PHARMACOKINETICS AND PHARMACODYNAMICS IN THE OPTIMIZATION OF ANTIRETROVIRAL TREATMENT. - ND

Conditions: Children 2-16 years old with documented vertical HIV-1 infection
MedDRA version: 9.1Level: LLTClassification code 10010504Term: Congenital HIV infection

Registration Number: EUCTR2007-003896-38-IT

Lead Sponsor: AZIENDA OSPEDALIERA UNIVERSITARIA SAN MARTINO GENOVA

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: Not specified

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

None

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.

Secondary Outcome Measures