A5223: SEX DIFFERENCES IN LPV/RTV IN HIV INFECTED MEN AND 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来源获得了主要资金，因此可以在其他CRISP条目中表示。所列机构为中心机构，不一定是研究者机构。这是首次在HIV-1感染者中进行的LPV/RTV PK性别差异的大型前瞻性研究。将进行密集的PK采样，并采取措施减少由于不同组间依从率差异而导致的潜在混杂因素。此外，人种/种族对抗逆转录病毒PK的影响有可能成为当前研究中的混杂因素。为了解决这一问题，研究建议按种族/族裔对男性和女性群体进行分层。入组研究的受试者的背景治疗方案是标准化的。接受LPV/RTV的受试者，如果有以下一种或多种情况：NRTI、替诺非韦（TDF）和恩夫韦肽（ENF），将有资格入选本研究。本研究不提供这些药物。据推测，在相似剂量的LPV/RTV下，女性的LPV药物水平高于男性。 在这项研究中，将招募78名年龄在18-64岁之间的不同种族的男性和女性。受试者将有记录的HIV感染，并将在筛选访视前至少14天接受LPV/RTV和联合治疗，将显示规定的实验室检查值，体重将超过50 kg。MetroHealth将入组4例受试者。要求受试者在一般临床研究中心停留约13小时。

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 is the first large prospective study of sex differences in the PK of LPV/RTV conducted in HIV-1-infected individuals. There will be intensive PK sampling and measures incorporated to reduce potential confounders due to differences in rate of compliance among the different groups. In addition, the effect of race/ethnicity on antiretroviral PK has the potential of being a confounder in the current study. In order to address this, the study proposes to stratify both male and female groups by race/ethnicity. The background regimen for subjects entering the study is standardized. Subjects on LPV/RTV with one or more of the following: NRTIs, tenofivir (TDF) and enfuvirtide (ENF), will be eligible to be included in the study. These drugs will not be provided by this study. It is hypothesized that women achieve higher LPV drug levels than do men on similar doses of LPV/RTV. In this study 78 men and women of various ethnicities between 18-64 years of age will be recruited. The subjects will have documented HIV infection and will have received LPV/RTV and combinations, for at least 14 days prior to the screening visit, will demonstrate defined laboratory values and will weigh more than 50kg. At MetroHealth, 4 subjects will be enrolled. Subjects will be required to spend approximately 13 hours at the General Clinical Research Center.