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

This study is currently recruiting participants.
Verified April 2013 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 29, 2013
Last verified: April 2013
History of Changes
  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:

MedlinePlus related topics: HIV/AIDS
Drug Information available for: Maraviroc
U.S. FDA Resources

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

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

  Show 249 Study Locations
Sponsors and Collaborators
ViiV Healthcare
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
To obtain contact information for a study center near you, click here.  This link exits the ClinicalTrials.gov site

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 29, 2013
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 May 21, 2013