United States, 90036
    - Peter J. Ruane, M.D. Inc.
  - Los Angeles, California, United States, 90036
    - Synergy Hematology-Oncology Associates
  - Los Angeles, California, United States, 90048
    - Erlmed Corp ABA Lim-Keith Muiltispecialty Clinic Inc.
  - Los Angeles, California, United States, 90069
    - Office of Anthony Mills, MD
  - Modesto, California, United States, 95350
    - Office of Dr. Salah Bibi, MD
  - Newport Beach, California, United States, 92663
    - Bonnie V Bock MD
  - Oakland, California, United States, 94609
    - Alta Bates Summit Medical Center
  - Palm Springs, California, United States, 92262
    - Desert Medical Group, Clinical Research Center
  - Riverside, California, United States, 92506
    - Riverside Medical Clinic
  - Sacramento, California, United States, 95816
    - Sutter Institute for Medical Research
  - Sacramento, California, United States, 95816
    - Sutter Medical Group
  - Sacramento, California, United States, 95816
    - Fort Sutter Medical Complex
  - San Francisco, California, United States, 94118
    - Kaiser Permanente Medical Center
  - San Francisco, California, United States, 94115-3029
    - Quest Clinical Research
  - Santa Clara, California, United States, 95051
    - Kaiser Permanente Santa Clara
  - Tarzana, California, United States, 91356
    - Tarzana Treatment Center
  - Tarzana, California, United States, 91356
    - Shared Medical Research Foundation
  - Victorville, California, United States, 92395
    - Bipin Bhagat MD Inc.
- Colorado
  - Denver, Colorado, United States, 80205
    - Kaiser Permanente of Colorado
  - Denver, Colorado, United States, 80205
    - Kaiser Permanente Colorado
  - Denver, Colorado, United States, 80220
    - Denver Infectious Disease Consultants, PLLC
  - Lafayette, Colorado, United States, 80026
    - Kaiser Permanente of Colorado
- Connecticut
  - Glastonbury, Connecticut, United States, 06033
    - Connecticut Health Care Group
  - Norwich, Connecticut, United States, 06360
    - Infectious disease clinic
- District of Columbia
  - Washington, District of Columbia, United States, 20009
    - Dupont Circle Physicians Group
- Florida
  - Bonita Springs, Florida, United States, 34134
    - Internal Medicine Associates of Lee County
  - Boynton Beach, Florida, United States, 33426
    - Infectious Disease Research Corp
  - Cape Coral, Florida, United States, 33990
    - Internal Medicine Associates of Lee County
  - Daytona Beach, Florida, United States, 32117
    - Daniel Warner M.D., P.A. Consultive Medicine
  - Fort Lauderdale, Florida, United States, 33308
    - Northpoint Medical, PA
  - Fort Lauderdale, Florida, United States, 33311
    - Comprehensive Care Center
  - Fort Lauderdale, Florida, United States, 33316
    - Office of Gary J. Richmond, MD
  - Fort Myers, Florida, United States, 33912
    - Internal Medicine Associates of Lee County
  - Ft. Lauderdale, Florida, United States, 33308
    - Therafirst Medical Centers
  - Hollywood, Florida, United States, 33021
    - Sunshine Medical Institute
  - Melbourne, Florida, United States, 32901
    - Osler Medical Inc.
  - Miami, Florida, United States, 33137
    - Care Resource
  - Miami, Florida, United States, 33133
    - Steinhart Medical Associates
  - Miami Beach, Florida, United States, 33139
    - Office of Albert Canas, MD
  - North Miami Beach, Florida, United States, 33162
    - Donald Johnson, MD
  - North Miami Beach, Florida, United States, 33169
    - Wohlfeiler, Piperato & Associates, LLC
  - Orlando, Florida, United States, 32803
    - Orlando Immunology Center
  - Orlando, Florida, United States, 32806
    - Infectious Diseases of Central Florida
