Pharmacovigilance study to define the long term safety profile of etravirine in HIV-infected children and adolescents in Europe

Study identification

• EU PAS number:
  EUPAS12694
• Study ID:
  28451
• Official title and acronym:
  Pharmacovigilance study to define the long term safety profile of etravirine in HIV-infected children and adolescents in Europe
• DARWIN EU® study:
  No
• Study countries:
  Belgium

  Germany

  Ireland

  Italy

  Poland

  Portugal

  Romania

  Russian Federation

  Spain

  Sweden

  Switzerland

  Thailand

  United Kingdom
• Study description:
  Etravirine (ETR, Intelence®), a non-nucleoside reverse transcriptase inhibitor, is indicated in Europe for use in antiretroviral treatment experienced patients aged ≥6 years. Little is known about the “real life” use and safety of ETR in the European population of HIV-infected childrenand adolescents. The Committee for Medicinal Products for Human Use (CHMP) has highlighted the need for a post-marketing surveillance study of ETR use in the paediatric population. Janssen-Cilag International NV has approached the PENTA Foundation/ European Pregnancy and Paediatric HIV Cohort Collaboration (EPPICC) about establishing such a study inHIV-infected children and adolescents living in Europe. The aim of this study is to collect long-term safety data on ETR use in children and adolescents with HIV infection in a “real world” setting in Europe . The objectives include describing incidence of serious and non-serious adverse events while on ETR and off-label use of ETR in children. This is an observational study involving the pooled analysis of individual patient data from prospective cohort studies participating in the EPPICC pharmacovigilance programme. In recent years this programme has expanded to include collaborating cohorts in Thailand and South Africa.
• Study status:
  Finalised

Research institutions and networks

Institutions

Medical Research Council (MRC) Clinical Trials Unit at UCL on behalf of EPPICC/PENTA

Networks

European Pregnancy and Paediatric HIV Cohort Collaboration (EPPICC)

Study timelines

Date when funding contract was signed

Actual:15/03/2013

Study start date

Actual:31/01/2014

Date of final study report

Planned:03/09/2018

Actual:16/07/2018

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Janssen-Cilag International NV

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)