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 type

• Study topic:
  Disease /health condition

  Human medicinal product
• Study type:
  Non-interventional study
• Scope of the study:
  Assessment of risk minimisation measure implementation or effectiveness

  Effectiveness study (incl. comparative)

  Safety study (incl. comparative)
• Data collection methods:
  Secondary use of data

Non-interventional study

• Non-interventional study design:
  Cohort

  Other
• Non-interventional study design, other:
  Descriptive study

Study drug and medical condition

• Study drug International non-proprietary name (INN) or common name:
  LOPINAVIR

  RITONAVIR
• Medical condition to be studied:
  Human immunodeficiency virus transmission

Population studied

• Short description of the study population:
  Children aged 14 days to 2 years with HIV-1 infection treated with Kaletra (lopinavir/ritonavir) oral solution identified from the 8 cohorts across 7 European countries.
• Age groups:
  • Term newborn infants (0 – 27 days)
  • Infants and toddlers (28 days – 23 months)
• Special population of interest:
  Immunocompromised

  Other
• Special population of interest, other:
  Patients with HIV transmission
• Estimated number of subjects:
  14

Study design details

• Main study objective:
  1. Describe characteristics of all children treated with Kaletra (including off-label use) in the EPPICC network in the EMA countries within Europe at or after approval date 26 July 2017. ; 2. Assess appropriateness of Kaletra dose for weight or body surface area using AbbVie Kaletra SmPC as reference. 3. Evaluate safety and tolerability of Kaletra.
• Outcomes:
  Adverse events, including SAEs and AESIs.
• Data analysis plan:
  Data from EPPICC will be summarized using descriptive statistics for the set of all patients and for each of the 4 groups described below. Due to the expected small sample size, graphic summary of individual patient response (e.g. CD4 and HIV-1 RNA viral load over time on Kaletra) may be explored. ; Patients will be categorized to a group based on their age, weight (or body surface area where height data are available), dose, and dosing frequency on the day of first reported Kaletra exposure. ; The 4 groups are as follows: ; Group 1: Licensed: patients 14 days to < 2 years of age initiating on a licensed dose ; Group 2: Unlicensed: patients 14 days to < 2 years of age initiating on an unlicensed dose ; Group 3: Patients < 14 days of age ; Group 4: Patients 14 days to < 2 years of age with missing weight and/or dose data at Kaletra initiation