  - Port St. Lucie, Florida, United States, 34952
    - Associates in Infectious Diseases
  - Safety Harbor, Florida, United States, 34695
    - Barry Rodwick, MD
  - Sarasota, Florida, United States, 34239
    - Infectious Diseases Associates
  - Sarasota, Florida, United States, 34243
    - University Hepatitis Center at Bach & Godofsky, MD,PA
  - St. Petersburg, Florida, United States, 33701
    - All Children's Hospital
  - Tallahassee, Florida, United States, 32308
    - Eric Nicholson, M.D., P.A.
  - Tampa, Florida, United States, 33606
    - University of South Florida
  - Tampa, Florida, United States, 33614
    - Midtown Medical Center
  - Tampa, Florida, United States, 33612
    - University of Sout Florida
  - West Palm Beach, Florida, United States, 33401
    - Donald Watren MD
- Georgia
  - Atlanta, Georgia, United States, 30309
    - Philip Brachman MD
  - Atlanta, Georgia, United States, 30318-2513
    - Family Health Care of Atlanta
  - Atlanta, Georgia, United States, 30318
    - Midtown West Medical
  - Atlanta, Georgia, United States, 30329
    - Absolute CARE
  - Atlanta, Georgia, United States, 30339
    - Kaiser Permanente
  - Decatur, Georgia, United States, 30033
    - Atlanta VA Medical Center
  - Decatur, Georgia, United States, 30033
    - Infectious Disease Specialists of Atlanta
  - Jonesboro, Georgia, United States, 30236
    - Kaiser Permanente
  - Riverdale, Georgia, United States, 30274
    - Infectious Diseases Associates, PC
  - Savannah, Georgia, United States, 31405
    - Chatham County Health Department
  - Tucker, Georgia, United States, 30084-8128
    - Infectious Disease Consultants
- Illinois
  - Chicago, Illinois, United States, 60612
    - Ruth M. Rothstein CORE Center
  - Chicago, Illinois, United States, 60657
    - Northstar Medical Center
  - Chicago, Illinois, United States, 60613
    - Roger Trinh
- Kansas
  - Topeka, Kansas, United States, 66606-1670
    - Cotton-O'Neil Clinic
  - Wichita, Kansas, United States, 67214
    - Via Christi Research, Inc.
  - Wichita, Kansas, United States, 67214
    - Kansas University Internal Medicine Midtown Clinic
- Maryland
  - Baltimore, Maryland, United States, 21201
    - Chase Brexton Health Services Inc
  - Greenbelt, Maryland, United States, 20770-3525
    - Metro Health Care
  - Silver Spring, Maryland, United States, 20910
    - Dr.'s Alpert, Trinh, and Posorske
- Massachusetts
  - Boston, Massachusetts, United States, 02111
    - TUFTS - New England Medical Center
  - Boston, Massachusetts, United States, 02115
    - Fenway Community Health
  - Boston, Massachusetts, United States, 02215-3318
    - Community Research Initiative of New England
  - Springfield, Massachusetts, United States, 01107
    - Community Research Initiative of New England
- Michigan
  - Berkley, Michigan, United States, 48072
    - The Office of Dr. Paul A. Benson, DO
  - Grand Rapids, Michigan, United States, 49546
    - Private Practice (Dr. Gregory Kuldanek)
  - Grosse Pointe Woods, Michigan, United States, 48236
    - St. John Hospital and Medical Center
  - Keego Harbor, Michigan, United States, 48320
    - Private Practice
  - Lansing, Michigan, United States, 48910
    - MSU Adult Medicine, 10
- Minnesota
  - Minneapolis, Minnesota, United States, 55415
    - Hennepin County Medical Center
- Missouri
  - Kansas City, Missouri, United States, 64111
    - Nemechek Health Renewal
  - St. Louis, Missouri, United States, 63117
    - Private Practice (Dr. Mark Scheperle)
- Montana
  - Missoula, Montana, United States, 59802
    - Partnership Health Center
- New Jersey
  - Englewood, New Jersey, United States, 07631
    - CPMC Research Pharmacy
