Prospective Observational Epidemiologic Study of Maraviroc's Safety
POEM
AN INTERNATIONAL, MULTICENTER, PROSPECTIVE OBSERVATIONAL STUDY OF THE SAFETY OF MARAVIROC USED WITH OPTIMIZED BACKGROUND THERAPY IN TREATMENT-EXPERIENCED HIV-1 INFECTED PATIENTS
3 other identifiers
observational
2,500
11 countries
269
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Mar 2008
Longer than P75 for all trials
269 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
Study Start
First participant enrolled
March 31, 2008
CompletedFirst Submitted
Initial submission to the registry
April 23, 2008
CompletedFirst Posted
Study publicly available on registry
April 24, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 14, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
February 14, 2019
CompletedResults Posted
Study results publicly available
April 7, 2020
CompletedOctober 18, 2022
October 1, 2022
10.9 years
April 23, 2008
February 12, 2020
October 12, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (15)
Density Rate Per 1000 Participant-Years for Incidence of Centers for Disease Control and Prevention Category C AIDS -Defining Opportunistic Infections
Density rate per 1000 participant-years for incidence of centers for disease control and prevention category C acquired immunodeficiency syndrome (AIDS) -defining opportunistic infections was reported. Density rate was calculated as the number of events (n) per 1000 participant-years at risk. Poisson regressions were fit to the categorical events with only treatment in the model to obtain the crude rate and confidence interval (CI).
Up to 5 years following enrollment
Density Rate Per 1000 Participant-Years for Incidence of Viral Encephalitis
Density rate per 1000 participant-years for incidence of viral encephalitis was reported. Density rate was calculated as the number of events (n) per 1000 participant-years at risk. Poisson regressions were fit to the categorical events with only treatment in the model to obtain the crude rate and CI.
Up to 5 years following enrollment
Density Rate Per 1000 Participant-Years for Incidence of All Malignancies (AIDS Defining Malignancies and Non-AIDS Defining Malignancies)
Density rate per 1000 participant-years for incidence of all malignancies as well as its types (categorized as: AIDS defining malignancies and non-AIDS defining malignancies) were reported. AIDS defining malignancies included malignancies due to any of these: cervical cancer, Kaposi's sarcoma or lymphoma; whereas all other malignancies (except AIDS-defining) were non-aids defining malignancies. Density rate was calculated as the number of events (n) per 1000 participant-years at risk. Poisson regressions were fit to the categorical events with only treatment in the model to obtain the crude rate and CI.
Up to 5 years following enrollment
Density Rate Per 1000 Participant-Years for Incidence of Liver Failure
Density rate per 1000 participant-years for incidence of liver failure was reported. Density rate was calculated as the number of events (n) per 1000 participant-years at risk. Poisson regressions were fit to the categorical events with only treatment in the model to obtain the crude rate and CI.
Up to 5 years following enrollment
Density Rate Per 1000 Participant-Years for Incidence of Myocardial Infarction or Ischemia: Events Adjudicated as 'Definite' or 'Possible'
Density rate per 1000 participant-years for incidence of myocardial infarction or ischemia (definite + possible) was reported. Events of myocardial infarction or ischemia were adjudicated as definite or possible; where definite= an event had definitely occurred; possible =an event had possibly occurred. Density rate was calculated as the number of events (n) per 1000 participant-years at risk. Poisson regressions were fit to the categorical events with only treatment in the model to obtain the crude rate and CI. In this outcome measure, density rate per 1000 participant-years for incidence of myocardial infarction or ischemia (which included sum of definite + possible events) was reported.
Up to 5 years following enrollment
Density Rate Per 1000 Participant-Years for Incidence of Myocardial Infarction or Ischemia: Events Adjudicated as 'Definite' or 'Possible' or 'Insufficient Data'
Density rate per 1000 participant-years for incidence of myocardial infarction or ischemia (definite + possible + insufficient data) was reported. Events of myocardial infarction or ischemia were adjudicated as definite or possible or insufficient data; where definite= an event had definitely occurred; possible =an event had possibly occurred; insufficient =insufficient data to determine whether an event had occurred. Density rate was calculated as the number of events (n) per 1000 participant-years at risk. Poisson regressions were fit to the categorical events with only treatment in the model to obtain the crude rate and CI. In this outcome measure, density rate per 1000 participant-years for incidence of myocardial infarction or ischemia (which included sum of definite + possible events + insufficient data) was reported.
