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A PHASE II PHARMACOKINETIC STUDY OF THE TRANSDERMAL CONTRACEPTIVE SYSTEM AND

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
依托单位国家:
美国
项目类别:
财政年份:
2007
资助国家:
美国
项目状态:
已结题
起止时间:
2007-12-01 至 2008-05-31

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中文摘要
翻译
这个子项目是众多研究子项目之一
英文摘要
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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A PHASE II PHARMACOKINETIC STUDY OF THE TRANSDERMAL CONTRACEPTIVE SYSTEM AND
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