Know Cancer

or
forgot password

Post-Licensure Safety Study of ISENTRESS™ in a US Managed Care Network


N/A
18 Years
N/A
Open (Enrolling)
Both
HIV-1 Infections

Thank you

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

Name

Location