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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 28-Day Study of Diclazuril in the Treatment of Cryptosporidiosis in Patients with AIDS

2. Pulmonary Complications of HIV Infection Study (PACS)

3. Drug Interactions of Amprenavir and Efavirenz, in Combination with a Second Protease Inhibitor, in HIV-Negative Volunteers

4. HIV in Specific Parts of the Body of Patients Who Are Changing or Starting Potent Anti-HIV Drugs

5. A Study of Physical and Metabolic Abnormalities in HIV Infected and Uninfected Children and Youth

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