Prospective Observational Epidemiologic Study of Maraviroc's Safety (POEM)

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2016 by ViiV Healthcare
Sponsor:
Collaborator:
Pfizer
Information provided by (Responsible Party):
ViiV Healthcare
ClinicalTrials.gov Identifier:
NCT00665561
First received: April 23, 2008
Last updated: April 28, 2016
Last verified: April 2016
  Purpose
The study will assess if use of maraviroc along with an optimized background regimen of antiretroviral drugs in usual clinical practice is as safe as using only an optimized regimen of antiretroviral drugs.

Condition Intervention
Human Immunodeficiency Virus
Drug: Maraviroc along with an optimized background antiretroviral drug regimen
Drug: Optimized background antiretroviral drug regimen without maraviroc

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: An International, Multicenter, Prospective Observational Study Of The Safety Of Maraviroc Used With Optimized Background Therapy In Treatment-experienced Hiv-1 Infected Patients

Resource links provided by NLM:


Further study details as provided by ViiV Healthcare:

Primary Outcome Measures:
  • CDC Category C AIDS defining infections, Viral encephalitis, Rhabdomyolysis, Liver failure, Liver related deaths [ Time Frame: Followed till 6 months after drug discontinuation up to a total of 5 years. ] [ Designated as safety issue: Yes ]
  • All Malignancies (AIDS defining and non-AIDS defining), Myocardial ischemia or infarction, All cause mortality [ Time Frame: Followed for a total of up to 5 years regardless of the time of drug discontinuaion. ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • There are no Secondary Outcomes for this study. [ Time Frame: 0 ] [ Designated as safety issue: No ]

Estimated Enrollment: 3000
Study Start Date: March 2008
Estimated Study Completion Date: October 2018
Estimated Primary Completion Date: October 2018 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Maraviroc exposed Drug: Maraviroc along with an optimized background antiretroviral drug regimen
Maraviroc prescribed per approved local label.
Other Name: Selzentry
Maraviroc unexposed Drug: Optimized background antiretroviral drug regimen without maraviroc
Optimized background antiretroviral therapy prescribed per approved local label and treatment guidelines.

Detailed Description:
All patients meeting the study eligibility criteria at participating sites will be invited to participate.
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Treatment experienced, HIV-1 infected patients in routine clinical practice.
Criteria

Inclusion Criteria:

  • Treatment experienced, HIV-1 infected patients
  • 18 years or older
  • Receive an approved assay for determination of HIV-1 tropism

Exclusion Criteria:

  • Pregnant or lactating
  • Using CCR5 inhibitor other than maraviroc
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00665561