Up to 5 years following enrollment
Density Rate Per 1000 Participant-Years for Incidence of Rhabdomyolysis
Density rate per 1000 participant-years for incidence of rhabdomyolysis was reported. Density rate was calculated as the number of events (n) per 1000 participant-years at risk. Poisson regressions were fit to the categorical events with only treatment in the model to obtain the crude rate and CI.
Up to 5 years following enrollment
Density Rate Per 1000 Participant-Years for Incidence of Death From Liver-Related Cause
Density rate per 1000 participant-years for incidence of death from liver-related cause was reported. Density rate was calculated as the number of events (n) per 1000 participant-years at risk. Poisson regressions were fit to the categorical events with only treatment in the model to obtain the crude rate and CI.
Up to 5 years following enrollment
Density Rate Per 1000 Participant-Years for Incidence of Death Due to Any Cause
Density rate per 1000 participant-years for incidence of death due to any cause was reported. Density rate was calculated as the number of events (n) per 1000 participant-years at risk. Poisson regressions were fit to the categorical events with only treatment in the model to obtain the crude rate and CI.
Up to 5 years following enrollment
Adjusted Density Rate Per 1000 Participant-Years for Incidence of Centers for Disease Control and Prevention Category C Aids-Defining Opportunistic Infections
Adjusted density rate per 1000 participant-years for incidence of centers for disease control and prevention category c aids-defining opportunistic infections was reported. Density rate was calculated as the number of events (n) per 1000 participant-years at risk. Poisson regressions were fit to the categorical events with treatment as the main effect, propensity score (PS) quartile and imputed Framingham score (FS) as covariates in the model to obtain the adjusted rate and CI.
Up to 5 years following enrollment
Adjusted Density Rate Per 1000 Participant-Years for Incidence of All Malignancies (AIDS Defining Malignancies and Non-AIDS Defining Malignancies)
Adjusted density rate per 1000 participant-years for incidence of all malignancies as well as its types (categorized as AIDS defining malignancies and non-AIDS defining malignancies) were reported. AIDS defining malignancies included malignancies due to any of these: cervical cancer, Kaposi's sarcoma or lymphoma; whereas all other malignancies (except AIDS-defining) were non-AIDS defining malignancies. Density rate was calculated as the number of events (n) per 1000 participant-years at risk. Poisson regressions were fit to the categorical events with treatment as the main effect, PS quartile and imputed FS as covariates in the model to obtain the adjusted rate and CI.
Up to 5 years following enrollment
Adjusted Density Rate Per 1000 Participant-Years for Incidence of Myocardial Infarction or Ischemia: Events Adjudicated as 'Definite' or 'Possible'
Adjusted density rate per 1000 participant-years for incidence of myocardial infarction or ischemia (definite + possible) was reported. Events of myocardial infarction or ischemia were adjudicated as definite or possible; where definite= an event had definitely occurred; possible =an event had possibly occurred. Density rate was calculated as the number of events (n) per 1000 participant-years at risk. Poisson regressions were fit to the categorical events with treatment as the main effect, PS quartile and imputed FS as covariates in the model to obtain the adjusted rate and CI. In this outcome measure, adjusted density rate per 1000 participant-years for incidence of myocardial infarction or ischemia (which included sum of definite + possible events) was reported.
