P1030: A PHASE I/II STUDY OF LOPINAVIR/RITONAVIR IN HIV-1 INFECTED INFANTS < 6

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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. Lopinavir is a potent protease inhibitor that is sensitive to pharmacokinetic enhancement by ritonavir (RTV) even at low RTV doses, thus providing therapeutic LPV concentrations over the entire dose interval. Lopinavir/ritonavir has shown significant antiviral activity and tolerability in clinical trials in adults and children > 6 months of age. The primary objectives of this study are to 1) evaluate lopinavir/ritonavir (LPV/RTV) dose requirements for HIV-infected infants < 6 months of age that provide systemic exposure similar to that which has been shown to be safe and effective in older children and adults and 2) determine the short-term and long-term safety and tolerance of LPV/RTV initiated in HIV-infected infants < 6 months of age as part of a combination regimen including nucleoside analogs.