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Home > "A" Clinical Trials Conditions > Antihyperlipidemic Effects of Oyster Mushrooms  Antihyperlipidemic Effects of Oyster Mushrooms
Antihyperlipidemic Effects of Oyster Mushrooms
For Condition: HIV Infections,Hyperlipidemia
Status: Not yet recruiting
Sponsor(s): National Center for Complementary and Alternative Medicine (NCCAM) ,
Synopsis: 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 ritonavir, a protease inhibitor (PI) that is commonly used in highly active antiretroviral therapy (HAART).
Details: 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:
Study Type: Interventional, Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry 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 >= 190 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.
Total Enrollment: 20
Location and Contact Information:
Overall Study Official:
DonaldAbrams, Principal Investigator, University of California, San Francisco
General Clinical Research Center, San Francisco General Hospital
San Francisco, California,
United States
Paul Couey 415-476-9554
Additional Information:
Study ID Numbers: R21 AT001782-01;
Study Start Date: June 2004
Record last reviewed: April 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00069524
Other Hiv Infections Studies:
1. A Pilot Study to Compare the Antiviral and Immunologic Effects of Stavudine ( d4T ) Versus Placebo in Subjects With Evidence of Recent HIV Infection.
2. A Phase I, Randomized, Double-Blind, Placebo-Controlled, Clinical Trial to Compare the Safety and Immunogenicity of Recombinant Envelope Protein rgp120/HIV-1SF2 (BIOCINE) Combined With Seven Adjuvants in Healthy HIV-1 Uninfected Individuals
3. A Phase I, Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial to Evaluate the Safety and Immunogenicity of HIV-1 MN rsgp120 and Bivalent AIDSVAX B/E (HIV-1 MN rgp120/A244 rgp120) in Combination with QS-21 With or Without Alum in Healthy HIV-1 Uninfected Adults
4. A Treatment Protocol for the Use of Intravenous Ganciclovir in AIDS Patients With Immediately Sight-Threatening CMV Retinitis
5. Effectiveness of Interleukin-2 (IL-2) Plus Anti-HIV Therapy in HIV-Positive Patients
Related Studies:
Other HIV Infections Clinical Trials
Other California Clinical Trials
Other San Francisco Clinical Trials
Antihyperlipidemic Effects of Oyster Mushrooms
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