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

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

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Key information

Conditions

HIV-1 Infections

Age range

16 year and older

Sex eligibility

All sexes

Study type

Observational

About this study

Time Perspective: Retrospective and Prospective

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Adults 16 years old and older with HIV-1

Exclusion criteria

Subjects will be excluded if they have no prospective follow up

Treatment and study plan

Primary outcomes

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)

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)

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)

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)

All participant deaths were recorded

Sponsors and collaborators

Lead sponsor

Merck Sharp & Dohme LLC

Industry

Collaborators

Copenhagen HIV Programme

Registry information

Official study 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

Important dates

Study start: 2008
Primary completion: 2014
Study completion: 2014
First posted: Mar 2, 2010
Registry last updated: Nov 25, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed