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: 7717574
• 负责人: Michael Phillip Dube
• 金额: $ 0.18万
• 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/7717574
• 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.

这个子项目是许多研究子项目中的一个 由NIH/NCRR资助的中心赠款提供的资源。子项目和 研究者（PI）可能从另一个NIH来源获得了主要资金， 因此可以在其他CRISP条目中表示。所列机构为 研究中心，而研究中心不一定是研究者所在的机构。 A5209是一项双盲、随机、安慰剂对照、交叉研究，旨在确定依折麦布（Zetia）治疗联合正在进行的他汀类药物治疗在LDL胆固醇升高的HIV感染受试者中的安全性、疗效和耐受性。 将招募年龄> 18岁的HIV感染男性和女性，其在进入研究之前接受高效抗逆转录病毒疗法（HAART）和他汀类药物疗法至少3个月，并且在进入研究之前接受稳定的他汀类药物和HAART至少30天，并且具有升高的低密度脂蛋白胆固醇（LDL-c）>130 mg/dL。共有43例受试者将在28周内接受9次研究访视。 受试者将接受依折麦布10 mg口服，每日一次，持续12周。研究评估包括病史和体格检查、实验室检查和问卷调查。