Antihyperlipidemic Effects of Oyster Mushrooms

This study has been completed.

First Received: September 29, 2003 Last Updated: September 25, 2007 History of Changes

Sponsors and Collaborators:	National Center for Complementary and Alternative Medicine (NCCAM) Office of Dietary Supplements (ODS)
Information provided by:	National Center for Complementary and Alternative Medicine (NCCAM)
ClinicalTrials.gov Identifier:	NCT00069524

Purpose

The primary goal of this study is to evaluate the short-term safety and potential efficacy of oyster mushrooms (Pleurotus ostreatus) for treatment of hyperlipidemia in HIV-infected patients who are taking Kaletra, a protease inhibitor (PI) that is commonly used in highly active antiretroviral therapy (HAART).

Condition	Intervention	Phase
HIV Infections Hyperlipidemia	Drug: oyster mushroom	Phase I Phase II

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study
Official Title:	Antihyperlipidemic Effects of Oyster Mushrooms

Resource links provided by NLM:

MedlinePlus related topics: AIDS

U.S. FDA Resources

Further study details as provided by National Center for Complementary and Alternative Medicine (NCCAM):

Estimated Enrollment:	20
Study Start Date:	June 2004
Study Completion Date:	May 2006

Detailed Description:

This is a single-arm, open-label, 8-week "proof of concept" pilot study in 20 subjects to determine if there are detectable lipid-lowering effects of oyster mushrooms in patients with HIV and hyperlipidemia who are taking Kaletra (a ritonavir-containing HAART regimen). The study will also assess whether the concurrent administration of oyster mushrooms and such regimens is safe, and investigate the mechanism of action whereby oyster mushrooms may exert their antihyperlipidemic effect.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion criteria:

Documented HIV infection (positive ELISA and Western Blot or measurable plasma HIV RNA).
Taking Kaletra (ritonavir/lopinavir), a ritonavir-containing antiretroviral therapy, for at least 12 weeks
Elevated non-HDL cholesterol >= 160 mg/dl as defined by the National Cholesterol Education Program guidelines (within 30 days of enrollment)
AST or ALT <2.5 times the upper limit of normal (ULN) within 30 days of study entry.

Exclusion criteria:

Currently receiving antihyperlipidemic treatment (e.g., statins, fibrates, bile sequestrants, niacin)
Pregnancy or breastfeeding
Documented history of myopathy or myalgias on HMG-CoA reductase inhibitors
Documented history of rhabdomyolysis
Documented diagnosis of diabetes mellitus
Any condition that, in the judgment of the investigator, precludes successful participation in the study.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00069524

Locations

United States, California
General Clinical Research Center, San Francisco General Hospital
San Francisco, California, United States

Sponsors and Collaborators

National Center for Complementary and Alternative Medicine (NCCAM)

Office of Dietary Supplements (ODS)

Investigators

Principal Investigator:

Donald I Abrams, MD

University of California, San Francisco

More Information

No publications provided

Study ID Numbers:	R21 AT001782-01
Study First Received:	September 29, 2003
Last Updated:	September 25, 2007
ClinicalTrials.gov Identifier:	NCT00069524 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by National Center for Complementary and Alternative Medicine (NCCAM):

Highly active antiretroviral therapy (HAART)
Ritonavir
Oyster mushrooms

Non-HDL cholesterol
Complementary Therapies
Treatment Experienced

Study placed in the following topic categories:

Antimetabolites
Sexually Transmitted Diseases, Viral
Hyperlipidemias
Metabolic Diseases
Antilipemic Agents
Acquired Immunodeficiency Syndrome
Immunologic Deficiency Syndromes
Virus Diseases

HIV Infections
Ritonavir
Sexually Transmitted Diseases
Retroviridae Infections
Metabolic Disorder
Dyslipidemias
Lipid Metabolism Disorders

Additional relevant MeSH terms:

Antimetabolites
RNA Virus Infections
Sexually Transmitted Diseases, Viral
Metabolic Diseases
Hyperlipidemias
Slow Virus Diseases
Molecular Mechanisms of Pharmacological Action
Immune System Diseases
Antilipemic Agents
Acquired Immunodeficiency Syndrome
Infection

Pharmacologic Actions
Immunologic Deficiency Syndromes
Virus Diseases
HIV Infections
Therapeutic Uses
Sexually Transmitted Diseases
Lentivirus Infections
Retroviridae Infections
Dyslipidemias
Lipid Metabolism Disorders

ClinicalTrials.gov processed this record on July 02, 2009