Contacts
Contact: Pfizer CT.gov Call Center 1-800-718-1021

  Hide Study Locations
Locations
United States, Alabama
Health Services Center Active, not recruiting
Hobson City, Alabama, United States, 36201
AAC/Davis Clinic Terminated
Huntsville, Alabama, United States, 35801
Alabama Infectious Diseases Center Terminated
Huntsville, Alabama, United States, 35801
United States, California
Office of Franco Antonio Felizarta MD Active, not recruiting
Bakersfield, California, United States, 93301
Providence Clinical Research Terminated
Burbank, California, United States, 91505
Lalla-Reddy Medical Corporation Active, not recruiting
Fountain Valley, California, United States, 92708
Memorial Miller Children's Hospital Bickerstaff Pediatric Family HIV Center Active, not recruiting
Long Beach, California, United States, 90806
Tower Infectious Disease Medical Associates Active, not recruiting
Los Angeles, California, United States, 90048
Office of Peter J. Ruane, MD Active, not recruiting
Los Angeles, California, United States, 90036
LA Gay and Lesbian Center Active, not recruiting
Los Angeles, California, United States, 90028
Alta Bates Summit Medical Centre East Bay AIDS Center Active, not recruiting
Oakland, California, United States, 94609
University of California Irvine Medical Center Active, not recruiting
Orange, California, United States, 92868
A Professional Corporation, Research Department Active, not recruiting
Palm Desert, California, United States, 92211
Stanford ACTG Active, not recruiting
Palo Alto, California, United States, 94304-5350
CARES Active, not recruiting
Sacramento, California, United States, 95814
University of California Active, not recruiting
Sacramento, California, United States, 95817
Kaiser Permanente Medical Center Terminated
San Francisco, California, United States, 94118
San Francisco Veterans Affairs Medical Center Terminated
San Francisco, California, United States, 94121
Statnford University Medical Center Active, not recruiting
Stanford, California, United States, 94305
Bipin Bhagat MD Inc. Terminated
Victorville, California, United States, 92395
United States, Colorado
Kaiser Permanente Active, not recruiting
Denver, Colorado, United States, 80205
National Jewish Health Active, not recruiting
Denver, Colorado, United States, 80206
Kaiser Permanete of Colorado Rock Creek Medical Offices Active, not recruiting
Lafayette, Colorado, United States, 80026
United States, Connecticut
Yale University School of Medicine Aids Program Active, not recruiting
New Haven, Connecticut, United States, 06510
Clinical AIDS & HIV Terminated
New Haven, Connecticut, United States, 06511
Hospital of Saint Raphael Terminated
New Haven, Connecticut, United States, 06511
Circle Medical, LLC Active, not recruiting
Norwalk, Connecticut, United States, 06851
United States, District of Columbia
Dupont Circle Physician's Group Active, not recruiting
Washington, District of Columbia, United States, 20009
Family Medical Counseling Service Terminated
Washington, District of Columbia, United States, 20020
Office of Mahmoud H. Mustafa, MD, FACP Terminated
Washington, District of Columbia, United States, 20037
George Washington University Medical Faculty Assoc Active, not recruiting
Washington, District of Columbia, United States, 20037
Division of Infectious Diseases, George Washington University Medical Center Active, not recruiting
Washington, District of Columbia, United States, 20037
United States, Florida
ID Consultants Inc & Infectious Disease Research Corp. Terminated
Boynton Beach, Florida, United States, 33426
Daniel A. Warner/Consultive Medicine Active, not recruiting
Daytona Beach, Florida, United States, 32114
The McGregor Clinic Active, not recruiting
Fort Myers, Florida, United States, 33901
Associates in Infectious Disease Active, not recruiting
