Expanded Access Program for Maraviroc At Multiple Centers
A Multicenter, Open Label, Expanded Access Trial Of Maraviroc
3 other identifiers
interventional
1,047
25 countries
350
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3 hiv-infections
Started Feb 2007
350 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 22, 2007
CompletedFirst Posted
Study publicly available on registry
January 25, 2007
CompletedStudy Start
First participant enrolled
February 1, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2010
CompletedResults Posted
Study results publicly available
October 17, 2011
CompletedJune 29, 2016
May 1, 2016
3.3 years
January 22, 2007
June 2, 2011
May 23, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (11)
Percentage of Participants With Grade 3 and Grade 4 Adverse Events (AE)
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
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
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
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
Baseline up to Week 144
Percentage of Participants With Possible Acquired Immunodeficiency Syndrome (AIDS) Related Infections and Malignancies by Baseline/Nadir CD4 Cell Counts
Baseline up to Week 144
Percentage of Participants With Possible Acquired Immunodeficiency Syndrome (AIDS) Related Infections and Malignancies by Time on Therapy
Baseline up to Week 144
Percentage of Participants With All Causality Treatment-emergent Adverse (AEs) Events by Gender
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
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
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
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 Outcomes (13)
Percentage of Participants With ≥0.5 log10 Reduction From Baseline in Human Immunodeficiency Virus 1 Ribonucleic Acid (HIV 1 RNA)
Baseline up to Week 144
Percentage of Participants With ≥1.0 log10 Reduction From Baseline in HIV 1 RNA
Baseline up to Week 144
Percentage of Participants With HIV-1 RNA Levels Below the Limit of Quantification: <400 Copies/mL
Baseline up to Week 144
Percentage of Participants With HIV-1 RNA Levels Below the Limit of Quantification: <50 Copies/mL
Baseline up to Week 144
Change From Baseline in CD4 Cell Count
Baseline up to Week 144
- +8 more secondary outcomes
Study Arms (1)
1
EXPERIMENTALInterventions
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- Failed prior treatment with any CCR5 antagonist, in any ongoing CCR5 trial or having previously prematurely discontinued Maraviroc in trials
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- ViiV Healthcarelead
Study Sites (361)
The University of Alabama
Birmingham, Alabama, 35294-2050, United States
Health Services Center
Hobson City, Alabama, 36201, United States
El Rio, Special Immunology Associates
Tucson, Arizona, 85745, United States
Health for Life Clinic PLLC
Little Rock, Arkansas, 72207, United States
Thomas T Jefferson, MD
Little Rock, Arkansas, 72207, United States
Vista Medical
Beverly Hills, California, 90210-4212, United States
AHF Research Center
Beverly Hills, California, 90211, United States
Orange County Center for Special Immunology
Fountain Valley, California, 92708, United States
Kaiser Permanente
Hayward, California, 94545, United States
Living Hope Clinical Trials
Long Beach, California, 90813, United States
AltaMed Health Services Corporation
Los Angeles, California, 90022, United States
Kaiser Permanente Medical Center
Los Angeles, California, 90027, United States
Robert Bolan, MD
Los Angeles, California, 90028, United States
Maternal-Child and Adolescent Clinic of Infectious Diseases and Virology
Los Angeles, California, 90033, United States
Peter J. Ruane, M.D. Inc.
Los Angeles, California, 90036, United States
Synergy Hematology-Oncology Associates
Los Angeles, California, 90036, United States
Cedars-Sinai Medical Center
Los Angeles, California, 90048, United States
Erlmed Corp ABA Lim-Keith Muiltispecialty Clinic Inc.
Los Angeles, California, 90048, United States
Office of Anthony Mills, MD
Los Angeles, California, 90069, United States
Office of Dr. Salah Bibi, MD
Modesto, California, 95350, United States
Bonnie V Bock MD
Newport Beach, California, 92663, United States
Alta Bates Summit Medical Center
Oakland, California, 94609, United States
Desert Medical Group, Clinical Research Center
Palm Springs, California, 92262, United States
Riverside Medical Clinic
Riverside, California, 92506, United States
Fort Sutter Medical Complex
Sacramento, California, 95816, United States
Sutter Institute for Medical Research
Sacramento, California, 95816, United States
Sutter Medical Group
Sacramento, California, 95816, United States
Quest Clinical Research
San Francisco, California, 94115-3029, United States
Kaiser Permanente Medical Center
San Francisco, California, 94118, United States
Kaiser Permanente Santa Clara
Santa Clara, California, 95051, United States
Shared Medical Research Foundation
Tarzana, California, 91356, United States
Tarzana Treatment Center
Tarzana, California, 91356, United States
Bipin Bhagat MD Inc.
