SEX DIFFERENCES IN LOPINAVIR/RITONAVIR PHARMACOKINETICS IN HIV-1 INF MEN & WOMEN

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。所列机构为中心机构，不一定为研究者机构。假设女性在服用相似剂量的洛匹那韦/利托那韦时，洛匹那韦药物水平高于男性。主要目的是比较目前接受相似剂量洛匹那韦/利托那韦的HIV-1感染男性和女性之间洛匹那韦的PK参数、浓度-时间曲线下面积（AUC）。 将对78例可评价受试者（39例男性和39例女性）在洛匹那韦/利托那韦（LPV/RTV）早晨给药前和给药后12小时内采集的血浆样本进行药代动力学（PK）评价，这些受试者目前接受LPV/RTV作为抗逆转录病毒治疗方案的一部分。 78例HIV感染受试者，39例男性和39例女性，年龄≥ 18岁，目前接受LPV/RTV（洛匹那韦400 mg/利托那韦100 mg，口服，每日两次）联合以下一种或多种药物：核苷逆转录酶抑制剂（NRTI）、替诺福韦（一种核苷酸TRI）和恩夫韦肽（一种融合抑制剂）。受试者必须在筛选前接受相同的方案至少14天。

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 hypothesis is that women achieve higher lopinavir drug levels than men do on similar doses of lopinavir/ritonavir. The primary objective is to compare the PK parameter, area under the concentration-time curve (AUC) of lopinavir between HIV-1 infected men and women currently receiving similar doses of lopinavir/ritonavir. Pharmacokinetic (PK) evaluations will be performed on plasma samples obtained prior to and up to 12 hours after the administration of the morning dose of lopinavir/ritonavir (LPV/RTV) in 78 evaluable subjects (39 men and 39 women) currently managed on LPV/RTV as part of their antiretroviral regimen. Seventy-eight HIV-infected subjects, 39 men and 39 women, age greater than or equal to 18 years currently receiving LPV/RTV (lopinavir 400 mg/ritonavir 100 mg by mouth twice a day) plus one or more of the following: nucleoside reverse transcriptase inhibitors (NRTIs), tenofovir (a nucleotide TRI), and enfuvirtide (a fusion inhibitor). Subjects must be on the same regimen for at least 14 days prior to screening.