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Garlic in Hyperlipidemia Caused by HAART

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00029250
Recruitment Status : Withdrawn
First Posted : January 10, 2002
Last Update Posted : March 22, 2013
Information provided by (Responsible Party):
National Center for Complementary and Integrative Health (NCCIH)

Brief Summary:
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).

Condition or disease Intervention/treatment Phase
HIV Infections Hypercholesterolemia Hypertriglyceridemia Hyperglycemia Drug: Garlic powder standardized to allicin Phase 2

Detailed Description:

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
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
Study Start Date : November 2001
Actual Primary Completion Date : May 2003
Actual Study Completion Date : May 2003

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00029250

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United States, Washington
Bastyr University Center for Natural Health
Seattle, Washington, United States, 98103
University of Washington Harborview Medical Center
Seattle, Washington, United States, 98104
Sponsors and Collaborators
National Center for Complementary and Integrative Health (NCCIH)
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Principal Investigator: Leanna J Standish, ND, PhD Bastyr University
Standish LJ, Johnson LC, Kozak L & Richards T. Neural Energy Transfer Between Human Subjects at a Distance. In the Proceedings of the Third Annual Meeting of the Science and Spirituality of Healing, Bridging Worlds and Filling Gaps in the Science of Healing W. Jonas and R. Chez (eds), 2002.

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Responsible Party: National Center for Complementary and Integrative Health (NCCIH) Identifier: NCT00029250    
Other Study ID Numbers: R21AT000328-01 ( U.S. NIH Grant/Contract )
First Posted: January 10, 2002    Key Record Dates
Last Update Posted: March 22, 2013
Last Verified: March 2013
Keywords provided by National Center for Complementary and Integrative Health (NCCIH):
complementary therapies
Allium sativum
metabolic diseases
Protease inhibitors
Additional relevant MeSH terms:
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Lipid Metabolism Disorders
Metabolic Diseases
Glucose Metabolism Disorders
Anti-Infective Agents
Hypolipidemic Agents
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Protective Agents
Physiological Effects of Drugs
Hypoglycemic Agents
Free Radical Scavengers