Fort Pierce, Florida, United States, 34982
Duval County Health Department Active, not recruiting
Jacksonville, Florida, United States, 32203
University of Miami Active, not recruiting
Miami, Florida, United States, 33136
Care Resource Active, not recruiting
Miami, Florida, United States, 33137
South Florida Infectious Deisease and Tropical Medicine Center Active, not recruiting
Miami, Florida, United States, 33176
Office of Albert Canas, MD Active, not recruiting
Miami Beach, Florida, United States, 33139
Health Positive Terminated
Safety Harbor, Florida, United States, 34695
Pinellas Care Clinic Active, not recruiting
St. Petersburg, Florida, United States, 33713
Tampa Care Clinic Active, not recruiting
Tampa, Florida, United States, 33614
Midtown Medical Center Active, not recruiting
Tampa, Florida, United States, 33614
St. Joseph's Hospital Comprehensive Research Institute Active, not recruiting
Tampa, Florida, United States, 33614
Infectious Disease Research Institute, Inc Active, not recruiting
Tampa, Florida, United States, 33614
Rowan Tree Medical, PA Active, not recruiting
Wilton Manors, Florida, United States, 33305
United States, Georgia
Atlanta Specialty Research Active, not recruiting
Atlanta, Georgia, United States, 30342
Atlanta Primary Care Terminated
Atlanta, Georgia, United States, 30312
PMI Health Research Group Terminated
Atlanta, Georgia, United States, 30312
Family Health Care of Atlanta Active, not recruiting
Atlanta, Georgia, United States, 30318-2513
Absolute Care Medical Center Terminated
Atlanta, Georgia, United States, 30329
The Southeast Permanente Medical Group Active, not recruiting
Atlanta, Georgia, United States, 30339-3915
Atlanta Infectious Disease Group Active, not recruiting
Atlanta, Georgia, United States, 30309
Georgia Health Sciences University Terminated
Augusta, Georgia, United States, 30912
Atlanta VA Medical Center Active, not recruiting
Decatur, Georgia, United States, 30033
WellStar Clinical Trials Office Active, not recruiting
Marietta, Georgia, United States, 30060
WellStar Infectious Disease Active, not recruiting
Marietta, Georgia, United States, 30060
WellStar Kennestone Hospital Active, not recruiting
Marietta, Georgia, United States, 30060
Infectious Diseases Associates Active, not recruiting
Riverdale, Georgia, United States, 30274
Chatham County Health Department Active, not recruiting
Savannah, Georgia, United States, 31401
United States, Illinois
Ruth M. Rothstein CORE Center Active, not recruiting
Chicago, Illinois, United States, 60612
Howard Brown Health Center Active, not recruiting
Chicago, Illinois, United States, 60613
University of Chicago Active, not recruiting
Chicago, Illinois, United States, 60637
Southside Health Association Terminated
Olympia Fields, Illinois, United States, 60461
Office of William Johnson, M.D. Terminated
Olympia fields, Illinois, United States, 60461
Southern Illinois University School of Medicine Active, not recruiting
Springfield, Illinois, United States, 62702
United States, Iowa
University of Iowa Hospitals and Clinics Terminated
Iowa City, Iowa, United States, 52242
United States, Kentucky
University of Kentucky Active, not recruiting
Lexington, Kentucky, United States, 40536
University of Kentucky Medical Center Active, not recruiting
Lexington, Kentucky, United States, 40536
Blue Grass Care Clinic Active, not recruiting
Lexington, Kentucky, United States, 40536
United States, Louisiana
Louisiana State University Health Sciences Center Active, not recruiting
New Orleans, Louisiana, United States, 70112
Louisiana State University Health Sciences Center Active, not recruiting
New Orleans, Louisiana, United States, 70119
United States, Maryland
Montgomery Infectious Disease Associates, P.A. (Private Practice) Active, not recruiting
