Dettagli per singolo studio

DEC-NET Serial number IT332

Published online	05/11/2004 13.23.00
Last updated	15/11/2004 10.48.10

Other protocol ID number
Current trial status	Open (actively recruiting new participants)
Major Disease (ICD9 class)	HUMAN IMMUNO VIRUS DIS
Experimental drug
Antiretroviral therapy Treatment regimen (dosage and duration) N/A
Gender	Both
Age (range)	1 month . 17 years
Eligibility criteria
Inclusion criteria
i- confirmed HIV-infected, i.e. positive plasma HIV-1 RNA or DNA test on two consecutive occasions (for children less than 18 months old), or positive HIV serology (for children aged 18 months and older), aged one month to 17 years inclusive ii- parents/guardians, and children where appropriate, are willing and able to give informed consent iii- plasma HIV-1 RNA viral load  1000 copies/ml iv- pre-treated children, including children who have received antiretroviral therapy only as prophylaxis to reduce mother to child transmission, who are prepared to wait for the results of a resistance test before starting new therapy v- starting antiretroviral therapy or switching to a new antiretroviral regimen considered likely to be highly active according to the results of a local resistance test, and containing either a PI or NNRTI or both; that is with . either 3 or more active drugs including a PI and/or NNRTI, . or 2 active drugs: a boosted PI and an NNRTI.
Exclusion criteria
Grade 3 or 4 creatinine or liver function tests
Trial design/methodology
Phase	3
Kind of study	Efficacy Safety Pharmacokinetics
Design	Controlled Randomised
Purpose of study
- To assess the effect of different levels of Therapeutic Drug Monitoring (TDM) compared with no TDM on plasma HIV-1 RNA response in children starting or switching to a new HAART regimen including a protease inhibitor (PI) and/or non-nucleoside reverse transcriptase inhibitor (NNRTI). - To generate age-related population pharmacokinetic models for PIs and NNRTIs used in children. - To describe the impact of a didactic adherence support tool for children taking HAART, which will be offered to centers participating in the trial.