A5188: A PHASE II, PHARMACOKINETIC STUDY OF THE TRANSDERMAL CONTRACEPTIVE

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。A5188是一项II期、开放标签、非随机、多中心PK研究，将在HIV-1感染的育龄妇女中检查稳定的PI(LPV/r)方案与Ortho Evra Patech之间的相互作用。此外，还将研究LPV/r对单剂口服避孕药1/35的EE PK的影响。为了确定使用TCS，Ortho Evra贴片的LPV/r对EE PK的影响，这项研究将监测LPV/r稳定患者和没有接受PI、NNRTIs或任何抗逆转录病毒(ARV)治疗的女性在贴片周期第3周(研究周M3至M4)的EE水平。在TCS周期的第3周，将在两个研究区域测量NGMN PK。这项研究将比较启动Ortho Evra贴片前后的血浆HIV-1RNA水平、CD4/CD8细胞计数和临床参数。

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. A5188 is a phase II, open label, non-randomized, multicenter PK study that will examine the interaction between a stable PI (LPV/r)-containing regimen and the ORTHO EVRA patech in HIV-1-infected women of reproductive age. The effect of LPV/r on the EE PK of single dose oral contraceptive ON 1/35 will also be studied. To determine the effect of LPV/r on EE PK with the TCS, ORTHO EVRA patch, the study will monitor EE levels during patch cycle week 3 (study weeks M+3 to M+4) in women on stable LPV/r and those who are not receiving PIs, NNRTIs, or any antiretrovial (ARV) therapy. NGMN PK will be measured in both study arems during TCS cycle week 3. The study will compare plasma HIV-1 RNA levels, CD4+/CD8+ cell counts, and clinical parameters before and after the initiation of the ORTHO EVRA patch.