A PILOT STUDY OF THE SAFETY, EFFICACY, AND TOLERABILITY OF EZETIMIBE (ZETIA?)

依泽替米贝 (Zetia?) 安全性、有效性和耐受性的试点研究

• 批准号: 7606477
• 负责人: MICHAEL P DUBE
• 金额: $ 0.76万
• 依托单位: INDIANA UNIV-PURDUE UNIV AT INDIANAPOLIS
• 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/7606477
• 关键词: Age-Years; Computer Retrieval of Information on Scientific Projects Database; Cross-Over Studies; Daily; Double-Blind Method; Enrollment; Evaluation Studies; Funding; Grant; Highly Active Antiretroviral Therapy; Institution; LDL Cholesterol Lipoproteins; Laboratories; Oral cavity; Pilot Projects; Placebo Control; Questionnaires; Randomized; Recording of previous events; Research; Research Design; Research Personnel; Resources; Safety; Schering-Plough brand of ezetimibe; Source; Testing; United States National Institutes of Health; Visit; Week; Woman; day; ezetimibe; men

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. A5209 is a double-blind, randomized, placebo-controlled, crossover study designed to determine the safety, efficacy, and tolerability of ezetimibe (Zetia) therapy in combination with ongoing statin therapy in HIV-infected subjects with elevated LDL cholesterol. HIV-infected men and women > 18 years of age on highly active antiretroviral therapy (HAART) and statin therapy for at least 3 months prior to study entry and on stable statin and HAART for at least 30 days prior to study entry and with elevated low-density lipoprotein cholesterol (LDL-c) >130 mg/dL will be enrolled. A total of 43 subjects will have 9 study visits over a 28- week period. Subjects will receive ezetimibe 10 mg by mouth once daily for 12 weeks. Study evaluations include history and physical exams, laboratory testing, and questionnaires.

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。子项目及 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。 A5209 是一项双盲、随机、安慰剂对照、交叉研究，旨在确定 ezetimibe (Zetia) 疗法与正在进行的他汀类药物疗法联合治疗 LDL 胆固醇升高的 HIV 感染者的安全性、有效性和耐受性。 年龄 > 18 岁的 HIV 感染男性和女性在研究开始前至少 3 个月接受高效抗逆转录病毒治疗 (HAART) 和他汀类药物治疗，并在研究开始前至少 30 天接受稳定他汀类药物和 HAART 治疗，并且低血压升高-密度脂蛋白胆固醇（LDL-c）> 130 mg/dL 将被纳入。总共 43 名受试者将在 28 周内进行 9 次研究访视。 受试者将每天口服一次依折麦布 10 mg，持续 12 周。研究评估包括病史和体格检查、实验室测试和问卷调查。