Victorville, California, 92395, United States
Kaiser Permanente Colorado
Denver, Colorado, 80205, United States
Kaiser Permanente of Colorado
Denver, Colorado, 80205, United States
Denver Infectious Disease Consultants, PLLC
Denver, Colorado, 80220, United States
Kaiser Permanente of Colorado
Lafayette, Colorado, 80026, United States
Connecticut Health Care Group
Glastonbury, Connecticut, 06033, United States
Infectious Disease Clinic
Norwich, Connecticut, 06360, United States
Dupont Circle Physicians Group
Washington D.C., District of Columbia, 20009, United States
Internal Medicine Associates of Lee County
Bonita Springs, Florida, 34134, United States
Infectious Disease Research Corp
Boynton Beach, Florida, 33426, United States
Internal Medicine Associates of Lee County
Cape Coral, Florida, 33990, United States
Daniel Warner M.D., P.A. Consultive Medicine
Daytona Beach, Florida, 32117, United States
Northpoint Medical, PA
Fort Lauderdale, Florida, 33308, United States
Therafirst Medical Centers
Fort Lauderdale, Florida, 33308, United States
Comprehensive Care Center
Fort Lauderdale, Florida, 33311, United States
Office of Gary J. Richmond, MD
Fort Lauderdale, Florida, 33316, United States
Internal Medicine Associates of Lee County
Fort Myers, Florida, 33912, United States
Sunshine Medical Institute
Hollywood, Florida, 33021, United States
Osler Medical Inc.
Melbourne, Florida, 32901, United States
Steinhart Medical Associates
Miami, Florida, 33133, United States
Care Resource
Miami, Florida, 33137, United States
Office of Albert Canas, MD
Miami Beach, Florida, 33139, United States
Donald Johnson, MD
North Miami Beach, Florida, 33162, United States
Wohlfeiler, Piperato & Associates, LLC
North Miami Beach, Florida, 33169, United States
Orlando Immunology Center
Orlando, Florida, 32803, United States
Infectious Diseases of Central Florida
Orlando, Florida, 32806, United States
Associates in Infectious Diseases
Port Saint Lucie, Florida, 34952, United States
Barry Rodwick, MD
Safety Harbor, Florida, 34695, United States
Infectious Diseases Associates
Sarasota, Florida, 34239, United States
University Hepatitis Center at Bach & Godofsky, MD,PA
Sarasota, Florida, 34243, United States
All Children's Hospital
St. Petersburg, Florida, 33701, United States
Eric Nicholson, M.D., P.A.
Tallahassee, Florida, 32308, United States
University of South Florida
Tampa, Florida, 33606, United States
University of Sout Florida
Tampa, Florida, 33612, United States
Midtown Medical Center
Tampa, Florida, 33614, United States
Donald Watren MD
West Palm Beach, Florida, 33401, United States
Philip Brachman MD
Atlanta, Georgia, 30309, United States
Family Health Care of Atlanta
Atlanta, Georgia, 30318-2513, United States
Midtown West Medical
Atlanta, Georgia, 30318, United States
Absolute CARE
Atlanta, Georgia, 30329, United States
Kaiser Permanente
Atlanta, Georgia, 30339, United States
Atlanta VA Medical Center
Decatur, Georgia, 30033, United States
Infectious Disease Specialists of Atlanta
Decatur, Georgia, 30033, United States
Kaiser Permanente
Jonesboro, Georgia, 30236, United States
Infectious Diseases Associates, PC
Riverdale, Georgia, 30274, United States
Chatham County Health Department
Savannah, Georgia, 31405, United States
Infectious Disease Consultants
Tucker, Georgia, 30084-8128, United States
Ruth M. Rothstein CORE Center
Chicago, Illinois, 60612, United States
Roger Trinh
Chicago, Illinois, 60613, United States
Northstar Medical Center
Chicago, Illinois, 60657, United States
Cotton-O'Neil Clinic
Topeka, Kansas, 66606-1670, United States
Kansas University Internal Medicine Midtown Clinic
Wichita, Kansas, 67214, United States
Via Christi Research, Inc.