Up to 5 years following enrollment
Adjusted Density Rate Per 1000 Participant-Years for Incidence of Myocardial Infarction or Ischemia: Events Adjudicated as 'Definite' or 'Possible' or 'Insufficient Data'
Adjusted density rate per 1000 participant-years for incidence of myocardial infarction or ischemia (definite + possible + insufficient data) was reported. Events of myocardial infarction or ischemia were adjudicated as definite or possible or insufficient data; where definite= an event had definitely occurred; possible =an event had possibly occurred; insufficient =insufficient data to determine whether an event had occurred. Density rate was calculated as the number of events (n) per 1000 participant-years at risk. Poisson regressions were fit to the categorical events with treatment as the main effect, PS quartile and imputed FS as covariates in the model to obtain the adjusted rate and CI. In this outcome measure, adjusted density rate per 1000 participant-years for incidence of myocardial infarction or ischemia (which included sum of definite + possible events + insufficient data) was reported.
Up to 5 years following enrollment
Adjusted Density Rate Per 1000 Participant-Years for Incidence of Death Due to Any Cause
Adjusted density rate per 1000 participant-years for incidence of death due to any cause was reported. Density rate was calculated as the number of events (n) per 1000 participant-years at risk. Poisson regressions were fit to the categorical events with treatment as the main effect, PS quartile and imputed FS as covariates in the model to obtain the adjusted rate and CI.
Up to 5 years following enrollment
Percentage of Participants With All-Cause Mortality
All-cause death was defined as the death due to any cause during the course of study.
Up to 5 years following enrollment
Study Arms (2)
Maraviroc exposed
Maraviroc unexposed
Interventions
Maraviroc prescribed per approved local label.
Optimized background antiretroviral therapy prescribed per approved local label and treatment guidelines.
Eligibility Criteria
Treatment experienced, HIV-1 infected patients in routine clinical practice.
You may qualify if:
- Treatment experienced, HIV-1 infected patients
- years or older
- Receive an approved assay for determination of HIV-1 tropism
You may not qualify if:
- Pregnant or lactating
- Using CCR5 inhibitor other than maraviroc
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- ViiV Healthcarelead
- Pfizercollaborator
Study Sites (269)
Health Services Center
Hobson City, Alabama, 36201, United States
AAC/Davis Clinic
Huntsville, Alabama, 35801, United States
Alabama Infectious Diseases Center
Huntsville, Alabama, 35801, United States
Office of Franco Antonio Felizarta MD
Bakersfield, California, 93301, United States
Providence Clinical Research
Burbank, California, 91505, United States
Lalla-Reddy Medical Corporation
Fountain Valley, California, 92708, United States
Bickerstaff Pediatric Family HIV Center
Long Beach, California, 90806, United States
LA Gay and Lesbian Center
Los Angeles, California, 90028, United States
Office of Peter J. Ruane, MD
Los Angeles, California, 90036, United States
Cedars Sinai Medical Group
Los Angeles, California, 90048, United States
Alta Bates Summit Medical Center East Bay AIDS Center
Oakland, California, 95035, United States
University of California Irvine Medical Center
Orange, California, 92868, United States
A Professional Corporation, Research Department
Palm Desert, California, 92211, United States
Stanford ACTG
Palo Alto, California, 94304-5350, United States
University of California
Sacramento, California, 95817, United States
Kaiser Permanente Medical Center
San Francisco, California, 94118, United States
San Francisco Veterans Affairs Medical Center
San Francisco, California, 94121, United States
Statnford University Medical Center
Stanford, California, 94305, United States
Bipin Bhagat MD Inc.
Victorville, California, 92395, United States
Kaiser Permanente
Denver, Colorado, 80205, United States
National Jewish Health
Denver, Colorado, 80206, United States
Kaiser Permanete of Colorado Rock Creek Medical Offices
Lafayette, Colorado, 80026, United States
Yale University School of Medicine Aids Program
New Haven, Connecticut, 06510, United States
Clinical AIDS & HIV
New Haven, Connecticut, 06511, United States
Hospital of Saint Raphael
New Haven, Connecticut, 06511, United States
Circle Medical, LLC
Norwalk, Connecticut, 06851, United States
Dupont Circle Physician's Group
Washington D.C., District of Columbia, 20009, United States
Family Medical Counseling Service
Washington D.C., District of Columbia, 20020, United States
Division of Infectious Diseases, George Washington University Medical Center
Washington D.C., District of Columbia, 20037, United States
George Washington University Medical Faculty Assoc
Washington D.C., District of Columbia, 20037, United States
Office of Mahmoud H. Mustafa, MD, FACP
Washington D.C., District of Columbia, 20037, United States
ID Consultants Inc & Infectious Disease Research Corp.