  - Englewood, New Jersey, United States, 07631
    - Leonia Medical Associates
  - Hackensack, New Jersey, United States, 07601
    - Hackensack University Medical Center
  - Hackensack, New Jersey, United States, 07601
    - Center for Infectious Diseaes
  - Newark, New Jersey, United States, 07103
    - University Hospital
  - Newark, New Jersey, United States, 07103
    - UMDNJ
  - Newark, New Jersey, United States, 07114
    - Newark Community Health Center
  - Somers Point, New Jersey, United States, 08244
    - South Jersey Infectious Disease
  - Toms River, New Jersey, United States, 08755
    - Premier Medical Research Group
  - Voorhees, New Jersey, United States, 08043
    - Garden State Infectious Disease Associates, PA
- New York
  - Albany, New York, United States, 12208
    - Upstate Infectious Disease Associates
  - Bronx, New York, United States, 10457
    - Bronx Lebanon Hospital Center
  - Bronx, New York, United States, 10454
    - Allmed Medical and Rehabilitaion of NY
  - Brooklyn, New York, United States, 11215
    - New York Methodist Hospital
  - Brooklyn, New York, United States, 11206
    - Woodhull Medical Center
  - Brooklyn, New York, United States, 11215
    - NYM Medical Pavilion
  - Buffalo, New York, United States, 14215
    - Chiu-Bin Hsiao, MD
  - Buffalo, New York, United States, 14215
    - The Office of Dr. Zale P. Bernstein, MD.
  - Flushing, New York, United States, 11367
    - NYHQ
  - Great Neck, New York, United States, 11042
    - Schneider Children's Hospital
  - Manhasset, New York, United States, 11030
    - North Shore University Hospital, Department of Infectious Disease
  - New York, New York, United States, 10016
    - Bellevue Hospital
  - New York, New York, United States, 10003
    - Beth Israel Medical Center
  - New York, New York, United States, 10029
    - Mount Sinai School of Medicine
  - New York, New York, United States, 10029
    - Mount Sinai Medical Center
  - New York, New York, United States, 10016
    - NYU School of Medicine
  - New York, New York, United States, 10032
    - New York-Presbyterian Hospital
  - New York, New York, United States, 10003
    - Astor Medical Group, LLP
  - New York, New York, United States, 10003
    - Paul Bellman, MD
  - New York, New York, United States, 10003
    - Sidney Hillman Family Health Center
  - New York, New York, United States, 10011
    - Ricky Hsu
  - New York, New York, United States, 10018
    - Perion Smith
  - New York, New York, United States, 10019-1819
    - James I Jones Jr, MD
  - New York, New York, United States, 10024
    - Sharon Lewin MD and Michael Rendel MD
  - New York, New York, United States, 10026
    - Lenox Ave Clinic
  - New York, New York, United States, 10029
    - Harlem Medical Associates
  - Rochester, New York, United States, 14605
    - Dr. Steven Fine
  - Stanton Island, New York, United States, 10304
    - Jordon Glaser, MD
  - Syracuse, New York, United States, 13210
    - SUNY Upstate Medical University
- North Carolina
  - Gastonia, North Carolina, United States, 28054
    - ID Associates
  - Huntersville, North Carolina, United States, 28078
    - Rosedale Infectious Diseases
- Ohio
  - Cleveland, Ohio, United States, 44109
    - Metro Health Systems
  - Dayton, Ohio, United States, 45429
    - South Dayton Acute Care Consultants Inc.
  - Toledo, Ohio, United States, 43614-5812
    - University of Toledo - Health Science Campus
- Oklahoma
  - Tulsa, Oklahoma, United States, 74135
    - University of Oklahoma - Schusterman Clinic
- Oregon
  - Portland, Oregon, United States, 97210
    - The Research & Education Group
  - Portland, Oregon, United States, 97227
