LOPINAVIR PHARMACOKINETICS IN MEN AND WOMEN

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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. Adult AIDS Clinical Trials Group protocol A5223 is a multicenter, prospective study to evaluate the pharmacokinetics (PK) of Lopinavir/Ritonavir (Kaletra , LPV/RTV) in women and men. LPV is a protease inhibitor (PI) used in the treatment of HIV infection and is co-formulated with low dose RTV, a PI used to enhance the systemic exposure of LPV. HIV infected individuals who are taking LPV/RTV for at least 14 days (as part of their HIV treatment regimen) will be enrolled. Blood concentrations of LPV and RTV will be assessed immediately before and then following an observed oral dose of LPV/RTV (400mg/100mg) at 1, 2, 3, 4, 5, 6, 8, 10, and 12 hours post dose. These data will be used to derive standard PK parameters. There will be 78 subjects enrolled nationally (approximately 8 of these locally).