PACTG 1038:PHASE I/II HIGH DOSE LOPINAVIR/RITONAVIR WITH OR WITHOUT SAQUINAVIR I

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This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. Primary: 1. To determine the safety and tolerability of high dose LPV/r in Group 1 (400/100 mg/m2 PO Q12H) and Group 2 (480/120 mg/m2 PO Q12H) with concurrent NNRTI treatment. 2. To evaluate the safety and tolerability of saquinavir (750mg/m2 or 1200 mg/m2 PO Q12H) in combination with LPV/r in children and adolescents (Step 2 and Step 3). 3. To estimate pharmacokinetic parameters for LPV/r and saquinavir in protease inhibitor experienced HIV-infected children and adolescents receiving combination antiretroviral regimens.