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.
- Documented HIV infection (positive ELISA and Western Blot or measurable plasma HIV
- 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.
- Currently receiving antihyperlipidemic treatment (e.g., statins, fibrates, bile
- 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.