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

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/17982
• EU PAS number:
  EUPAS17981
• Study ID:
  17982
• Official title and acronym:
  Post-Licensure Safety Study of ISENTRESS™ in a US Managed Care Network
• DARWIN EU® study:
  No
• Study countries:
  United States
• Study description:
  The objective of this study is to monitor Health Outcomes of Interest (HOI) in participants with human immunodeficiency virus-1 (HIV-1) infection following treatment with raltegravir. Study participants contributed data to one or more of 3 cohorts: 1) Historical Cohort: HIV-infected participants treated with antiretroviral therapy in the course of ordinary clinical practice at the clinics and medical centers of Kaiser Permanente (KP) between 1 January 2000 and 12 October 2007 (date of market authorization for raltegravir in USA), 2) Concurrent Cohort: HIV-infected participants treated with a new non-raltegravir antiretroviral therapy in the course of ordinary clinical practice at the clinics and medical centers of KP on or after 12 October 2007, and 3) Raltegravir Cohort: HIV-infected participants treated with raltegravir in the course of ordinary clinical practice at the clinics and medical centers of KP on or after 12 October 2007. Participants could contribute data to more than one cohort, but no overlap in follow-up time was allowed.
• Study status:
  Finalised

Research institutions and networks

Institutions

Merck & Co.

Kaiser Permanente Northern California Division of Research

Study timelines

Date when funding contract was signed

Actual: 21/04/2008

Study start date

Actual: 31/08/2009

Data analysis start date

Actual: 09/12/2014

Date of final study report

Actual: 09/12/2014

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Merck Sharp & Dohme Corp.

Regulatory

• Was the study required by a regulatory body?:
  No
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable

Other study registration identification numbers and links

NCT01078246