ACTG A5223: SEX DIFFERENCES IN LOPINAVIR/RITONAVIR PHARMACOKINETICS AMONG

ACTG A5223：洛匹那韦/利托那韦药代动力学的性别差异

• 批准号: 7378744
• 负责人: WILLIAM AUSTIN O'BRIEN
• 金额: $ 0.14万
• 依托单位: UNIVERSITY OF TEXAS MED BR GALVESTON
• 依托单位国家: 美国
• 财政年份: 2006
• 资助国家: 美国
• 起止时间: 2006-04-01 至 2007-03-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7378744
• 关键词: ACTG; A5223; SEX; DIFFERENCES; LOPINAVIR

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.

该子项目是利用NIH/NCRR资助的中心赠款提供的资源的许多研究子项目之一。子项目和研究者（PI）可能从另一个NIH来源获得主要资金，因此可以在其他CRISP条目中表示。所列机构为中心，不一定是研究者所在机构。本研究的目的是确定接受Kaletra的男性和女性之间的药代动力学差异。 在相似剂量的LPV/RTV下，女性获得的LPV药物水平高于男性。 符合条件的参与者将前来登记/参观。他们将在PK访视前48小时在药物日记中记录Kaletra给药。PK访视时，受试者将在上午7点至9点之间前往GCRC。他们不吃早餐，也不吃早餐。参观时间约十三小时。他们将在GCRC获得特殊的早餐和早晨剂量的Kaletra。然后，他们将在服药后1，2，3，4，5，6，8，10和12小时抽取1茶匙血液。 这是一项PK研究。筛选访视将在PK访视前30天内进行。受试者将返回进行登记/入组访视，以入组研究，并获得48小时用药日记。要求受试者在GCRC中待约13小时。将在给药后1、2、3、4、5、6、8、10和12小时进行PK评价。 研究结果将提供给参与者。