WOMEN'S INTERAGENCY HIV STUDY (WIHS): INTENSIVE PHARMACOKINETIC STUDY (IPS)

女性机构间艾滋病毒研究 (WIHS)：强化药代动力学研究 (IPS)

• 批准号: 7376135
• 负责人: MARY A YOUNG
• 金额: $ 4.87万
• 依托单位: CHILDREN'S RESEARCH INSTITUTE
• 依托单位国家: 美国
• 财政年份: 2005
• 资助国家: 美国
• 起止时间: 2005-12-01 至 2006-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7376135
• 关键词: WOMEN; INTERAGENCY; HIV; STUDY; WIHS

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. The Women's Interagency HIV Study initiated the Intensive Pharmacokinetic Sub-study in order to assess exposure to antiretroviral treatment among HIV-positive women, including indices of adherence, clearance and bioavailability, and to identify the factors that significantly influence variance in bioavailability and clearance of the most commonly used antiretroviral protease inhibitors and the most commonly used non-nucleoside reverse transcriptase inhibitors among WIHS women, including use of other drugs and medications, ethnicity, multidrug-resistance transporter 1 genotype, body mass, liver and renal function, diet, symptoms such as diarrhea and fever, smoking and concurrent infections such as hepatitis C. The four drugs chosen for study are Nelfinavir (Viracept), Lopinavir (Kaletra), Efavirenz (Sustiva), and Nevirapine (Viramune). The sub-study will include 480 women across the country, 80 from the Washington Metropolitan WIHS. Women are admitted to the GCRC within 30 days of their core WIHS study visit. During their GCRC stay, a urine pregnancy test is completed and blood is drawn at intervals determined by the target medication they are taking. All blood specimens are shipped to the Benet Lab in San Francisco, CA., for pharmacokinetic testing and analysis will include these test results and data gathered at the core WIHS visit.

该子项目是利用 NIH/NCRR 资助的中心拨款提供的资源的众多研究子项目之一。子项目和研究者 (PI) 可能已从另一个 NIH 来源获得主要资金，因此可以在其他 CRISP 条目中出现。列出的机构是中心的机构，不一定是研究者的机构。妇女机构间艾滋病毒研究启动了强化药代动力学子研究，以评估艾滋病毒阳性妇女接受抗逆转录病毒治疗的情况，包括依从性、清除率和生物利用度指数，并确定显着影响生物利用度和清除率变化的因素。 WIHS 女性中最常用的抗逆转录病毒蛋白酶抑制剂和最常用的非核苷逆转录酶抑制剂，包括使用其他药物和药物，种族、多重耐药转运蛋白1基因型、体重、肝肾功能、饮食、腹泻和发烧等症状、吸烟和丙型肝炎等并发感染。选择用于研究的四种药物是奈非那韦（Viracept）、洛匹那韦（Kaletra） ）、依法韦仑（Sustiva）和奈韦拉平（Viramune）。该子研究将包括全国 480 名女性，其中 80 名来自华盛顿大都会 WIHS。女性在核心 WIHS 研究访视后 30 天内被纳入 GCRC。在 GCRC 住院期间，将完成尿妊娠测试，并按照他们正在服用的目标药物确定的时间间隔进行抽血。所有血液样本均被运送到加利福尼亚州旧金山的 Benet 实验室进行药代动力学测试和分析，其中将包括这些测试结果和在核心 WIHS 访问中收集的数据。