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资助的中心赠款提供的资源的许多研究子项目之一。子弹和调查员（PI）可能已经从其他NIH来源获得了主要资金，因此可以在其他清晰的条目中代表。列出的机构是针对该中心的，这不是调查人员的机构。 A5186是II期，随机，开放标签的多站点试验，用于确定潜在的研究受试者是感染HIV的男性和女性18岁及以前的男性和女性，他们在过去的3个月中一直处于稳定的HAART状态，并且不打算在研究的22周内改变其HAART治疗方案，并在研究的22周内使用脂质脂质脂质质量/低密度LIPOPROTE（DL LIPOPORTORE [dl lipopopote）[= 160 = 160 = 160] 400 mg/dL），并带有血浆HIV-1 RNA = 10,000副本/毫升。在研究期间，受试者应保留在目前的HAART方案上。该研究不会提供HAART药物。研究治疗将在第18周提供。在这项研究中最多将有两个步骤：步骤1-在研究条目中，将随机分为以下臂之一：ARM A：ARM A：ARM A：鱼油补充3 GM PO BID ARM B：FENOFIBRATE 160 mg PO QD对研究治疗的响应在研究治疗中被定义为在tecing <200 mg/dl Week new Week new Week new Week。在第8周没有反应的受试者将在第10周注册第2步。第10周，第10周未反应单剂治疗的受试者将开始对非诺贝特和鱼油进行联合治疗，并在第18周之前保持合并治疗。