    - Kaiser Permanente-Northwest Region, Immune Deficiency Clinic
- Pennsylvania
  - Allentown, Pennsylvania, United States, 18102
    - Lehigh Valley Hospital
  - Philadelphia, Pennsylvania, United States, 19107
    - Philadelphia FIGHT
  - West Reading, Pennsylvania, United States, 19611
    - RPS Infectious Diseases
- Rhode Island
  - Providence, Rhode Island, United States, 02906
    - The Miriam Hospital
- South Carolina
  - Charleston, South Carolina, United States, 29425
    - Medical University of South Carolina
  - Charleston, South Carolina, United States, 29403
    - Medical University of South Carolina
  - Charleston, South Carolina, United States, 29401
    - Investigational Drug Services
- Tennessee
  - Memphis, Tennessee, United States, 38119
    - Infectious Disease Associates of Memphis
- Texas
  - Dallas, Texas, United States, 75204
    - The Office of Dr. Nicholaos C. Bellos, MD
  - Dallas, Texas, United States, 75219
    - The Office of Dr. Patrick W. Daly, MD.
  - Dallas, Texas, United States, 75231
    - The Office of Dr. Susan M. Diamond, MD.
  - El Paso, Texas, United States, 79925
    - La Fe CARE Center Clinic
  - Fort Worth, Texas, United States, 76104-3048
    - Kelly, Allan Rowman MD
  - Ft. Worth, Texas, United States, 76104
    - Tarrant County Infectious Disease Associates
  - Harlingen, Texas, United States, 78550
    - Fernando Garcia, MD
  - Houston, Texas, United States, 77030
    - Baylor College of Medicine
  - Houston, Texas, United States, 77030
    - The University of Texas Health Sciences Center at Houston
  - Houston, Texas, United States, 77009
    - Thomas Street Clinic
  - Houston, Texas, United States, 77098
    - Research Access Network
  - Houston, Texas, United States, 77009
    - Harris County Hospital District
  - Houston, Texas, United States, 77027
    - Diversified Medical Practices, PA
  - Houston, Texas, United States, 77098-2807
    - Brewton, Gary W MD
  - Houston, Texas, United States, 77098
    - The Office of Dr. Gordon E. Crofoot, MD.
  - Longview, Texas, United States, 75605
    - DCOL Center for Clinical Research
  - Longview, Texas, United States, 75605
    - Diagnostic Clinic of Longview, PA
  - San Antonio, Texas, United States, 78212
    - Dr. James Bromley
  - San Antonio, Texas, United States, 78258
    - Responsive ID Solutions
- Virginia
  - Annandale, Virginia, United States, 22003
    - Clinical Alliance for Research & Education - Infectious Diseases
  - Arlington, Virginia, United States, 22205-3633
    - Infectious Diseases
  - Danville, Virginia, United States, 24541
    - Infectious Diseases Associates of Central Virginia
  - Fairfax, Virginia, United States, 22030
    - Infectious Disease Consultants
  - Hampton, Virginia, United States, 23666
    - Hampton Roads Medical Specialists
  - Lynchburg, Virginia, United States, 24501
    - Barbara Cassie
  - Richmond, Virginia, United States, 23224
    - Crossover Ministry
- Washington
  - Edmonds, Washington, United States, 98026
    - William F. Ehni, MD
  - Seattle, Washington, United States, 98112
    - Group Health Cooperative
  - Seattle, Washington, United States, 98109
    - Emerald City Medical Arts
  - Spokane, Washington, United States, 99204
    - The Office of Dr. Daniel R. Coulston, MD
  - Vancouver, Washington, United States, 98664
    - The Vancouver Clinic, Inc., P.S.
- West Virginia
  - Charleston, West Virginia, United States, 25304
    - CAMC Memorial Hospital
  - Charleston, West Virginia, United States, 25304
    - Clinical Trials Center
  - Huntington, West Virginia, United States, 25701
    - University Physicians Internal Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Description

