Observational Safety Data Analysis From Routine Follow-up in the EuroSIDA Study of Patients Treated With Raltegravir in a Five-Year Post Authorization Period
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Merck Sharp & Dohme LLC
- Enrollment
- 6,617
- Primary Endpoint
- Incidence of All-Cause Mortality
Study Overview
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 Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Other
Eligibility Criteria
- Ages
- 16 Years to — (Child, Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Adults 16 years old and older with HIV-1
Exclusion Criteria
- •Subjects will be excluded if they have no prospective follow up
Outcomes
Primary Outcomes
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
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.
Secondary Outcomes
No secondary outcomes reported