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

Condition
HIV-1 Infections

Study Type: Observational
Study Design: Observational Model: Cohort
Official Title: Observational Safety Data Analysis From Routine Follow-up in the EuroSIDA Study of Patients Treated With Raltegravir in a Five-Year Post Authorization Period

Resource links provided by NLM:


Further study details as provided by Merck Sharp & Dohme Corp.:

Primary Outcome Measures:
  • 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


Enrollment: 6617
Study Start Date: May 2008
Study Completion Date: March 2014
Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
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.

Detailed Description:
Time Perspective: Retrospective and Prospective
  Eligibility

Ages Eligible for Study:   16 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Adults 16 years old and older in the EuroSIDA database
Criteria

Inclusion Criteria:

  • Adults 16 years old and older with HIV-1

Exclusion Criteria:

  • Subjects will be excluded if they have no prospective follow up
  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: NCT01078233

Sponsors and Collaborators
Merck Sharp & Dohme Corp.
EuroSIDA Coordinating Centre, Copenhagen HIV Programme (CHIP)
Investigators
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
  More Information

No publications provided

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT01078233     History of Changes
Other Study ID Numbers: 0518-058  2010_020  EP08025.005 
Study First Received: February 26, 2010
Results First Received: June 15, 2015
Last Updated: August 17, 2015
Health Authority: Denmark: Danish Medicines Agency

Keywords provided by Merck Sharp & Dohme Corp.:
HIV
antiretroviral treatment
HIV Cohort
Treatment

ClinicalTrials.gov processed this record on February 08, 2016