Boynton Beach, Florida, 33426, United States
Daniel A. Warner/Consultive Medicine
Daytona Beach, Florida, 32114, United States
The McGregor Clinic
Fort Myers, Florida, 33901, United States
Associates in Infectious Disease
Ft. Pierce, Florida, 34982, United States
Duval County Health Department
Jacksonville, Florida, 32206, United States
University of Miami
Miami, Florida, 33136, United States
Care Resource
Miami, Florida, 33137, United States
South Florida Infectious Deisease and Tropical Medicine Center
Miami, Florida, 33176, United States
Office of Albert Canas, MD
Miami Beach, Florida, 33139, United States
Health Positive
Safety Harbor, Florida, 34695, United States
Pinellas Care Clinic
St. Petersburg, Florida, 33713, United States
Infectious Disease Research Institute, Inc
Tampa, Florida, 33614, United States
Midtown Medical Center
Tampa, Florida, 33614, United States
St. Joseph's Hospital Comprehensive Research Institute
Tampa, Florida, 33614, United States
Tampa Care Clinic
Tampa, Florida, 33614, United States
Rowan Tree Medical, PA
Wilton Manors, Florida, 33305, United States
Atlanta Infectious Disease Group
Atlanta, Georgia, 30309, United States
Atlanta Primary Care
Atlanta, Georgia, 30312, United States
PMI Health Research Group
Atlanta, Georgia, 30312, United States
Family Health Care of Atlanta, PC
Atlanta, Georgia, 30318, United States
Absolute Care Medical Center
Atlanta, Georgia, 30329, United States
Kaiser Permanente
Atlanta, Georgia, 30339-3915, United States
Atlanta Specialty Research
Atlanta, Georgia, 30342, United States
Georgia Health Sciences University
Augusta, Georgia, 30912, United States
Atlanta VA Medical Center
Decatur, Georgia, 30033, United States
WellStar Clinical Trials Office
Marietta, Georgia, 30060, United States
WellStar Infectious Disease
Marietta, Georgia, 30060, United States
WellStar Kennestone Hospital
Marietta, Georgia, 30060, United States
Infectious Diseases Associates
Riverdale, Georgia, 30274, United States
Chatham County Health Department
Savannah, Georgia, 31401, United States
Ruth M. Rothstein CORE Center
Chicago, Illinois, 60612, United States
Howard Brown Health Center
Chicago, Illinois, 60613, United States
University of Chicago
Chicago, Illinois, 60637, United States
Office of William Johnson, M.D.
Olympia Fields, Illinois, 60461, United States
Southside Health Association
Olympia Fields, Illinois, 60461, United States
Southern Illinois University School of Medicine
Springfield, Illinois, 62702, United States
University of Iowa Hospitals and Clinics
Iowa City, Iowa, 52242, United States
Blue Grass Care Clinic
Lexington, Kentucky, 40536, United States
University of Kentucky Medical Center
Lexington, Kentucky, 40536, United States
University of Kentucky
Lexington, Kentucky, 40536, United States
Louisiana State University Health Sciences Center
New Orleans, Louisiana, 70112, United States
Louisiana State University Health Sciences Center
New Orleans, Louisiana, 70119, United States
Montgomery Infectious Disease Associates, P.A. (Private Practice)
Silver Spring, Maryland, 20910, United States
St. Elizabeth's Medical Center
Brighton, Massachusetts, 02135, United States
The Research Institute
Springfield, Massachusetts, 01107, United States
Baystate Infectious Diseases Clinical Research
Springfield, Massachusetts, 01199, United States
University Of Michigan Health Systems
Ann Arbor, Michigan, 48109, United States
Henry Ford Hospital
Detroit, Michigan, 48202, United States
St. John hospital and Medical Center
