A5188: A PHASE II, PHARMACOKINECTIC STUDY OF THE TRANSDERMAL CONTRACEPTIVE SYST

A5188：透皮避孕系统的 II 期药代动力学研究

• 批准号: 7604220
• 负责人: MARY VOGLER
• 金额: $ 0.53万
• 依托单位: WEILL MEDICAL COLL OF CORNELL UNIV
• 依托单位国家: 美国
• 财政年份: 2007
• 资助国家: 美国
• 起止时间: 2007-04-01 至 2007-09-16
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7604220
• 关键词: Age; Area; Computer Retrieval of Information on Scientific Projects Database; Contraceptive Agents; Contraceptive methods; Cytochromes; Enzymes; Funding; Grant; HIV-1; Institution; Measures; Metabolism; Phase; Research; Research Personnel; Resources; Source; Time; United States National Institutes of Health; Week; Woman; 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. Hypothesis: Due to the presumed avoidance of the first-pass effect and metabolism by gut cytochrome enzymes in HIV-1 infected women of reproductive age, it is hypothesized that there will be no difference in EE area under the concentration-time curve (AUC) at transdermal contraception week 3 (study weeks M+3 to M+4) between women on stable LPV/r and those not on PIs or NNRTIs or on any ARV therapy. Primary Objectivs: To evaluate the effect of LPV/r on the PK of EE in HIV-1-infected women of reproductive age by comparing the EE AUC during ORTHO EVRA¿¿ transdermal contraceptive patch week 3 (study weeks M+3 to M+4) in women on LPV/r with the EE AUC measured in women who are not receiving PIs, NNRTIs, or any ARV therapy.

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。子项目和 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。 假设： 由于假定避免了 HIV-1 感染的育龄妇女肠道细胞色素酶的首过效应和代谢，因此推测在透皮避孕第 3 周（研究第 M+3 至 M+4 周），服用稳定 LPV/r 的妇女与未服用 PI 或 NNRTI 或任何药物的妇女之间，浓度-时间曲线 (AUC) 下的 EE 面积没有差异。 抗病毒治疗。 主要目标： 通过比较使用 LPV/r 的女性在 ORTHO EVRA 透皮避孕贴片第 3 周（第 M+3 至 M+4 研究周）期间的 EE AUC 与未接受 PI、NNRTI 或任何 ARV 治疗的女性中测量的 EE AUC，评估 LPV/r 对 HIV-1 感染的育龄女性 EE PK 的影响。