Observational Data Analysis in EuroSIDA (MK-0518-058)
This study has been completed.
Sponsor:
Merck Sharp & Dohme Corp.
Collaborator:
EuroSIDA Coordinating Centre, Copenhagen HIV Programme (CHIP)
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT01078233
First received: February 26, 2010
Last updated: August 17, 2015
Last verified: August 2015
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Purpose
The main objective of the study is to monitor health outcomes associated with antiretroviral drugs in a population of HIV-infected patients.
| Condition |
|---|
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HIV-1 Infections |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort |
| 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 |
Resource links provided by NLM:
Further study details as provided by Merck Sharp & Dohme Corp.:
Primary Outcome Measures:
- 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) ] [ Designated as safety issue: Yes ]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) ] [ Designated as safety issue: Yes ]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) ] [ Designated as safety issue: Yes ]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) ] [ Designated as safety issue: Yes ]All participant deaths were recorded
| Enrollment: | 6617 |
| Study Start Date: | May 2008 |
| Study Completion Date: | March 2014 |
| Primary Completion Date: | March 2014 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
|---|
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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.
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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.
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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.
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Detailed Description:
Time Perspective: Retrospective and Prospective
Eligibility| Ages Eligible for Study: | 16 Years and older (Child, Adult, Senior) |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Study Population
Adults 16 years old and older in the EuroSIDA database
Criteria
Inclusion Criteria:
- Adults 16 years old and older with HIV-1
Exclusion Criteria:
- Subjects will be excluded if they have no prospective follow up
Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01078233
Please refer to this study by its ClinicalTrials.gov identifier: NCT01078233
Sponsors and Collaborators
Merck Sharp & Dohme Corp.
EuroSIDA Coordinating Centre, Copenhagen HIV Programme (CHIP)
Investigators
| Study Director: | Medical Monitor | Merck Sharp & Dohme Corp. |
More Information
| Responsible Party: | Merck Sharp & Dohme Corp. |
| ClinicalTrials.gov Identifier: | NCT01078233 History of Changes |
| Other Study ID Numbers: | 0518-058 2010_020 EP08025.005 |
| Study First Received: | February 26, 2010 |
| Results First Received: | June 15, 2015 |
| Last Updated: | August 17, 2015 |
| Health Authority: | Denmark: Danish Medicines Agency |
Keywords provided by Merck Sharp & Dohme Corp.:
|
HIV antiretroviral treatment HIV Cohort Treatment |
Additional relevant MeSH terms:
|
Raltegravir Potassium Anti-HIV Agents Anti-Retroviral Agents Antiviral Agents Anti-Infective Agents |
HIV Integrase Inhibitors Integrase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on September 23, 2016