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Background:
This abstract reports on the long-term treatment of HIV-infected children with
Kaletra (lopinavir/ritonavir, formerly know as ABT-378/r).
Methods:
100 antiretroviral (ARV) naive and experienced (exp.) but NNRTI naļve pediatric
subjects ages 6 months to 12 years old were randomized to Kaletra (300/75 mg/m2
BID) with naive subjects receiving d4T and 3TC and exp. subjects receiving
nevirapine and 1-2 NRTIs. For
analysis, subjects were classified into three groups with varying ARV treatment
experience: 44 naļve (I), 32 NRTI exp. (II) and 24 NRTI + PI exp. (III).
Results:
By an intent-to-treat analysis, HIV RNA % <400 (and <50) copies/mL
was 77 (68) for I, 81 (66) for II and 54 (54) for III at Week 60.
Mean % CD4 increase from baseline (and mean % CD4 at Week 60) was 9.7
(31.3) for I, 6.4 (35.6) for II and 5.3 (30.1) for III.
The most commonly reported AE of at least moderate severity and probable
or possible relationship to Kaletra was rash (2%).
No Grade 3 or higher elevations in glucose, triglyceride or cholesterol
were observed (NIH Division of AIDS Toxicity Grades for pediatrics). Of the two discontinuations prior to Week 60; one (due to
pancreatitis) appeared to be related to study drug. Virologic response with respect to baseline protease genotype
and phenotype was similar to that observed in adults treated with Kaletra.
Baseline resistance data was available for 20 of 24 subjects in Group
III. Of these, 1 of 3 subjects with >10 fold and 10 of 17 subjects with
<10 fold reduced susceptibility (by phenotypic assay) to Kaletra had HIV RNA
<400 copies/mL at Week 60. The study is currently ongoing and these results will be
updated.
Conclusion: Kaletra oral solution appears to be generally well-tolerated and associated with antiviral activity in treatment naļve and experienced children.
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