Wichita, Kansas, 67214, United States
Chase Brexton Health Services Inc
Baltimore, Maryland, 21201, United States
Metro Health Care
Greenbelt, Maryland, 20770-3525, United States
Dr.'s Alpert, Trinh, and Posorske
Silver Spring, Maryland, 20910, United States
Tufts - New England Medical Center
Boston, Massachusetts, 02111, United States
Fenway Community Health
Boston, Massachusetts, 02115, United States
Community Research Initiative of New England
Boston, Massachusetts, 02215-3318, United States
Community Research Initiative of New England
Springfield, Massachusetts, 01107, United States
The Office of Dr. Paul A. Benson, DO
Berkley, Michigan, 48072, United States
Private Practice (Dr. Gregory Kuldanek)
Grand Rapids, Michigan, 49546, United States
St. John hospital and Medical Center
Grosse Pointe Woods, Michigan, 48236, United States
Private Practice
Keego Harbor, Michigan, 48320, United States
MSU Adult Medicine, 10
Lansing, Michigan, 48910, United States
Hennepin County Medical Center
Minneapolis, Minnesota, 55415, United States
Nemechek Health Renewal
Kansas City, Missouri, 64111, United States
Private Practice (Dr. Mark Scheperle)
St Louis, Missouri, 63117, United States
Partnership Health Center
Missoula, Montana, 59802, United States
CPMC Research Pharmacy
Englewood, New Jersey, 07631, United States
Leonia Medical Associates
Englewood, New Jersey, 07631, United States
Center for Infectious Diseaes
Hackensack, New Jersey, 07601, United States
Hackensack University Medical Center
Hackensack, New Jersey, 07601, United States
UMDNJ
Newark, New Jersey, 07103, United States
University Hospital
Newark, New Jersey, 07103, United States
Newark Community Health Center
Newark, New Jersey, 07114, United States
South Jersey Infectious Disease
Somers Point, New Jersey, 08244, United States
Premier Medical Research Group
Toms River, New Jersey, 08755, United States
Garden State Infectious Disease Associates, PA
Voorhees Township, New Jersey, 08043, United States
Upstate Infectious Disease Associates
Albany, New York, 12208, United States
Woodhull Medical Center
Brooklyn, New York, 11206, United States
New York Methodist Hospital
Brooklyn, New York, 11215, United States
NYM Medical Pavilion
Brooklyn, New York, 11215, United States
Chiu-Bin Hsiao, MD
Buffalo, New York, 14215, United States
The Office of Dr. Zale P. Bernstein, MD.
Buffalo, New York, 14215, United States
NYHQ
Flushing, New York, 11367, United States
Schneider Children's Hospital
Great Neck, New York, 11042, United States
North Shore University Hospital, Department of Infectious Disease
Manhasset, New York, 11030, United States
Astor Medical Group, LLP
New York, New York, 10003, United States
Beth Israel Medical Center
New York, New York, 10003, United States
Paul Bellman, MD
New York, New York, 10003, United States
Sidney Hillman Family Health Center
New York, New York, 10003, United States
Ricky Hsu
New York, New York, 10011, United States
Bellevue Hospital
New York, New York, 10016, United States
NYU School of Medicine
New York, New York, 10016, United States
Perion Smith
New York, New York, 10018, United States
James I Jones Jr, MD
New York, New York, 10019-1819, United States
Sharon Lewin MD and Michael Rendel MD
New York, New York, 10024, United States
Lenox Ave Clinic
New York, New York, 10026, United States
Harlem Medical Associates
New York, New York, 10029, United States
Mount Sinai Medical Center
New York, New York, 10029, United States
Mount Sinai School of Medicine
New York, New York, 10029, United States
New York-Presbyterian Hospital
New York, New York, 10032, United States
Dr. Steven Fine
Rochester, New York, 14605, United States
Jordon Glaser, MD
Stanton Island, New York, 10304, United States
SUNY Upstate Medical University
Syracuse, New York, 13210, United States
Allmed Medical and Rehabilitaion of NY
The Bronx, New York, 10454, United States
Bronx Lebanon Hospital Center
The Bronx, New York, 10457, United States
ID Associates
Gastonia, North Carolina, 28054, United States
Rosedale Infectious Diseases
Huntersville, North Carolina, 28078, United States
Metro Health Systems
Cleveland, Ohio, 44109, United States
South Dayton Acute Care Consultants Inc.