Silver Spring, Maryland, United States, 20910
United States, Massachusetts
St. Elizabeth's Medical Center Terminated
Brighton, Massachusetts, United States, 02135
The Research Institute Active, not recruiting
Springfield, Massachusetts, United States, 01107
Baystate Infectious Diseases Clinical Research Active, not recruiting
Springfield, Massachusetts, United States, 01199
United States, Michigan
University Of Michigan Health Systems Active, not recruiting
Ann Arbor, Michigan, United States, 48109
Henry Ford Hospital Active, not recruiting
Detroit, Michigan, United States, 48202
St. John hospital and Medical Center Active, not recruiting
Grosse Pointe Woods, Michigan, United States, 48236
Ingham County Health Department Active, not recruiting
Lansing, Michigan, United States, 48910
Michigan State University College of Osteopathic Medicine Active, not recruiting
Lansing, Michigan, United States, 48910
Providence Cancer Institute Active, not recruiting
Southfield, Michigan, United States, 48075
United States, Minnesota
Federal Medical Center Rochester Active, not recruiting
Rochester, Minnesota, United States, 55904
Mayo Medical Clinic Active, not recruiting
Rochester, Minnesota, United States, 55905
United States, Missouri
Nemechek Health Renewal Terminated
Kansas City, Missouri, United States, 64111-2610
Central West Clinical Research Active, not recruiting
Saint Louis, Missouri, United States, 63108
United States, New Jersey
Monmouth Medical Center Active, not recruiting
Long Branch, New Jersey, United States, 07740
Jersey Shore Medical Center Active, not recruiting
Neptune, New Jersey, United States, 07754
Meridian Medical Associates Active, not recruiting
Neptune, New Jersey, United States, 07754
Saint Michael's Medical Center Terminated
Newark, New Jersey, United States, 07102
United States, New York
Erie County Medical Center, HIV Services Active, not recruiting
Buffalo, New York, United States, 14215
Guthrie Medical Group Active, not recruiting
Ithaca, New York, United States, 14850
North Shore University Hospital Active, not recruiting
Manhasset, New York, United States, 11030
Beth Israel Medical Center Active, not recruiting
New York, New York, United States, 10003
Beth Israel Medical Clinic Active, not recruiting
New York, New York, United States, 10003
Mount Sinai Beth Israel Medical Center Active, not recruiting
New York, New York, United States, 10003
HIV & Internal Medicine Terminated
New York, New York, United States, 10011
Mount Sinai Downtown Comprehensive Health Program Active, not recruiting
New York, New York, United States, 10011
Columbia University Medical Center Active, not recruiting
New York, New York, United States, 10032
CUMC Research Pharmacy Active, not recruiting
New York, New York, United States, 10032
AIDS Care Active, not recruiting
Rochester, New York, United States, 14607
New York Medical College Active, not recruiting
Valhalla, New York, United States, 10595
Westchester Medical Center Active, not recruiting
Valhalla, New York, United States, 10595
United States, North Carolina
ID Associates Terminated
Gastonia, North Carolina, United States, 28054
East Carolina University Active, not recruiting
Greenville, North Carolina, United States, 27834
Rosedale Infectious Diseases Terminated
Huntersville, North Carolina, United States, 28078
Wake Forest University Health Sciences Active, not recruiting
Winston-Salem, North Carolina, United States, 27157
United States, Ohio
University of Cincinnati Medical Center Active, not recruiting
Cincinnati, Ohio, United States, 45267
Ohio State Medical Center Active, not recruiting
Columbus, Ohio, United States, 43210-1228
The Ohio State University Medical Center Active, not recruiting
Columbus, Ohio, United States, 43210
University of Toledo: Health Sciences Campus Active, not recruiting
