A Study of Fluconazole in the Treatment of Fungal Infections of the Throat in Patients With Weakened Immune Systems
Information source: NIH AIDS Clinical Trials Information Service
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Candidiasis, Esophageal; HIV Infections
Intervention: Fluconazole (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: Pfizer
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.
Clinical Details
Official title: An Open Multicenter Trial of Fluconazole Oral Suspension in the Treatment of Esophageal Candidiasis in Immunocompromised Patients
Study design: Treatment, Safety Study
Detailed 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.
Eligibility
Minimum age: 13 Years.
Maximum age: 70 Years.
Gender(s): Both.
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.
Locations and Contacts
Los Angeles County - USC Med Ctr, Los Angeles, California 90033, United States
Houston Veterans Administration Med Ctr, Houston, Texas 77030, United States
Additional Information
Related publications: 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.
Last updated: June 23, 2005
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