Antihyperlipidemic Effects of Oyster Mushrooms

This study has been completed.

Sponsor:

ClinicalTrials.gov Identifier:

NCT00069524

First Posted: October 1, 2003

Last Update Posted: September 26, 2007

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.

Collaborator:

Office of Dietary Supplements (ODS)

Information provided by:

National Center for Complementary and Integrative Health (NCCIH)

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 1 Phase 2


Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment
Official Title:	Antihyperlipidemic Effects of Oyster Mushrooms

Resource links provided by NLM:

MedlinePlus related topics: HIV/AIDS

U.S. FDA Resources

Further study details as provided by National Center for Complementary and Integrative Health (NCCIH):


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

Information from the National Library of Medicine

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Ages Eligible for Study:	18 Years and older (Adult, Senior)
Sexes Eligible for Study:	All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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 Integrative Health (NCCIH)

Office of Dietary Supplements (ODS)

Investigators


Principal Investigator:	Donald I Abrams, MD	University of California, San Francisco

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Abrams DI, Couey P, Shade SB, Kelly ME, Kamanu-Elias N, Stamets P. Antihyperlipidemic effects of Pleurotus ostreatus (oyster mushrooms) in HIV-infected individuals taking antiretroviral therapy. BMC Complement Altern Med. 2011 Aug 10;11:60. doi: 10.1186/1472-6882-11-60.


ClinicalTrials.gov Identifier:	NCT00069524 History of Changes
Other Study ID Numbers:	R21AT001782-01 ( U.S. NIH Grant/Contract )
First Submitted:	September 29, 2003
First Posted:	October 1, 2003
Last Update Posted:	September 26, 2007
Last Verified:	September 2007

Keywords provided by National Center for Complementary and Integrative Health (NCCIH):


Highly active antiretroviral therapy (HAART) Ritonavir Oyster mushrooms	Non-HDL cholesterol Complementary Therapies Treatment Experienced

Additional relevant MeSH terms:


HIV Infections Hyperlipidemias Hyperlipoproteinemias Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases	Immunologic Deficiency Syndromes Immune System Diseases Dyslipidemias Lipid Metabolism Disorders Metabolic Diseases Hypolipidemic Agents Antimetabolites Molecular Mechanisms of Pharmacological Action Lipid Regulating Agents

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