Toledo, Ohio, United States, 43614
United States, Oklahoma
University of Oklahoma Health Sciences Center Active, not recruiting
Oklahoma City, Oklahoma, United States, 73104
United States, Oregon
The Research and Education Group Terminated
Portland, Oregon, United States, 97210
Kaiser Permanente Northwest Region, Immune Deficiency Clinic Active, not recruiting
Portland, Oregon, United States, 97227
United States, Pennsylvania
Lehigh Valley Hospital Active, not recruiting
Allentown, Pennsylvania, United States, 18102
Pinnacle Health Medical Services Terminated
Harrisburg, Pennsylvania, United States, 17110
Philadelphia Fight Active, not recruiting
Philadelphia, Pennsylvania, United States, 19107
University of Pennsylvania Active, not recruiting
Philadelphia, Pennsylvania, United States, 19104
Guthrie Clinic, Ltd. Active, not recruiting
Sayre, Pennsylvania, United States, 18840
United States, South Carolina
Low Country Infectious Diseases, P.A. Terminated
Charleston, South Carolina, United States, 29414
Medical University of South Carolina Active, not recruiting
Charleston, South Carolina, United States, 29425
MCC Clinic Active, not recruiting
Columbia, South Carolina, United States, 29203
University of South Carolina School of Medicine Active, not recruiting
Columbia, South Carolina, United States, 29203
University Speciality Clinics Active, not recruiting
Columbia, South Carolina, United States, 29203
United States, Texas
Central Texas Clinical Research Terminated
Austin, Texas, United States, 78705
Saint Hope Foundation Active, not recruiting
Bellaire, Texas, United States, 77401
Southwest Infectious Disease Clinical Research, Inc. Active, not recruiting
Dallas, Texas, United States, 75219
UT Southwestern Medical Center HIV/AIDS Research Unit Active, not recruiting
Dallas, Texas, United States, 75235
Pillar Clinical Research LLC Terminated
Dallas, Texas, United States, 75243
Dallas VA Medical Center Active, not recruiting
Dallas, Texas, United States, 75216
Tarrant County Infectious Disease Associates Active, not recruiting
Fort Worth, Texas, United States, 76104
Tarrant County Infectious Disease Assocciates Active, not recruiting
Fort Worth, Texas, United States, 76104
Office of Allan Rowan Kelly MD Active, not recruiting
Fort Worth, Texas, United States, 76104
Garcias' Family Health Group Active, not recruiting
Harlingen, Texas, United States, 78550
Valley Aids Council Terminated
Harlingen, Texas, United States, 78550
Michael E. DeBakey Veterans Affairs Medical Center Active, not recruiting
Houston, Texas, United States, 77030
Diversified Medical Practices, PA Active, not recruiting
Houston, Texas, United States, 77057
Dr. Howard Kussman, MD Terminated
Plano, Texas, United States, 75075
University Health Care System Active, not recruiting
San Antonio, Texas, United States, 78207
South Texas Veterans Health Care System Active, not recruiting
San Antonio, Texas, United States, 78229
United States, Virginia
Infectious Diseases Associates of Central Virginia Active, not recruiting
Danville, Virginia, United States, 24541
Infectious Diseases Associates of Central Virginia Active, not recruiting
Lynchburg, Virginia, United States, 24501
United States, Washington
Group Health Cooperative Active, not recruiting
Seattle, Washington, United States, 98112
United States, West Virginia
Marshall University Joan C. Edwards School of Medicine Active, not recruiting
Huntington, West Virginia, United States, 25701
Belgium
Institute of Tropical Medicine Active, not recruiting
Antwerpen, Belgium, B-2000
Cliniques Universitaires Saint-Luc Active, not recruiting
Brussels, Belgium, 1200
CHU Saint Pierre Active, not recruiting
Brussels, Belgium, 1000
Universitair Ziekenhuis Gasthuisberg, Inwendige Geneeskunde Active, not recruiting
Leuven, Belgium, B-3000
