Clinical trial NCT00029250: 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
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: HIV Infections
Hypercholesterolemia
Hypertriglyceridemia
Hyperglycemia
Keywords: complementary therapies
garlic
Allium sativum
metabolic diseases
HAART
Protease inhibitors
Lead sponsor: National Center for Complementary and Integrative Health (NCCIH)
Sponsor class: NIH
First posted: 2002-01-10
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Seattle
country: United States
facility: Bastyr University Center for Natural Health
state: Washington
city: Seattle
country: United States
facility: University of Washington Harborview Medical Center
state: Washington
Study officials:
affiliation: Bastyr University
name: Leanna J Standish, ND, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.