Garlic in Hyperlipidemia Caused by HAART

This study has been withdrawn prior to enrollment.
Sponsor:
Information provided by (Responsible Party):
National Center for Complementary and Alternative Medicine (NCCAM)
ClinicalTrials.gov Identifier:
NCT00029250
First received: January 9, 2002
Last updated: March 21, 2013
Last verified: March 2013
  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 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
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

Resource links provided by NLM:


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

Enrollment: 0
Study Start Date: November 2001
Study Completion Date: May 2003
Primary Completion Date: May 2003 (Final data collection date for primary outcome measure)
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
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, see Learn About Clinical Studies.

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
Investigators
Principal Investigator: Leanna J Standish, ND, PhD Bastyr University
  More Information

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.

Responsible Party: National Center for Complementary and Alternative Medicine (NCCAM)
ClinicalTrials.gov Identifier: NCT00029250     History of Changes
Other Study ID Numbers: R21 AT000328-01
Study First Received: January 9, 2002
Last Updated: March 21, 2013
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

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
Hypercholesterolemia
Hyperglycemia
Hyperlipidemias
Hypertriglyceridemia
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases
Glucose Metabolism Disorders
Allicin
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Antioxidants
Protective Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on July 29, 2014