AACTG A5188: A PHASE II PHARMACOKINETIC STUDY OF THE TRANSDERMAL CONTRACEPTI

AACTG A5188：透皮避孕药的 II 期药代动力学研究

• 批准号: 7716698
• 负责人: LASHONDA Y SPENCER
• 金额: $ 6.85万
• 依托单位: UNIVERSITY OF SOUTHERN CALIFORNIA
• 依托单位国家: 美国
• 财政年份: 2008
• 资助国家: 美国
• 起止时间: 2008-04-20 至 2008-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7716698
• 关键词: Age; Computer Retrieval of Information on Scientific Projects Database; Contraceptive Agents; Dose; Drug Kinetics; Ethinyl Estradiol; Funding; Grant; HIV-1; Institution; Label; Lopinavir; Monitor; Oral Contraceptives; Ortho Evra; Ortho-Novum; Phase; Protease Inhibitor; Randomized; Research; Research Personnel; Resources; Source; System; Treatment Protocols; United States National Institutes of Health; Week; Woman; reproductive

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. A phase II open-label, non-randomized, multicenter pharmacokinetic (PK) study that will examine the interactiion between a stable protease inhibitor (PI) containing regimen, (lopinavir [LPV/r]0, and the transdermal contraceptive system (TCS), ORTHO EVRA patch, in HIV-1 infected women of reproductive age. The effect of LPV/r on the ethinyl estradiol (EE) PK of single dose oral contraceptive Ortho Novum (ON 1/35) will also be studied. To determine the effect of LPV/r on EE PK with the ORTHO EVRA patch, the study will monitor EE levels during the patch cycle week 3 (study weeks M+3 to M=4) in subjects on stable LPV/r and subjects who are not receiving PI NNRTIs or any antriretroviral (ARV) therapy.

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。 一项II期开放、非随机、多中心药代动力学(PK)研究，将考察含有稳定的蛋白酶抑制剂(PI)方案(Lopinavir[LPV/r]0)与经皮避孕系统(TCS)Ortho Evra贴片在HIV-1感染育龄妇女中的相互作用。此外，还将研究LPV/r对单剂口服避孕药Ortho Novum(On 1/35)中乙炔雌二醇(EE)PK的影响。为了确定使用Ortho Evra贴片的LPV/r对EE PK的影响，这项研究将监测LPV/r稳定的受试者和没有接受PI NNRTIs或任何抗逆转录病毒(ARV)治疗的受试者在贴片周期第3周(研究周M+3至M=4)的EE水平。