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

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2014 by ViiV Healthcare
Sponsor:
Collaborator:
Pfizer
Information provided by (Responsible Party):
ViiV Healthcare
ClinicalTrials.gov Identifier:
NCT00665561
First received: April 23, 2008
Last updated: September 10, 2014
Last verified: September 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
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

  Show 245 Study Locations
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: September 10, 2014
Health Authority: United States: Food and Drug Administration

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

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

ClinicalTrials.gov processed this record on September 18, 2014