GARLIC THERAPY IN HYPERLIPIDEMIA CAUSED BY HAART

这是一项I/II期随机、双盲、安慰剂对照试验，研究大蒜作为高脂血症hiv感染者接受高效抗逆转录病毒治疗（HAART）的降脂疗法。我们将在接受HAART治疗的HIV感染受试者（n=102，每组51人）中使用大蒜素/TM，这是一种大蒜素标准化的干大蒜补充剂，分三次递增剂量（700 mg、1400 mg和2800 mg/天）。本研究的主要目的是测量三种递增剂量的大蒜素/TM对血清总胆固醇的影响。次要目的包括确定与三种不断增加的大蒜素/TM剂量相关的耐受性和不良事件，并收集有关空腹血清甘油三酯、基础葡萄糖和胰岛素水平以及血清转氨酶（ALT和AST）影响的初步数据。

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).