Antihyperlipidemic Effects of Oyster Mushrooms

This study has been completed.

Sponsor:

Collaborator:

Office of Dietary Supplements (ODS)

Information provided by:

National Center for Complementary and Integrative Health (NCCIH)

ClinicalTrials.gov Identifier:

NCT00069524

First received: September 29, 2003

Last updated: September 25, 2007

Last verified: September 2007

History of Changes

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: 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


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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 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 ( US NIH Grant/Contract Award Number )
Study First Received:	September 29, 2003
Last Updated:	September 25, 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 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

ClinicalTrials.gov processed this record on June 22, 2017

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