A PHASE II PHARMACOKINETIC STUDY OF THE TRANSDERMAL CONTRACEPTIVE SYSTEM AND

透皮避孕系统的 II 期药代动力学研究

• 批准号: 7717525
• 负责人: Kenneth H. Fife
• 金额: $ 0.45万
• 依托单位: INDIANA UNIV-PURDUE UNIV AT INDIANAPOLIS
• 依托单位国家: 美国
• 财政年份: 2007
• 资助国家: 美国
• 起止时间: 2007-12-01 至 2008-05-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7717525
• 关键词: Age; Clinical; Computer Retrieval of Information on Scientific Projects Database; Contraceptive Agents; Count; Dose; Drug Kinetics; Enrollment; Ethinyl Estradiol; Funding; Grant; HIV-1; Institution; Label; Laboratories; Lopinavir/Ritonavir; Measures; Menstrual fluid; Menstruation; Monitor; Oral Contraceptives; Ortho Evra; Ortho-Novum; Phase; Plasma; Protease Inhibitor; Questionnaires; Randomized; Research; Research Personnel; Resources; Source; System; Telephone; Testing; Treatment Protocols; United States National Institutes of Health; Visit; Week; Woman; antiretroviral therapy; non-nucleoside reverse transcriptase inhibitors; norelgestromin; 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. This open label and non-randomized pharmacokinetic (PK) study will examine the interaction between a stable protease inhibitor (PI)-containing regimen, (lopinavir/ritonavir [LPV/r]), 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 menses (M)+3 to M+4) in subjects on stable LPV/r and subjects who are not receiving PIs, non-nucleoside reverse transcriptase inhibitors (NNRTIs), or any antiretroviral (ARV) therapy. Norelgestromin (NGMN) PK will also be measured during patch cycle week 3. The study will compare plasma HIV-1 RNA, CD4+/CD8+ counts, and clinical parameters before and after the initiation of the ORTHO EVRA patch. Nationally, 54 subjects will be enrolled with local expected enrolled to be approximately 10 subjects. Subjects will undergo physical exams, laboratory testing, and questionnaire completion. There will be 10 study visits and one telephone contact within a period of less than three months.

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