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Garlic in Hyperlipidemia Caused by HAART

Primary Purpose

HIV Infections, Hypercholesterolemia, Hypertriglyceridemia

Status
Withdrawn
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Garlic powder standardized to allicin
Sponsored by
National Center for Complementary and Integrative Health (NCCIH)
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for HIV Infections focused on measuring complementary therapies, garlic, Allium sativum, metabolic diseases, HAART, Protease inhibitors

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Bastyr University Center for Natural Health
  • University of Washington Harborview Medical Center

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
January 9, 2002
Last Updated
March 21, 2013
Sponsor
National Center for Complementary and Integrative Health (NCCIH)
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1. Study Identification

Unique Protocol Identification Number
NCT00029250
Brief Title
Garlic in Hyperlipidemia Caused by HAART
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 Type
Interventional

2. Study Status

Record Verification Date
March 2013
Overall Recruitment Status
Withdrawn
Study Start Date
November 2001 (undefined)
Primary Completion Date
May 2003 (Actual)
Study Completion Date
May 2003 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Center for Complementary and Integrative Health (NCCIH)

4. Oversight

5. Study Description

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).
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections, Hypercholesterolemia, Hypertriglyceridemia, Hyperglycemia
Keywords
complementary therapies, garlic, Allium sativum, metabolic diseases, HAART, Protease inhibitors

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Garlic powder standardized to allicin

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Leanna J Standish, ND, PhD
Organizational Affiliation
Bastyr University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Bastyr University Center for Natural Health
City
Seattle
State/Province
Washington
ZIP/Postal Code
98103
Country
United States
Facility Name
University of Washington Harborview Medical Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98104
Country
United States

12. IPD Sharing Statement

Citations:
Citation
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.
Results Reference
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PubMed Identifier
14640097
Citation
Standish LJ, Johnson LC, Kozak L, Richards T. Evidence of correlated functional magnetic resonance imaging signals between distant human brains. Altern Ther Health Med. 2003 Jan-Feb;9(1):128, 122-5. No abstract available.
Results Reference
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PubMed Identifier
15165411
Citation
Standish LJ, Kozak L, Johnson LC, Richards T. Electroencephalographic evidence of correlated event-related signals between the brains of spatially and sensory isolated human subjects. J Altern Complement Med. 2004 Apr;10(2):307-14. doi: 10.1089/107555304323062293.
Results Reference
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Garlic in Hyperlipidemia Caused by HAART

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