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: 7379132
• 负责人: Kenneth H. Fife
• 金额: $ 0.15万
• 依托单位: INDIANA UNIV-PURDUE UNIV AT INDIANAPOLIS
• 依托单位国家: 美国
• 财政年份: 2005
• 资助国家: 美国
• 起止时间: 2005-12-01 至 2006-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7379132
• 关键词: PHASE; II; PHARMACOKINETIC; STUDY; TRANSDERMAL

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NIH/NCRR资助的中心赠款提供的资源的许多研究子项目之一。子项目和研究者（PI）可能从另一个NIH来源获得主要资金，因此可以在其他CRISP条目中表示。所列机构为中心，不一定是研究者所在机构。本项开放标签和非随机药代动力学（PK）研究将在HIV-1感染的育龄女性中检查稳定的含蛋白酶抑制剂（PI）方案（洛匹那韦/利托那韦[LPV/r]）与透皮避孕系统（TCS）（ORTHO EVRA？贴剂）之间的相互作用。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对使用ORTHO EVRA贴剂的EE PK的影响，研究将在贴剂周期第3周（研究周月经（M）+3至M+4）期间监测接受稳定LPV/r的受试者和未接受PI、非核苷逆转录酶抑制剂（NNRTI）或任何抗逆转录病毒（ARV）治疗的受试者的EE水平。还将在贴剂周期第3周测量诺孕曲明（NGMN）PK。本研究将比较使用ORTHO EVRA补片前后的血浆HIV-1 RNA、CD 4 +/CD 8+计数和临床参数。在全国范围内，将入组54例受试者，当地预计入组约10例受试者。受试者将接受体格检查、实验室检查和问卷填写。在不到3个月的时间内，将进行10次研究访视和1次电话联系。