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

Pfizer

Status and phase: Completed; Phase 3

Conditions: Candidiasis, Esophageal; HIV Infections

Treatments: Drug: Fluconazole

Study type: Interventional

Funder types: Industry

Identifiers

NCT00002339

R-0220

120

Details and patient eligibility

About

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

Full description

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.

Sex: All

Ages: 13 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.