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A Comparison of the Safety and Effectiveness of Fluconazole or Clotrimazole in the Treatment of Fungal Infections of the Mouth and Throat in Patients With AIDS

This study has been completed.
Study NCT00002282.   Last updated on June 23, 2005.   Information provided by NIH AIDS Clinical Trials Information Service

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Descriptive Information Fields
Brief Title  A Comparison of the Safety and Effectiveness of Fluconazole or Clotrimazole in the Treatment of Fungal Infections of the Mouth and Throat in Patients With AIDS
Official Title  A Randomized Multicenter Study of the Efficacy, Safety, and Toleration of Fluconazole or Clotrimazole Troches in the Treatment of Patients With Oropharyngeal Candidiasis in Association With the Acquired Immunodeficiency Syndrome
Brief Summary

To compare the efficacy, safety, and tolerance of fluconazole single daily capsule for 14 days versus clotrimazole troche 5 x daily for 14 days in the treatment of oropharyngeal candidiasis in patients with AIDS.

Detailed Description
Study Phase
Study Type  Interventional
Study Design  Treatment
Primary Outcome Measure 
Secondary Outcome Measure 
Condition  Candidiasis, Oral
HIV Infections
Intervention  Drug: Clotrimazole
Drug: Fluconazole
MEDLINE PMIDs
Links
Recruitment Information Fields
Recruitment Status  Completed
Enrollment 
Start Date 
Completion Date
Eligibility Criteria 

Inclusion Criteria

Concurrent Medication:

Allowed:

  • Cimetidine.

Exclusion Criteria

Co-existing Condition:

Patients with the following are excluded:

  • Known history of intolerance or allergy to imidazoles or triazoles, or the non-azole components of clotrimazole troches (dextrose, cellulose, povidone, magnesium stearate).
  • Moderate or severe liver disease defined by specified lab values.

Concurrent Medication:

Excluded pending results of phase I studies to determine whether interaction between fluconazole and these agents occurs:

  • Barbiturates.
  • Phenytoin.
  • Coumarin-type anticoagulants.
  • Rifampin.
  • Oral hypoglycemics.
  • Cyclosporin.

Patients with the following are excluded:

  • Known history of intolerance or allergy to imidazoles or triazoles, or the non-azole components of clotrimazole troches (dextrose, cellulose, povidone, magnesium stearate).
  • Unable to tolerate oral medication.
  • Moderate or severe liver disease defined by specified lab values.
  • Life expectancy < 4 weeks.
  • Unable or unwilling to be followed at the same center for the conduct of this study.

Prior Medication:

Excluded within 3 days of study entry:

  • Other antifungal agents.
  • Excluded pending results of phase I studies to determine whether interaction between fluconazole and these agents occurs:
  • Barbiturates.
  • Phenytoin.
  • Coumarin-type anticoagulants.
  • Rifampin.
  • Oral hypoglycemics.
  • Cyclosporin.

Patients meeting CDC criteria for diagnosis of AIDS, or having serologic or virologic evidence of HIV infection (but without AIDS-defining opportunistic infections as of yet).

  • Patients who have given informed consent in writing to their participation in the study.
  • Patients with signs of oropharyngeal candidiasis, i.e., with typical white plaques.
Gender Both
Ages 13 Years and older
Accepts Healthy Volunteers No
Contacts ††
Location Countries  United States
Administrative Information Fields
NCT ID  NCT00002282
Organization ID 012M
Secondary IDs †† 056-171
Study Sponsor  Pfizer
Collaborators ††
Investigators 
Information Provided By NIH AIDS Clinical Trials Information Service
Verification Date February 1990
First Received Date  November 2, 1999
Last Updated Date June 23, 2005

 †    Required WHO trial registration data element.
††   WHO trial registration data element that is required only if it exists.




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