NCT00029250

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).

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Nov 2001

Shorter than P25 for phase_2 hiv-infections

Geographic Reach
1 country

2 active sites

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2001

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

January 9, 2002

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 10, 2002

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2003

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2003

Completed
Last Updated

March 22, 2013

Status Verified

March 1, 2013

Enrollment Period

1.5 years

First QC Date

January 9, 2002

Last Update Submit

March 21, 2013

Conditions

HIV InfectionsHypercholesterolemiaHypertriglyceridemiaHyperglycemia

Keywords

complementary therapiesgarlicAllium sativummetabolic diseasesHAARTProtease inhibitors

Interventions

Garlic powder standardized to allicinDRUG

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Bastyr University Center for Natural Health

Seattle, Washington, 98103, United States

Location

University of Washington Harborview Medical Center

Seattle, Washington, 98104, United States

Location

Related Publications (3)

  • 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.

    BACKGROUND

  • 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.

    PMID: 14640097BACKGROUND

  • 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.

    PMID: 15165411BACKGROUND

MeSH Terms

Conditions

HIV InfectionsHypercholesterolemiaHypertriglyceridemiaHyperglycemiaMetabolic Diseases

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System DiseasesHyperlipidemiasDyslipidemiasLipid Metabolism DisordersNutritional and Metabolic DiseasesGlucose Metabolism Disorders

Study Officials

  • Leanna J Standish, ND, PhD

    Bastyr University

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
NIH
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 9, 2002

First Posted

January 10, 2002

Study Start

November 1, 2001

Primary Completion

May 1, 2003

Study Completion

May 1, 2003

Last Updated

March 22, 2013

Record last verified: 2013-03

Locations

US(2)