EFFECT OF COMBTHERW/FISH OIL SUPP&FENOFIBRATE ON TG LEVELS IN SBJCTS ON HAART

梳子/鱼油补充剂的功效

• 批准号: 7377831
• 负责人: John G. Gerber
• 金额: $ 0.18万
• 依托单位: UNIVERSITY OF COLORADO DENVER
• 依托单位国家: 美国
• 财政年份: 2006
• 资助国家: 美国
• 起止时间: 2006-04-01 至 2007-03-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7377831
• 关键词: EFFECT; COMBTHERW; FISH; OIL; SUPP&FENOFIBRATE

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. A5186 is a phase II, randomized, open-label, multi-site trial to determine the efficacy and safety of fish oil combined with fenofibrate in HIV-infected subjects on highly active antiretroviral therapy (HAART) with elevated serum triglycerides (TG) who are not responding to either agent alone. Potential study subjects are HIV-infected men and women 18 years of age and older, who have been on stable HAART for the previous 3 months and do not plan to change their HAART regimen for the 22 weeks of the study, with fasting lipid abnormalities (low-density lipoprotein [LDL] =160 mg/dL and TG ¿ 400 mg/dL), and with plasma HIV-1 RNA =10,000 copies/mL. Subjects should remain on their current individual HAART regimen for the duration of the study. HAART medications will not be supplied by the study. Study treatment will be provided through week 18. There will be a maximum of two steps in this study: Step 1 - At study entry, subjects will be randomized to one of the following arms: Arm A: Fish oil supplement 3 gm PO BID Arm B: Fenofibrate 160 mg PO QD Response to study treatment is defined as fasting serum triglycerides < 200 mg/dL at week 8. Subjects who are responding at week 8 will remain on single agent therapy through week 18. Subjects who are not responding at week 8 will register to Step 2 at week 10. Step 2 At week 10, subjects who have not responded to single agent therapy will begin combined therapy of fenofibrate and fish oil and remain on combined therapy through week 18.

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，该子项目和研究者 (PI) 可能已从其他 NIH 来源获得主要资助，因此可以在其他 CRISP 机构中得到体现。列出的是该中心，不一定是研究者所在的机构。 A5186 是一项 II 期、随机、开放标签、多中心试验，旨在确定鱼油联合非诺贝特治疗 HIV 感染者的有效性和安全性。接受高效抗逆转录病毒治疗 (HAART) 且血清甘油三酯 (TG) 升高且对单独任一药物均无反应的受试者 潜在的研究受试者是 18 岁及以上的 HIV 感染男性和女性，他们已接受稳定的 HAART 治疗。前 3 个月内，且不计划在研究的 22 周内改变其 HAART 治疗方案，且空腹血脂异常（低密度脂蛋白 [LDL] = 160 mg/dL 且TG ¿400 mg/dL)，且血浆 HIV-1 RNA = 10,000 拷贝/mL。研究期间，受试者应继续采用当前的个人 HAART 治疗方案。提供至第 18 周。本研究最多有两个步骤： 步骤 1 - 在研究开始时，受试者将被随机分配到以下组之一： A 组：鱼油补充剂 3 克 PO BID 组 B：非诺贝特 160 mg PO QD 对研究治疗的反应定义为第 8 周空腹血清甘油三酯 < 200 mg/dL。第 8 周有反应的受试者将继续接受单药治疗直至第 18 周。无反应的受试者第 8 周将注册到第 10 周的步骤 2。 步骤 2 在第 10 周，对单药治疗没有反应的受试者将开始非诺贝特和鱼油并继续联合治疗直至第 18 周。