Grosse Pointe Woods, Michigan, 48236, United States
Ingham County Health Department
Lansing, Michigan, 48910, United States
Michigan State University College of Osteopathic Medicine
Lansing, Michigan, 48910, United States
Newland Medical Associates
Southfield, Michigan, 48075, United States
Federal Medical Center Rochester
Rochester, Minnesota, 55904, United States
Mayo Medical Clinic
Rochester, Minnesota, 55905, United States
Nemechek Health Renewal
Kansas City, Missouri, 64111-2610, United States
Central West Clinical Research
St Louis, Missouri, 63108, United States
Monmouth Medical Center
Long Branch, New Jersey, 07740, United States
Jersey Shore Medical Center
Neptune City, New Jersey, 07754, United States
Meridian Medical Associates
Neptune City, New Jersey, 07754, United States
Saint Michael's Medical Center
Newark, New Jersey, 07102, United States
Erie County Medical Center, HIV Services
Buffalo, New York, 14215, United States
Guthrie Medical Group
Ithaca, New York, 14850, United States
North Shore University Hospital
Manhasset, New York, 11030, United States
Beth Israel Medical Center
New York, New York, 10003, United States
Beth Israel Medical Clinic
New York, New York, 10003, United States
Mount Sinai Beth Israel Medical Center
New York, New York, 10003, United States
HIV & Internal Medicine
New York, New York, 10011, United States
Mount Sinai Downtown Comprehensive Health Program
New York, New York, 10011, United States
Columbia University Medical Center
New York, New York, 10032, United States
CUMC Research Pharmacy
New York, New York, 10032, United States
AIDS Care
Rochester, New York, 14607, United States
New York Medical College
Valhalla, New York, 10595, United States
Westchester Medical Center
Valhalla, New York, 10595, United States
ID Associates
Gastonia, North Carolina, 28054, United States
East Carolina University
Greenville, North Carolina, 27834, United States
Rosedale Infectious Diseases
Huntersville, North Carolina, 28078, United States
Wake Forest University Health Sciences
Winston-Salem, North Carolina, 27157, United States
University of Cincinnati Medical Center
Cincinnati, Ohio, 45267, United States
The Ohio State University Medical Center
Columbus, Ohio, 43210, United States
University of Toledo: Health Sciences Campus
Toledo, Ohio, 43614, United States
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, 73104, United States
The Research and 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
Pinnacle Health Medical Services
Harrisburg, Pennsylvania, 17110, United States
University of Pennsylvania
Philadelphia, Pennsylvania, 19104-6073, United States
University of Pennsylvania
Philadelphia, Pennsylvania, 19104, United States
Philadelphia Fight
Philadelphia, Pennsylvania, 19107, United States
Guthrie Clinic, Ltd.
Sayre, Pennsylvania, 18840, United States
Low Country Infectious Diseases, P.A.
Charleston, South Carolina, 29414, United States
Medical University of South Carolina
Charleston, South Carolina, 29425, United States
MCC Clinic
Columbia, South Carolina, 29203, United States
University of South Carolina School of Medicine
Columbia, South Carolina, 29203, United States
University Speciality Clinics
Columbia, South Carolina, 29203, United States
Central Texas Clinical Research
Austin, Texas, 78705, United States
Saint Hope Foundation
Bellaire, Texas, 77401, United States
Dallas VA Medical Center
Dallas, Texas, 75216, United States
Southwest Infectious Disease Clinical Research, Inc.
