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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Pfizer
Information provided by (Responsible Party):
ViiV Healthcare
ClinicalTrials.gov Identifier:
NCT00665561
First received: April 23, 2008
Last updated: April 9, 2014
Last verified: April 2014
  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 Phase
Human Immunodeficiency Virus
Drug: Maraviroc along with an optimized background antiretroviral drug regimen
Drug: Optimized background antiretroviral drug regimen without maraviroc
Phase 4

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

  Hide Study Locations
Locations
United States, Alabama
Pfizer Investigational Site
Hobson City, Alabama, United States, 36201
Pfizer Investigational Site
Huntsville, Alabama, United States, 35801
United States, California
Pfizer Investigational Site
Bakersfield, California, United States, 93301
Pfizer Investigational Site
Burbank, California, United States, 91505
Pfizer Investigational Site
Garden Grove, California, United States, 92845
Pfizer Investigational Site
Irvine, California, United States, 92697
Pfizer Investigational Site
Long Beach, California, United States, 90801-1428
Pfizer Investigational Site
Los Angeles, California, United States, 90048
Pfizer Investigational Site
Los Angeles, California, United States, 90036
Pfizer Investigational Site
Los Angelos, California, United States, 90028
Pfizer Investigational Site
Oakland, California, United States, 94609-3480
Pfizer Investigational Site
Orange, California, United States, 92868
Pfizer Investigational Site
Palm Desert, California, United States, 92211
Pfizer Investigational Site
Sacramento, California, United States, 95814
Pfizer Investigational Site
Sacramento, California, United States, 95817
Pfizer Investigational Site
San Francisco, California, United States, 94121
Pfizer Investigational Site
San Francisco, California, United States, 94118
Pfizer Investigational Site
Stanford, California, United States, 94305
Pfizer Investigational Site
Victorville, California, United States, 92395
United States, Colorado
Pfizer Investigational Site
Denver, Colorado, United States, 80206
Pfizer Investigational Site
Denver, Colorado, United States, 80205
Pfizer Investigational Site
Lafayette, Colorado, United States, 80026
United States, Connecticut
Pfizer Investigational Site
New Haven, Connecticut, United States, 06510
Pfizer Investigational Site
New Haven, Connecticut, United States, 06511
Pfizer Investigational Site
Norwalk, Connecticut, United States, 06851
United States, District of Columbia
Pfizer Investigational Site
Washington, District of Columbia, United States, 20037
Pfizer Investigational Site
Washington, District of Columbia, United States, 20020
Pfizer Investigational Site
Washington, District of Columbia, United States, 20009
United States, Florida
Pfizer Investigational Site
Boynton Beach, Florida, United States, 33426
Pfizer Investigational Site
Daytona Beach, Florida, United States, 32117-4547
Pfizer Investigational Site
Fort Lauderdale, Florida, United States, 33308
Pfizer Investigational Site
Fort Myers, Florida, United States, 33901
Pfizer Investigational Site
Fort Pierce, Florida, United States, 34982
Pfizer Investigational Site
Jacksonville, Florida, United States, 32206
Pfizer Investigational Site
Miami, Florida, United States, 33176
Pfizer Investigational Site
Miami, Florida, United States, 33137
Pfizer Investigational Site
Miami, Florida, United States, 33136
Pfizer Investigational Site
Miami Beach, Florida, United States, 33139
Pfizer Investigational Site
Safety Harbor, Florida, United States, 34695
Pfizer Investigational Site
St. Petersburg, Florida, United States, 33713
Pfizer Investigational Site
Tampa, Florida, United States, 33614
United States, Georgia
Pfizer Investigational Site
Atlanta, Georgia, United States, 30339-3915
Pfizer Investigational Site
Atlanta, Georgia, United States, 30342
Pfizer Investigational Site
Atlanta, Georgia, United States, 30309
Pfizer Investigational Site
Atlanta, Georgia, United States, 30318-2513
Pfizer Investigational Site
Atlanta, Georgia, United States, 30312
Pfizer Investigational Site
Augusta, Georgia, United States, 30912
Pfizer Investigational Site
Decatur, Georgia, United States, 30033-4004
