A PHASE II PHARMACOKINETIC STUDY OF THE TRANSDERMAL CONTRACEPTIVE SYSTEM AND

本子项目是利用由NIH/NCRR资助的中心赠款提供的资源的众多研究子项目之一。子项目和研究者（PI）可能已经从另一个NIH来源获得了主要资金，因此可以在其他CRISP条目中表示。列出的机构是中心的，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）研究将检查含有稳定的酶抑制剂（洛匹那韦/利托那韦[LPV/r]）的方案与透皮避孕系统（TCS） ORTHO EVRA¿贴片在hiv -1感染育龄妇女中的相互作用。我们还将研究LPV/r对单剂量口服避孕药Ortho Novum （on 1/35）的乙炔雌二醇（EE） PK的影响。为了确定LPV/r对使用ORTHO EVRA贴片的EE PK的影响，该研究将监测贴片周期第3周（研究周月经(M)+3至M+4）期间LPV/r稳定受试者和未接受pi、非核苷类逆转录酶抑制剂（NNRTIs）或任何抗逆转录病毒（ARV）治疗的受试者的EE水平。在补片周期第3周也将测量去瑞孕酮（NGMN） PK。该研究将比较注射ORTHO EVRA贴片前后的血浆HIV-1 RNA、CD4+/CD8+计数和临床参数。全国将招收54个学科，当地预计招收约10个学科。受试者将接受体格检查、实验室测试和问卷调查。在不到三个月的时间内，将有10次研究访问和一次电话联系。

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.