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

This study has been completed.
Sponsor:
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
Results First Received: June 15, 2015  
Study Type: Observational
Study Design: Observational Model: Cohort
Condition: HIV-1 Infections

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
The analyses in this study are based on data collected from a cohort of HIV-1-infected participants in a setting of routine clinical care in Europe (EuroSIDA Cohort Study). Participants could contribute data to more than one cohort, but no overlap in follow-up time was allowed.

Reporting Groups
  Description
Raltegravir Cohort Only Participants with HIV-1 infection who started raltegravir on or after 21 December 2007 (the authorization date in the European Union). Participants had no previous exposure to the new drug and had at least 1 month prospective follow-up in this cohort. These participants contributed data only to the Raltegravir Cohort.
Historical and Raltegravir Cohorts Only Participants with HIV-1 infection who 1) 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 and had at least 1 month prospective follow-up in the Historical Cohort, and 2) started raltegravir on or after 21 December 2007 and had at least 1 month prospective follow-up in the Raltegravir Cohort. These participants contributed data to the Historical Cohort and the Raltegravir Cohort.
Historical Cohort Only Participants with HIV-1 infection who started a new antiretroviral drug as part of a cART regimen on or after 1 January 2006 and before 21 December 2007 and had at least 1 month prospective follow-up in this cohort. These participants contributed data only to the Historical Cohort.
Historical and Concurrent Cohorts Participants with HIV-1 infection who 1) started a new antiretroviral drug as part of a cART regimen on or after 1 January 2006 and before 21 December 2007 and had at least 1 month prospective follow-up in the Historical Cohort, and 2) started a new antiretroviral drug other than raltegravir as part of a cART regimen on or after 21 December 2007, had no previous exposure to the new drug and had at least 1 month prospective follow-up in the Concurrent Cohort. These participants contributed data to the Historical Cohort and the Concurrent Cohort.
Concurrent Cohort Only 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, had no previous exposure to the new drug and had at least 1 month prospective follow-up in the Concurrent Cohort. These participants contributed data only to the Concurrent Cohort.
Concurrent and Raltegravir Cohorts Only Participants with HIV-1 infection who 1) started a new antiretroviral drug other than raltegravir as part of a cART regimen on or after 21 December 2007, had no previous exposure to the new drug and had at least 1 month prospective follow-up in the Concurrent Cohort, and 2) started raltegravir on or after 21 December 2007 and had at least 1 month prospective follow-up in the Raltegravir Cohort. These participants contributed data to the Concurrent Cohort and the Raltegravir Cohort.

Participant Flow:   Overall Study
    Raltegravir Cohort Only     Historical and Raltegravir Cohorts Only     Historical Cohort Only     Historical and Concurrent Cohorts     Concurrent Cohort Only     Concurrent and Raltegravir Cohorts Only  
STARTED     656     296     1681     631     3199     154  
COMPLETED     656     296     1681     631     3199     154  
NOT COMPLETED     0     0     0     0     0     0  



  Baseline Characteristics
  Hide Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Raltegravir Cohort Only Participants with HIV-1 infection who started raltegravir on or after 21 December 2007 (the authorization date in the European Union). Participants had no previous exposure to the new drug and had at least 1 month prospective follow-up in this cohort. These participants contributed data only to the Raltegravir Cohort.
Historical and Raltegravir Cohorts Only Participants with HIV-1 infection who 1) 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 and had at least 1 month prospective follow-up in the Historical Cohort, and 2) started raltegravir on or after 21 December 2007 and had at least 1 month prospective follow-up in the Raltegravir Cohort. These participants contributed data to the Historical Cohort and the Raltegravir Cohort.
Historical Cohort Only Participants with HIV-1 infection who started a new antiretroviral drug as part of a cART regimen on or after 1 January 2006 and before 21 December 2007 and had at least 1 month prospective follow-up in this cohort. These participants contributed data only to the Historical Cohort.
Historical and Concurrent Cohorts Participants with HIV-1 infection who 1) started a new antiretroviral drug as part of a cART regimen on or after 1 January 2006 and before 21 December 2007 and had at least 1 month prospective follow-up in the Historical Cohort, and 2) started a new antiretroviral drug other than raltegravir as part of a cART regimen on or after 21 December 2007, had no previous exposure to the new drug and had at least 1 month prospective follow-up in the Concurrent Cohort. These participants contributed data to the Historical Cohort and the Concurrent Cohort.
Concurrent Cohort Only 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, had no previous exposure to the new drug and had at least 1 month prospective follow-up in the Concurrent Cohort. These participants contributed data only to the Concurrent Cohort.
Concurrent and Raltegravir Cohorts Only Participants with HIV-1 infection who 1) started a new antiretroviral drug other than raltegravir as part of a cART regimen on or after 21 December 2007, had no previous exposure to the new drug and had at least 1 month prospective follow-up in the Concurrent Cohort, and 2) started raltegravir on or after 21 December 2007 and had at least 1 month prospective follow-up in the Raltegravir Cohort. These participants contributed data to the Concurrent Cohort and the Raltegravir Cohort.
Total Total of all reporting groups

Baseline Measures
    Raltegravir Cohort Only     Historical and Raltegravir Cohorts Only     Historical Cohort Only     Historical and Concurrent Cohorts     Concurrent Cohort Only     Concurrent and Raltegravir Cohorts Only     Total  
Number of Participants  
[units: participants]
  656     296     1681     631     3199     154     6617  
Age  
[units: Years]
Median (Inter-Quartile Range)
  49   (44 to 55)     49   (44 to 55)     44   (39 to 50)     47   (41 to 53)     42   (34 to 50)     50   (45 to 57)     44   (37 to 51)  
Gender  
[units: Participants]
             
Female     176     72     422     174     873     27     1744  
Male     480     224     1259     457     2326     127     4873  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   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) ]

2.  Primary:   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) ]

3.  Primary:   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) ]

4.  Primary:   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) ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information
  Hide More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Senior Vice President, Global Clinical Development
Organization: Merck Sharp & Dohme Corp.
phone: 1-800-672-6372
e-mail: ClinicalTrialsDisclosure@merck.com


No publications provided


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 )
Study First Received: February 26, 2010
Results First Received: June 15, 2015
Last Updated: August 17, 2015
Health Authority: Denmark: Danish Medicines Agency