Pfizer Investigational Site
Marietta, Georgia, United States, 30060
Pfizer Investigational Site
Riverdale, Georgia, United States, 30274
Pfizer Investigational Site
Savannah, Georgia, United States, 31401
United States, Illinois
Pfizer Investigational Site
Chicago, Illinois, United States, 60612
Pfizer Investigational Site
Chicago, Illinois, United States, 60637
Pfizer Investigational Site
Chicago, Illinois, United States, 60613
Pfizer Investigational Site
Olympia, Illinois, United States, 60461
Pfizer Investigational Site
Olympia Fields, Illinois, United States, 60461
Pfizer Investigational Site
Springfield, Illinois, United States, 62702
United States, Iowa
Pfizer Investigational Site
Iowa City, Iowa, United States, 52242
United States, Kentucky
Pfizer Investigational Site
Lexington, Kentucky, United States, 40536
United States, Louisiana
Pfizer Investigational Site
New Orleans, Louisiana, United States, 70112
Pfizer Investigational Site
New Orleans, Louisiana, United States, 70119
United States, Maryland
Pfizer Investigational Site
Silver Spring, Maryland, United States, 20910
United States, Massachusetts
Pfizer Investigational Site
Boston, Massachusetts, United States, 02135
Pfizer Investigational Site
Springfield, Massachusetts, United States, 01199
Pfizer Investigational Site
Springfield, Massachusetts, United States, 01107
United States, Michigan
Pfizer Investigational Site
Ann Arbor, Michigan, United States, 48109
Pfizer Investigational Site
Detroit, Michigan, United States, 48202
Pfizer Investigational Site
East Lansing, Michigan, United States, 48824
Pfizer Investigational Site
Grosse Pointe Woods, Michigan, United States, 48236
Pfizer Investigational Site
Lansing, Michigan, United States, 48910
Pfizer Investigational Site
Southfield, Michigan, United States, 48075
United States, Minnesota
Pfizer Investigational Site
Rochester, Minnesota, United States, 55904
Pfizer Investigational Site
Rochester, Minnesota, United States, 55905
United States, Missouri
Pfizer Investigational Site
Kansas City, Missouri, United States, 64111-2610
Pfizer Investigational Site
Saint Louis, Missouri, United States, 63108
United States, New Jersey
Pfizer Investigational Site
Long Branch, New Jersey, United States, 07740
Pfizer Investigational Site
Neptune, New Jersey, United States, 07754
Pfizer Investigational Site
Newark, New Jersey, United States, 07102
United States, New York
Pfizer Investigational Site
Buffalo, New York, United States, 14215
Pfizer Investigational Site
Ithaca, New York, United States, 14850
Pfizer Investigational Site
Manhasset, New York, United States, 11030
Pfizer Investigational Site
New York, New York, United States, 10003
Pfizer Investigational Site
New York, New York, United States, 10032
Pfizer Investigational Site
New York, New York, United States, 10011
Pfizer Investigational Site
Rochester, New York, United States, 14607
Pfizer Investigational Site
Valhalla, New York, United States, 10595
United States, North Carolina
Pfizer Investigational Site
Gastonia, North Carolina, United States, 28054
Pfizer Investigational Site
Greenville, North Carolina, United States, 27834
Pfizer Investigational Site
Huntersville, North Carolina, United States, 28078
Pfizer Investigational Site
Winston-Salem, North Carolina, United States, 27157
United States, Ohio
Pfizer Investigational Site
Cincinnati, Ohio, United States, 45267
Pfizer Investigational Site
Columbus, Ohio, United States, 43210-1228
Pfizer Investigational Site
Columbus, Ohio, United States, 43210
Pfizer Investigational Site
Toledo, Ohio, United States, 43614
United States, Oklahoma
Pfizer Investigational Site
Oklahoma City, Oklahoma, United States, 73104-5022
United States, Oregon
Pfizer Investigational Site
Portland, Oregon, United States, 97227
Pfizer Investigational Site
Portland, Oregon, United States, 97210
United States, Pennsylvania
Pfizer Investigational Site
Allentown, Pennsylvania, United States, 18102
Pfizer Investigational Site
Harrisburg, Pennsylvania, United States, 17110
Pfizer Investigational Site
Philadelphia, Pennsylvania, United States, 19104
Pfizer Investigational Site
Philadelphia, Pennsylvania, United States, 19107
United States, South Carolina
Pfizer Investigational Site
Charleston, South Carolina, United States, 29425
