Dettagli per singolo studio

DEC-NET Serial number FR337

Published online	18/11/2004 17.10.00
Last updated	06/09/2005 11.19.09

Other protocol ID number
Current trial status	Complete(closed to recruitment of participants: follow-up complete)
Major Disease (ICD9 class)	HUMAN IMMUNODEFICIENCY VIRUS (HIV) DISEASE
Experimental drug
lamivudine Treatment regimen (dosage and duration) 8 mg/kg/day in two divided doses
zidovudine Treatment regimen (dosage and duration) 360 mg/m2/day in two or three divided doses
abacavir Treatment regimen (dosage and duration) 16 mg/kg/day in two divided doses
nelfinavir Treatment regimen (dosage and duration) 75-90 mg/kg/day in three divided doses
Gender	Both
Age (range)	3 months -16 years
Eligibility criteria
Inclusion criteria
HIV + children, who nerver received antiretroviral treatment (except in-utero or for perinatal prophylaxis up to 6 weeks after delivery) with materno-fetal transmission ou contaminated by transfusion
Exclusion criteria
children previously treated with cytotoxics for a malignant disease or having haematological, hepatic, or renal contra-indications to abacavir, zidovudine, lamivudine or nelfinavir.
Trial design/methodology
Phase	2
Kind of study	Efficacy Safety
Design	Controlled Randomised Blinded Single blind blinded partially
Purpose of study
Primary objective : To compare the toxicity, tolerance and activity of 3 dual combinations of NRTIs (zidovudine + lamivudine, zidovudine + abacavir, abacavir +lamivudine) in children receiving nelfinavir (NFV) or placebo (Part A) and in those receiving NFV (Part B); To evaluate the tolerance and toxicity of NFV in children included in Part A. Secondary objectives : - To evaluate the activity of NFV in children receiving one of the 3 dual combinations of part A; - To describe the effect on viral resistance, on the number of CD4 and the clinical progression for the NRTI, NFV and NFV-placebo groups, ; - To compare the plasmatic viral load (ARN-HIV-1) of the various arms,in children receiving NFV or NFV and placebo.




Summary of study design, objectives, and ongoing research findings
The aims are to compare the activity and safety of three dual nucleoside analogue reverse-transcriptase inhibitors (NRTI)regimens with or without a protease inhibitor in previously untreated HIV-1 children. Results already obtained : randoimisation was as follows: zidovudine and lamivudine n=36, zidovudine and abacavir n=45, and lamivudine and abacavir n=47. Symptom free children (n=55)were also randomly assigned to receive nelfinavir or placebo, while those with a more advanced disease (n=73) received open-label nelfinavir (73). Findings : Children had a median CD4 content of 22% (IQR 15.29) and a mean HIV-1 RNA concentration of 5·0 log copies/mL (SD 0·8). At 48 weeks, mean HIV-1 RNA had decreased by 1·71, 2·19, and 2·63 log copies/mL, in the zidovudine/lamivudine,zidovudine/abacavir, and lamivudine/abacavir groups respectively (estimated in absence of nelfinavir)(p=0·02 after adjustment for baseline factors). One child had a hypersensitivity reaction to abacavir; and three with possible reactions stopped abacavir. There were 24 serious adverse events.six in the symptom-free children (all on nelfinavir), but none were attributed to nelfinavir. Conclusion: Regimens containing abacavir were more effective than those with zidovudine / lamivudine. Such regimens could be combined with protease inhibitors and non-nucleoside reverse transcriptase inhibitors for safe and effective treatment of previously untreated children with HIV-1.