Garlic in Hyperlipidemia Caused by HAART

Study Overview
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Brief Summary
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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).

Detailed Description
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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.

Official Title
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Phase II, Randomized, Double-blind, Placebo-controlled, Dose-escalation Study on the Effects of Garlic on Hyperlipidemia Induced by HAART in HIV-positive Individuals

Conditions
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HIV Infections, Hypercholesterolemia, Hypertriglyceridemia, Hyperglycemia

Intervention / Treatment
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* Drug: Garlic powder standardized to allicin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: HIV-1 seropositive confirmed by medical history 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Garlic powder standardized to allicin|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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HAART, complementary therapies, garlic, Allium sativum, metabolic diseases, Protease inhibitors