Garlic in Hyperlipidemia Caused by HAART - Full Text View

Sponsored by:	National Center for Complementary and Alternative Medicine (NCCAM)
Information provided by:	National Center for Complementary and Alternative Medicine (NCCAM)
ClinicalTrials.gov Identifier:	NCT00029250

Purpose

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	Intervention	Phase
HIV Infections Hypercholesterolemia Hypertriglyceridemia Hyperglycemia	Drug: Garlic powder standardized to allicin	Phase II

Study Type:	Interventional
Study 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

Resource links provided by NLM:

Genetics Home Reference related topics: hypercholesterolemia

MedlinePlus related topics: AIDS Cholesterol Metabolic Disorders Triglycerides

Drug Information available for: Allicin Allium sativum extract

U.S. FDA Resources

Further study details as provided by National Center for Complementary and Alternative Medicine (NCCAM):

Estimated Enrollment:	146
Study Start Date:	November 2001

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.

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00029250

Locations

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 Alternative Medicine (NCCAM)

Investigators

Principal Investigator:

Leanna J Standish, ND, PhD

Bastyr University

More Information

Additional Information:

Recruitment information This link exits the ClinicalTrials.gov site

Publications:

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.

Standish LJ, Johnson LC, Kozak L, Richards T. Evidence of Correlated Functional Magnetic Resonance Imaging Signals Between Distant Human Brains. Alternative Therapies in Health & Medicine, Vol. 9, #1, January 2003.

Standish LJ, Kozak L, Johnson LC, Richards T. EEG evidence of correlated event related signals between the brains of spatially and sensory isolated human subjects. Journal of Complementary & Alternative Medicine, Vol.10, #2, April 2004, 307-314.

Study ID Numbers:	R21 AT000328-01
Study First Received:	January 9, 2002
Last Updated:	August 2, 2007
ClinicalTrials.gov Identifier:	NCT00029250 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by National Center for Complementary and Alternative Medicine (NCCAM):

complementary therapies
garlic
Allium sativum

metabolic diseases
HAART
Protease inhibitors

Study placed in the following topic categories:

Sexually Transmitted Diseases, Viral
Hyperlipidemias
Metabolic Diseases
Hypertriglyceridemia
Allicin
Acquired Immunodeficiency Syndrome
Immunologic Deficiency Syndromes
Protease Inhibitors
Virus Diseases
Hyperglycemia

HIV Seropositivity
HIV Infections
Sexually Transmitted Diseases
Garlic
Glucose Metabolism Disorders
Metabolic Disorder
Hypercholesterolemia
Retroviridae Infections
Dyslipidemias
Lipid Metabolism Disorders

Additional relevant MeSH terms:

RNA Virus Infections
Sexually Transmitted Diseases, Viral
Metabolic Diseases
Slow Virus Diseases
Hyperlipidemias
Hypertriglyceridemia
Immune System Diseases
Acquired Immunodeficiency Syndrome
Infection
Immunologic Deficiency Syndromes

Virus Diseases
Hyperglycemia
HIV Infections
Sexually Transmitted Diseases
Lentivirus Infections
Glucose Metabolism Disorders
Hypercholesterolemia
Retroviridae Infections
Dyslipidemias
Lipid Metabolism Disorders

ClinicalTrials.gov processed this record on July 02, 2009