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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
ClinicalTrials.gov Identifier:
NCT01078246
First received: February 26, 2010
Last updated: February 27, 2013
Last verified: February 2010
History of Changes
  Purpose

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


Condition
HIV-1 Infections

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Post-Licensure Safety Study of ISENTRESS™ in a US Managed Care Network

Resource links provided by NLM:

MedlinePlus related topics: HIV/AIDS
U.S. FDA Resources

Further study details as provided by Merck:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 1000
Study Start Date: August 2009
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Adults 18 years old and older

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01078246

Sponsors and Collaborators
Merck
Kaiser Permanente
Investigators
Study Director: Medical Monitor Merck
  More Information

No publications provided

Responsible Party: Merck
ClinicalTrials.gov Identifier: NCT01078246     History of Changes
Other Study ID Numbers: 0518-268, MK0518, EP08025.006, 2010_021
Study First Received: February 26, 2010
Last Updated: February 27, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Merck:
HIV

Additional relevant MeSH terms:
HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
 Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases

ClinicalTrials.gov processed this record on May 19, 2013