Dettagli per singolo studio

DEC-NET Serial number IT333
See also: ES401
Published online	05/11/2004 14.25.00
Last updated	25/06/2005 14.09.26

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)	2-15 years
Eligibility criteria
Inclusion criteria
- HIV-1 infected children on any ART regimen containing 3 or more drugs which they have taken for at least 24 weeks with confirmed (on 2 occasions at least one month apart) CD4% >30% and HIV-1 RNA <50 copies/ml. - parents/guardians, and children where appropriate, willing and able to give informed consent - children and parents prepared to restart the same ART regimen after treatment interruption if CD4% falls <20% (confirmed on a second sample); children and parents prepared to continue on current therapy until clinical or virological failure if randomised to the continuous therapy arm. - most recent two plasma HIV-1 RNA viral load <50 copies/ml (at least 1 month apart) - most recent two CD4% >30% with TLC>1000 (at least 1 month apart); most recent two CD4% should be stable (different by no more than 4%).
Exclusion criteria
- cannot or unwilling to attend regularly - unwilling to restart ART if CD4 percent or count indicates this is necessary - intercurrent illness (randomisation can take place after the illness) - pregnancy or risk of pregnancy in girls of child-bearing potential
Trial design/methodology
Phase	2
Kind of study	Efficacy Safety Pharmacokinetics
Design	Controlled Randomised
Purpose of study
The overall aim of the PENTA 11 trial is to evaluate the role of planned treatment interruptions in the management of HIV infected children who have responded well to antiretroviral therapy. The specific objectives are: . To determine whether children with chronic HIV infection undergoing planned antiretroviral (ART) treatment interruptions are disadvantaged clinically, immunologically or virologically by periods of time off ART. . To assess HIV-specific immune responses during and after interruptions of ART, compared with continuous ART, in an immunology/virology substudy