ACTG A5223: SEX DIFFERENCES IN LOPINAVIR/RITONAVIR PHARMACOKINETICS AMONG

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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. The purpose of this study is to identify Pharmacokinetic differences between men and women receiving Kaletra. Women achieve higher LPV drug levels than do men on similar doses of LPV/RTV. Eligible participants will come for a registration/entry visit. They will record their Kaletra dosing in a medication diary for 48 hours before the day of their PK visit. At the PK visit, the participant will come to the GCRC between 7 and 9am. They will not take their morning dose of Kaletra nor eat their breakfast. The visit will last about 13 hours. They will be given a special breakfast and their morning dose of Kaletra in the GCRC. Then they will have 1 teaspoon of blood drawn at 1, 2, 3, 4, 5, 6, 8, 10, and 12 hours after they have taken their medication. This is a PK study. A screening visit will occur within 30 days prior to the PK visit. Subjects will return for a registration/entry visit to enroll into the study and to be given the 48-hour medication diary. Subjects will be required to spend approximately 13 hours in the GCRC. PK evaluations will be performed at 1, 2, 3, 4, 5, 6, 8, 10, and 12 hours post dosing. Study findings will be available to participants.