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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Kaiser Permanente
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT01078246
First received: February 26, 2010
Last updated: August 13, 2014
Last verified: August 2014

February 26, 2010
August 13, 2014
August 2009
December 2015   (final data collection date for primary outcome measure)
  • Incidence of Malignancy (All malignancy collected) [ Time Frame: January 2000 - December 2014 ] [ Designated as safety issue: Yes ]
  • Incidence of Significant hepatic events [ Time Frame: January 2000 - December 2014 ] [ Designated as safety issue: Yes ]
  • Incidence of Significant skin events [ Time Frame: January 2000 - December 2014 ] [ Designated as safety issue: Yes ]
  • Incidence of Significant muscle events [ Time Frame: January 2000 - December 2014 ] [ Designated as safety issue: Yes ]
  • Incidence of Lipodystrophy [ Time Frame: January 2000 - December 2014 ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01078246 on ClinicalTrials.gov Archive Site
  • Incidence of Significant cardiovascular events [ Time Frame: January 2000 - December 2014 ] [ Designated as safety issue: Yes ]
  • Incidence of all-cause mortality [ Time Frame: January 2000 - December 2014 ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Post-Licensure Safety Study of ISENTRESS™ in a US Managed Care Network (MK-0518-268)
Post-Licensure Safety Study of ISENTRESS™ in a US Managed Care Network

The objective of this study is to monitor Health Outcomes of Interest (HOI) following treatment with Raltegravir.

Not Provided
Observational
Observational Model: Cohort
Time Perspective: Retrospective
Not Provided
Not Provided
Non-Probability Sample

Adults 18 years old and older

HIV-1 Infections
Not Provided
  • Raltegravir
    HIV-infected patients from the Kaiser Permanente (KP) medical centers treated with RAL in the course of ordinary clinical practice
  • Historical comparison cohort
    An observational cohort of HIV-infected patients receiving treatment with antiretroviral therapy at KP between January 1, 2000 and October 12, 2007
  • Concurrent comparison cohort
    A post-licensure concurrent comparison cohort of HIV-infected patients receiving treatment with a new antiretroviral therapy at KP after licensure of RAL, and not receiving treatment with RAL after licensure
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
1000
December 2015
December 2015   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • All HIV-infected patients treated with RAL in the course of ordinary clinical practice at the clinics and medical centers of Kaiser Permanente (KP) during the study period will be included in the study
  • Subjects must have at least one year of continuous membership with KP prior to index date to allow for the assessment of medical and treatment history

Exclusion Criteria:

  • Patients less than 18 years of age
  • KP HIV-infected patients who do not receive their medications through the KP pharmacy system
  • KP HIV-infected patients who do not receive their laboratory examinations through the KP system
  • Patients participating in the phase III or expanded access program
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT01078246
0518-268, MK0518, EP08025.006, 2010_021
Yes
Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
Kaiser Permanente
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
August 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP