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

Pfizer

Status: Completed

Conditions: HIV Infections; Candidiasis, Oral

Treatments: Drug: Fluconazole; Drug: Clotrimazole

Study type: Interventional

Funder types: Industry

Identifiers

NCT00002282

056-171

012M

Details and patient eligibility

About

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.

Sex: All

Ages: 13+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.