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

April 23, 2008
April 9, 2014
March 2008
October 2018   (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. ] [ 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 ]
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 ] [ Designated as safety issue: No ]
There are no Secondary Outcomes for this study. [ Time Frame: 0 ] [ Designated as safety issue: No ]
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
3000
October 2018
October 2018   (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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Belgium,   Brazil,   Canada,   France,   Germany,   Greece,   Italy,   Puerto Rico,   Spain,   United Kingdom
 
NCT00665561
A4001067
No
ViiV Healthcare
ViiV Healthcare
Pfizer
Study Director: Pfizer CT.gov Call Center Pfizer
ViiV Healthcare
April 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP