A PHASE II PHARMACOKINETIC STUDY OF THE TRANSDERMAL CONTRACEPTIVE SYSTEM AND

这个子项目是利用由NIH/NCRR资助的中心拨款提供的资源的许多研究子项目之一。子项目和调查员(PI)可能从另一个NIH来源获得了主要资金，因此可能会出现在其他CRISE条目中。列出的机构是针对中心的，而不一定是针对调查员的机构。这项开放标签和非随机药代动力学(PK)研究将在HIV-1感染育龄妇女中检验含有稳定的蛋白酶抑制(PI)方案(Lopinavir/ritonavir[LPV/r])和透皮避孕系统(TCS)Ortho Evra？Patch之间的相互作用。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、非核苷类逆转录酶抑制剂(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(研究周月经(M)3至M4)内的EE水平。在贴片周期的第3周，还将测定去甲孕酮(NGMN)PK。这项研究将比较开始使用Ortho Evra贴片前后的血浆HIV-1RNA、CD4/CD8计数和临床参数。全国将招收54个科目，当地预计招收约10个科目。受试者将接受体检、实验室测试和问卷填写。在不到三个月的时间内，将进行10次考察访问和1次电话联系。

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.