C.H.U. Sart-Tilman Active, not recruiting
Liege, Belgium, 4000
Brazil
Hospital Dia Active, not recruiting
Brasilia, DF, Brazil, 70351-580
Instituto A.Z. de Pesquisa e Ensino Active, not recruiting
Curitiba, Parana, Brazil, 80240-280
Hospital Geral de Nova Iguacu Active, not recruiting
Nova Iguacu, RJ, Brazil, 26030-380
Faculdade de Medicina do ABC Active, not recruiting
Santo André, SP, Brazil, 09060-650
Centro de Referencia e Treinamento DST/AIDS Active, not recruiting
Sao Paulo, SP, Brazil, 04121-000
Hospital Heliopolis Active, not recruiting
São Paulo, SP, Brazil, 04231-030
Canada, British Columbia
University of British Columbia/ Downtown Infectious Diseases Clinic Active, not recruiting
Vancouver, British Columbia, Canada, V6Z 2C7
Canada, Nova Scotia
Queen Elizabeth II Health Sciences Center Active, not recruiting
Halifax, Nova Scotia, Canada, B3H 1V7
Canada, Ontario
Sunnybrook Health Sciences Centre Active, not recruiting
Toronto, Ontario, Canada, M4N 3M5
University Health Network Active, not recruiting
Toronto, Ontario, Canada, M5G 2N2
Canada, Quebec
CHUM, Hotel-Dieu Hospital Active, not recruiting
Montreal, Quebec, Canada, H2W 1T8
Clinique Medicale du Quartier Latin Terminated
Montreal, Quebec, Canada, H2L 5B1
Canada
Recherche Clinique Médicale des Campus Terminated
Quebec, Canada, G1V 4X7
France
Sainte Marguerite Hospital Active, not recruiting
Marseille, Cedex 09, France, 13274
Hopital Jean Verdier, Unite de maladies infectieuses Active, not recruiting
Bondy, France, 93140
Hopital Saint-andre CHU de Bordeaux Active, not recruiting
Bordeaux, France, 33075
Hopital Pellegrin Active, not recruiting
Bordeaux, France, 33076
Raymond Poincare Hospital Active, not recruiting
Garches, France, 92380
Hopital de L'Hotel Dieu Active, not recruiting
Lyon, France, 69288
Saint-Louis Hospital Active, not recruiting
Paris, France, 75010
Cochin Hospital Active, not recruiting
Paris, France, 75014
Hopital Tenon Active, not recruiting
Paris, France, 75020
Hopital Pitie Salpetriere Active, not recruiting
Paris, France, 75651
Hopital Europeen Georges Pompidou Active, not recruiting
Paris, France, 75908
CH Perpignan Terminated
Perpignan, France, 66000
Hôpital Haut Leveque Active, not recruiting
Pessac, France, 33600
Centre Hospitalier Universitaire de Rennes Active, not recruiting
Rennes, France, 35033 Cedex 09
Centre Hospitalier de Tourcoing Active, not recruiting
Tourcoing, France, 59208
Germany
Arztpraxis fuer Innere Medizin Dr. Knechten Active, not recruiting
Aachen, Germany, 52062
Praxis Dr. Christiane Cordes Active, not recruiting
Berlin, Germany, D-10243
Praxis City Ost Medizinisches Zentrum Active, not recruiting
Berlin, Germany, 10243
Klinikum Dortmund Active, not recruiting
Dortmund, Germany, 44137
Universitaetsklinikum Carl Gustav Carus, Klinik und Poliklinik fuer Dermatologie Active, not recruiting
Dresden, Germany, D-01307
Hospital of the J.W. Goethe University, Medical Clinic II Active, not recruiting
Frankfurt am Main, Germany, D-60590
Praxis Dr. Lothar Schneider Interne Medizin, HIV Schwerpunkt Terminated
Fuerth, Germany, 90762
IPM - Study - Center Active, not recruiting
Hamburg, Germany, 20146
Universitaetsklinikum Hamburg-Eppendorf, Ambulanzzentrum des UKE GmbH, Bereich Infektiologie Active, not recruiting
Hamburg, Germany, 20246
ifi-Institut am Allgemeines Krankenhaus St.Georg Active, not recruiting
Hamburg, Germany, D-20099
Klinik I fuer Innere Medizin der Uni-Klinik Koeln Active, not recruiting
Koeln, Germany, D-50937
Universitaetsklinikum Mainz, I. Medizinische Klinik und Poliklinik, Terminated
Mainz, Germany, D-55131
Mannheimer Onkologie Praxis Active, not recruiting
Mannheim, Germany, D-68161
Ludwig-Maximilians-Universitaet, Klinikum Innenstadt, Medizinische Poliklinik Active, not recruiting
Muenchen, Germany, D-80336
Medizinisches Versorgungszentrum Active, not recruiting
