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

这个子项目是许多研究子项目中利用 资源由NIH/NCRR资助的中心拨款提供。子项目和 调查员(PI)可能从NIH的另一个来源获得了主要资金， 并因此可以在其他清晰的条目中表示。列出的机构是 该中心不一定是调查人员的机构。 A5188是一项II期、开放标签、非随机、多中心的PK研究，将检验稳定的PI(LPV/r)方案与Ortho Evra贴片在HIV-1感染的育龄妇女中的相互作用。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，Orth Evra，Patch的LPV/r对EE PK的影响，该研究将监测LPV/r稳定患者和未接受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，将在两个研究分支中测量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 patch 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, ORTH 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 antiretroviral (ARV) therapy. NGMN PK will be measured in both study arms 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.