A Study of Amphotericin B in the Treatment of Fungal Infections of the Mouth in HIV-Infected Patients Who Have Not Had Success With Fluconazole

Inclusion Criteria

Patients must have:

• HIV infection OR diagnosis of AIDS.
• Diffuse oral candidiasis, symptomatic or asymptomatic, that is resistant to fluconazole.

Exclusion Criteria

Co-existing Condition:

Patients with the following symptoms or conditions are excluded:

• Current symptoms of esophageal candidiasis unless there are negative endoscopic visualization and biopsy for Candida or related yeasts.
• Perioral lesions only (e.g., angular stomatitis, perleche).
• Inability to swish and swallow oral solution.
• Inability to tolerate further oral therapy for thrush.

Concurrent Medication:

Excluded:

• Fluconazole.
• Itraconazole.
• Ketoconazole.
• Flucytosine.
• Intravenous amphotericin or other non-study formulations.
• Nystatin.
• Clotrimazole.
• Other investigational antifungal agents.
• Systemic cytotoxic chemotherapy for malignancy.

Concurrent Treatment:

Excluded:

• Radiation therapy to the mouth, neck, or chest.

Patients with the following prior conditions are excluded:

• Esophageal candidiasis, proven or presumptive, occurring since fluconazole failure.
• Successful treatment of thrush with fluconazole at <= 200 mg/day after original treatment failure.
• History of oral candidiasis that recurred or persisted despite IV amphotericin B given once or more weekly.
• History of anaphylaxis to amphotericin B.
• History of hypersensitivity to components in amphotericin B oral suspension.

Prior Medication:

Excluded within 6 weeks prior to study entry:

• Cytotoxic therapy for malignancy.
• Corticosteroids at higher than replacement doses.