A5223: SEX DIFFERENCES IN LPV/RTV IN HIV INFECTED MEN AND WOMEN

A5223：HIV 感染男性和女性 LPV/RTV 的性别差异

• 批准号: 7378024
• 负责人: ROBERT C KALAYJIAN
• 金额: $ 0.26万
• 依托单位: CASE WESTERN RESERVE UNIVERSITY
• 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/7378024
• 关键词: A5223; SEX; DIFFERENCES; LPV; RTV

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.

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。这是对HIV-1感染个体进行的LPV/RTV PK的性别差异的首次大型前瞻性研究。由于不同群体之间的合规率差异，将进行密集的PK采样和措施，以减少潜在的混杂因素。此外，种族/民族对抗逆转录病毒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，研究提议按种族/种族对男性和女性群体进行分层。进入研究的受试者的背景方案是标准化的。 LPV/RTV上具有以下一个或多个的受试者：NRTIS，Tenofivir（TDF）和Enfuvirtide（ENF）将有资格包括在研究中。这些药物将不提供本研究。假设女性在类似剂量的LPV/RTV上获得的LPV药物水平高于男性。 在这项研究中，将招募78名各种种族的男女。受试者将记录艾滋病毒感染，并将在筛查访问前至少14天接受LPV/RTV和组合，将证明定义的实验室值，重量超过50kg。在MetroHealth，将招收4名受试者。受试者将被要求在一般临床研究中心花费大约13个小时。