A Study of Fluconazole in the Treatment of Fungal Infections of the Throat in Patients With Weakened Immune Systems

Patients receive fluconazole oral suspension for a minimum of 3 weeks and maximum of 8 weeks. Patients are evaluated weekly, and treatment continues for 2 weeks after resolution of symptoms. Endoscopic exams and possibly biopsies are performed at baseline and at the end of treatment. Patients undergo follow-up at 2 weeks post-treatment.

Inclusion criteria

Patients must have:

• AIDS or other immunocompromising condition.
• Candidal esophagitis.
• Life expectancy of at least 2 months.

Exclusion criteria

Co-existing Condition:

Patients with the following symptoms or conditions are excluded:

• Evidence of non-candidal systemic fungal infection.
• Abnormalities that may preclude esophagoscopy or endoscopy.
• Unable to tolerate fluconazole.
• Unable to give informed consent.
• Enrollment in other experimental trials of approved or non-approved drugs or systemic compounds (unless approved by the Pfizer Clinical Monitor).
• Other condition that would make patient unsuitable for enrollment.

Concurrent Medication:

Excluded:

• Concomitant oral or topical antifungal agent.
• Other experimental medications.

Patients with the following prior condition are excluded:

History of allergy to imidazoles or azoles.

Prior Medication:

Excluded:

• Any oral or topical antifungal therapy within the past 3 days. Active use of illicit or illegal drugs.