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。hiv相关的血脂异常可能会增加患过早冠心病的风险。初步研究表明，降脂药物，如他汀类药物和贝特类药物，可能在使hiv相关血脂异常患者的血脂水平正常化方面部分有效。然而，这些药物潜在的严重副作用可能会因联合使用抗逆转录病毒药物而加剧，导致医生和患者不愿使用它们来治疗hiv相关的血脂异常。由于艾滋病毒感染者通常使用替代疗法，因此具有脂质修饰特性的替代疗法至少具有相同的有效性和更少的副作用，将是治疗艾滋病毒相关血脂异常的有价值的选择。其中一种选择是糖醇，一种从纯化甘蔗蜡中提取的膳食补充剂。在非hiv感染人群中，多酚已被证明具有耐受性和降脂特性，因此可能有益于hiv相关血脂异常的治疗。由于没有关于肝皂苷醇在hiv相关血脂异常患者中的安全性和有效性的数据，我们计划收集在这一人群中使用这种新方法的初步数据。我们建议对70例hiv相关血脂异常患者进行为期12周的甘蔗衍生糖醇治疗的安全性和有效性评估。安全性和有效性结果将在筛查访问和0、2、6和12周时进行测量。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。

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.