ACTG A5223: SEX DIFFERENCES IN LOPINAVIR/RITONAVIR PHARMACOKINETICS

ACTG A5223：洛匹那韦/利托那韦药代动力学的性别差异

• 批准号: 7378347
• 负责人: JUDITH Ann ABERG
• 金额: $ 2.17万
• 依托单位: NEW YORK UNIVERSITY SCHOOL OF MEDICINE
• 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/7378347
• 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. This study hypothesizes that women achieve higher lopinavir (LPV) drug levels than do men on similar doses of LPV and ritonavir (RTV). The primary objective is to compare the pharmacokinetic (PK) parameter, area under the concentration-time curve (AUC) of LPV between HIV-1-infected men and women currently receiving similar doses of LPV/RTV. PK evaluations will be performed on plasma samples obtained prior to and up to 12 hours after the administration of the morning dose of LPV/RTV in 78 evaluable subjects (39 men and 39 women) currently managed on LPV/RTV as part of their antiretroviral regimen. A screening visit will occur within 30 days prior to the PK visit. Upon confirmation of eligibility, subjects will return for a registration/entry visit to enroll into the study and will be given a 48-hour medication diary to complete. Subjects will be required to spend approximately 13 hours at the GCRC for the intensive PK blood sampling. Subjects will be > 18 years old and currently receiving LPV/RTV (lopinavir 400 mg/ritonavir 100 mg po bid) plus one or more of the following: nucleoside reverse transcriptase inhibitors (NRTIs), tenofovir (a nucleotide RTI), and enfuvirtide (a fusion inhibitor). Subjects must be on the same regimen for at least 14 days prior to screening. Subjects will be stratified by race/ethnicity. This study may lead to increased power and generalizability of findings in men; preliminary studies suggest differences in PK, side effects, and therapeutic effects in women.

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。这项研究假设，服用类似剂量的LPV和利托那韦(RTV)的女性比男性获得更高的LPV药物水平。主要目的是比较目前接受相似剂量LPV/RTV的HIV-1感染男性和女性LPV的药代动力学参数(PK)、浓度-时间曲线下面积(AUC)。将对78名可评估受试者(39名男性和39名女性)在早上服用LPV/RTV之前和之后12小时内获得的血浆样本进行PK评估，这是作为其抗逆转录病毒方案的一部分接受LPV/RTV治疗的。在PK访问前30天内将进行筛查访问。在确认合格后，受试者将返回注册/进入访问以登记加入研究，并将被给予48小时的药物日记以完成。受试者将被要求在GCRC花费大约13个小时进行密集的PK血液采样。受试者将为18岁，目前正在接受LPV/RTV(洛比那韦400毫克/利托那韦100毫克，po，2次)加一种或多种以下药物：核苷逆转录酶抑制剂(NRTI)、替诺福韦(一种核苷酸RTI)和恩福韦德(一种融合抑制剂)。受试者必须在筛查前至少14天接受相同的方案。研究对象将按种族/民族分层。这项研究可能会增加男性研究结果的力量和普适性；初步研究表明，女性在PK、副作用和治疗效果方面存在差异。