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

A5188：透皮避孕系统的 II 期药代动力学研究

• 批准号: 7716705
• 负责人: FRED R SATTLER
• 金额: $ 0.66万
• 依托单位: UNIVERSITY OF SOUTHERN CALIFORNIA
• 依托单位国家: 美国
• 财政年份: 2008
• 资助国家: 美国
• 起止时间: 2008-04-20 至 2008-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7716705
• 关键词: Age; CD8-Positive T-Lymphocytes; Cell Count; Clinical; Computer Retrieval of Information on Scientific Projects Database; Contraceptive Agents; Dose; Drug Kinetics; Funding; Grant; HIV-1; Institution; Label; Measures; Monitor; Oral Contraceptives; Ortho Evra; Phase; Plasma; RNA; Randomized; Research; Research Personnel; Resources; Source; Treatment Protocols; United States National Institutes of Health; Upper arm; Week; Woman; antiretroviral therapy; reproductive

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.

该子项目是利用该技术的众多研究子项目之一 资源由 NIH/NCRR 资助的中心拨款提供。子项目及 研究者 (PI) 可能已从 NIH 的另一个来源获得主要资金， 因此可以在其他 CRISP 条目中表示。列出的机构是 对于中心来说，它不一定是研究者的机构。 A5188 是一项 II 期、开放标签、非随机、多中心 PK 研究，将检查含稳定 PI (LPV/r) 的方案与 ORTHO EVRA 贴片在 HIV-1 感染的育龄妇女中的相互作用。 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、ORTH EVRA、补丁的 EE PK 的影响，该研究将在补丁周期第 3 周（第 M+3 至 M+4 研究周）期间监测使用稳定 LPV/r 的女性和那些女性的 EE 水平。未接受 PI、NNRTI 或任何抗逆转录病毒 (ARV) 治疗的人。 NGMN PK 将在 TCS 周期第 3 周期间在两个研究组中进行测量。该研究将比较 ORTHO EVRA 贴片启动前后的血浆 HIV-1 RNA 水平、CD4+/CD8+ 细胞计数和临床参数。