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

This study is ongoing, but not recruiting participants.
Information provided by (Responsible Party):
ViiV Healthcare Identifier:
First received: April 23, 2008
Last updated: September 1, 2017
Last verified: September 2017
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. ]
  • 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. ]

Secondary Outcome Measures:
  • There are no Secondary Outcomes for this study. [ Time Frame: 0 ]

Enrollment: 2454
Actual Study Start Date: March 31, 2008
Estimated Study Completion Date: February 26, 2019
Estimated Primary Completion Date: February 26, 2019 (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.

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Treatment experienced, HIV-1 infected patients in routine clinical practice.

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 identifier: NCT00665561

  Show 266 Study Locations
Sponsors and Collaborators
ViiV Healthcare
Study Director: Pfizer Call Center Pfizer
  More Information

Additional Information:
Responsible Party: ViiV Healthcare Identifier: NCT00665561     History of Changes
Other Study ID Numbers: A4001067
2007-006148-24 ( EudraCT Number )
POEM ( Other Identifier: Alias Study Number )
Study First Received: April 23, 2008
Last Updated: September 1, 2017

Keywords provided by ViiV Healthcare:

Additional relevant MeSH terms:
Immunologic Deficiency Syndromes
Acquired Immunodeficiency Syndrome
HIV Infections
Immune System Diseases
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Slow Virus Diseases
CCR5 Receptor Antagonists
Molecular Mechanisms of Pharmacological Action
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents processed this record on September 19, 2017