Dallas, Texas, 75219, United States
UT Southwestern Medical Center HIV/AIDS Research Unit
Dallas, Texas, 75235, United States
Pillar Clinical Research LLC
Dallas, Texas, 75243, United States
Office of Allan Rowan Kelly MD
Fort Worth, Texas, 76104, United States
Tarrant County Infectious Disease Assocciates
Fort Worth, Texas, 76104, United States
Tarrant County Infectious Disease Associates
Fort Worth, Texas, 76104, United States
Garcias' Family Health Group
Harlingen, Texas, 78550, United States
Valley Aids Council
Harlingen, Texas, 78550, United States
Michael E. DeBakey Veterans Affairs Medical Center
Houston, Texas, 77030, United States
Diversified Medical Practices, PA
Houston, Texas, 77057, United States
Dr. Howard Kussman, MD
Plano, Texas, 75075, United States
University Health Care System
San Antonio, Texas, 78207, United States
South Texas Veterans Health Care System
San Antonio, Texas, 78229, United States
Infectious Diseases Associates of Central Virginia
Danville, Virginia, 24541, United States
Infectious Diseases Associates of Central Virginia
Lynchburg, Virginia, 24501, United States
Group Health Cooperative
Seattle, Washington, 98112, United States
Marshall University Joan C. Edwards School of Medicine
Huntington, West Virginia, 25701, United States
Institute of Tropical Medicine
Antwerp, B-2000, Belgium
CHU Saint Pierre
Brussels, 1000, Belgium
Cliniques Universitaires Saint-Luc
Brussels, 1200, Belgium
Universitair Ziekenhuis Gasthuisberg, Inwendige Geneeskunde
Leuven, B-3000, Belgium
C.H.U. Sart-Tilman
Liège, 4000, Belgium
Hospital Dia
Brasília, Federal District, 70351-580, Brazil
Instituto A.Z. de Pesquisa e Ensino
Curitiba, Paraná, 80240-280, Brazil
Hospital Geral de Nova Iguacu
Nova Iguaçu, Rio de Janeiro, 26030-380, Brazil
Faculdade de Medicina do ABC
Santo André, São Paulo, 09060-650, Brazil
Centro de Referencia e Treinamento DST/AIDS
São Paulo, São Paulo, 04121-000, Brazil
Hospital Heliopolis
São Paulo, São Paulo, 04231-030, Brazil
University of British Columbia/ Downtown Infectious Diseases Clinic
Vancouver, British Columbia, V6Z 2C7, Canada
Queen Elizabeth II Health Sciences Center
Halifax, Nova Scotia, B3H 1V7, Canada
Sunnybrook Health Sciences Centre
Toronto, Ontario, M4N 3M5, Canada
University Health Network
Toronto, Ontario, M5G 2N2, Canada
Clinique Medicale du Quartier Latin
Montreal, Quebec, H2L 5B1, Canada
CHUM, Hotel-Dieu Hospital
Montreal, Quebec, H2W 1T8, Canada
Recherche Clinique Médicale des Campus
Québec, Quebec, G1V 4X7, Canada
Hopital Jean Verdier, Unite de maladies infectieuses
Bondy, 93140, France
Hopital Saint-andre CHU de Bordeaux
Bordeaux, 33075, France
Hopital Pellegrin
Bordeaux, 33076, France
Raymond Poincare Hospital
Garches, 92380, France
Hopital de L'Hotel Dieu
Lyon, 69288, France
Hopital Sainte Marguerite
Marseille, 13274, France
Saint-Louis Hospital
Paris, 75010, France
Cochin Hospital Saint Vincent de Paul
Paris, 75014, France
Hopital Tenon
Paris, 75020, France
Hopital Pitie Salpetriere
Paris, 75651, France
Hopital Europeen Georges Pompidou
Paris, 75908, France
CH Perpignan
Perpignan, 66000, France
Hôpital Haut - Leveque - Centre Francois Magendie
