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

HIV Infections Clinical Trial

Official title:

An Open Multicenter Trial of Fluconazole Oral Suspension in the Treatment of Esophageal Candidiasis in Immunocompromised Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00002339
• Other study ID #: 120
• Secondary ID: R-0220
• Status: Completed
• Phase: Phase 3
• First received: November 2, 1999
• Last updated: June 23, 2005

Study information

• Verified date: April 1996
• Source: NIH AIDS Clinical Trials Information Service
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 13 Years to 70 Years

Eligibility

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.

Study Design

Endpoint Classification: Safety Study, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Candidiasis
• Candidiasis, Esophageal
• HIV Infections

Intervention

Drug:
• Fluconazole

Locations

Country	Name	City	State
United States	Houston Veterans Administration Med Ctr	Houston	Texas
United States	Los Angeles County - USC Med Ctr	Los Angeles	California

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Country where clinical trial is conducted

United States, 

References & Publications (1)

Agresti MG, de Bernardis F, Mondello F, Bellocco R, Carosi GP, Caputo RM, Milazzo F, Chiodo F, Giannini V, Minoli L, et al. Clinical and mycological evaluation of fluconazole in the secondary prophylaxis of esophageal candidiasis in AIDS patients. An open, multicenter study. Eur J Epidemiol. 1994 Feb;10(1):17-22. — View Citation