Antihyperlipidemic Effects of Oyster Mushrooms
This study has been completed.
Sponsor:
National Center for Complementary and Integrative Health (NCCIH)
Collaborator:
Office of Dietary Supplements (ODS)
Information provided by:
National Center for Complementary and Integrative Health (NCCIH)
ClinicalTrials.gov Identifier:
NCT00069524
First received: September 29, 2003
Last updated: September 25, 2007
Last verified: September 2007
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Purpose
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 |
Resource links provided by NLM:
Further study details as provided by National Center for Complementary and Integrative Health (NCCIH):
| 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.
Eligibility| Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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.
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00069524
Please refer to this study by its ClinicalTrials.gov identifier: NCT00069524
Locations
| United States, California | |
| General Clinical Research Center, San Francisco General Hospital | |
| San Francisco, California, United States | |
Sponsors and Collaborators
National Center for Complementary and Integrative Health (NCCIH)
Office of Dietary Supplements (ODS)
Investigators
| Principal Investigator: | Donald I Abrams, MD | University of California, San Francisco |
More Information
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| ClinicalTrials.gov Identifier: | NCT00069524 History of Changes |
| Other Study ID Numbers: | R21AT001782-01 |
| 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 Integrative Health (NCCIH):
|
Highly active antiretroviral therapy (HAART) Ritonavir Oyster mushrooms |
Non-HDL cholesterol Complementary Therapies Treatment Experienced |
Additional relevant MeSH terms:
|
HIV Infections Hyperlipidemias Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes |
Immune System Diseases Dyslipidemias Lipid Metabolism Disorders Metabolic Diseases Hypolipidemic Agents Antimetabolites Molecular Mechanisms of Pharmacological Action Lipid Regulating Agents |
ClinicalTrials.gov processed this record on September 26, 2016