Dayton, Ohio, 45429, United States
University of Toledo - Health Science Campus
Toledo, Ohio, 43614-5812, United States
University of Oklahoma - Schusterman Clinic
Tulsa, Oklahoma, 74135, United States
The Research & Education Group
Portland, Oregon, 97210, United States
Kaiser Permanente-Northwest Region, Immune Deficiency Clinic
Portland, Oregon, 97227, United States
Lehigh Valley Hospital
Allentown, Pennsylvania, 18102, United States
Philadelphia FIGHT
Philadelphia, Pennsylvania, 19107, United States
RPS Infectious Diseases
West Reading, Pennsylvania, 19611, United States
The Miriam Hospital
Providence, Rhode Island, 02906, United States
Investigational Drug Services
Charleston, South Carolina, 29401, United States
Medical University of South Carolina
Charleston, South Carolina, 29403, United States
Medical University of South Carolina
Charleston, South Carolina, 29425, United States
Infectious Disease Associates of Memphis
Memphis, Tennessee, 38119, United States
The Office of Dr. Nicholaos C. Bellos, MD
Dallas, Texas, 75204, United States
The Office of Dr. Patrick W. Daly, MD.
Dallas, Texas, 75219, United States
The Office of Dr. Susan M. Diamond, MD.
Dallas, Texas, 75231, United States
La Fe CARE Center Clinic
El Paso, Texas, 79925, United States
Kelly, Allan Rowman MD
Fort Worth, Texas, 76104-3048, United States
Tarrant County Infectious Disease Associates
Fort Worth, Texas, 76104, United States
Fernando Garcia, MD
Harlingen, Texas, 78550, United States
Harris County Hospital District
Houston, Texas, 77009, United States
Thomas Street Clinic
Houston, Texas, 77009, United States
Diversified Medical Practices, PA
Houston, Texas, 77027, United States
Baylor College of Medicine
Houston, Texas, 77030, United States
The University of Texas Health Sciences Center at Houston
Houston, Texas, 77030, United States
Brewton, Gary W MD
Houston, Texas, 77098-2807, United States
Research Access Network
Houston, Texas, 77098, United States
The Office of Dr. Gordon E. Crofoot, MD.
Houston, Texas, 77098, United States
DCOL Center for Clinical Research
Longview, Texas, 75605, United States
Diagnostic Clinic of Longview, PA
Longview, Texas, 75605, United States
Dr. James Bromley
San Antonio, Texas, 78212, United States
Responsive ID Solutions
San Antonio, Texas, 78258, United States
Clinical Alliance for Research & Education - Infectious Diseases
Annandale, Virginia, 22003, United States
Infectious Diseases
Arlington, Virginia, 22205-3633, United States
Infectious Diseases Associates of Central Virginia
Danville, Virginia, 24541, United States
Infectious Disease Consultants
Fairfax, Virginia, 22030, United States
Hampton Roads Medical Specialists
Hampton, Virginia, 23666, United States
Barbara Cassie
Lynchburg, Virginia, 24501, United States
Crossover Ministry
Richmond, Virginia, 23224, United States
William F. Ehni, MD
Edmonds, Washington, 98026, United States
Emerald City Medical Arts
Seattle, Washington, 98109, United States
Group Health Cooperative
Seattle, Washington, 98112, United States
The Office of Dr. Daniel R. Coulston, MD
Spokane, Washington, 99204, United States
The Vancouver Clinic, Inc., P.S.
