A Phase II Trial of Amphotericin B Oral Suspension for Fluconazole-Resistant Oral Candidiasis in HIV-Infected Patients

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.

History of severe allergic reactions to study medication Currently pregnant or breastfeeding Recent participation in another clinical trial within the last 30 days Presence of uncontrolled medical conditions that could affect safety