Muenchen, Germany, D 80335
Gemeinschaftspraxis Untersendling Active, not recruiting
Muenchen, Germany, 81371
Centrum fuer interdisziplinaere Medizin Muenster GmbH Terminated
Muenster, Germany, 48143
Klinikum Osnabruck Active, not recruiting
Osnabruck, Germany, D-49090
Infectomed GbR Zentrum für medizinische Studien Active, not recruiting
Stuttgart, Germany, D-70197
Privatpraxis Dres. Ulmer, Frietsch, Müller Active, not recruiting
Stuttgart, Germany, D-70197
Greece
University Hospital of Patras Active, not recruiting
Patras, Achaia, Greece, 26 500
Andreas Sygros Hospital Active, not recruiting
Athens, Greece, 161 21
Infectious Disease Unit Tzaneion General Hospital ofPiraeus Active, not recruiting
Piraeus, Greece, 185 36
Italy
Clinica Malattie Infettive Active, not recruiting
Bari, Italy, 70124
Ambulatorio Day Hospital Malattie Infettive Active, not recruiting
Bologna, Italy, 40133
Dipartimento di Medicina Clinica Specialistica e Sperimentale Active, not recruiting
Bologna, Italy, 40138
Busto Arsizio Hospital Active, not recruiting
Busto Arsizio (Va), Italy, 21052
SOD Malattie Infettive, La Piastra dei Servizi Active, not recruiting
Firenze, Italy, 50139
Ente Ospedaliero Ospedali Galliera Active, not recruiting
Genova, Italy, 16128
Clinic of Infectious and Tropical Diseases-University of Milan-San Paolo Hospital Active, not recruiting
Milan, Italy, 20142
1 Divisione di Malattie Infettive e Servizio di Allergologia, Ospedale L. Sacco Active, not recruiting
Milano, Italy, 20157
Universita' degli Studi di Milano, Dipartimento di scienza clinica Luigi Sacco Active, not recruiting
Milano, Italy, 20157
San Raffaele Hospital Active, not recruiting
Milano, Italy, 20127
Azienda Ospedaliero Universitaria Policlinico di Modena Active, not recruiting
Modena, Italy, 41100
Azienda Ospedal Universitaria II Univ degli Studi di Napoli Servizio di Diagnosi e Terapia Active, not recruiting
Naples, Italy, 80135
Azienda Ospedaliera "Domenico Cotugno" Terminated
Napoli, Italy, 80137
AOUP Paolo Giaccone, UOC Malattie Infettive Active, not recruiting
Palermo, Italy, 90127
Irccs Policlinico San Matteo Active, not recruiting
Pavia, Italy, 27100
Azienda Sanitaria Locale Ospedale Civile dello Spirito Santo Presidio Ospedaliero Active, not recruiting
Pescara, Italy, 65100
Universita' di Roma La Sapienza, Dipartimento di Malattie Infettive Active, not recruiting
Roma, Italy, 00161
Istituto Nazionale Malattie Infettive INMI- "L. Spallanzani"- I.R.C.C.S. Recruiting
Roma, Italy, 00149
Universita'Cattolica del Sacro Cuore Policlinico Gemelli Active, not recruiting
Roma, Italy, 00168
Istituto Nazionale Malattie Infettive "L.Spallanzani"-IRCCS Active, not recruiting
Roma, Italy, 00149
Azienda Ospedaliera San Giovanni Addolorata Presidio Santa Maria Active, not recruiting
Rome, Italy, 00184
Ospedale Amedeo di Savoia, Clinica Universitaria di Malattie Infettive Active, not recruiting
Torino, Italy, 10149
Ospedale Amedeo Savoia Active, not recruiting
Torino, Italy, 10100
Puerto Rico
Ararat Research Center Active, not recruiting
Ponce, Puerto Rico, 00717
HOPE Clinical Research Active, not recruiting
San Juan, Puerto Rico, 00909
Spain
Clinica Mutua de Terrassa Terminated
Terrassa, Barcelona, Spain, 08221
Hospital San Pedro Active, not recruiting
Logroño, La Rioja, Spain, 26006
Hospital de Tortosa Verge de La Cinta Terminated
Tortosa, Tarragona, Spain, 43500
Complejo Hospitalario Juan Canalejo Active, not recruiting
A Coruña, Spain, 15006
Hospital General Universitário de Alicante Active, not recruiting
Alicante, Spain, 03010
Hospital Del Mar Active, not recruiting
Barcelona, Spain, 08003
Hospital Clinic I Provincial de Barcelona Active, not recruiting
Barcelona, Spain, 08036
Hospital Universitario Germans Tias I Pujol Active, not recruiting
Barcelona, Spain, 08916