Pfizer Investigational Site
Charleston, South Carolina, United States, 29414
Pfizer Investigational Site
Columbia, South Carolina, United States, 29203
United States, Texas
Pfizer Investigational Site
Addison, Texas, United States, 75001
Pfizer Investigational Site
Austin, Texas, United States, 78705
Pfizer Investigational Site
Bellaire, Texas, United States, 77401
Pfizer Investigational Site
Dallas, Texas, United States, 75235
Pfizer Investigational Site
Dallas, Texas, United States, 75216
Pfizer Investigational Site
Dallas, Texas, United States, 75243
Pfizer Investigational Site
Fort Worth, Texas, United States, 76104-3048
Pfizer Investigational Site
Fort Worth, Texas, United States, 76104
Pfizer Investigational Site
Harlingen, Texas, United States, 78550
Pfizer Investigational Site
Houston, Texas, United States, 77057
Pfizer Investigational Site
Houston, Texas, United States, 77030
Pfizer Investigational Site
Plano, Texas, United States, 75075
Pfizer Investigational Site
San Antonio, Texas, United States, 78229
Pfizer Investigational Site
San Antonio, Texas, United States, 78207
United States, Virginia
Pfizer Investigational Site
Danville, Virginia, United States, 24541
Pfizer Investigational Site
Lynchburg, Virginia, United States, 24501
United States, Washington
Pfizer Investigational Site
Seattle, Washington, United States, 98112
United States, West Virginia
Pfizer Investigational Site
Huntington, West Virginia, United States, 25701
Belgium
Pfizer Investigational Site
Antwerpen, Belgium, B-2000
Pfizer Investigational Site
Brussels, Belgium, 1200
Pfizer Investigational Site
Brussels, Belgium, 1000
Pfizer Investigational Site
Leuven, Belgium, 3000
Pfizer Investigational Site
Liege, Belgium, 4000
Brazil
Pfizer Investigational Site
Brasilia, DF, Brazil, 70351-580
Pfizer Investigational Site
Curitiba, PR, Brazil, 80240-280
Pfizer Investigational Site
Nova Iguacu, RJ, Brazil, 26030-380
Pfizer Investigational Site
Santo André, SP, Brazil, 09060-650
Pfizer Investigational Site
Sao Paulo, SP, Brazil, 04121-000
Pfizer Investigational Site
São Paulo, SP, Brazil, 04231-030
Canada, British Columbia
Pfizer Investigational Site
Vancouver, British Columbia, Canada, V6Z 2C7
Canada, Nova Scotia
Pfizer Investigational Site
Halifax, Nova Scotia, Canada, B3H 1V7
Canada, Ontario
Pfizer Investigational Site
Toronto, Ontario, Canada, M4N 3M5
Pfizer Investigational Site
Toronto, Ontario, Canada, M5G 2N2
Canada, Quebec
Pfizer Investigational Site
Montreal, Quebec, Canada, H2W 1T8
Pfizer Investigational Site
Montreal, Quebec, Canada, H2L 5B1
Canada
Pfizer Investigational Site
Quebec, Canada, G1V 4X7
France
Pfizer Investigational Site
Marseille, Cedex 09, France, 13274
Pfizer Investigational Site
Bondy, France, 93140
Pfizer Investigational Site
Bordeaux, France, 33000
Pfizer Investigational Site
Bordeaux, France, 33076
Pfizer Investigational Site
Garches, France, 92380
Pfizer Investigational Site
LYON Cedex 4, France, 69317
Pfizer Investigational Site
Paris, France, 75908
Pfizer Investigational Site
Paris, France, 75013
Pfizer Investigational Site
Paris Cedex 10, France, 75475
Pfizer Investigational Site
Paris CEDEX 14, France, 75679
Pfizer Investigational Site
Paris, 75, France, 75020
Pfizer Investigational Site
Perpignan, France, 66000
Pfizer Investigational Site
Pessac, France, 33604
Pfizer Investigational Site
Rennes, France, 35033
Pfizer Investigational Site
Tourcoing, France, 59208
Germany
Pfizer Investigational Site
Aachen, Germany, 52062
Pfizer Investigational Site
Berlin, Germany, 10243
Pfizer Investigational Site
Dortmund, Germany, 44137
Pfizer Investigational Site
Dresden, Germany, 01307
Pfizer Investigational Site
Frankfurt am Main, Germany, 60590
Pfizer Investigational Site
Fuerth, Germany, 90762
Pfizer Investigational Site
Hamburg, Germany, 20246
Pfizer Investigational Site
Hamburg, Germany, 20146
Pfizer Investigational Site
Hamburg, Germany, 20099
Pfizer Investigational Site
Koeln, Germany, 50937
Pfizer Investigational Site
Mainz, Germany, 55131
Pfizer Investigational Site
Mannheim, Germany, 68161
Pfizer Investigational Site
Muenchen, Germany, 81371
Pfizer Investigational Site
Muenchen, Germany, 80337
Pfizer Investigational Site
Muenchen, Germany, 80336
Pfizer Investigational Site
Muenchen, Germany, 80335