Pessac, 33604, France
Centre Hospitalier Universitaire de Rennes
Rennes, 35033 Cedex 09, France
Centre Hospitalier de Tourcoing
Tourcoing, 59208, France
Arztpraxis fuer Innere Medizin Dr. Knechten
Aachen, 52062, Germany
Praxis City Ost Medizinisches Zentrum
Berlin, 10243, Germany
Praxis Dr. Christiane Cordes
Berlin, D-10243, Germany
Klinik I fuer Innere Medizin der Uni-Klinik Koeln
Cologne, D-50937, Germany
Klinikum Dortmund
Dortmund, 44137, Germany
Universitaetsklinikum Carl Gustav Carus, Klinik und Poliklinik fuer Dermatologie
Dresden, D-01307, Germany
Hospital of the J.W. Goethe University, Medical Clinic II
Frankfurt am Main, D-60590, Germany
Praxis Dr. Lothar Schneider Interne Medizin, HIV Schwerpunkt
Fürth, 90762, Germany
IPM - Study - Center
Hamburg, 20146, Germany
ifi-Institut am Allgemeines Krankenhaus St.Georg
Hamburg, D-20099, Germany
Universitaetsklinikum Hamburg-Eppendorf, Ambulanzzentrum des UKE GmbH, Bereich Infektiologie
Hamburg, D-20246, Germany
Universitaetsklinikum Mainz, I. Medizinische Klinik und Poliklinik,
Mainz, D-55131, Germany
Mannheimer Onkologie Praxis
Mannheim, D-68161, Germany
Gemeinschaftspraxis Untersendling
München, 81371, Germany
Medizinisches Versorgungszentrum
München, D 80335, Germany
Ludwig-Maximilians-Universitaet, Klinikum Innenstadt, Medizinische Poliklinik
München, D-80336, Germany
Centrum fuer interdisziplinaere Medizin Muenster GmbH
Münster, 48143, Germany
Klinikum Osnabruck
Osnabrück, D-49090, Germany
Infectomed GbR Zentrum für medizinische Studien
Stuttgart, D-70197, Germany
Privatpraxis Ulmer, Frietsch, Müller
Stuttgart, D-70197, Germany
University Hospital of Patras
Pátrai, Achaia, 26 500, Greece
Andreas Syngros Hospital
Athens, 161 21, Greece
Tzaneion General Hospital of Piraeus
Piraeus, 185 36, Greece
Clinica Malattie Infettive
Bari, 70124, Italy
Ambulatorio Day Hospital Malattie Infettive
Bologna, 40133, Italy
Dipartimento di Medicina Clinica Specialistica e Sperimentale
Bologna, 40138, Italy
Busto Arsizio Hospital
Busto Arsizio, 21052, Italy
SOD Malattie Infettive, La Piastra dei Servizi
Florence, 50139, Italy
Ente Ospedaliero Ospedali Galliera
Genova, 16128, Italy
San Raffaele Hospital
Milan, 20127, Italy
Clinic of Infectious and Tropical Diseases-University of Milan-San Paolo Hospital
Milan, 20142, Italy
1 Divisione di Malattive Infettive e Servizio di Allergologia, Ospedale L. Sacco
Milan, 20157, Italy
Universita' degli Studi di Milano, Dipartimento di scienza clinica Luigi Sacco
Milan, 20157, Italy
Azienda Ospedaliero Universitaria Policlinico di Modena
Modena, 41100, Italy
Azienda Ospedal Universitaria II Univ degli Studi di Napoli Servizio di Diagnosi e Terapia
Naples, 80135, Italy
Azienda Ospedaliera "Domenico Cotugno"
Napoli, 80137, Italy
AOUP Paolo Giaccone, UOC Malattie Infettive
Palermo, 90127, Italy
Fondazione IRCCS Policlinico San Matteo
Pavia, 27100, Italy
Azienda Sanitaria Locale Ospedale Civile dello Spirito Santo Presidio Ospedaliero
Pescara, 65100, Italy
Istituto Nazionale Malattie Infettive "L.Spallanzani"-IRCCS
Roma, 00149, Italy
Istituto Nazionale Malattie Infettive INMI- "L. Spallanzani"- I.R.C.C.S.
