An observational study on growth in HIV-infected children and adolescents on antiretroviral therapy in Europe, with special reference to darunavir (TMC114-EPPICC)

Study identification

• EU PAS number:
  EUPAS9708
• Study ID:
  20959
• Official title and acronym:
  An observational study on growth in HIV-infected children and adolescents on antiretroviral therapy in Europe, with special reference to darunavir (TMC114-EPPICC)
• DARWIN EU® study:
  No
• Study countries:
  Belgium

  Denmark

  France

  Germany

  Greece

  Italy

  Netherlands

  Poland

  Portugal

  Romania

  Russian Federation

  Spain

  Sweden

  Switzerland

  Thailand

  Ukraine

  United Kingdom
• Study description:
  To what extent is the height of HIV-infected children inEurope aged <18 years affected by exposure to adarunavir-based ART regimen?The objectives of this study are to: (i) describe thecharacteristics of HIV-infected children aged <18years in Europe initiating treatment with a combinationART (cART) regimen and ever taking a darunavir containingregimen including a descriptive summary oftheir drug utilization data, (ii) describe change inheight for age z-score (HAZ) pre- and post-darunavirexposure in these children, (iii) compare the change inHAZ in those taking a darunavir-containing regimen tothose taking other non-darunavir containing regimens(if a cohort with similar demographic and clinicalcharacteristics to those taking darunavir can beidentified), while adjusting for potential confoundingfactors including pre-regimen HAZ. Thecharacteristics of the children taking the non-darunavircontaining regimens will also be described.
• Study status:
  Finalised

Research institutions and networks

Institutions

Fondazione PENTA Onlus

Networks

EPPICC

Study timelines

Date when funding contract was signed

Actual:27/03/2011

Study start date

Actual:01/12/2013

Date of final study report

Planned:30/09/2017

Actual:18/08/2017

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)