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.
Sponsor:
Information provided by:
NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier:
NCT00002282
First received: November 2, 1999
Last updated: June 23, 2005
Last verified: February 1990

November 2, 1999
June 23, 2005
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Complete list of historical versions of study NCT00002282 on ClinicalTrials.gov Archive Site
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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
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

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.

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Interventional
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Primary Purpose: Treatment
  • Candidiasis, Oral
  • HIV Infections
  • Drug: Clotrimazole
  • Drug: Fluconazole
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
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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.
Both
13 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00002282
012M, 056-171
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Pfizer
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NIH AIDS Clinical Trials Information Service
February 1990

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP