Preliminary Study of Safety and Efficacy of Policosanol

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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.