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

HIV-1 Infections Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01078233
• Other study ID #: 0518-058
• Secondary ID: 2010_020EP08025.
• Status: Completed
• Start date: May 5, 2008
• Est. completion date: March 6, 2014

Study information

• Verified date: November 2019
• Source: Merck Sharp & Dohme Corp.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

Description:

Time Perspective: Retrospective and Prospective

Recruitment information / eligibility

• Status: Completed
• Enrollment: 6617
• Est. completion date: March 6, 2014
• Est. primary completion date: March 6, 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years and older

Eligibility

Inclusion Criteria:

• Adults 16 years old and older with HIV-1

Exclusion Criteria:

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

Related Conditions & MeSH terms

• HIV-1 Infections

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Merck Sharp & Dohme Corp.	EuroSIDA Coordinating Centre, Copenhagen HIV Programme (CHIP)

References & Publications (1)

Cozzi-Lepri A, Zangerle R, Machala L, Zilmer K, Ristola M, Pradier C, Kirk O, Sambatakou H, Fätkenheuer G, Yust I, Schmid P, Gottfredsson M, Khromova I, Jilich D, Flisiak R, Smidt J, Rozentale B, Radoi R, Losso MH, Lundgren JD, Mocroft A; EuroSIDA Study G — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of Malignancy	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.	Historical Cohort: up to 24 months (January 2006 to December 2007); Raltegravir and Concurrent Cohorts: up to 68 months (December 2007 to July 2013)
Primary	Incidence of Clinically Important Hepatic Events	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.	Historical Cohort: up to 24 months (January 2006 to December 2007); Raltegravir and Concurrent Cohorts: up to 68 months (December 2007 to July 2013)
Primary	Incidence of Lipodystrophy	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.	Historical Cohort: up to 24 months (January 2006 to December 2007); Raltegravir and Concurrent Cohorts: up to 68 months (December 2007 to July 2013)
Primary	Incidence of All-Cause Mortality	All participant deaths were recorded	Historical Cohort: up to 24 months (January 2006 to December 2007); Raltegravir and Concurrent Cohorts: up to 68 months (December 2007 to July 2013)

External Links

•   EUPAS Register (EUPAS17912)