Observational Data Analysis in EuroSIDA (MK-0518-058)
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ClinicalTrials.gov Identifier: NCT01078233 |
Recruitment Status
:
Completed
First Posted
: March 2, 2010
Results First Posted
: September 17, 2015
Last Update Posted
: July 11, 2017
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Condition or disease |
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HIV-1 Infections |
Study Type : | Observational |
Actual Enrollment : | 6617 participants |
Observational Model: | Cohort |
Time Perspective: | Other |
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 |
Actual Study Start Date : | May 5, 2008 |
Actual Primary Completion Date : | March 6, 2014 |
Actual Study Completion Date : | March 6, 2014 |

Group/Cohort |
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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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- 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.
- 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

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Ages Eligible for Study: | 16 Years and older (Child, Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
Inclusion Criteria:
- Adults 16 years old and older with HIV-1
Exclusion Criteria:
- Subjects will be excluded if they have no prospective follow up

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01078233
Study Director: | Medical Monitor | Merck Sharp & Dohme Corp. |
Additional Information:
Study Data/Documents: CSR Synopsis

Responsible Party: | Merck Sharp & Dohme Corp. |
ClinicalTrials.gov Identifier: | NCT01078233 History of Changes |
Other Study ID Numbers: |
0518-058 2010_020 ( Other Identifier: Merck ) EP08025.005 ( Other Identifier: Merck ) |
First Posted: | March 2, 2010 Key Record Dates |
Results First Posted: | September 17, 2015 |
Last Update Posted: | July 11, 2017 |
Last Verified: | June 2017 |
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 |