Unidad de Enfermedades Infecciosas Active, not recruiting
Cadiz, Spain, 11009
Hospital Universitario Reina Sofia Active, not recruiting
Cordoba, Spain, 14004
Hospital General Universitario de Elche Active, not recruiting
Elche, Spain, 03203
Hospital Clinico San Cecilio Active, not recruiting
Granada, Spain, 18012
Hospital de La Princesa Active, not recruiting
Madrid, Spain, 28006
Hospital Carlos Iii Active, not recruiting
Madrid, Spain, 28029
Hospital Ramon Y Cajal Active, not recruiting
Madrid, Spain, 28034
Hospital Clinico San Carlos Active, not recruiting
Madrid, Spain, 28040
Hospital Universitario 12 de Octubre Active, not recruiting
Madrid, Spain, 28041
Hospital Univ. La Paz Active, not recruiting
Madrid, Spain, 28046
Complejo Hospitalario Carlos Haya Active, not recruiting
Malaga, Spain, 29010
Mataro Hospital Active, not recruiting
Mataro, Spain, 8304
Hospital de Mostoles Active, not recruiting
Mostoles, Madrid, Spain, 28935
Hospital Donostia Active, not recruiting
San Sebastian, Spain, 20014
Hospital Universitario Virgen de La Macarena Active, not recruiting
Sevilla, Spain, 41009
Hospital Virgen Del Rocio Active, not recruiting
Sevilla, Spain, 41013
Hospital Universitario de Canarias Active, not recruiting
Tenerife, Canary Island, Spain, 38320
Hospital Clinico Universitario Active, not recruiting
Valencia, Spain, 46010
United Kingdom
Hull & East Yorkshire Hospitals NHS Trust Active, not recruiting
Cottingham, East Yorkshire, United Kingdom, HU16 5JQ
NewCastle General hospital Active, not recruiting
Newcastle upon Tyne, Newcastle, United Kingdom, NE4 6BE
Royal Victoria Hospital Active, not recruiting
Belfast, United Kingdom, BT12 6BA
Selly Oak Hospital Active, not recruiting
Birmingham, United Kingdom, B4 6DH
Brighton and Sussex University Hospitals NHS Trust Active, not recruiting
Brighton, United Kingdom, BN2 1ES
North Manchester General Hospital Active, not recruiting
Crumpsall, Manchester, United Kingdom, M8 5RB
Darlington Memorial Hospital Terminated
Darlington, United Kingdom, DL36HX
Regional Infectious Diseases Unit Active, not recruiting
Edinburgh, United Kingdom, EH4 2XU
Royal Free Hospital, Ian Charleson Day Centre Active, not recruiting
London, United Kingdom, NW3 2QG
North Middlesex Hospital Active, not recruiting
London, United Kingdom, N18 1QX
Chelsea and Westminster Hospital Active, not recruiting
London, United Kingdom, SW10 9NH
St. George's Hospital Active, not recruiting
London, United Kingdom, SW17 0QT
Grahame Hayton Unit Active, not recruiting
London, United Kingdom, E1 1BB
Royal Victoria Infirmary Active, not recruiting
Newcastle upon Tyne, United Kingdom, NE1 4LP
Warren browne Unit, Southlands Hospital Active, not recruiting
Shoreham-by-sea, West Sussex, United Kingdom, BN43 6TQ
Cobridge Community Health Centre Active, not recruiting
Stoke on Trent, Staffordshire, United Kingdom, ST6 2JW
Sponsors and Collaborators
ViiV Healthcare
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
Responsible Party: ViiV Healthcare
ClinicalTrials.gov Identifier: NCT00665561     History of Changes
Other Study ID Numbers: A4001067  2007-006148-24  POEM 
Study First Received: April 23, 2008
Last Updated: April 28, 2016
Health Authority: United States: Food and Drug Administration

Keywords provided by ViiV Healthcare:
Maraviroc
HIV-1
Safety
Non-interventional

Additional relevant MeSH terms:
Acquired Immunodeficiency Syndrome
HIV Infections
Immunologic Deficiency Syndromes
Immune System Diseases
Lentivirus Infections
RNA Virus Infections
Retroviridae Infections
Sexually Transmitted Diseases
Sexually Transmitted Diseases, Viral
Slow Virus Diseases
Virus Diseases
Maraviroc
Anti-HIV Agents
Anti-Infective Agents
Anti-Retroviral Agents
Antiviral Agents
CCR5 Receptor Antagonists
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 26, 2016