Antihyperlipidemic Effects of Oyster Mushrooms

• Status: Completed
• Trial end date: 2006-05-01
• Target enrollment: 0
• Participant gender: All

Summary

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).

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Center for Complementary and Integrative Health (NCCIH)
• Collaborator: Office of Dietary Supplements (ODS)
• Treatments: Hypolipidemic Agents

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.