Back to resultsAntihyperlipidemic Effects of Oyster Mushrooms
Primary Purpose
HIV Infections, Hyperlipidemia
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
oyster mushroom
Sponsored by
About this trial
This is an interventional treatment trial for HIV Infections focused on measuring Highly active antiretroviral therapy (HAART), Ritonavir, Oyster mushrooms, Non-HDL cholesterol, Complementary Therapies, Treatment Experienced
Eligibility 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.
Sites / Locations
- General Clinical Research Center, San Francisco General Hospital
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT00069524
First Posted
September 29, 2003
Last Updated
September 25, 2007
Sponsor
National Center for Complementary and Integrative Health (NCCIH)
Collaborators
Office of Dietary Supplements (ODS)
1. Study Identification
Unique Protocol Identification Number
NCT00069524
Brief Title
Antihyperlipidemic Effects of Oyster Mushrooms
Official Title
Antihyperlipidemic Effects of Oyster Mushrooms
Study Type
Interventional
2. Study Status
Record Verification Date
September 2007
Overall Recruitment Status
Completed
Study Start Date
June 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
May 2006 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
National Center for Complementary and Integrative Health (NCCIH)
Collaborators
Office of Dietary Supplements (ODS)
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections, Hyperlipidemia
Keywords
Highly active antiretroviral therapy (HAART), Ritonavir, Oyster mushrooms, Non-HDL cholesterol, Complementary Therapies, Treatment Experienced
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
20 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
oyster mushroom
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Donald I Abrams, MD
Organizational Affiliation
University of California, San Francisco
Official's Role
Principal Investigator
Facility Information:
Facility Name
General Clinical Research Center, San Francisco General Hospital
City
San Francisco
State/Province
California
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
21831304
Citation
Abrams DI, Couey P, Shade SB, Kelly ME, Kamanu-Elias N, Stamets P. Antihyperlipidemic effects of Pleurotus ostreatus (oyster mushrooms) in HIV-infected individuals taking antiretroviral therapy. BMC Complement Altern Med. 2011 Aug 10;11:60. doi: 10.1186/1472-6882-11-60.
Results Reference
derived
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Antihyperlipidemic Effects of Oyster Mushrooms
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