Antihyperlipidemic Effects of Oyster Mushrooms

Status

Completed

Phases

Phase 1Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00069524

Enrollment

Registered

2003-10-01

Start date

2004-06-30

Completion date

2006-05-31

Last updated

2007-09-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HIV Infections, Hyperlipidemia

Keywords

Highly active antiretroviral therapy (HAART), Ritonavir, Oyster mushrooms, Non-HDL cholesterol, Complementary Therapies, Treatment Experienced

Brief 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).

Detailed description

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.

Interventions

DRUGoyster mushroom

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026