Vancouver, Washington, 98664, United States
CAMC Memorial Hospital
Charleston, West Virginia, 25304, United States
Clinical Trials Center
Charleston, West Virginia, 25304, United States
University Physicians Internal Medicine
Huntington, West Virginia, 25701, United States
Fundacion Huesped, Departamento de Investigacion Clinica
Buenos Aires, C1202ABB, Argentina
FUNCEI
Buenos Aires, C1425AWK, Argentina
Holdsworth House Medical Practice
Darlinghurst, New South Wales, 2010, Australia
St. Vincent's Hospital
Darlinghurst, New South Wales, 2010, Australia
Albion Street Centre
Surry Hills, New South Wales, 2010, Australia
Westmead Hospital
Wentworthville, New South Wales, 2145, Australia
AIDS Medical Centre
Brisbane, Queensland, 4000, Australia
Infectious Diseases Unit
Herston, Queensland, 4029, Australia
Infectious Diseases Unit
Adelaide, South Australia, 5000, Australia
Melbourne Sexual Health Centre
Carlton, Victoria, 3053, Australia
Northside Clinic
Fitzroy North, Victoria, 3068, Australia
Clinical Research Unit, Infectious Diseases
Melbourne, Victoria, 3004, Australia
Prahran Market Clinic
South Yarra, Victoria, 3141, Australia
Allgemeines Krankenhaus Wien
A-1090, Austria
Landeskrankenhaus Graz West / Abteilung fuer Innere Medizin 1
Graz, A-8020, Austria
Sozialmedizinisches Zentrum Baumgartner Hoehe / 2. Interne Lungenabteilung
Vienna, A-1140, Austria
Instituut voor Tropische Geneeskunde, Inwendige Geneeskunde
Antwerp, 2000, Belgium
Centre Hospitalier Universitaire Saint-Pierre, Maladies Infectieuses
Brussels, 1000, Belgium
Hôpital Erasme, Médecine Interne
Brussels, 1070, Belgium
Cliniques Universitaires Saint-Luc, Maladies Infectieuses
Brussels, 1200, Belgium
Centre Hospitalier Universitaire de Charleroi, Médecine Interne
Charleroi, 6000, Belgium
Universitair Ziekenhuis Gent, Inwendige Geneeskunde
Ghent, 9000, Belgium
Academisch Ziekenhuis VUB
Jette, B-1090, Belgium
Universitair Ziekenhuis Gasthuisberg, Inwendige Geneeskunde
Leuven, 3000, Belgium
CHU Sart-Tilman, Medecine Interne
Liège, 4000, Belgium
Queen Elizabeth II Health Sciences Center
Halifax, Nova Scotia, B3H 1V7, Canada
Hamilton Health Sciences - McMaster University Medical Centre
Hamilton, Ontario, L8N 3Z5, Canada
Sunnybrook Health Sciences Centre
Toronto, Ontario, M4N 3M5, Canada
Canadian Immunodeficiency Research Collaborative
Toronto, Ontario, M5B 1L6, Canada
Clinique médicale l'Actuel
Montreal, Quebec, H2L 4P9, Canada
Clinique Medicale du Quartier Latin
Montreal, Quebec, H2L 5B1, Canada
CHUM Hôtel-Dieu
Montreal, Quebec, H2W 1T8, Canada
Projet L.O.R.I.
