Antihyperlipidemic Effects of Oyster Mushrooms

Completed · Phase 1/Phase 2

Conditions studied: HIV Infections, Hyperlipidemia

In brief

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).

Key facts

Study ID

NCT00069524

Run by

National Center for Complementary and Integrative Health (NCCIH)

People needed

20

Starts

2004-06-01

Expected to finish

2006-05-01

Last updated by the study team

2007-09-26

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

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

Full record on ClinicalTrials.gov

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