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

这个子项目是许多研究子项目中利用 资源由NIH/NCRR资助的中心拨款提供。子项目和 调查员(PI)可能从NIH的另一个来源获得了主要资金， 并因此可以在其他清晰的条目中表示。列出的机构是 该中心不一定是调查人员的机构。 A5209是一项双盲、随机、安慰剂对照的交叉研究，旨在确定依折麦布(Zetia)治疗与正在进行的他汀类药物联合治疗低密度脂蛋白升高的艾滋病毒感染者的安全性、有效性和耐受性。艾滋病毒感染的男性和女性在研究进入前至少3个月接受高效抗逆转录病毒治疗(HAART)和他汀类药物治疗至少3个月，在研究进入之前至少30天接受稳定的他汀类药物和HAART治疗，并伴有升高的低密度脂蛋白胆固醇(LDL-c)和HAART；130 mg/dL将被纳入研究。共有43名受试者将在28周内进行9次考察访问。受试者每天口服依折麦布10毫克，为期12周。研究评估包括历史和体检、实验室测试和问卷调查。

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.