A Comparison of the Safety and Effectiveness of Fluconazole or Clotrimazole in the Treatment of F… (NCT00002282) | Clinical Trial Compass
CompletedNot Applicable
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
United States
Plain-language 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.
Who can participate
Age range13 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 vir…