Pediatric patients with diagnosed HIV1- infection aged 3 to 18 years
Conditions
Interventions
Trade Name: Kaletra 100mg/25mg
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: LOPINAVIR
CAS Number: 192725-17-0
Concentration unit: mg milligram(s)
Concentration type: equal
Concentratio
Sponsors
Dean of Medical Faculty of Goethe University Frankfurt
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - male and female patients aged between 3 and 18 years - secured diagnosis of HIV1 - infection - actual therapy with Kaletra®-Tablets lasting for a minimum of 4 weeks and prior therapy for at least 4 weeks with Kaletra®-capsules or Kaletra®-solution - documented pharmacokinetic investigation under Kaletra®-capsules or Kaletra®-solution treatment (retrospective data) - Informed consent and assent Are the trial subjects under 18? yes Number of subjects for this age range: 15 F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: - Non-Compliance - Co-Therapy with Nevirapine, Efavirenz, Tipranavir, Darunavir or Fosamprenavir - Hämophilie A - intended or existing pregnancy or breastfeeding mother - Vomitting or diarrhoe > grade 1 DAIDS-AE-listing or actual bacterial or viral infection with fever, liver or renal dysfunction - existence or appearence of contraindications as described in the SmPC (potential study participants are already under therapy with Kaletra before study start and will therefore be checked for contraindications, which will be checked again before inclusion: hypersensitivity (allergic) to lopinavir, ritonavir or any of the other ingredients, severe liver disease, medicines that are broken down by P450 Isoenzym CYP3A, Intake of St John’s wort - condition that would rule out the participation in the clinical trial at the discretion of the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Comparison of pharmakokinetic parameters of the different formulations (tablets, capules and oral solution);Secondary Objective: Correlation between cognitive abilities of a subpopulation of patients with pharmacological, virological and immunological results ;Primary end point(s): comparison of pharmakological parameters Cmax, AUC, Ctrough, tmax between the different formulation (tablets, capsules, oral solution);Timepoint(s) of evaluation of this end point: timepoints 0, 1, 2, 3, 4, 6, 8, 10, 12 hours after medication | — |
Secondary
| Measure | Time frame |
|---|---|
| Timepoint(s) of evaluation of this end point: at the day of the pharmakokinetic assessment;Secondary end point(s): neurocognitive examination incl. "Hamburger-Wechsler-Intelligenztest für Kinder IV (HAWIK-IV)" | — |
Countries
Germany
Contacts
Public ContactPrincipal investigator- Dr Koenigs
University Hospital of Goethe University Frankfurt
Outcome results
None listed