A PHASE II PHARMACOKINETIC STUDY OF THE TRANSDERMAL CONTRACEPTIVE SYSTEM AND

透皮避孕系统的 II 期药代动力学研究

• 批准号: 7606428
• 负责人: Kenneth H. Fife
• 金额: $ 1.91万
• 依托单位: INDIANA UNIV-PURDUE UNIV AT INDIANAPOLIS
• 依托单位国家: 美国
• 财政年份: 2006
• 资助国家: 美国
• 起止时间: 2006-12-01 至 2007-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7606428
• 关键词: Age; Clinical; Computer Retrieval of Information on Scientific Projects Database; Contraceptive Agents; Count; Dose; Drug Kinetics; Enrollment; Ethinyl Estradiol; Funding; Grant; HIV-1; Institution; Label; Laboratories; Lopinavir/Ritonavir; Measures; Menstrual fluid; Menstruation; Monitor; Oral Contraceptives; Ortho Evra; Ortho-Novum; Phase; Plasma; Protease Inhibitor; Questionnaires; Randomized; Research; Research Personnel; Resources; Source; System; Telephone; Testing; Treatment Protocols; United States National Institutes of Health; Visit; Week; Woman; antiretroviral therapy; non-nucleoside reverse transcriptase inhibitors; norelgestromin; 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. This open label and non-randomized pharmacokinetic (PK) study will examine the interaction between a stable protease inhibitor (PI)-containing regimen, (lopinavir/ritonavir [LPV/r]), 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 menses (M)+3 to M+4) in subjects on stable LPV/r and subjects who are not receiving PIs, non-nucleoside reverse transcriptase inhibitors (NNRTIs), or any antiretroviral (ARV) therapy. Norelgestromin (NGMN) PK will also be measured during patch cycle week 3. The study will compare plasma HIV-1 RNA, CD4+/CD8+ counts, and clinical parameters before and after the initiation of the ORTHO EVRA patch. Nationally, 54 subjects will be enrolled with local expected enrolled to be approximately 10 subjects. Subjects will undergo physical exams, laboratory testing, and questionnaire completion. There will be 10 study visits and one telephone contact within a period of less than three months.

该子项目是利用该技术的众多研究子项目之一 资源由 NIH/NCRR 资助的中心拨款提供。子项目及 研究者 (PI) 可能已从 NIH 的另一个来源获得主要资金， 因此可以在其他 CRISP 条目中表示。列出的机构是 对于中心来说，它不一定是研究者的机构。 这项开放标签和非随机药代动力学 (PK) 研究将检查含稳定蛋白酶抑制剂 (PI) 的方案（洛匹那韦/利托那韦 [LPV/r]）与透皮避孕系统 (TCS)、ORTHO EVRA¿ 贴片在感染 HIV-1 的育龄妇女中的相互作用。还将研究 LPV/r 对单剂量口服避孕药 Ortho Novum (ON 1/35) 乙炔雌二醇 (EE) PK 的影响。 为了确定 LPV/r 对 ORTHO EVRA 贴片对 EE PK 的影响，该研究将监测稳定 LPV/r 受试者和未接受 PI、非核苷逆转录酶抑制剂 (NNRTI) 或任何抗逆转录病毒 (ARV) 治疗的受试者在贴片周期第 3 周（研究周月经 (M)+3 至 M+4）期间的 EE 水平。诺孕曲明 (NGMN) PK 还将在贴剂周期第 3 周进行测量。该研究将比较 ORTHO EVRA 贴剂开始前后的血浆 HIV-1 RNA、CD4+/CD8+ 计数和临床参数。 全国范围内将招收 54 名受试者，本地预计招收约 10 名受试者。受试者将接受体检、实验室测试和完成问卷调查。 不到三个月的时间里将有10次考察访问和1次电话联系。