SWITCH TO ATAZANAVIR AND BRACHIAL ARTERY REACTIVITY (SABAR) STUDY: ENDOTHELIA

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。 人类免疫缺陷病毒(HIV)蛋白酶抑制剂(PI)具有显著的免疫学和临床益处，已被广泛接受为HIV感染患者抗逆转录病毒治疗的关键组成部分。不幸的是，接受艾滋病毒感染的患者中，高达60%会出现高脂血症、高血糖和中心性肥胖。由于这些形态和代谢变化对动脉粥样硬化性血管疾病的几个危险因素产生不利影响，人们担心心血管疾病可能成为获得性免疫缺陷综合征(AIDS)相关的重要并发症。在接受HIV PI的患者中，已经出现了严重的过早冠状动脉疾病(CAD)的病例报告。 HIV PI的使用与内皮功能障碍有关，内皮功能障碍是动脉粥样硬化的早期和初始步骤，可预测未来的不良心血管事件。这项研究的主要目的是比较从基线到第24周期间改用ATV的受试者的肱动脉血流介导的血管扩张(FMD)的变化与继续接受稳定的抗逆转录病毒治疗的受试者的臂动脉FMD的变化。 在这项研究中，接受含有稳定的蛋白酶抑制剂(PI)的抗逆转录病毒方案的HIV感染者将被随机(1：1)继续他们目前的抗逆转录病毒方案或将PI改为阿扎那韦(ATV)24周。这些患者的空腹低密度脂蛋白水平为130 mg/dL或空腹甘油三酯水平为200 mg/dL。 非专业术语摘要 蛋白酶抑制剂(PI)是一类用于治疗HIV感染的药物，已导致人类免疫缺陷病毒-1(HIV)相关发病率和死亡率的显著改善。不幸的是，接受PI治疗的人中，多达60%的人血液中的脂肪水平(甘油三酯或低密度脂蛋白)升高，这与心脏病的发展有关。PI的使用也与血管松弛能力降低有关，因此血管内部保持较小。当血液流经较小的血管时，这会导致血液中含胆固醇物质的变化，并被认为可能导致心脏病的发生。这项研究的目的是确定将目前的蛋白酶抑制剂治疗改为阿特拉那韦治疗对血管松弛(内皮功能)的影响。 接受含有稳定的蛋白酶抑制剂(PI)的抗逆转录病毒方案的HIV感染者，如果他们的空腹低密度脂蛋白水平为130 mg/dL或空腹甘油三酯水平为200 mg/dL，则将被随机分配到继续他们目前的抗逆转录病毒方案或将PI改为阿扎那韦(ATV)24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. Human immunodeficiency virus (HIV) protease inhibitors (PIs) confer striking immunologic and clinical benefits that have led to their widespread acceptance as key components of antiretroviral therapy in patients with HIV infection. Unfortunately, up to 60% of patients receiving HIV PIs develop hyperlipidemia, hyperglycemia, and central obesity. Because these morphological and metabolic changes adversely affect several risk factors for atherosclerotic vascular disease, there is concern that cardiovascular disease may become an important acquired immune deficiency syndrome (AIDS)-related complication. Case reports of severe premature coronary artery disease (CAD) in patients receiving HIV PIs already have appeared in the medical literature. Use of HIV PIs has been associated with endothelial dysfunction, an early and initiating step in atherosclerosis that predicts future adverse cardiovascular events. The primary objective of this study is to compare the change in brachial artery flow mediated vasodilation (FMD) from baseline to week 24 in subjects switching to ATV with the change in brachial artery FMD in subjects continuing on a stable antiretroviral regimen. In this study, HIV-infected subjects on a stable protease inhibitor (PI) containing antiretroviral regimen with plasma HIV RNA <500 copies/mL, who have fasting LDL cholesterol levels >130 mg/dL or fasting triglycerides levels >200 mg/dL, will be randomized (1:1) to continue their current antiretroviral regimen or to switch the PI to atazanavir (ATV) for 24 weeks. ABSTRACT IN LAY TERMS Protease inhibitors (PIs), a class of drugs used to treat HIV infection, have resulted in impressive improvements in human immunodeficiency virus-1 (HIV)-related morbidity and mortality. Unfortunately, up to 60% of individuals receiving PIs develop elevated fat levels in their blood (triglycerides or LDL cholesterol), which are associated with the development of heart disease. The use of PIs has also been associated with reduced ability of blood vessels to relax, and therefore the inside of the vessel stays small. This can cause changes in cholesterol-containing substances in the blood when it flows through the smaller-sized vessel and is thought to possibly contribute to the development of heart disease. The purpose of this study is to determine the effects of switching the current protease inhibitor therapy to atazanavir therapy on how well the blood vessels relax (endothelial function). HIV-infected subjects on a stable protease inhibitor (PI) containing antiretroviral regimen with HIV vial load <500 copies/mL, who have fasting LDL cholesterol levels >130 mg/dL or fasting triglycerides levels >200 mg/dL, will be assigned by chance to continue their current antiretroviral regimen or to switch the PI to atazanavir (ATV) for 24 weeks.