Montreal, Quebec, H3H 1V1, Canada
Hospital Clínica Universidad Católica
Santiago, RM, 8330023, Chile
Hospital Clínico San Borja Arriarán
Santiago, RM, 8360160, Chile
Fundación para el Desarrollo de la Lucha contra el SIDA
Barrio Aranjuez, Provincia de San José, Costa Rica
Instituto Dominicano de Estudios Virologicos
Santo Domingo, Dominican Republic
Hopital Sainte Marguerite
Marseille, Cedex 09, 13274, France
Hopital Saint Antoine
Paris, Cedex 12, 75571, France
Centre Hospitalier Universitaire de Caen
Caen, Cedex, 14033, France
Hôpital Saint Jacques
Besançon, France, 25030, France
Hopital Gabriel Montpied
Clermont-Ferrand, France, 63000, France
CHU Michallon
Grenoble, France, 38043, France
Centre Hospitalier Cochin Saint Vincent de Paul
Paris, France, 75679, France
Chu Pontchaillou, Service des maladies infectieuses
Rennes, France, 35033, France
Hôpital de Purpan
Toulouse, France, 31059, France
Hopital Avicenne
Bobigny, 93009, France
Hôpital Saint-andré
Bordeaux, 33075, France
Hopital Pellegrin - Service des Maladies Infectieuses et Medecine Interne
Bordeaux, 33076, France
Hopital La Source
La Source, 45100, France
Hopital de Bicêtre
Le Kremlin-Bicêtre, 94270, France
Hôpital de la Croix Rousse
Lyon, 690317, France
Hopital de l'Hotel-Dieu, Service d'Hepato-Gastroenterologie
Lyon, 69288, France
Hopital Gui de Chauliac
Montpellier, 34295, France
CHU de Nantes - Hopital Hotel Dieu
Nantes, 44093, France
Hopital de l Archet 1
Nice Cedex 3, 06, 06202, France
Hôpital de la Pitié Salpétrière
Paris, 75013, France
Hopital Europeen George Pompidou
Paris, 75015, France
Hopital Bichat-Claude Bernard, Service des Maladies Infectieuses
Paris, 75018, France
Hopital Tenon, Service des Maladies Infectieuses
Paris, 75020, France
Hopital Saint-Louis
Paris, 75475, France
Hôpital Necker-Service des Maladies Infectieuses et Tropicales
Paris, 75743, France
CHU de Tourcoing
Tourcoing, 59208, France
Hopital Paul Brousse
Villejuif, 94800, France
Praxisgemeinschaft Bieniek & Cordes
Berlin, 10243, Germany
Universitaetsklinikum Koeln, Klinik I fuer Innere Medizin,
Cologne, 50937, Germany
Universitaetsklinikum Carl Gustav Carus, Klinik und Poliklinik fuer Dermatologie
Dresden, 01307, Germany
Universitaetsklinikum Essen, HIV-Ambulanz, Hautklinik
Essen, 45122, Germany
Gemeinschaftspraxis Dres. Rump und Usadel
Freiburg im Breisgau, 79098, Germany
Medizinische Hochschule Hannover, Klinische Immunologie, Zentrum Innere Medizin
Hanover, 30625, Germany
Evagelismos Hospital
Athens, Attica, 10676, Greece
Greek Red Cross Hospital
Athens, Attica, 115 26, Greece
General Hospital of Athens G. Gennimatas
Athens, 115 27, Greece
Andreas Sygros Hospital
Athens, 161 21, Greece
University Hospital of Patras
Pátrai, 265 00, Greece
Regional General Hospital Tzaneio
Piraeus, 185 36, Greece
AHEPA Hospital
Thessaloniki, 54636, Greece
Department of Medicine Queen Elizabeth Hospital
Kowloon, Hong Kong
Department of Medicine, St. John's Medical College Hospital
Bangalore, Karnataka, 560 034, India
Department of HIV Medicine (I D Clinic), Jaslok Hospital & Research Centre
Mumbai, Maharashtra, 400 026, India
YR Gaitonde Centre for AIDS Research and Education (YRG CARE)
Chennai, Tamil Nadu, 600 113, India
Catherine McAuley Centre
Dublin, 7, Ireland
St. James's Hospital
Dublin, 8, Ireland
Universita' degli Studi di Bari, Clinica Malattie Infettive, Policlinico
Bari, 70124, Italy
Unita' Operativa Malattie Infettive
Bologna, 40138, Italy
Istituto di Malattie Infettive e Tropicali
Brescia, 25123, Italy