Inclusion Criteria:

Subjects must be failing to achieve adequate virologic suppression on their current regimen and have HIV-1 RNA greater than or equal to 1000 copies/ml, at screening
Have only R5 HIV-1 at Screening as verified by the Monogram Biosciences Trofile assay
Minimum age must be 16 years or minimum adult age as determined by local regulatory authorities or directed by local law.

Exclusion Criteria:

Failed prior treatment with any CCR5 antagonist, in any ongoing CCR5 trial or having previously prematurely discontinued Maraviroc in trials

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized

Number of Arms

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 1	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.

Participant Group / Arm

Intervention / Treatment

Experimental: 1

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants With Grade 3 and Grade 4 Adverse Events (AE) Time Frame: Baseline up to Week 144	AEs as defined by the Division of AIDS (DAIDS) toxicity grading scale: Grade 3 = severe: interrupted usual daily activity and traditionally required systemic drug therapy or other treatment. Grade 4 = very severe: events that were unacceptable and intolerable or were irreversable or caused imminent danger of death. If same participant had more than 1 occurrence in the same preferred term event category, only the most severe (grade 4) occurrence was taken. Treatment-related = investigator assessment of a reasonable possibility that the investigational product caused or contributed to the AE.	Baseline up to Week 144
Percentage of Participants With Grade 3 Laboratory Abnormalities Without Regards to Baseline Abnormalities Time Frame: Baseline up to Week 144	Laboratory abnormalities as defined by the Division of AIDS (DAIDS) toxicity grading scale: Grade 3, Severe =events that interrupted participants usual daily activity and traditionally required systemic drug therapy or other treatment.	Baseline up to Week 144
Percentage of Participants With Grade 4 Laboratory Abnormalities Without Regards to Baseline Abnormalities Time Frame: Baseline up to Week 144	Laboratory abnormalities as defined by the Division of AIDS (DAIDS) toxicity grading scale: Grade 4, Very Severe = events which were unacceptable and intolerable or were irreversible or caused the participant to be in imminent danger of death.	Baseline up to Week 144
Percentage of Participants With Acquired Immunodeficiency Syndrome (AIDS)-Defining Illnesses Time Frame: Baseline up to Week 144	Treatment-emergent AIDS-defining opportunistic illnesses based on investigator classification guided by a predefined list of clinical Category C adverse events per Center for Disease Control (CDC) HIV Classification System. Includes events occurring up to 30 days after last dose of study drug.	Baseline up to Week 144
Percentage of Participants With Possible Acquired Immunodeficiency Syndrome (AIDS) Related Infections and Malignancies by Baseline Viral Load Time Frame: Baseline up to Week 144		Baseline up to Week 144
Percentage of Participants With Possible Acquired Immunodeficiency Syndrome (AIDS) Related Infections and Malignancies by Baseline/Nadir CD4 Cell Counts Time Frame: Baseline up to Week 144		Baseline up to Week 144
Percentage of Participants With Possible Acquired Immunodeficiency Syndrome (AIDS) Related Infections and Malignancies by Time on Therapy Time Frame: Baseline up to Week 144		Baseline up to Week 144
Percentage of Participants With All Causality Treatment-emergent Adverse (AEs) Events by Gender Time Frame: Baseline up to Week 144	Treatment-emergent AEs by gender that occurred up to 30 days after the last dose of study medication.	Baseline up to Week 144
Percentage of Participants With Treatment-emergent Adverse Events (AEs) by Race Time Frame: Baseline up to Week 144	Treatment-emergent AEs by race that occurred up to 30 days after the last dose of study medication.	Baseline up to Week 144
Percentage of Participants With Treatment-emergent Adverse Events (AEs) by Age Time Frame: Baseline up to Week 144	Treatment-emergent AEs by age that occurred up to 30 days after the last dose of study medication.	Baseline up to Week 144
Percentage of Participants With Treatment-emergent Averse Events (AEs) by Baseline Hepatitis B and Hepatitis C Virus Serology Status Time Frame: Baseline up to Week 144	Treatment emergent AEs by hepatis B and hepatitis C serology status that occurred up to 30 days post last dose.	Baseline up to Week 144