Roma, 00149, Italy
Universita' di Roma La Sapienza, Dipartimento di Malattie Infettive e Tropicali
Roma, 00161, Italy
Universita'Cattolica del Sacro Cuore Policlinico Gemelli
Roma, 00168, Italy
Azienda Ospedaliera San Giovanni Addolorata Presidia Santa Maria
Rome, 00184, Italy
Ospedale Amedeo di Savoia
Torino, 10100, Italy
Ospedale Amedeo di Savoia, Clinica Universitaria di Malattie Infettive
Torino, 10149, Italy
Ararat Research Center
Ponce, PR, 00717-1567, Puerto Rico
HOPE Clinical Research
San Juan, 00909, Puerto Rico
Clinica Mutua de Terrassa
Terrassa, Barcelona, 08221, Spain
Hospital San Pedro
Logroño, La Rioja, 26006, Spain
Hospital de Tortosa Verge de La Cinta
Tortosa, Tarragona, 43500, Spain
Complejo Hospitalario Juan Canalejo
A Coruña, 15006, Spain
Hospital General Universitário de Alicante
Alicante, 03010, Spain
Hospital Del Mar
Barcelona, 08003, Spain
Hospital Clinic I Provincial de Barcelona
Barcelona, 08036, Spain
Hospital Universitario Germans Tias I Pujol
Barcelona, 08916, Spain
Unidad de Enfermedades Infecciosas
Cadiz, 11009, Spain
Hospital Universitario Reina Sofia
Córdoba, 14004, Spain
Hospital Donostia
Donostia / San Sebastian, 20014, Spain
Hospital General Universitario de Elche
Elche, 03203, Spain
Hospital Clinico San Cecilio
Granada, 18012, Spain
Hospital Universitario de La Princesa
Madrid, 28006, Spain
Hospital Carlos Iii
Madrid, 28029, Spain
Hospital Ramon Y Cajal
Madrid, 28034, Spain
Hospital Clinico San Carlos
Madrid, 28040, Spain
Hospital Universitario 12 de Octubre
Madrid, 28041, Spain
Hospital Univ. La Paz
Madrid, 28046, Spain
Hospital de Mostoles
Madrid, 28935, Spain
Mataro Hospital
Mataró, 08304, Spain
Complejo Hospitalario Carlos Haya
Málaga, 29010, Spain
Hospital Universitario de Canarias
Santa Cruz de Tenerife, 38320, Spain
Hospital Universitario Virgen de La Macarena
Seville, 41009, Spain
Hospital Universitario Virgen Del Rocio
Seville, 41013, Spain
Hospital Clinico Universitario
Valencia, 46010, Spain
Hull & East Yorkshire Hospitals NHS Trust
Cottingham, EAST Yorkshire, HU16 5JQ, United Kingdom
Clinical Resource Building, Level 7
Newcastle upon Tyne, Newcastle, NE1 4LP, United Kingdom
Royal Victoria Hospital
Belfast, BT12 6BA, United Kingdom
Selly Oak Hospital
Birmingham, B4 6DH, United Kingdom
Brighton and Sussex University Hospitals NHS Trust
Brighton, BN2 1ES, United Kingdom
North Manchester General Hospital
Crumpsall, M8 5RB, United Kingdom
Darlington Memorial Hospital
Darlington, DL36HX, United Kingdom
Regional Infectious Diseases Unit
Edinburgh, EH4 2XU, United Kingdom
Grahame Hayton Unit
London, E1 1BB, United Kingdom
North Middlesex Hospital
London, N18 1QX, United Kingdom
Royal Free Hospital, Ian Charleson Day Centre
London, NW3 2QG, United Kingdom
1st Floor St Stephens Centre
London, SW10 9NH, United Kingdom
Royal Victoria Infirmary Hospital
Newcastle upon Tyne, NE1 4LP, United Kingdom
Royal Victoria Infirmary
Newcastle upon Tyne, NE1 4LP, United Kingdom
Warren browne Unit, Southlands Hospital
Shoreham-by-Sea, BN43 6TQ, United Kingdom
Cobridge Community Health Centre
Stoke-on-Trent, ST6 2JW, United Kingdom
St. George's Hospital
Tooting, SW17 0QT, United Kingdom
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
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
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 23, 2008
First Posted
April 24, 2008
Study Start
March 31, 2008
Primary Completion
February 14, 2019
Study Completion
February 14, 2019
Last Updated
October 18, 2022
Results First Posted
April 7, 2020
Record last verified: 2022-10
Data Sharing
- IPD Sharing
- Will not share
Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.