Unita' Operativa di Malattie Infettive
Catania, 95126, Italy
Presidio Ospedaliero SS Annunziata
Chieti Scalo, 66100, Italy
Arcispedale S. Anna Azienda Ospedaliera Universitaria di Ferrara
Ferrara, 44100, Italy
SOD Malattie Infettive, La Piastra dei Servizi
Florence, 50100, Italy
Unita' Operativa Clinica Malattie Infettive, Dipartimento di Medicina Interna e Malattie Infettive
Genova, 16132, Italy
Fondazione Centro San Raffaele del Monte Tabor
Milan, 20127, Italy
Dipartimento di Scienze Cliniche, Divisione Clinicizzata Malattie Infettive
Milan, 20157, Italy
Clinica Malattie Infettive e Tropicali, Universita' degli Studi di Modena Reggio Emilia
Modena, 41100, Italy
Unita Operativa di Malattie Infettive e Tropicali
Padua, 35128, Italy
Fondazione IRCCS Policlinico S. Matteo
Pavia, 27100, Italy
Reparto di Malattie Infettive, Azienda Sanitaria Locale
Pescara, 65124, Italy
Policlinico Tor Vergata, Divisione Malattie Infettive
Roma, 00133, Italy
IRCCS Lazzaro Spallanzani Istituto Nazionale per la Malattie Infettive
Roma, 00149, Italy
IRCCS Lazzaro Spallanzani Istituto Nazionale per le Malattie Infettive
Roma, 00149, Italy
IRCCS Lazzaro Spallanzani, Istituto Nazionale per le Malattie Infettive
Roma, 00149, Italy
Dipartimento di Malattie Infettive e Tropicali, Universita' di Roma La Sapienza
Roma, 00161, Italy
Universita'Cattolica del Sacro Cuore Policlinico Gemelli
Roma, 00168, Italy
Azienda Ospedaliera San Giovanni Addolorata
Roma, 00184, Italy
Clinica Universitaria di Malattie Infettive, Ospedale Amedeo di Savoia
Torino, 10149, Italy
Uni. Politecnica delle Marche, Ist. Malattie Infettive e Medicina P.
Torrette Di Ancona, 60121, Italy
Unita' Operativa di Malattie Infettive
Venezia, 30122, Italy
Physician Clinic
Kota Bharu, Kelantan, 15586, Malaysia
Hospital Sungai Buloh
Sungai Buloh, Selangor, 47000, Malaysia
Antiguo Hospital Civil de Guadalajara "Fray Antonio Alcalde"
Guadalajara, Jalisco, 44280, Mexico
Hospital Regional Lic. Adolfo Lopez Mateos
Mexico City, Mexico City, 01030, Mexico
Instituto Nacional de Ciencias Medicas Y Nutricion Dr Salvador Zubiran
Tlalpan, Mexico Df, CP 14000, Mexico
Academisch Ziekenhuis Utrecht
Utrecht, NL 3584 CX, Netherlands
Centro Hospitalar de Cascais
Cascais, 2750-349, Portugal
Centro Hospitalar de Lisboa - Zona Central - Hospital Santo António Capuchos
Lisbon, 1169-050, Portugal
Hospital Sta. Maria
Lisbon, 1649-035, Portugal
Hospital São João
Porto, 4200-319, Portugal
Centro Ararat Inc
Ponce, PR, 00717-1563, Puerto Rico
HOPE Clinical Research
San Juan, 00909, Puerto Rico
Spitalul Clinic de Boli Infectioase Constanta
Constanța, Constanța County, 900709, Romania
Spitalul Clinic de Boli Infectioase Sf. Parascheva
Iași, Iaşi, 700116, Romania
Institutul de Boli Infectioase "Prof. Matei Bals"
Bucharest, Sector 2, 021105, Romania
Spitalul de Boli Infectioase si Tropicale Victor Babes
Bucharest, 030303, Romania
Hospital General Universitario de Alicante
Alicante, Alicante, 03010, Spain
Hospital General Universitario de Elche
Elche, Alicante, 03202, Spain
H. Universitari Germans Trias I Pujol
Badalona, Barcelona, 08916, Spain
Hospital Del Mar
Barcelona, Barcelona, 08003, Spain
Fund. de Gest. Sanitaria de L' Hospital de La Sta. Creu I Sant Pau
Barcelona, Barcelona, 08025, Spain
Hospital Universitari Vall D'Hebron
Barcelona, Barcelona, 08035, Spain
Hospital Clinic I Provincial de Barcelona
Barcelona, Barcelona, 08036, Spain
Hospital General de Granollers
Granollers, Barcelona, 08400, Spain
Hospital Universitari de Bellvitge