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants With ≥0.5 log10 Reduction From Baseline in Human Immunodeficiency Virus 1 Ribonucleic Acid (HIV 1 RNA) Time Frame: Baseline up to Week 144	Defined as HIV-1 RNA levels < 400 Copies/mL or at least 0.5 Log 10-decrease from baseline in HIV-1 RNA levels. Baseline value calculated as average of the screening and baseline values if both values were within 1 log10 difference.	Baseline up to Week 144
Percentage of Participants With ≥1.0 log10 Reduction From Baseline in HIV 1 RNA Time Frame: Baseline up to Week 144	Defined as HIV-1 RNA levels < 400 copies/mL or at least 1.0 Log 10-decrease from baseline in HIV-1 RNA levels. Baseline value calculated as average of the screening and baseline values if both values were within 1 log10 difference.	Baseline up to Week 144
Percentage of Participants With HIV-1 RNA Levels Below the Limit of Quantification: <400 Copies/mL Time Frame: Baseline up to Week 144	Limit of quantification defined as <400 copies/mL. Baseline value calculated as average of the screening and baseline values if both values were within 1 log 10 difference.	Baseline up to Week 144
Percentage of Participants With HIV-1 RNA Levels Below the Limit of Quantification: <50 Copies/mL Time Frame: Baseline up to Week 144	Limit of quantification defined as <50 copies/mL. Baseline value calculated as average of the screening and baseline values if both values were within 1 log 10 difference.	Baseline up to Week 144
Change From Baseline in CD4 Cell Count Time Frame: Baseline up to Week 144	Change from baseline in cluster of differentiation 4 helper T cells (CD4) cell count. If baseline value was not available, it was taken from immediate preceding non-missing value.	Baseline up to Week 144
Change From Baseline in CD4 Cell Count Percent Time Frame: Baseline up to Week 144	Change from baseline in CD4 cell count percent . If baseline value was not available, it was taken from immediate preceding non-missing value.	Baseline up to Week 144
Change From Baseline in CD8 Cell Count Time Frame: Baseline up to Week 144	Change from baseline in cluster of differentiation 8 suppressor T cells (CD8) cell count. If baseline value was not available, it was taken from immediate preceding non-missing value.	Baseline up to Week 144
Change From Baseline in CD8 Cell Count Percent Time Frame: Baseline up to Week 144	Change from baseline in CD8 cell count percent . If baseline value was not available, it was taken from immediate preceding non-missing value.	Baseline up to Week 144
Median Time to Virologic Failure Time Frame: Day 1 up to Week 144	Computed as time from the first dose of study medication to the loss of virologic response. Virologic failure defined as: failure to achieve a reduction from baseline (BL) in HIV 1 RNA ≥ 0.5 log10 copies /mL by the second viral load determination (unless viral load was below the lower limit level of quantification [LLOQ]); or a ≥ 0.5 log10 increase from nadir in HIV 1 RNA after achieving a HIV 1 RNA reduction from BL >0.5 log10 copies/mL; or a HIV 1 RNA level of >1000 copies/mL after having achieved a HIV 1 RNA level below LLOQ.	Day 1 up to Week 144
Percentage of Participants With Changes in HIV-1 RNA Level in Participants Meeting the Definition of Virologic Failure Time Frame: Baseline up to Week 144	Reasons for virologic failure: A) failure to achieve a reduction in HIV-1 RNA>=0.5 log10 copies/ml from baseline (BL) by second viral load determination (unless below level of quantification [LOQ]); B) >=0.5 log10 increase from nadir in HIV-1 RNA after achieving an HIV-1 RNA reduction from BL >0.5 log10 copies/ml ; C) HIV-1 RNA >1000 copies/ml after having achieved an HIV-1 RNA below LOQ.	Baseline up to Week 144
Percentage of Participants With Change in Chemokine Co-receptor Tropism From Screening to Time of Virologic Failure Time Frame: Screening up to Week 144	Tropism status (CCR5 [R5], CXCR4 [X4], Dual Mixed [DM], or Non-reportable [NR]) at Screening (Scr) and time of virologic failure (V fail). Virologic failure defined as: failure to achieve a reduction from baseline (BL) in HIV 1 RNA ≥0.5 log10 copies/mL by second viral load determination (unless viral load was below lower limit level of quantification [LLOQ]); or a ≥ 0.5 log10 increase from nadir in HIV 1 RNA after achieving HIV 1 RNA reduction from BL >0.5 log10 copies/mL; or a HIV 1 RNA level of >1000 copies/mL after having achieved a HIV 1 RNA level below LLOQ.	Screening up to Week 144
Number of Participants With Reduced Maraviroc Susceptibility as Defined by Change From Baseline to Time of Virologic Failure in Inhibitory Concentration of 50% (IC 50) and Presence of Plateau Time Frame: Baseline up to Week 144	Resistance to maravroc in viruses from participants failing therapy with R5 virus was investigated using the in vitro phenotypic (drug susceptibility) assay. The number of participants who failed with R5 virus were assessed successfully for maraviroc susceptibility at Baseline and Last on--treatment (Week 144). Samples were analyzed for change from Baseline to time of virologic failure in IC 50 and presence of plateau. A maximal percent inhibition (MPI) <95% established as a plateau in inhibition at high concentrations of maraviroc was used to identify viruses which had reduced phenotypic susceptibility to maraviroc.	Baseline up to Week 144
Number of Participants With Emergence of Resistance to Maraviroc as Defined by Genotypic Changes in the V3 Loop of Glycoprotein 120 (gp 120) Time Frame: Baseline up to Week 144	Virus from participants who experienced virologic failure was analyzed for resistance to maraviroc. Resistance testing was performed on archived samples of participants which were available pre--treatment at time of virologic failure. For participants who met definition of virologic failure during the trial, the sequencing of the V3 loop of HIV--1 viral envelope gp 120 was evaluated to identify any amino acid changes concomitant with decreased susceptibility to maraviroc.	Baseline up to Week 144

