AACTG A5188: A PHASE II PHARMACOKINETIC STUDY OF THE TRANSDERMAL

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，将检验包含稳定PI(LPV/r)的方案和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，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M+3至M+4)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。研究对象将根据他们目前的口服ARV方案被登记到以下研究分支之一：ARM A：LPV/r(LPV 400 mg加利托那韦100 mg，po，i.d。)加上两个或更多NRTI(没有额外的PI或NNRTI)。ARM B：未使用抗逆转录病毒药物的HIV感染对照，或仅接受NRTI(没有PIs或NNRTIs)的人

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, 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 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. Study subjects will be enrolled into one of the study arms below in accordance with their current oral ARV regimens: Arm A: LPV/r (LPV 400 mg plus ritonavir 100 mg po b.i.d.) plus two or more NRTIs (no additional PIs or NNRTIs). Arm B: HIV-infected controls not on ARVs, or who are receiving only NRTIs (no PIs or NNRTIs)