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

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Pfizer
• Treatments: Clotrimazole; Fluconazole; Miconazole

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.