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

ViiV Healthcare

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

To obtain contact information for a study center near you, click here.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2007

Primary Completion (Actual)

June 1, 2010

Study Completion (Actual)

June 1, 2010

Study Registration Dates

First Submitted

January 22, 2007

First Submitted That Met QC Criteria

January 23, 2007

First Posted (Estimate)

January 25, 2007

Study Record Updates

Last Update Posted (Estimate)

June 29, 2016

Last Update Submitted That Met QC Criteria

May 23, 2016

Last Verified

May 1, 2016

More Information

Terms related to this study

Keywords

HIV Infections

Additional Relevant MeSH Terms

Other Study ID Numbers

A4001050
2006-004306-50 (EudraCT Number)
EAP (Other Identifier: Alias Study Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Study Overview

Status

Conditions

Intervention / Treatment

Study Type

Enrollment (Actual)

Phase

Contacts and Locations

Study Locations

Participation Criteria

Eligibility Criteria

Ages Eligible for Study

Accepts Healthy Volunteers

Genders Eligible for Study

Description

Study Plan

How is the study designed?

Design Details

Number of Arms

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure

Measure Description

Time Frame

Secondary Outcome Measures

Outcome Measure

Measure Description

Time Frame

Collaborators and Investigators

Sponsor

Publications and helpful links

Helpful Links

Study record dates

Study Major Dates

Study Start

Primary Completion (Actual)

Study Completion (Actual)

Study Registration Dates

First Submitted

First Submitted That Met QC Criteria

First Posted (Estimate)

Study Record Updates

Last Update Posted (Estimate)

Last Update Submitted That Met QC Criteria

Last Verified

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Clinical Trials on HIV Infections

Clinical Trials on maraviroc

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Dominican Republic

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations