SEX DIFFERENCES IN LOPINAVIR/RITONAVIR PHARMACOKINETICS AMONG HIV-1-INFECTED

这个子项目是许多研究子项目中利用 资源由NIH/NCRR资助的中心拨款提供。子项目和 调查员(PI)可能从NIH的另一个来源获得了主要资金， 并因此可以在其他清晰的条目中表示。列出的机构是 该中心不一定是调查人员的机构。 A5223是一项针对78名(39名男性和39名女性)HIV-1感染者的前瞻性评估，旨在确定洛匹那韦(LPV)在18岁男性和女性体内的药代动力学(PK)。受试者目前必须接受洛比那韦400毫克/利托那韦100毫克，每日2次口服，外加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。筛查访问将在PK访问前30天内进行。在确认合格后，受试者将返回注册/进入访问，以登记参加研究并获得48小时的药物日记。受试者将被要求在GCRC花费大约13个小时进行密集的PK血液采样。

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. A5223 is a prospective evaluation of 78 (39 men and 39 women) HIV-1-infected subjects designed to determine the pharmacokinetics (PK) of lopinavir (LPV) in men and women ?18 years of age. Subjects must be currently receiving 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. The 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 to be given a 48-hour medication diary. Subjects will be required to spend approximately 13 hours in the GCRC for the intensive PK blood sampling.