NCT00069524

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for phase_1 hiv-infections

Timeline
Completed

Started Jun 2004

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 29, 2003

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 1, 2003

Completed
8 months until next milestone

Study Start

First participant enrolled

June 1, 2004

Completed
1.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2006

Completed
Last Updated

September 26, 2007

Status Verified

September 1, 2007

First QC Date

September 29, 2003

Last Update Submit

September 25, 2007

Conditions

HIV InfectionsHyperlipidemia

Keywords

Highly active antiretroviral therapy (HAART)RitonavirOyster mushroomsNon-HDL cholesterolComplementary TherapiesTreatment Experienced

Interventions

oyster mushroomDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

General Clinical Research Center, San Francisco General Hospital

San Francisco, California, United States

Location

Related Publications (1)

  • 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.

    PMID: 21831304DERIVED

MeSH Terms

Conditions

HIV InfectionsHyperlipidemias

Interventions

pleurotolysin B, oyster mushroom

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System DiseasesDyslipidemiasLipid Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • Donald I Abrams, MD

    University of California, San Francisco

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
NIH

Study Record Dates

First Submitted

September 29, 2003

First Posted

October 1, 2003

Study Start

June 1, 2004

Study Completion

May 1, 2006

Last Updated

September 26, 2007

Record last verified: 2007-09

Locations

US(1)