HIV Infections Clinical Trial
Official title:
Phase II, Randomized, Double-blind, Placebo-controlled, Dose-escalation Study on the Effects of Garlic on Hyperlipidemia Induced by HAART in HIV-positive Individuals
The purpose of this study is to test the effectiveness and tolerability of garlic pills in lowering cholesterol and triglycerides in hyperlipidemic HIV-infected individuals who are being treated with highly active antiretroviral therapy (HAART).
Clinical evaluation of garlic in HIV disease is warranted for several reasons. First, garlic
is used as a botanical medicine and as an alternative therapy by many HIV-infected
individuals. Baseline data from the Bastyr's Alternative Medicine Care Outcomes in AIDS
(AMCOA) study [1] indicate that garlic is the most frequently used botanical medicine among
HIV-infected men and women (52.9%) who utilize complementary and alternative medicine (CAM).
In the same cohort, 50% of the subjects who use antiretroviral therapy are also taking
garlic supplements. Second, there is a growing body of studies that indicate that garlic
exhibits lipid and glucose lowering as well as hepato-protective activities. Third, several
of the pharmacological activities of garlic and their reported clinical benefits in other
conditions, especially in hyperlipidemia, may be relevant in the management of highly active
antiretroviral therapy (HAART) in HIV-infected subjects.
Study Medication: We will utilize GarlicinTM, an allicin-standardized dried garlic
supplement in two escalating doses in HIV-infected subjects who are receiving HAART.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
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