Observational Data Analysis in EuroSIDA (0518-058)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
EuroSIDA Coordinating Centre, Copenhagen HIV Programme (CHIP)
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT01078233
First received: February 26, 2010
Last updated: February 21, 2014
Last verified: February 2014

February 26, 2010
February 21, 2014
May 2008
December 2014   (final data collection date for primary outcome measure)
  • Incidence of Malignancy (All malignancy collected) [ Time Frame: January 2000 - December 2014 ] [ Designated as safety issue: Yes ]
  • Incidence of clinically important liver outcomes (as measured by hepatic encephalopathy (stage III or IV) or discontinuation of Raltegravir use where liver toxicity is listed as the reason for discontinuation. [ Time Frame: January 2000 -December 2014 ] [ Designated as safety issue: Yes ]
  • Incidence of Lipodystrophy events as measured by the detection of the first reported event for loss of fat from extremities, buttocks or face. [ Time Frame: January 2000 - December 2014 ] [ Designated as safety issue: Yes ]
  • All cause mortality (as measured by report of any death as collected for the follow-up visit for each patient) [ Time Frame: January 2000 - December 2014 ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01078233 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Observational Data Analysis in EuroSIDA (0518-058)
Observational Safety Data Analysis From Routine Follow-up in the EuroSIDA Study of Patients Treated With Raltegravir in a Five-Year Post Authorization Period

The main objective of the study is to monitor health outcomes associated with antiretroviral drugs in a population of HIV-infected patients.

Time Perspective: Retrospective and Prospective

Observational
Observational Model: Cohort
Not Provided
Not Provided
Non-Probability Sample

Adults 16 years old and older in the EuroSIDA database

HIV-1 Infections
Not Provided
  • Raltegravir
    HIV-infected patients from the EuroSIDA study who are exposed to Raltegravir
  • Pre-Raltegravir
    Historical comparison cohort of HIV-infected patients from the EuroSIDA study from the time period prior to the availability of Raltegravir for patient use
  • Non-Raltegravir
    Concurrent comparison cohort of HIV-infected patients from patients in the EuroSIDA study that are contemporaneous with Raltegravir users but who are not exposed to Raltegravir
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
1000
December 2014
December 2014   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Adults 16 years old and older with HIV-1

Exclusion Criteria:

  • Subjects will be excluded if they have no prospective follow up
Both
16 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT01078233
0518-058, 2010_020, EP08025.005
Yes
Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
EuroSIDA Coordinating Centre, Copenhagen HIV Programme (CHIP)
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
February 2014

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