- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00069524
Antihyperlipidemic Effects of Oyster Mushrooms
September 25, 2007 updated by: National Center for Complementary and Integrative Health (NCCIH)
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).
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment
20
Phase
- Phase 2
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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California
-
San Francisco, California, United States
- General Clinical Research Center, San Francisco General Hospital
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NON_RANDOMIZED
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 2004
Study Completion (ACTUAL)
May 1, 2006
Study Registration Dates
First Submitted
September 29, 2003
First Submitted That Met QC Criteria
September 30, 2003
First Posted (ESTIMATE)
October 1, 2003
Study Record Updates
Last Update Posted (ESTIMATE)
September 26, 2007
Last Update Submitted That Met QC Criteria
September 25, 2007
Last Verified
September 1, 2007
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- R21AT001782-01 (NIH)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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