Observational Safety Data Analysis from Routine Follow-up in the EuroSIDA Study of Patients Treated with Raltegravir in a Five-Year Post Authorization Period (MK-0518-058)

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/18914
• EU PAS number:
  EUPAS17912
• Study ID:
  18914
• Official title and acronym:
  Observational Safety Data Analysis from Routine Follow-up in the EuroSIDA Study of Patients Treated with Raltegravir in a Five-Year Post Authorization Period (MK-0518-058)
• DARWIN EU® study:
  No
• Study countries:
  Argentina

  Austria

  Belarus

  Belgium

  Bulgaria

  Croatia

  Czechia

  Denmark

  Estonia

  Finland

  France

  Germany

  Greece

  Hungary

  Ireland

  Israel

  Italy

  Latvia

  Lithuania

  Luxembourg

  Netherlands

  Norway

  Poland

  Portugal

  Romania

  Russian Federation

  Serbia

  Slovakia

  Spain

  Sweden

  Switzerland

  Ukraine

  United Kingdom
• Study description:
  The purpose of this data analysis is to continue to monitor the safety of raltegravir post-licensure in accordance with the product-specific Risk Management Plan. The main objective of the study was to monitor health outcomes associated with antiretroviral drugs in a population of HIV-infected patients.
• Study status:
  Finalised

Research institution and networks

Institutions

Merck & Co.

Multiple centres: 33 centres are involved in the study

Networks

EuroSIDA Study Group

Study timelines

Date when funding contract was signed

Actual: 08/04/2008

Study start date

Actual: 05/05/2008

Data analysis start date

Actual: 06/03/2014

Date of final study report

Actual: 06/03/2014

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Merck & Co., Inc

Regulatory

• Was the study required by a regulatory body?:
  Yes
• Is the study required by a Risk Management Plan (RMP)?:
  EU RMP category 3 (required)

Other study registration identification numbers and links

NCT01078233