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

NCT ID: NCT01078233

Last Updated: 2019-11-25

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

6617 participants

Study Classification

OBSERVATIONAL

Study Start Date

2008-05-05

Study Completion Date

2014-03-06

Brief Summary

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

Detailed Description

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Time Perspective: Retrospective and Prospective

Conditions

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HIV-1 Infections

Study Design

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Observational Model Type

COHORT

Study Time Perspective

OTHER

Study Groups

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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.

No interventions assigned to this group

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.

No interventions assigned to this group

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.

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Adults 16 years old and older with HIV-1

Exclusion Criteria

* Subjects will be excluded if they have no prospective follow up
Minimum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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EuroSIDA Coordinating Centre, Copenhagen HIV Programme (CHIP)

UNKNOWN

Sponsor Role collaborator

Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Medical Monitor

Role: STUDY_DIRECTOR

Merck Sharp & Dohme LLC

References

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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.

Reference Type RESULT
PMID: 28984429 (View on PubMed)

Study Documents

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Document Type: CSR Synopsis

View Document

Related Links

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Other Identifiers

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2010_020

Identifier Type: OTHER

Identifier Source: secondary_id

EP08025.005

Identifier Type: OTHER

Identifier Source: secondary_id

0518-058

Identifier Type: -

Identifier Source: org_study_id

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