Garlic in hyperlipidemia caused by HAART

This is a double-blind randomized placebo controlled trial to test the use of garlic to lower cholesterol and triglycerides in hyperlipidemic HIV-infected individuals who are being treated with highly active antiretroviral therapy (HAART). The garlic will be administered as enteric-coated tablets and in two escalating dosages.

Condition:
– HIV Infections
– Hypercholesterolemia
– Hypertriglyceridemia
– Hyperglycemia

This is a double-blind randomized placebo controlled trial to test the use of garlic to lower cholesterol and triglycerides in hyperlipidemic HIV-infected individuals who are being treated with highly active antiretroviral therapy (HAART). The garlic will be administered as enteric-coated tablets and in two escalating dosages. Condition: – HIV Infections- Hypercholesterolemia- Hypertriglyceridemia- HyperglycemiaStudy Type: InterventionalStudy Design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study 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 Further Study Details: Background: Clinical evaluation of garlic (Allium sativum L.) 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 design: This is a phase II randomized double-blind, placebo controlled trial to study garlic as lipid lowering therapy in hyperlipidemic HIV-infected subjects treated with highly active antiretroviral therapy (HAART). Study Medication: We will utilize GarlicinTM, an allicin-standardized dried garlic supplement in two escalating doses (700 mg and 1400 mg /day) in HIV-infected subjects (n = 102, with 51/arm) who are receiving HAART. Study Aims: The primary aim of this study is to measure the effects of two escalating doses of GarlicinTM on total serum cholesterol. Secondary aims include determining the tolerability and adverse events associated with two escalating doses of GarlicinTM and gathering preliminary data on the effects on fasting serum triglycerides, glucose, insulin, transaminases (ALT and AST) and plasma HIV-1 RNA titers. Eligibility Ages Eligible for Study: 18 Years – 65 Years, Genders Eligible for Study: Both Criteria HIV-1 seropositive confirmed by medical history. >18 years and < 65 years of age. On stable HAART for at least 6 months before study entry without the likelihood of HAART therapy changes in the following 6 months due to viral rebound or adverse events. CD4+ lymphocyte number > 100 cells/mm3 measured within 60 days before study entry. HIV-1 viral load < 2000 RNA copies/ml. Cholesterol > 200 mg/dL. Triglycerides > 250 mg/dL < 1000 mg/dL. Willing and able to avoid raw or dry garlic, onion, leeks and shallots as well as supplements containing garlic during the 16 weeks of the trial. Willing and able to provide inform consent. Willing and able to understand and follow protocol for the duration of the study. Willing and able to maintain a consistent lifestyle routine, eg. diet, exercise, medications, dietary supplements and sleep schedule for the duration of the study. Willing and able to understand and follow the Step 1 guidelines from the National Cholesterol Education Program (NCEP) for the duration of the study. Willing to remain adherent to the current HAART regimen.Expected Total Enrollment: 146 (Source: Leanna J Standish, ND, Ph.D., Principal Investigator, Bastyr University, March 2004)