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

本子项目是利用由NIH/NCRR资助的中心赠款提供的资源的众多研究子项目之一。子项目和研究者（PI）可能已经从另一个NIH来源获得了主要资金，因此可以在其他CRISP条目中表示。列出的机构是中心的，不一定是研究者的机构。A5186是一项II期、随机、开放标签、多地点试验，旨在确定鱼油联合非诺贝特对单独使用任何一种药物对血清甘油三酯（TG）升高的hiv感染者进行高活性抗逆转录病毒治疗（HAART）的有效性和安全性。潜在的研究对象是年龄在18岁及以上的艾滋病毒感染者，他们在过去的3个月里一直在接受稳定的HAART治疗，并且在研究的22周内不打算改变他们的HAART治疗方案，空腹脂质异常（低密度脂蛋白[LDL] =160 mg/dL, TG = 400 mg/dL），血浆HIV-1 RNA =10,000拷贝/mL。在研究期间，受试者应继续使用他们目前的HAART治疗方案。该研究将不提供HAART药物。研究治疗将持续到第18周。本研究最多分为两个步骤：第一步-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 gm PO BID； B组：非诺贝特160 mg PO QD；对研究治疗的反应定义为在第8周空腹血清甘油三酯< 200 mg/dL。在第8周有反应的受试者将继续接受单药治疗直至第18周。在第8周没有反应的受试者将在第10周注册到步骤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的联合治疗，并持续到第18周。

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.