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Home > "A" Clinical Trials Conditions > A Study of Fluconazole in the Treatment of Fungal Infections of the Throat in Patients with Weakened Immune Systems  A Study of Fluconazole in the Treatment of Fungal Infections of the Throat in Patients with Weakened Immune Systems
A Study of Fluconazole in the Treatment of Fungal Infections of the Throat in Patients with Weakened Immune Systems
For Condition: Candidiasis, esophageal,HIV Infections
Status: Completed
Sponsor(s): Pfizer ,
Synopsis: To determine the safety, toleration, and efficacy of fluconazole oral suspension in the treatment of esophageal candidiasis in immunocompromised patients, including those with AIDS.
Details: 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:
Study Type: Interventional, Treatment, Safety Study
Minimum Age/Maximum Age: 13 Years/70 Years
Genders: Both
Protocol Entry 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.
Total Enrollment: 100
Location and Contact Information:
Houston Veterans Administration Med Ctr
Houston, Texas, 77030
United States
Los Angeles County - USC Med Ctr
Los Angeles, California, 90033
United States
Additional Information:
Study ID Numbers: 120; R-0220
Study Start Date:
Record last reviewed: April 1996
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00002339
Other Candidiasis, Esophageal Studies:
1. A Randomized, Prospective, Double-Blind Study Comparing Fluconazole With Placebo for Primary and Secondary Prophylaxis of Mucosal Candidiasis in HIV-Infected Women
2. A Study of Fluconazole in the Treatment of Fungal Infections of the Throat in Patients with Weakened Immune Systems
3. Randomized, Controlled, Double-Blind Study of Itraconazole Oral Solution Versus Fluconazole Tablets for the Treatment of Esophageal Candidiasis.
4. Evaluation of Amphotericin B in the Treatment of Biopsy Proven Candida Esophagitis in Immunocompromised Patients
5. A Study of the Side Effects of L-743,872 in Men with Candidal Esophagitis
Related Studies:
Other Candidiasis, esophageal Clinical Trials
Other Texas Clinical Trials
Other Houston Clinical Trials
A Study of Fluconazole in the Treatment of Fungal Infections of the Throat in Patients with Weakened Immune Systems
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