Post-Licensure Safety Study of ISENTRESS™ (Raltegravir) in a United States Managed Care Network (MK-0518-268)

This study has been completed.
Sponsor:
Collaborator:
Kaiser Permanente
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT01078246
First received: February 26, 2010
Last updated: March 9, 2016
Last verified: March 2016
Results First Received: March 9, 2016  
Study Type: Observational
Study Design: Observational Model: Cohort;   Time Perspective: Retrospective
Condition: HIV-1 Infections

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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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 human immunodeficiency virus (HIV-1)-infected participants in a setting of routine clinical care at the Kaiser Permanente medical centers in California, United States. 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 received raltegravir (RAL) on or after 12 October 2007 (the market authorization date in the United States) (Raltegravir Cohort). These participants contributed data to the Raltegravir Cohort only.
Historical and Raltegravir Cohorts Only Participants with HIV-1 infection who 1) received antiretroviral therapy (non-RAL) between 1 January 2005 and 11 October 2007 (Historical Cohort), and 2) received RAL on or after 12 October 2007 (Raltegravir Cohort). These participants contributed data to the Historical and Raltegravir Cohorts only.
Historical Cohort Only Participants with HIV-1 infection who received antiretroviral therapy (non-RAL) between 1 January 2005 and 11 October 2007 (Historical Cohort). These participants contributed data to the Historical Cohort only.
Historical and Concurrent Cohorts Only Participants with HIV-1 infection who 1) received antiretroviral therapy (non-RAL) between 1 January 2005 and 11 October 2007 (Historical Cohort), and 2) received therapy with a new non-RAL antiretroviral therapy after 12 October 2007 (Concurrent Cohort). These participants contributed data to the Historical and Concurrent Cohorts only.
Concurrent Cohort Only Participants with HIV-1 infection who received therapy with a new non-RAL antiretroviral therapy after 12 October 2007 (Concurrent Cohort). These participants contributed data to the Concurrent Cohort only.
Concurrent and Raltegravir Cohorts Only Participants with HIV-1 infection who 1) received therapy with a new non-RAL antiretroviral therapy on or after 12 October 2007 (Concurrent Cohort), and 2) received RAL after 12 October 2007 (Raltegravir Cohort). These participants contributed data to the Concurrent and Raltegravir Cohorts only.
Historical, Concurrent and Raltegravir Cohorts Participants with HIV-1 infection who 1) received antiretroviral therapy (non-RAL) between 1 January 2005 and 11 October 2007 (Historical Cohort), 2) received therapy with a new non-RAL antiretroviral therapy on or after 12 October 2007 (Concurrent Cohort), and 3) received RAL after 12 October 2007 (Raltegravir Cohort). These participants contributed data to all three cohorts.

Participant Flow:   Overall Study
    Raltegravir Cohort Only     Historical and Raltegravir Cohorts Only     Historical Cohort Only     Historical and Concurrent Cohorts Only     Concurrent Cohort Only     Concurrent and Raltegravir Cohorts Only     Historical, Concurrent and Raltegravir Cohorts  
STARTED     1041     405     1963     152     3310     231     22  
COMPLETED     1041     405     1963     152     3310     231     22  
NOT COMPLETED     0     0     0     0     0     0     0  



