GARLIC THERAPY IN HYPERLIPIDEMIA CAUSED BY HAART

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This is a phase I/II randomized double-blind, placebo controlled trial to study garlic as lipid lowering therapy in hyperlipidemic HIV-infected subjects treated with highly active anti-retroviral therapy (HAART). We will utilize Garlicin/TM, an allicin-standardized dried garlic supplement in three escalating doses (700 mg, 1400 mg, and 2800 mg/day) in HIV- infected subjects (n=102, with 51/arm) who are receiving HAART. The primary aim of this study is to measure the effects of three escalating doses of Garlicin/TM on total serum cholesterol. Secondary aims include determining the tolerability and adverse events associated with three escalating doses of Garlicin/TM and gathering preliminary data on the effects on fasting serum triglycerides, basal glucose and insulin levels as well as serum transaminases (ALT and AST).