Children 2-16 years old with documented vertical HIV-1 infection MedDRA version: 9.1 Level: LLT Classification code 10010504 Term: Congenital HIV infection
Conditions
Interventions
Trade Name: KALETRA
Pharmaceutical Form: Capsule, soft
INN or Proposed INN: LOPINAVIR
CAS Number: 192725-17-0
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 133.3-
Sponsors
AZIENDA OSPEDALIERA UNIVERSITARIA SAN MARTINO GENOVA
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Children >2 and =16 years old, with documented vertical HIV-1 infection and stable antiretroviral therapy (HAART) containing lopinavir or atazanavir or fosamprenavir (all PIs can be associated to ritonavir) or nevirapine o efavirez plus a backbone with nucleoside analogue reverse transcriptase inhibitor (NRTI). Written informed consent will be obtained from parents or guardians Are the trial subjects under 18? yes Number of subjects for this age range: 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: None
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Inter-individual and intra-individual plasma concentrations of used PIs and NNRTIs paedriatic patients.;Secondary Objective: - Trough concentration, baseline resistence mutations, and GIQ. - Comparative evaluation of drug concentration in plasma, baseline resistance mutations, and GIQ in their capability of predictig virologic and immunologic response to treatment. - Comparative evaluation of drug concentration in plasma and side effects. - Drugs and food interaction with HAART. - Adherence to antiviral therapy.;Primary end point(s): Monitoring frequent sampling of plasma concentrations of the most important and used PIs and NNRTIs in the paediatric patients, defining the interaction between pharmacokinetics and resistance, and monitoring adherence and the development of mutations. | — |
Countries
Italy
Outcome results
None listed