CLINICAL TRIAL: EFFECT OF PREGNANCY ON THE PHARMACOKINETICS OF THE KALETRALO

临床试验：怀孕对 KALETRALO 药代动力学的影响

• 批准号: 7716898
• 负责人: Angela D Kashuba
• 金额: $ 0.3万
• 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/7716898
• 关键词: Anti-Retroviral Agents; Binding Proteins; Clinical Research; Clinical Trials; Computer Retrieval of Information on Scientific Projects Database; Dose; Drug Kinetics; Funding; Grant; Hour; Institution; Label; Lopinavir/Ritonavir; Postpartum Period; Pregnancy; Pregnant Women; Protein Binding; Proteins; Purpose; Research; Research Personnel; Resources; Second Pregnancy Trimester; Source; Standards of Weights and Measures; Third Pregnancy Trimester; Treatment Protocols; United States National Institutes of Health; Visit; Week; Woman; dosage

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 purpose of this study is to better understand how to dose antiretroviral agents in HIV-infected women during pregnancy. This study will compare exposures of both protein-unbound and total (protein bound + protein unbound) lopinavir/ritonavir (Kaletra¿) concentrations in the second and third trimesters of pregnancy, and before and after an empiric dosage increase in lopinavir/ritonavir in the third trimester. HIV-infected pregnant women receiving lopinavir/ritonavir as a component of antiretroviral treatment will participate. This open-label, non-blinded pharmacokinetic (PK) study will require subjects to undergo 3 or 4 intensive 12 hour pharmacokinetic visits in the UNC General Clinical Research Center (GCRC). The first visit will occur at approximately 20 weeks? gestation (second trimester), the second at 30 weeks (third trimester, using standard Kaletra¿ dosing), and the third at 32 weeks gestation (third trimester, after a dose increase in Kaletra¿). At two weeks post-partum, the Kaletra¿ dose will be reduced to the standard regimen. An optional 6-12 week postpartum PK visit will be offered.

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。 这项研究的目的是更好地了解如何在怀孕期间给感染艾滋病毒的妇女服用抗逆转录病毒药物。这项研究将比较妊娠中期和晚期的蛋白质非结合和总(蛋白质结合+蛋白质非结合)Lopinavir/ritonavir(Kaletra？)浓度的暴露情况，以及在妊娠晚期经验剂量增加之前和之后。作为抗逆转录病毒治疗的一部分，接受洛匹那韦/利托那韦治疗的艾滋病毒感染孕妇将参加。这项开放的、非盲目的药代动力学(PK)研究将要求受试者在北卡罗来纳大学综合临床研究中心(GCRC)接受3到4次强化的12小时药代动力学访问。第一次访问将于 大约20周？第三次是妊娠(第二个三个月)，第二个是30周(第三个三个月，使用标准Kaletra？剂量)，第三个是在怀孕32周(第三个三个月，在Kaletra剂量增加后)。两点 产后几周，Kaletra的剂量将减少到标准方案。将提供产后6-12周的可选PK访问。