Clinical Trials

MainTitle

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

This study has been terminated
( Dr. Vindas completed his fellowship + low enrollment )

Sponsor
University of Florida


Information provided by (Responsible Party)
University of Florida
ClinicalTrials.gov Identifier
NCT00692783

First received: May 28, 2008
Last updated: May 7, 2015
Last Verified: May 2015
History of Changes
Purpose

Purpose

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
Candidiasis
HIV Infections

Study Type: Observational
Study Design: 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.)

Further study details as provided by University of Florida:

Primary Outcome Measures

  • 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 ]

Enrollment: 10
Study Start Date: May 2008
Study Completion Date: January 2009
Estimated Primary Completion Date: October 2008 (Final data collection date for primary outcome measure)

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.

Eligibility

Eligibility

Ages Eligible for Study: 18 Years to 65 Years  
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

Criteria

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).

contacts and locations

Contacts and Locations

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Please refer to this study by its ClinicalTrials.gov identifier: NCT00692783

Locations

United States, Florida
Duval County Department of Health. Boulevard Comprehensive Care Center
Jacksonville, Florida, United States, 32206

Sponsors and Collaborators

University of Florida

Investigators

Principal Investigator: Jose Vindas, MD University of Florida
More Information

More Information


Responsible Party: University of Florida  
ClinicalTrials.gov Identifier: NCT00692783   History of Changes  
Other Study ID Numbers: UFJ2008-19  
Study First Received: May 28, 2008  
Last Updated: May 7, 2015  

Keywords provided by University of Florida:

candida
dubliniensis
candidiasis
HIV
AIDS
azole resistance.

Additional relevant MeSH terms:
HIV Infections
Candidiasis
Disease Susceptibility
Candidiasis, Oral

ClinicalTrials.gov processed this data on December 08, 2017
This information is provided by ClinicalTrials.gov.