ACTG A5223: SEX DIFFERENCES IN LOPINAVIR/RITONAVIR PHARMACOKINETICS AMONG

这个子项目是利用由NIH/NCRR资助的中心拨款提供的资源的许多研究子项目之一。子项目和调查员(PI)可能从另一个NIH来源获得了主要资金，因此可能会出现在其他CRISE条目中。列出的机构是针对中心的，而不一定是针对调查员的机构。这项研究的目的是确定接受卡莱特拉治疗的男性和女性之间的药代动力学差异。与服用类似剂量LPV/RTV的男性相比，女性获得更高的LPV药物水平。符合条件的参赛者将前来注册/入境参观。他们将在PK访问的前48小时将他们的Kaletra剂量记录在药物日记中。在PK参观时，参与者将在上午7点至9点之间来到GCRC他们不会服用早上服用的卡莱特拉，也不会吃早餐。访问将持续约13个小时。他们将在GCRC得到一份特别的早餐和他们早上服用的卡莱特拉。然后，他们将在服药后1、2、3、4、5、6、8、10和12小时抽取1茶匙血。这是一项PK研究。在PK访问前30天内将进行筛查访问。受试者将返回注册/进入访问，以登记加入这项研究，并获得48小时的药物日记。受试者将被要求在GCRC花费大约13个小时。PK评估将在给药后1、2、3、4、5、6、8、10和12小时进行。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.