A study with Kaletra to compare concentration levels in the human body of Kaletra-softgel capsules or –suspension to Kaletra-tablets in pediatric patients – C2T

• Register: EUCTR
• Last refreshed on: 2 June 2014
• Main ID: EUCTR2010-021622-35-DE
• Date of registration: 06/06/2011
• Prospective Registration: Yes
• Primary sponsor: Dean of Medical Faculty of Goethe University Frankfurt
• Public title: A study with Kaletra to compare concentration levels in the human body of Kaletra-softgel capsules or –suspension to Kaletra-tablets in pediatric patients – C2T
• Scientific title: A monocenter, non-controlled, non-randomized IST to compare bioavailability of Kaletra softgelcapsules or -suspension to Kaletra tablets in pediatric patients – C2T - C2T
• Date of first enrolment: 11/08/2011
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2010-021622-35
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: no Randomised: no Open: no Single blind: no Double blind: no Parallel group: no Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: no Other: no

Countries of recruitment

Germany

Contacts

• Name: Principal investigator- Dr Koenigs
• Affiliation: University Hospital of Goethe University Frankfurt

• Name: Principal investigator- Dr Koenigs
• Affiliation: University Hospital of Goethe University Frankfurt

Key inclusion & exclusion 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:
- 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.


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Therapeutic area: Diseases [C] - Virus Diseases [C02]

Pediatric patients with diagnosed HIV1- infection aged 3 to 18 years

Intervention(s)

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
Concentration number: 100-
INN or Proposed INN: RITONAVIR
CAS Number: 155213-67-5
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 25-

Trade Name: Kaletra 200mg/50mg
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: LOPINAVIR
CAS Number: 192725-17-0
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 200-
INN or Proposed INN: RITONAVIR
CAS Number: 155213-67-5
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 50-

Primary Outcome(s)

Main Objective: Comparison of pharmakokinetic parameters of the different formulations (tablets, capules and oral solution)

Primary end point(s): comparison of pharmakological parameters Cmax, AUC, Ctrough, tmax between the different formulation (tablets, capsules, oral solution)

Secondary Objective: Correlation between cognitive abilities of a subpopulation of patients with pharmacological, virological and immunological results

Timepoint(s) of evaluation of this end point: timepoints 0, 1, 2, 3, 4, 6, 8, 10, 12 hours after medication

Secondary Outcome(s)

Secondary end point(s): neurocognitive examination incl. "Hamburger-Wechsler-Intelligenztest für Kinder IV (HAWIK-IV)"

Timepoint(s) of evaluation of this end point: at the day of the pharmakokinetic assessment

Secondary ID(s)

C2T

Source(s) of Monetary Support

Abbott GmbH

Ethic committee, university hospital goethe university