CLINICAL TRIAL: SEX DIFFERENCES IN LOPINAVIR/RITONAVIR PHARMACO AMONG HIV-1 MEN

临床试验：洛匹那韦/利托那韦药物在 HIV-1 男性中的性别差异

• 批准号: 7716824
• 负责人: KRISTINE B. PATTERSON
• 金额: $ 1.7万
• 依托单位: UNIV OF NORTH CAROLINA CHAPEL HILL
• 依托单位国家: 美国
• 财政年份: 2008
• 资助国家: 美国
• 起止时间: 2008-04-02 至 2008-05-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7716824
• 关键词: Anti-Retroviral Agents; Clinical Trials; Computer Retrieval of Information on Scientific Projects Database; Data; Dose; Drug Kinetics; Evaluation; Funding; Grant; Hour; Individual; Institution; Lopinavir/Ritonavir; Pharmaceutical Preparations; Plasma; Prospective Studies; Research; Research Personnel; Resources; Sampling; Sex Characteristics; Source; Toxic effect; Treatment Protocols; United States National Institutes of Health; Woman; base; men; sex

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 a pharmacokinetic (PK) evaluation of 78 HIV-infected individuals (39 men and 39 women) who are currently taking lopinavir/ritonavir (LPV/RTV) as part of their antiretroviral regimen. Plasma samples will be obtained prior to and up to 12 hours after the administration of the morning dose of LPV/RTV. This is the first large prospective study of sex differences in the PK of LPV/RTV in HIV-infected individuals. This data obtained will be used as a basis for proposing larger studies with additional drugs specifically looking at potential differences in efficacy and toxicity between the sexes, and to stimulate study into the mechanistic basis of this difference.

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。 这是对78名艾滋病毒感染者(39名男性和39名女性)的药代动力学(PK)评估，他们目前正在服用洛比那韦/利托那韦(LPV/RTV)作为其抗逆转录病毒方案的一部分。在早上注射LPV/RTV之前和之后12小时内将采集血浆样本。这是首次对HIV感染者的LPV/RTV的PK的性别差异进行的大型前瞻性研究。获得的这些数据将被用作提议进行更大规模的研究的基础，这些研究将特别关注男女之间在疗效和毒性方面的潜在差异，并鼓励对这种差异的机制基础的研究。