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

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

To determine the safety, toleration, and efficacy of fluconazole oral suspension in the treatment of esophageal candidiasis in immunocompromised patients, including those with AIDS.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Pfizer
• Treatments: Fluconazole

Criteria

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.