Dettagli per singolo studio

DEC-NET Serial number IT335
See also: FR338
Published online	12/11/2004 10.11.00
Last updated	09/11/2005 14.57.58

Other protocol ID number
Current trial status	Open (actively recruiting new participants)
Major Disease (ICD9 class)	HUMAN IMMUNO VIRUS DIS
Experimental drug
Antiretrovirale therapy Treatment regimen (dosage and duration) N/A
Gender	Both
Age (range)	30 days . 18 years
Eligibility criteria
Inclusion criteria
. Female subjects who are sexually active and able to become pregnant must accept to use the approved birth control methods for the assigned drug regimen under PENPACT 1. In most cases drug regimens mandate the use of two methods of birth control. In these instances hormonal birth control alone would not be considered adequate, or effective. A medically accepted barrier method of contraception (e.g., condom) must also be used during the study. The interaction between study drugs and hormonal birth control has not been studied. . Parent/legally acceptable representative and child, where appropriate, must be able to provide written informed consent, and assent. . Antiretroviral naïve (or have received less than 56 consecutive days after birth of antiviral drugs used to prevent mother-to-infant transmission, and/or no more than two doses of nevirapine) infants, children, and adolescents.
Exclusion criteria
. Current Grade 3 or 4 clinical or laboratory toxicity as defined by age appropriate toxicity table Appendices IV and V (Grade 3 and 4 thrombocytopenia will be allowed only if it is of immunological origin). . Active opportunistic infection and/or serious bacterial infection at the time of study entry. (Children may be enrolled after the acute phase). . History of clinical pancreatitis, peripheral neuropathy, or other clinical, haematological, hepatic, or renal contraindications to receiving the trial therapies [i.e. impossibility to identify either a (2NRTI + PI regimen) or a (2NRTI + NNRTI regimen) that the child can take]. . Current treatment with any medication known to be contra-indicated with any of the drugs to be prescribed for patient.s ART-therapy in this trial [one of the NNRTIs or the selected PI (examples of drugs of this type are listed in Appendix XI)]. . Receipt of any cytotoxic therapy for malignancy. . Pregnancy or breastfeeding.
Trial design/methodology
Phase	3
Kind of study	Efficacy Safety
Design	Randomised Disegno fattoriale
Purpose of study
Primary objectives . To compare the combination of 2 NRTIs plus a protease inhibitor (PI) versus 2 NRTIs plus a non-nucleoside reverse transcriptase inhibitor (NNRTI) as initial therapy, followed by second-line therapy if failure occurs, in terms of their effects on a long-term virological endpoint. . To compare two different viral load criteria for switching from first-line to second-line therapy. Secondary objectives . To evaluate and compare the safety and tolerability of each drug combination (including first- and second-line therapies). . To compare the long-term clinical and immunological outcomes (by the initial randomisation). . To compare the proportions of children who have undergone one regimen switch or reached study end-point (by the initial randomisation). . To compare time from randomisation to virological failure (RNA > 400 copies/mL at or after Week 24) of the first-line therapy analysed by initial randomisation to either protease inhibitor (PI) or NNRTI containing regimens. . To compare time from randomisation to virological failure of the second line therapy (RNA > 30,000 copies/mL) analysed by the initial randomisation. . To compare the proportion of children with plasma HIV-1 RNA < 400 copies/mL at 4 years (by the initial randomisation). . To describe resistance patterns at four years (by the initial randomisation).