Antihyperlipidemic Effects of Oyster Mushrooms
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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).
Condition | Intervention | Phase |
---|---|---|
HIV Infections Hyperlipidemia |
Drug: oyster mushroom |
Phase 1 Phase 2 |
Study Type: | Interventional |
Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
Official Title: | Antihyperlipidemic Effects of Oyster Mushrooms |
Estimated Enrollment: | 20 |
Study Start Date: | June 2004 |
Study Completion Date: | May 2006 |
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 older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
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.
United States, California | |
General Clinical Research Center, San Francisco General Hospital | |
San Francisco, California, United States |
Principal Investigator: | Donald I Abrams, MD | University of California, San Francisco |
No publications provided by National Center for Complementary and Alternative Medicine (NCCAM)
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: | NCT00069524 History of Changes |
Other Study ID Numbers: | R21 AT001782-01 |
Study First Received: | September 29, 2003 |
Last Updated: | September 25, 2007 |
Health Authority: | United States: Food and Drug Administration |
Keywords provided by National Center for Complementary and Alternative Medicine (NCCAM):
Highly active antiretroviral therapy (HAART) Ritonavir Oyster mushrooms |
Non-HDL cholesterol Complementary Therapies Treatment Experienced |
Additional relevant MeSH terms:
HIV Infections Acquired Immunodeficiency Syndrome Hyperlipidemias Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases |
Slow Virus Diseases Dyslipidemias Lipid Metabolism Disorders Metabolic Diseases Hypolipidemic Agents Antimetabolites Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Lipid Regulating Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on March 03, 2013