European Pregnancy and Pediatric HIV Cohort Collaboration (EPPICC) study assessing the safety and efficacy of Kaletra oral solution in children aged 14 days to 2 years with HIV-1 infection in Europe

Study summary

No information provided.

Study identification

• EU PAS number:
  EUPAS32607
• Study ID:
  48122
• Official title and acronym:
  European Pregnancy and Pediatric HIV Cohort Collaboration (EPPICC) study assessing the safety and efficacy of Kaletra oral solution in children aged 14 days to 2 years with HIV-1 infection in Europe
• DARWIN EU® study:
  No
• Study countries:
  Belgium

  Denmark

  Greece

  Ireland

  Italy

  Poland

  Spain

  United Kingdom
• Study description:
  This study describes the characteristics of children aged less than 2 years of age while treated with Kaletra oral solution at or after the approval date of 26 July 2017 in the European Medicines Agency (EMA) scope of authority within Europe. ; The study also assesses the appropriateness of Kaletra oral formulation dose for weight or body surface area while under 2 years and the safety and tolerability of Kaletra in children under 2 years of age by describing adverse events experienced while on Kaletra, in particular in relation to propylene glycol or ethanol toxicity. ; In addition, the study also assesses the immune and virological response to Kaletra-containing therapy and the incidence and reasons for discontinuation of Kaletra.
• Study status:
  Finalised

Research institutions and networks

Institutions

Multiple centres: 8 centres are involved in the study

Networks

PENTA & EPPICC

Study timelines

Date when funding contract was signed

Actual:17/12/2018

Study start date

Actual:01/01/2019

Date of final study report

Planned:30/06/2022

Actual:15/09/2021

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

AbbVie

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

P19-106