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

Completed · Phase 3

Conditions studied: Candidiasis, Esophageal, HIV Infections

In brief

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

Key facts

Study ID

NCT00002339

Run by

Pfizer

People needed

100

Last updated by the study team

2005-06-24

Who can join

Age: 13 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

• 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.

Where it is running

• Los Angeles County - USC Med Ctr — Los Angeles, California, United States
• Houston Veterans Administration Med Ctr — Houston, Texas, United States

Full record on ClinicalTrials.gov

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