AACTG A5188: A PHASE II PHARMACOKINETIC STUDY OF THE TRANSDERMAL CONTRACEPTI

AACTG A5188：透皮避孕药的 II 期药代动力学研究

• 批准号: 7603922
• 负责人: LASHONDA Y SPENCER
• 金额: $ 42.64万
• 依托单位: UNIVERSITY OF SOUTHERN CALIFORNIA
• 依托单位国家: 美国
• 财政年份: 2006
• 资助国家: 美国
• 起止时间: 2006-12-01 至 2007-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7603922
• 关键词: Age; Computer Retrieval of Information on Scientific Projects Database; Contraceptive Agents; Dose; Drug Kinetics; Ethinyl Estradiol; Funding; Grant; HIV-1; Institution; Label; Lopinavir; Monitor; Oral Contraceptives; Ortho Evra; Ortho-Novum; Phase; Protease Inhibitor; Randomized; Research; Research Personnel; Resources; Source; System; Treatment Protocols; 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. A phase II open-label, non-randomized, multicenter pharmacokinetic (PK) study that will examine the interactiion between a stable protease inhibitor (PI) containing regimen, (lopinavir [LPV/r]0, and the transdermal contraceptive system (TCS), ORTHO EVRA patch, in HIV-1 infected women of reproductive age. The effect of LPV/r on the ethinyl estradiol (EE) PK of single dose oral contraceptive Ortho Novum (ON 1/35) will also be studied. To determine the effect of LPV/r on EE PK with the ORTHO EVRA patch, the study will monitor EE levels during the patch cycle week 3 (study weeks M+3 to M=4) in subjects on stable LPV/r and subjects who are not receiving PI NNRTIs or any antriretroviral (ARV) therapy.

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