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P1083 / Kaletra/Aluvia PK study

A Phase II/III Trial of Lopinavir/Ritonavir Dosed According to the WHO Pediatric Weight Band Dosing Guidelines

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P1083 was a phase II/III, intensive pharmacokinetic study of Lopinavir/Ritonavir (LPV/r) in HIV-infected infants and children ≥3 to <25 kg (stratified by weight) initiating LPV/r therapy at U.S. and non-U.S. IMPAACT sites.  The objectives of this study were to determine if the weight band antiretroviral (ARV) dosing recommendations of the WHO provide safe and tolerable dosing of LPV/r when administered as the heat stable pediatric tablet or the liquid formulation as part of a combination ARV regimen and to delineate the pharmacokinetics of LPV/r when dosed according to the WHO ARV weight band dosing schedule in HIV-infected infants and children.

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