Preliminary Study of Safety and Efficacy of Policosanol

描述（由申请人提供）：HIV感染及其治疗与许多不良反应有关。一个不良反应，艾滋病毒相关的血脂异常，可能会增加早发冠心病的风险。 初步研究表明，降脂药物，如他汀类药物和贝特类药物，可能是部分有效的正常血清脂质水平在艾滋病毒相关的血脂异常。然而，这些药物的潜在严重副作用可能会因抗逆转录病毒药物的联合给药而加剧，导致医生和患者不愿意利用它们来管理HIV相关的血脂异常。由于HIV感染者通常使用替代疗法，因此具有至少同等有效性和较少副作用的调脂特性的替代疗法将是管理HIV相关血脂异常的有价值的选择。其中一种选择是多廿烷醇，一种从纯化的甘蔗蜡中提取的膳食补充剂。在非HIV感染人群中，已证明了普利醇的耐受性和降脂特性，因此可能有利于HIV相关血脂异常的管理。由于尚无关于普利醇在HIV相关血脂异常患者中的安全性和有效性的数据，我们计划收集在该人群中使用这种新方法的初步数据。我们建议在70例HIV相关血脂异常患者中评估为期12周的甘蔗衍生多廿烷醇疗程的安全性和有效性。将在筛选访视以及第0、2、6和12周时测量安全性和有效性结局。开发新的，更自然的，毒性更小的方法来使HIV相关血脂异常患者的脂质和脂蛋白参数正常化是至关重要的。 通俗语言总结：高胆固醇水平在艾滋病毒感染者中很常见。然而，当给予HIV感染者时，常规的降胆固醇药物可能具有有害的副作用。因此，我们计划评估普利醇的安全性和有效性，普利醇是一种来自甘蔗的膳食补充剂，具有降低胆固醇的特性，可降低HIV感染者的胆固醇水平。

DESCRIPTION (provided by applicant): HIV infection and its treatment are associated with a number of adverse effects. One adverse effect, HIV-related dyslipidemia, may increase risk for the development of premature coronary heart disease. Preliminary studies suggest that lipid-lowering drugs, such as statins and fibrates, may be partially efficacious in normalizing serum lipid levels in HIV-related dyslipidemia. However, potentially serious side effects of these drugs can be exacerbated by co-administration of antiretroviral agents, resulting in physician and patient reluctance to utilize them to manage HIV-related dyslipidemia. Since alternative therapies are commonly used by persons with HIV infection, an alternative therapy with lipid-modifying properties that has at least equal effectiveness and fewer side effects would be a valuable option for managing HIV-related dyslipidemia. One such option is policosanol, a dietary suplement extracted from purified sugar cane wax. Policosanol has demonstrated tolerability and lipid-lowering properties in non HIV-infected populations, and thus may be beneficial for the management of HIV-related dyslipidemia. Since data on the safety and efficacy of policosanol in persons with HIV-related dyslipidemia are not available, we plan to collect preliminary data on the use of this novel approach in this population. We propose to evaluate the safety and efficacy of a 12-week course of sugar cane-derived policosanol in a sample of 70 persons with HIV-related dyslipidemia. Safety and effiacacy outcomes will be measured at the screening visit and at 0, 2, 6, and 12 weeks. Development of novel, more natural, and less toxic approaches to normalize lipid and lipoprotein parameters in individuals with HIV-related dyslipidemia is of critical importance. Lay Language Summary: High cholesterol levels are common in persons with HIV infection. However, conventional cholesterol-lowering medications may have harmful side effects when given to HIV-infected persons. Therefore, we plan to evaluate the safety and effectiveness of policosanol, a dietary supplement derived from sugar cane that has cholersterol-lowering properties, to lower cholesterol levels in persons with HIV infection.