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Incidence of Oral Candidiasis, Prevalence of C. Dubliniensis in HIV Patients and In-vitro Azole Susceptibility (ICONIC)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00692783
Recruitment Status : Terminated (Dr. Vindas completed his fellowship + low enrollment)
First Posted : June 6, 2008
Last Update Posted : May 8, 2015
Information provided by (Responsible Party):
University of Florida

Brief Summary:
C. dubliniensis has been identified as pathogen in Oropharyngeal Candidiasis(OPC)particularly among HIV patients. Azole therapy is a cornerstone in OPC, but resistance within C. dubliniensis isolates to diflucan is common.This is a prospective collection of biological specimens from oropharyngeal cavity with the purpose of determining the prevalence of C. dubliniensis in HIV/AIDS patients at the Duval County Department of Health Comprehensive care Center. It is hereto proposed an estimation of azole-resistance in these isolates.

Condition or disease
Candidiasis HIV Infections

Detailed Description:

This is a study to try to establish the prevalence of C. dubliniensis as a causative organism of OPC in HIV and/or AIDS patients. We will aim to establish the resistance pattern for azoles but also for Flucytosine and amphotericin of these isolates.

This study will serve as a support to previously published articles that have suggested intrinsic azole-resistance within this particular species of candida and we will try to postulate its possible correlation with clinical failure.

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Study Type : Observational
Actual Enrollment : 10 participants
Time Perspective: Prospective
Official Title: Incidence of Oral Candidiasis, Prevalence of Candida Dubliniensis in HIV Patients and In-vitro Azole Susceptibility. (I.C.O.N.I.C.)
Study Start Date : May 2008
Actual Primary Completion Date : October 2008
Actual Study Completion Date : January 2009

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. Incidence of oropharyngeal candidiasis in our HIV population; estimation of the prevalence of candida dubliniensis and pattern of azole resistance to direct future treatment [ Time Frame: April 2009 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
HIV with or without AIDS defining illnesses at the Boulevard Comprehensive Care Center

Inclusion Criteria:

  • Any patient 18 years old or older with a documented diagnosis of HIV infection with or without AIDS-defining illnesses at the time of assessment, who is presenting with clinical symptoms and physical findings compatible with oropharyngeal candidiasis (as defined by the IDSA Guidelines for the Treatment and Management of HIV and HIV- related complications.

Exclusion Criteria:

  • Any prior diagnosis or established treatment for oropharyngeal, mucocutaneous or esophageal candidiasis documented in the patient's chart or any proven diagnosis based on reviews of physically available medical records and or history provided by patients that can be subject to later confirmation pertaining to the use of parenteral antifungals within 6 months prior to enrollment (azoles, echinocandins, amphotericin B, Flucytosine, etc).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00692783

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United States, Florida
Duval County Department of Health. Boulevard Comprehensive Care Center
Jacksonville, Florida, United States, 32206
Sponsors and Collaborators
University of Florida
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Principal Investigator: Jose Vindas, MD University of Florida
Publications of Results:
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Responsible Party: University of Florida Identifier: NCT00692783    
Other Study ID Numbers: UFJ2008-19
First Posted: June 6, 2008    Key Record Dates
Last Update Posted: May 8, 2015
Last Verified: May 2015
Keywords provided by University of Florida:
azole resistance.
Additional relevant MeSH terms:
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Candidiasis, Oral
Mouth Diseases
Stomatognathic Diseases