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

改用阿扎那韦和肱动脉反应性 (SABAR) 研究：内皮细胞

• 批准号: 7717576
• 负责人: Michael Phillip Dube
• 金额: $ 0.48万
• 依托单位: INDIANA UNIV-PURDUE UNIV AT INDIANAPOLIS
• 依托单位国家: 美国
• 财政年份: 2007
• 资助国家: 美国
• 起止时间: 2007-12-01 至 2008-05-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7717576
• 关键词: Acquired Immunodeficiency Syndrome; Affect; Anti-Retroviral Agents; Atazanavir; Atherosclerosis; Blood; Blood Vessels; Cardiovascular Diseases; Cardiovascular system; Case Study; Central obesity; Cholesterol; Class; Clinical; Complication; Computer Retrieval of Information on Scientific Projects Database; Coronary Arteriosclerosis; Development; Drug usage; Employee Strikes; Endothelium; Event; Fasting; Fatty acid glycerol esters; Flow-It; Functional disorder; Funding; Future; Grant; HIV; HIV-1; Heart Diseases; Hyperglycemia; Hyperlipidemia; Immunologics; Individual; Institution; LDL Cholesterol Lipoproteins; Literature; Mediating; Medical; Metabolic; Morbidity - disease rate; Patients; Plasma; Protease Inhibitor; Purpose; Randomized; Research; Research Personnel; Resources; Risk Factors; Source; Thinking; Treatment Protocols; Triglycerides; United States National Institutes of Health; Vasodilation; Vial device; Virus Diseases; Week; abstracting; antiretroviral therapy; brachial artery; mortality; size; viral RNA

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.

该副本是利用众多研究子项目之一 由NIH/NCRR资助的中心赠款提供的资源。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 对于中心，这不一定是调查员的机构。 人类免疫缺陷病毒（HIV）蛋白酶抑制剂（PIS）赋予引人注目的免疫学和临床益处，这导致其作为HIV感染患者的抗逆转录病毒疗法的关键成分广泛接受。 不幸的是，多达60％的接受HIV PI的患者患有高脂血症，高血糖和中枢性肥胖症。 由于这些形态学和代谢变化对动脉粥样硬化血管疾病的几个危险因素不利，因此担心心血管疾病可能成为重要的可获得的免疫缺陷综合征（AIDS）相关的并发症。 接受HIV PI的患者严重过早冠状动脉疾病（CAD）的病例报告已经出现在医学文献中。 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启动步骤，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切换到ATV的受试者的臂动脉流介导的血管舒张（FMD）的变化与腕臂动脉FMD的变化在稳定的抗逆转录病毒方案中的受试者中的变化。 在这项研究中，在稳定蛋白酶抑制剂（PI）上感染了HIV感染的受试者，该蛋白酶抑制剂（PI）含有抗逆转录病毒方案，具有血浆HIV RNA <500份/ml，他们的禁食LDL胆固醇水平> 130 mg/dl或禁食甘油三酸酯水平> 200 mg/dl，将继续（200 mg/dl），将其随机派对（1：1：1：1：1：1：1：1：1：1：1：1：1：1：1：1：1：1：1） Atazanavir（ATV）24周。 摘要术语 蛋白酶抑制剂（PIS）是一种用于治疗HIV感染的药物，已导致人类免疫缺陷病毒-1（HIV）相关的发病率和死亡率的令人印象深刻的改善。 不幸的是，多达60％的接受PI的个体的血液（甘油三酸酯或LDL胆固醇）的脂肪水平升高，这与心脏病的发展有关。 PI的使用也与血管放松的能力降低有关，因此血管内部较小。这可能会导致血液中含有胆固醇的物质的变化，当它流过较小的血管时，它可能会导致心脏病的发展。这项研究的目的是确定将当前的蛋白酶抑制剂治疗转换为阿扎Zanavir治疗对血管松弛程度（内皮功能）的影响。 在稳定的蛋白酶抑制剂（PI）上感染了HIV的受试者，其中含有抗逆转录病毒治疗方案，其HIV瓶负荷<500份/ml，他们的禁食LDL胆固醇水平> 130 mg/dl或禁食甘油三酸酯或禁食触发剂> 200 mg/dL的机会，将在当前的PIMG/DL上分配，以继续进行PI（pi），以继续进行pi necimav ateraviraviraviraviraviraviral ofertraviral ofertraviral ofertraviral ofertraviral ofertraviral ofert or to to to to to to pi（ 24周。