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

Completed

• Conditions: HIV-1 Infections

• Registration Number: NCT01078233
• Lead Sponsor: Merck Sharp & Dohme LLC

Brief Summary

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

Detailed Description

Time Perspective: Retrospective and Prospective

Study Timeline

• Study Start: 2008-05-05
• Study First Submitted: 2010-02-26
• Study First Submitted QC: 2010-03-01
• Study First Posted: 2010-03-02
• Primary Completion: 2014-03-06
• Study Completion: 2014-03-06
• Results First Submitted: 2015-06-15
• Results First Submitted QC: 2015-08-17
• Results First Posted: 2015-09-17
• Status Verified: 2019-11
• Last Update Submitted: 2019-11-11
• Last Update Posted: 2019-11-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 6617

Inclusion Criteria

• Adults 16 years old and older with HIV-1

Exclusion Criteria

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Incidence of All-Cause Mortality	Historical Cohort: up to 24 months (January 2006 to December 2007); Raltegravir and Concurrent Cohorts: up to 68 months (December 2007 to July 2013)	All participant deaths were recorded
Incidence of Malignancy	Historical Cohort: up to 24 months (January 2006 to December 2007); Raltegravir and Concurrent Cohorts: up to 68 months (December 2007 to July 2013)	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	Historical Cohort: up to 24 months (January 2006 to December 2007); Raltegravir and Concurrent Cohorts: up to 68 months (December 2007 to July 2013)	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	Historical Cohort: up to 24 months (January 2006 to December 2007); Raltegravir and Concurrent Cohorts: up to 68 months (December 2007 to July 2013)	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.