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Antihyperlipidemic Effects of Oyster Mushrooms
This study has been completed.
Study NCT00069524   Information provided by National Center for Complementary and Alternative Medicine (NCCAM)
First Received: September 29, 2003   Last Updated: September 25, 2007   History of Changes

September 29, 2003
September 25, 2007
June 2004
 
 
 
Complete list of historical versions of study NCT00069524 on ClinicalTrials.gov Archive Site
 
 
 
Antihyperlipidemic Effects of Oyster Mushrooms
Antihyperlipidemic Effects of Oyster Mushrooms

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).

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.

Phase I, Phase II
Interventional
Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study
  • HIV Infections
  • Hyperlipidemia
Drug: oyster mushroom
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Completed
20
May 2006
 

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00069524
 
R21 AT001782-01
National Center for Complementary and Alternative Medicine (NCCAM)
Office of Dietary Supplements (ODS)
Principal Investigator: Donald I Abrams, MD University of California, San Francisco
National Center for Complementary and Alternative Medicine (NCCAM)
September 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP