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

• Status: Completed
• Trial end date: 1998-04-01
• Target enrollment: 0
• Participant gender: All

Summary

To assess response and toxicity in patients with fluconazole-resistant oral candidiasis ( thrush ) when given initial induction with amphotericin B oral suspension.

Experience with amphotericin B oral suspension for drug-sensitive thrush in HIV-infected patients is limited but encouraging.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
• Collaborator: Bristol-Myers Squibb
• Treatments: Amphotericin B; Fluconazole; Liposomal amphotericin B

Criteria

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.