L'Hospitalet de Llobregat, Barcelona, 08907, Spain
Hospital de Basurto
Basurto, Bilbao, 48078, Spain
Hospital Puerta Del Mar
Cadiz, Cadiz, 11009, Spain
Hospital Universitario Marques de Valdecilla
Santander, Cantabria, 39008, Spain
Hospital Universitario Reina Sofia
Córdoba, Cordoba, 14012, Spain
Hospital de Cabueñes
Cabueñes, Gijon, 33394, Spain
Hospital Universitario San Cecilio
Granada, Granada, 18012, Spain
Hospital Universitario Virgen de Las Nieves
Granada, Granada, 18014, Spain
Hospital Clinico Universitario de Santiago de Compostela
Santiago de Compostela, La Coruña, 15706, Spain
Hospital Universitario de La Princesa
Madrid, Madrid, 28006, Spain
Hospital General Gregorio Marañon
Madrid, Madrid, 28007, Spain
Hospital Carlos Iii
Madrid, Madrid, 28029, Spain
Hospital Ramon Y Cajal
Madrid, Madrid, 28034, Spain
Fundacion Jimenez Diaz
Madrid, Madrid, 28040, Spain
Hospital 12 de Octubre
Madrid, Madrid, 28041, Spain
Hospital Universitario La Paz
Madrid, Madrid, 28046, Spain
Complejo Hospitalario Carlos Haya
Málaga, Malaga, 29010, Spain
Hospital Virgen de La Victoria
Málaga, Malaga, 29010, Spain
Hospital Costa Del Sol
Málaga, Malaga, 29600, Spain
Complejo Hospitalario Xeral-Cies
Vigo, Pontevedra, 36204, Spain
Hospital Donostia-Donostia Ospitalea
Donostia / San Sebastian, San Sebastian, 20014, Spain
Hospital Universitario de Canarias
San Cristóbal de La Laguna, Santa Cruz de Tenerife, 38320, Spain
Hospital Virgen Del Rocio
Seville, Sevilla, 41013, Spain
Complejo Hospitalario Nuestra Señora de Valme
Seville, Sevilla, 41014, Spain
Hospital Universitario Virgen de La Macarena
Seville, Sevilla, 41071, Spain
Hospital de Tortosa Verge de La Cinta
Tortosa, Tarragona, 43500, Spain
Hospital Universitario La Fe
Valencia, Valencia, 46009, Spain
Hospital Clinico Universitario
Valencia, Valencia, 46010, Spain
Consorcio Hospital General Universitario de Valencia
Valencia, Valencia, 46014, Spain
Hospital Arnau de Vilanova
Valencia, Valencia, 46015, Spain
Hospital de Cruces
Barakaldo, Vizcaya, 48903, Spain
Universitätsspital Zürich
Zurich, 8091, Switzerland
Department of Infectious Disease, E-Da Hospital
Kaohsiung County, 824, Taiwan
Brighton and Sussex University Hospitals NHS Trust, The Elton John Centre
Brighton, Sussex, BN2 1ES, United Kingdom
North Manchester General Hospital
Crumpsall, Manchester, M8 6RB, United Kingdom
Regional Infectious Diseases Unit
Edinburgh, EH4 2XU, United Kingdom
Ian Charleson Centre
London, NW3 2QG, United Kingdom
Department of Sexual Health
London, SE5 9RS, United Kingdom
St Stephens Research Ltd
London, SW10 9NH, United Kingdom
Imperial College
London, W2 1NY, United Kingdom
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
Viral loads were not available for subjects uniformly as this expanded access study followed local country guidelines and practices that could vary significantly between countries, and testing frequency may have been affected by insurance status.
Results Point of Contact
- Title
- Pfizer ClinicalTrials.gov Call Center
- Organization
- Pfizer, Inc.
Study Officials
- STUDY DIRECTOR
Pfizer CT.gov Call Center
Pfizer
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NON RANDOMIZED
- Purpose
- TREATMENT
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 22, 2007
First Posted
January 25, 2007
Study Start
February 1, 2007
Primary Completion
June 1, 2010
Study Completion
June 1, 2010
Last Updated
June 29, 2016
Results First Posted
October 17, 2011
Record last verified: 2016-05