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This study has been withdrawn prior to enrollment.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

January 9, 2002
March 21, 2013
November 2001
May 2003   (final data collection date for primary outcome measure)
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Complete list of historical versions of study NCT00029250 on ClinicalTrials.gov Archive Site
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Garlic in Hyperlipidemia Caused by HAART
Phase II, Randomized, Double-blind, Placebo-controlled, Dose-escalation Study on the Effects of Garlic on Hyperlipidemia Induced by HAART in HIV-positive Individuals

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).

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.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
  • HIV Infections
  • Hypercholesterolemia
  • Hypertriglyceridemia
  • Hyperglycemia
Drug: Garlic powder standardized to allicin
Not Provided
  • 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Withdrawn
0
May 2003
May 2003   (final data collection date for primary outcome measure)

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
Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00029250
R21 AT000328-01
Not Provided
National Center for Complementary and Alternative Medicine (NCCAM)
National Center for Complementary and Alternative Medicine (NCCAM)
Not Provided
Principal Investigator: Leanna J Standish, ND, PhD Bastyr University
National Center for Complementary and Alternative Medicine (NCCAM)
March 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP