Trial Information
Post-Licensure Safety Study of ISENTRESS™ in a US Managed Care Network
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
Type of Study:
Observational
Study Design:
Observational Model: Cohort, Time Perspective: Prospective
Outcome Measure:
Incidence of Malignancy (All malignancy collected)
Outcome Time Frame:
January 2000 - December 2014
Safety Issue:
Yes
Principal Investigator
Medical Monitor
Investigator Role:
Study Director
Investigator Affiliation:
Merck
Authority:
United States: Institutional Review Board
Study ID:
0518-268
NCT ID:
NCT01078246
Start Date:
August 2009
Completion Date:
December 2015
Related Keywords:
- HIV-1 Infections
- HIV
- HIV Infections