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

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00665561
First Posted: April 24, 2008
Last Update Posted: September 4, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Pfizer
Information provided by (Responsible Party):
ViiV Healthcare
April 23, 2008
April 24, 2008
September 4, 2017
March 31, 2008
February 26, 2019   (Final data collection date for primary outcome measure)
  • 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. ]
Same as current
Complete list of historical versions of study NCT00665561 on ClinicalTrials.gov Archive Site
There are no Secondary Outcomes for this study. [ Time Frame: 0 ]
Same as current
Not Provided
Not Provided
 
Prospective Observational Epidemiologic Study of Maraviroc's Safety
An International, Multicenter, Prospective Observational Study Of The Safety Of Maraviroc Used With Optimized Background Therapy In Treatment-experienced Hiv-1 Infected Patients
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.
All patients meeting the study eligibility criteria at participating sites will be invited to participate.
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample
Treatment experienced, HIV-1 infected patients in routine clinical practice.
Human Immunodeficiency Virus
  • Drug: Maraviroc along with an optimized background antiretroviral drug regimen
    Maraviroc prescribed per approved local label.
    Other Name: Selzentry
  • Drug: Optimized background antiretroviral drug regimen without maraviroc
    Optimized background antiretroviral therapy prescribed per approved local label and treatment guidelines.
  • Maraviroc exposed
    Intervention: Drug: Maraviroc along with an optimized background antiretroviral drug regimen
  • Maraviroc unexposed
    Intervention: Drug: Optimized background antiretroviral drug regimen without maraviroc
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
2454
February 26, 2019
February 26, 2019   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Belgium,   Brazil,   Canada,   France,   Germany,   Greece,   Italy,   Puerto Rico,   Spain,   United Kingdom,   United States
Portugal
 
NCT00665561
A4001067
2007-006148-24 ( EudraCT Number )
POEM ( Other Identifier: Alias Study Number )
No
Not Provided
Not Provided
ViiV Healthcare
ViiV Healthcare
Pfizer
Study Director: Pfizer CT.gov Call Center Pfizer
ViiV Healthcare
September 2017