CLINICAL TRIAL: AACTG A5188: A PHASE II PHARMACOKINETIC STUDY OF THE TRANSDERMA

临床试验：AACTG A5188：透皮玛 II 期药代动力学研究

• 批准号: 7982107
• 负责人: LASHONDA Y SPENCER
• 金额: $ 4.92万
• 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: 2008-12-01 至 2009-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7982107
• 关键词: AIDS clinical trial group; Age; Clinical Research; Clinical Trials; Computer Retrieval of Information on Scientific Projects Database; Contraceptive Agents; Dose; Drug Kinetics; Ethinyl Estradiol; Funding; Grant; HIV-1; Institution; 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; Woman; open label; 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的一个 由NIH/NCRR资助的中心赠款提供的资源。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 研究中心，而研究中心不一定是研究者所在的机构。 一项II期、开放标签、非随机、多中心药代动力学（PK）研究，旨在检查含稳定蛋白酶抑制剂（PI）的方案（洛匹那韦[LPV/r]0）与透皮避孕系统（TCS）（ORTHO EVRA贴剂）在HIV-1感染的育龄女性中的相互作用。 还将研究LPV/r对单剂量口服避孕药Ortho Novum（ON 1/35）炔雌醇（EE）PK的影响。为了确定LPV/r对ORTHO EVRA贴剂的EE PK的影响，本研究将在贴剂周期第3周（研究第M+3周至M=4周）期间监测稳定LPV/r受试者和未接受PI NNRTI或任何抗逆转录病毒（ARV）治疗的受试者的EE水平。