  Baseline Characteristics
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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.
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Reporting Groups
  Description
Raltegravir Cohort Only Participants with HIV-1 infection who received raltegravir (RAL) on or after 12 October 2007 (the market authorization date in the United States) (Raltegravir Cohort). These participants contributed data to the Raltegravir Cohort only.
Historical and Raltegravir Cohorts Only Participants with HIV-1 infection who 1) received antiretroviral therapy (non-RAL) between 1 January 2005 and 11 October 2007 (Historical Cohort), and 2) received RAL on or after 12 October 2007 (Raltegravir Cohort). These participants contributed data to the Historical and Raltegravir Cohorts only.
Historical Cohort Only Participants with HIV-1 infection who received antiretroviral therapy (non-RAL) between 1 January 2005 and 11 October 2007 (Historical Cohort). These participants contributed data to the Historical Cohort only.
Historical and Concurrent Cohorts Only Participants with HIV-1 infection who 1) received antiretroviral therapy (non-RAL) between 1 January 2005 and 11 October 2007 (Historical Cohort), and 2) received therapy with a new non-RAL antiretroviral therapy after 12 October 2007 (Concurrent Cohort). These participants contributed data to the Historical and Concurrent Cohorts only.
Concurrent Cohort Only Participants with HIV-1 infection who received therapy with a new non-RAL antiretroviral therapy after 12 October 2007 (Concurrent Cohort). These participants contributed data to the Concurrent Cohort only.
Concurrent and Raltegravir Cohorts Only Participants with HIV-1 infection who 1) received therapy with a new non-RAL antiretroviral therapy on or after 12 October 2007 (Concurrent Cohort), and 2) received RAL after 12 October 2007 (Raltegravir Cohort). These participants contributed data to the Concurrent and Raltegravir Cohorts only.
Historical, Concurrent and Raltegravir Cohorts Participants with HIV-1 infection who 1) received antiretroviral therapy (non-RAL) between 1 January 2005 and 11 October 2007 (Historical Cohort), 2) received therapy with a new non-RAL antiretroviral therapy on or after 12 October 2007 (Concurrent Cohort), and 3) received RAL after 12 October 2007 (Raltegravir Cohort). These participants contributed data to all three cohorts.
Total Total of all reporting groups

Baseline Measures
    Raltegravir Cohort Only     Historical and Raltegravir Cohorts Only     Historical Cohort Only     Historical and Concurrent Cohorts Only     Concurrent Cohort Only     Concurrent and Raltegravir Cohorts Only     Historical, Concurrent and Raltegravir Cohorts     Total  
Number of Participants  
[units: participants]
  1041     405     1963     152     3310     231     22     7124  
Age  
[units: Years]
Mean (Standard Deviation)
  48.2  (10.7)     49.2  (10.0)     45.8  (10.1)     44.9  (9.9)     43.0  (11.5)     46.8  (12.4)     45.5  (9.9)     45.0  (11.1)  
Gender  
[units: Participants]
               
Female     121     41     195     23     340     33     4     757  
Male     920     364     1768     129     2970     198     18     6367  



  Outcome Measures
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1.  Primary:   Incidence of AIDS-defining and Non-AIDS-defining Malignancy   [ Time Frame: Historical Cohort: up to 33 months (January 2005 to October 2007); Raltegravir and Concurrent Cohorts: up to 69 months (October 2007 to June 2013) ]

2.  Primary:   Incidence of Clinically Important Hepatic Events   [ Time Frame: Historical Cohort: up to 33 months (January 2005 to October 2007); Raltegravir and Concurrent Cohorts: up to 69 months (October 2007 to June 2013) ]

3.  Primary:   Incidence of Clinically Important Skin Events   [ Time Frame: Historical Cohort: up to 33 months (January 2005 to October 2007); Raltegravir and Concurrent Cohorts: up to 69 months (October 2007 to June 2013) ]

4.  Primary:   Incidence of Clinically Important Muscle Events   [ Time Frame: Historical Cohort: up to 33 months (January 2005 to October 2007); Raltegravir and Concurrent Cohorts: up to 69 months (October 2007 to June 2013) ]

5.  Primary:   Incidence of Lipodystrophy   [ Time Frame: Historical Cohort: up to 33 months (January 2005 to October 2007); Raltegravir and Concurrent Cohorts: up to 69 months (October 2007 to June 2013) ]

6.  Secondary:   Incidence of Clinically Important Cardiovascular Events   [ Time Frame: Historical Cohort: up to 33 months (January 2005 to October 2007); Raltegravir and Concurrent Cohorts: up to 69 months (October 2007 to June 2013) ]

7.  Secondary:   Incidence of All-cause Mortality   [ Time Frame: Historical Cohort: up to 33 months (January 2005 to October 2007); Raltegravir and Concurrent Cohorts: up to 69 months (October 2007 to June 2013) ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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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
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  More Information
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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



Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT01078246     History of Changes
Other Study ID Numbers: 0518-268
EP08025.006 ( Other Identifier: Merck )
2010_021 ( Other Identifier: Merck )
Study First Received: February 26, 2010
Results First Received: March 9, 2016
Last Updated: March 9, 2016
Health Authority: United States: Institutional Review Board