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Antihyperlipidemic Effects of Oyster Mushrooms

This study has been completed.
Sponsor:
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
History of Changes
  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:

MedlinePlus related topics: HIV/AIDS
U.S. FDA Resources

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
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.

  Eligibility
Ages Eligible for Study:   18 Years and older
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. 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

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

No publications provided by National Center for Complementary and Integrative Health (NCCIH)

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 Integrative Health (NCCIH):
Highly active antiretroviral therapy (HAART)
Ritonavir
Oyster mushrooms
 Non-HDL cholesterol
Complementary Therapies
Treatment Experienced

Additional relevant MeSH terms:
Hypolipidemic Agents
Antimetabolites
Lipid Regulating Agents
 Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on March 01, 2015