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。子弹和调查员（PI）可能已经从其他NIH来源获得了主要资金，因此可以在其他清晰的条目中代表。列出的机构适用于该中心，这不一定是调查员的机构。这项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。 女性的LPV药物水平高于类似剂量的LPV/RTV的男性。 符合条件的参与者将来注册/入门访问。他们将在PK访问当天的药物日记中记录Kaletra剂量的48小时。在PK访问中，参与者将在早上7点至9点之间来到GCRC。他们不会服用kaletra的早晨剂量，也不会吃早餐。这次访问将持续约13个小时。他们将在GCRC中为他们提供特殊的早餐和早晨的kaletra剂量。然后，他们将在服药后的1、2、3、4、5、6、8、10和12小时时抽出1茶匙的血液。 这是一项PK研究。筛查将在PK访问前30天内进行。受试者将返回注册/入门访问以注册研究，并获得48小时的药物日记。受试者将被要求在GCRC上花费大约13个小时。剂量后，PK评估将在1、2、3、4、5、6、8、10和12小时进行。 研究结果将向参与者使用。