AACTG A5188: A PHASE II PHARMACOKINETIC STUDY OF THE TRANSDERMAL

该子项目是利用NIH/NCRR资助的中心赠款提供的资源的许多研究子项目之一。子项目和研究者（PI）可能从另一个NIH来源获得主要资金，因此可以在其他CRISP条目中表示。所列机构为中心，不一定是研究者所在机构。A5188是一项II期、开放标签、非随机、多中心PK研究，将在HIV-1感染的育龄女性中检查稳定的含PI（LPV/r）方案与ORTHO EVRA贴剂之间的相互作用。还将研究LPV/r对单剂量口服避孕药ON 1/35的EE PK的影响。为了确定LPV/r对TCS、ORTHO EVRA贴剂的EE PK的影响，本研究将监测接受稳定LPV/r的女性和未接受PI、NNRTI或任何抗逆转录病毒（ARV）治疗的女性在贴剂周期第3周（研究第M+3周至M+4周）的EE水平。将在TCS周期第3周测量两个研究组的NGMN PK。本研究将比较使用ORTHO EVRA补片前后的血浆HIV-1 RNA水平、CD 4 +/CD 8+细胞计数和临床参数。研究受试者将根据其当前口服ARV方案入组以下研究组之一：A组：LPV/r（LPV 400 mg+利托那韦100 mg po b.i.d.）加上两种或多种NRTI（无额外PI或NNRTI）。B组：未接受ARV治疗或仅接受NRTI治疗（未接受PI或NNRTI治疗）的HIV感染对照组

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)