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 ritonavir, a protease inhibitor (PI) that is commonly used in highly active antiretroviral therapy (HAART).

Condition	Treatment or Intervention	Phase
HIV Infections Hyperlipidemia	Drug: oyster mushroom	Phase I Phase II

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.

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

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 >= 190 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.

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

Study chairs or principal investigators

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

Study ID Numbers:  R21 AT001782-01
Record last reviewed:  April 2004
Record first received:  September 29, 2003
ClinicalTrials.gov Identifier:  NCT00069524
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2004-10-20