Pfizer Investigational Site
Muenster, Germany, 48143
Pfizer Investigational Site
Osnabrueck, Germany, 49090
Pfizer Investigational Site
Stuttgart, Germany, 70197
Greece
Pfizer Investigational Site
Patras, Achaia, Greece, 26 500
Pfizer Investigational Site
Athens, Greece, 161 21
Pfizer Investigational Site
Piraeus, Greece, 185 36
Italy
Pfizer Investigational Site
Bari, Italy, 70124
Pfizer Investigational Site
Bologna, Italy, 40138
Pfizer Investigational Site
Bologna, Italy, 40133
Pfizer Investigational Site
Busto Arsizio (Va), Italy, 21052
Pfizer Investigational Site
Firenze, Italy, 50139
Pfizer Investigational Site
Genova, Italy, 16128
Pfizer Investigational Site
Milano, Italy, 20142
Pfizer Investigational Site
Milano, Italy, 20127
Pfizer Investigational Site
Milano, Italy, 20157
Pfizer Investigational Site
Modena, Italy, 41100
Pfizer Investigational Site
Napoli, Italy, 80135
Pfizer Investigational Site
Napoli, Italy, 80131
Pfizer Investigational Site
Palermo, Italy, 90127
Pfizer Investigational Site
Pavia, Italy, 27100
Pfizer Investigational Site
Pescara, Italy, 65124
Pfizer Investigational Site
Roma, Italy, 00168
Pfizer Investigational Site
Roma, Italy, 00161
Pfizer Investigational Site
Roma, Italy, 00149
Pfizer Investigational Site
Rome, Italy, 00184
Pfizer Investigational Site
Torino, Italy, 10149
Puerto Rico
Pfizer Investigational Site
Ponce, Puerto Rico, 00717-1563
Pfizer Investigational Site
San Juan, Puerto Rico, 00909
Spain
Pfizer Investigational Site
Terrassa, Barcelona, Spain, 08221
Pfizer Investigational Site
Logroño, La Rioja, Spain, 26006
Pfizer Investigational Site
Tortosa, Tarragona, Spain, 43500
Pfizer Investigational Site
A Coruña, Spain, 15006
Pfizer Investigational Site
Alicante, Spain, 03010
Pfizer Investigational Site
Barcelona, Spain, 08916
Pfizer Investigational Site
Barcelona, Spain, 08003
Pfizer Investigational Site
Barcelona, Spain, 08036
Pfizer Investigational Site
Cadiz, Spain, 11009
Pfizer Investigational Site
Cordoba, Spain, 14004
Pfizer Investigational Site
Elche, Spain, 3202
Pfizer Investigational Site
Granada, Spain, 18012
Pfizer Investigational Site
Madrid, Spain, 28041
Pfizer Investigational Site
Madrid, Spain, 28046
Pfizer Investigational Site
Madrid, Spain, 28040
Pfizer Investigational Site
Madrid, Spain, 28006
Pfizer Investigational Site
Madrid, Spain, 28029
Pfizer Investigational Site
Madrid, Spain, 28034
Pfizer Investigational Site
Malaga, Spain, 29010
Pfizer Investigational Site
Mataro, Spain, 8304
Pfizer Investigational Site
Mostoles, Madrid, Spain, 28935
Pfizer Investigational Site
San Sebastian, Spain, 20014
Pfizer Investigational Site
Sevilla, Spain, 41009
Pfizer Investigational Site
Sevilla, Spain, 41013
Pfizer Investigational Site
Tarmgona, Spain, 43007
Pfizer Investigational Site
Tenerife, Canary Island, Spain, 38320
Pfizer Investigational Site
Valencia, Spain, 46010
United Kingdom
Pfizer Investigational Site
Sally Oak, Birmingham, United Kingdom, B29 6JD
Pfizer Investigational Site
Cottingham, East Yorkshire, United Kingdom, HU165JQ
Pfizer Investigational Site
Newcastle upon Tyne, Newcastle, United Kingdom, NE4 6BE
Pfizer Investigational Site
Belfast, United Kingdom, BT12 6BA
Pfizer Investigational Site
Brighton, United Kingdom, BN2 1ES
Pfizer Investigational Site
Crumpsall, Manchester, United Kingdom, M8 5RB
Pfizer Investigational Site
Darlington, United Kingdom, DL36HX
Pfizer Investigational Site
Edinburgh, United Kingdom, EH4 2XU
Pfizer Investigational Site
London, United Kingdom, SW10 9NH
Pfizer Investigational Site
London, United Kingdom, N18 1QX
Pfizer Investigational Site
London, United Kingdom, NW3 2QG
Pfizer Investigational Site
London, United Kingdom, E1 1BB
Pfizer Investigational Site
Shoreham, West Sussex, United Kingdom, BN436TQ
Pfizer Investigational Site
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:
No publications provided

Responsible Party: ViiV Healthcare
ClinicalTrials.gov Identifier: NCT00665561     History of Changes
Other Study ID Numbers: A4001067
Study First Received: April 23, 2008
Last Updated: April 9, 2014
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
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Slow Virus Diseases
Immune System Diseases

ClinicalTrials.gov processed this record on April 17, 2014