ACTG A5223: SEX DIFFERENCES IN LOPINAVIR/RITONAVIR PHARMACOKINETICS AMONG

本子项目是利用由NIH/NCRR资助的中心赠款提供的资源的众多研究子项目之一。子项目和研究者（PI）可能已经从另一个NIH来源获得了主要资金，因此可以在其他CRISP条目中表示。列出的机构是中心的，不一定是研究者的机构。本研究的目的是确定服用Kaletra的男性和女性之间的药代动力学差异。在LPV/RTV相同剂量下，女性的LPV药物水平高于男性。符合条件的参与者将前来登记/参观。患者将在PK访视前48小时在用药日记中记录其Kaletra剂量。在PK访问时，参与者将于上午7点至9点来到GCRC。他们不吃早饭，也不吃早餐。此次访问将持续约13个小时。他们将在GCRC获得特别的早餐和早晨剂量的Kaletra。然后在服药后1、2、3、4、5、6、8、10和12小时抽取一茶匙的血液。这是一项PK研究。筛选访问将在PK访问前30天内进行。受试者将返回进行登记/入职访问，以参加研究，并给予48小时用药日记。受试者将被要求在GCRC中度过大约13个小时。在给药后1、2、3、4、5、6、8、10和12小时进行PK评估。研究结果将提供给参与者。

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.