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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:
Merck
ClinicalTrials.gov Identifier:
NCT01078233
First received: February 26, 2010
Last updated: March 15, 2013
Last verified: March 2013
History of Changes
  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:

MedlinePlus related topics: HIV/AIDS
U.S. FDA Resources

Further study details as provided by Merck:

Primary Outcome Measures:
  • 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 ]

Estimated Enrollment: 1000
Study Start Date: May 2008
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
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

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01078233

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

No publications provided

Responsible Party: Executive Vice President, Clinical and Quantitative Sciences, 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
Last Updated: March 15, 2013
Health Authority: Denmark: Danish Medicines Agency

Keywords provided by Merck:
HIV
antiretroviral treatment
HIV Cohort
Treatment

Additional relevant MeSH terms:
HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
 Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases

ClinicalTrials.gov processed this record on May 21, 2013