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

Merck Sharp & Dohme (MSD)

Status: Completed

Conditions: HIV-1 Infections

Study type: Observational

Funder types: Industry; Other

Identifiers

NCT01078233

0518-058

EP08025.005 (Other Identifier)

2010_020 (Other Identifier)

Details and patient eligibility

About

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

Full description

Time Perspective: Retrospective and Prospective

Enrollment: 6,617 patients

Sex: All

Ages: 16+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Adults 16 years old and older with HIV-1

Exclusion criteria

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

Trial design

6,617 participants in 3 patient groups

Raltegravir Cohort

Description:

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

Description:

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

Description:

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.