Observational Data Analysis in EuroSIDA (MK-0518-058)

This study has been completed.
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: August 17, 2015
Last verified: August 2015

February 26, 2010
August 17, 2015
May 2008
March 2014   (final data collection date for primary outcome measure)
  • Incidence of Malignancy [ Time Frame: Historical Cohort: up to 24 months (January 2006 to December 2007); Raltegravir and Concurrent Cohorts: up to 68 months (December 2007 to July 2013) ] [ Designated as safety issue: Yes ]
    All-type malignancy, including both Acquired Immune Deficiency Syndrome (AIDS)-defining and non-AIDS-defining malignancy, was evaluated. Only the first occurrence of any malignancy type was counted for each participant.
  • Incidence of Clinically Important Hepatic Events [ Time Frame: Historical Cohort: up to 24 months (January 2006 to December 2007); Raltegravir and Concurrent Cohorts: up to 68 months (December 2007 to July 2013) ] [ Designated as safety issue: Yes ]
    Clinically important hepatic events were defined as either 1) hepatic encephalopathy (stage III or IV), or 2) discontinuation of raltegravir use where liver toxicity was listed as the reason for discontinuation.
  • Incidence of Lipodystrophy [ Time Frame: Historical Cohort: up to 24 months (January 2006 to December 2007); Raltegravir and Concurrent Cohorts: up to 68 months (December 2007 to July 2013) ] [ Designated as safety issue: Yes ]
    Lipodystrophy events were defined as the first report for either 1) loss of fat from extremities, buttocks, or face, or 2) accumulation of fat in abdomen, neck, breasts, or other defined location.
  • Incidence of All-Cause Mortality [ Time Frame: Historical Cohort: up to 24 months (January 2006 to December 2007); Raltegravir and Concurrent Cohorts: up to 68 months (December 2007 to July 2013) ] [ Designated as safety issue: Yes ]
    All participant deaths were recorded
  • 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 ]
Complete list of historical versions of study NCT01078233 on ClinicalTrials.gov Archive Site
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Observational Data Analysis in EuroSIDA (MK-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
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Non-Probability Sample
Adults 16 years old and older in the EuroSIDA database
HIV-1 Infections
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  • Raltegravir Cohort
    Participants with HIV-1 infection who started raltegravir on or after 21 December 2007 (the authorization date in the European Union) and had at least 1 month prospective follow-up in the Raltegravir Cohort. Participants from the Historical Cohort and Concurrent Cohort were eligible for inclusion in the Raltegravir Cohort.
  • Historical Cohort
    Participants with HIV-1 infection who started a new antiretroviral drug as part of a combination antiretroviral therapy (cART) regimen on or after 1 January 2006 and before 21 December 2007. Participants had no previous exposure to the new drug and had at least 1 month prospective follow-up in the Historical Cohort.
  • Concurrent Cohort
    Participants with HIV-1 infection who started a new antiretroviral drug other than raltegravir as part of a cART regimen on or after 21 December 2007. Participants had no previous exposure to the new drug and had at least 1 month prospective follow-up in the Concurrent Cohort. Participants from the Historical Cohort were eligible for inclusion in the Concurrent Cohort.
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
6617
March 2014
March 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   (Child, Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
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NCT01078233
0518-058, 2010_020, EP08025.005
Yes
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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.
August 2015

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