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

Observational Safety Data Analysis From Routine Follow-up in the EuroSIDA Study of Patients Treated With Raltegravir in a Five-Year Post Authorization Period

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

Study Overview

• Status: Completed
• Conditions: HIV-1 Infections

Detailed Description

Time Perspective: Retrospective and Prospective

• Study Type: Observational
• Enrollment (Actual): 6617

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Adults 16 years old and older in the EuroSIDA database

Description

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 Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort
Raltegravir Cohort; 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; 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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)
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)
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)
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)

Collaborators and Investigators

• Sponsor: Merck Sharp & Dohme LLC
• Collaborators: EuroSIDA Coordinating Centre, Copenhagen HIV Programme (CHIP)

Publications and helpful links

General Publications

• Cozzi-Lepri A, Zangerle R, Machala L, Zilmer K, Ristola M, Pradier C, Kirk O, Sambatakou H, Fatkenheuer 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 Group. Incidence of cancer and overall risk of mortality in individuals treated with raltegravir-based and non-raltegravir-based combination antiretroviral therapy regimens. HIV Med. 2018 Feb;19(2):102-117. doi: 10.1111/hiv.12557. Epub 2017 Oct 6.

Helpful Links

• EUPAS Register (EUPAS17912)

Study record dates

Study Major Dates

• Study Start (Actual): May 5, 2008
• Primary Completion (Actual): March 6, 2014
• Study Completion (Actual): March 6, 2014

Study Registration Dates

• First Submitted: February 26, 2010
• First Submitted That Met QC Criteria: March 1, 2010
• First Posted (Estimate): March 2, 2010

Study Record Updates

• Last Update Posted (Actual): November 25, 2019
• Last Update Submitted That Met QC Criteria: November 11, 2019
• Last Verified: November 1, 2019

More Information

Terms related to this study

• Keywords: Treatment; HIV; antiretroviral treatment; HIV Cohort
• Other Study ID Numbers: 0518-058; 2010_020 (Other Identifier: Merck); EP08025.005 (Other Identifier: Merck)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf

Study Data/Documents

1. CSR Synopsis