Garlic in Hyperlipidemia Caused by HAART - Tabular View

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Garlic in Hyperlipidemia Caused by HAART

This study has been terminated.
Information provided by National Center for Complementary and Alternative Medicine (NCCAM)

This Tabular View shows the required WHO registration data elements as marked by ^†

Descriptive Information Fields

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

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.

Study Phase

Phase II

Study Type ^†

Interventional

Study Design ^†

Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study

Primary Outcome Measure ^†

Secondary Outcome Measure ^†

Condition ^†

HIV Infections
Hypercholesterolemia
Hypertriglyceridemia
Hyperglycemia

Intervention ^†

Drug: Garlic powder standardized to allicin

MEDLINE PMIDs

Links

Recruitment information This link exits the ClinicalTrials.gov site

Recruitment Information Fields

Recruitment Status ^†

Terminated

Enrollment ^†

146

Start Date ^†

November 2001

Completion Date

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

Gender

Both

Ages

18 Years to 65 Years

Accepts Healthy Volunteers

Contacts ^††

Location Countries ^†

United States

Administrative Information Fields

NCT ID ^†

NCT00029250

Organization ID

R21 AT000328-01

Secondary IDs ^††

Study Sponsor ^†

National Center for Complementary and Alternative Medicine (NCCAM)

Collaborators ^††

Investigators ^†

Principal Investigator:

Leanna J Standish, ND, PhD

Bastyr University

Information Provided By

National Center for Complementary and Alternative Medicine (NCCAM)

Verification Date

August 2006

First Received Date ^†

January 9, 2002

Last Updated Date

August 2, 2007

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.