HIV Infections Clinical Trial
Official title:
An Open Multicenter Trial of Fluconazole Oral Suspension in the Treatment of Esophageal Candidiasis in Immunocompromised Patients
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 |
To determine the safety, toleration, and efficacy of fluconazole oral suspension in the treatment of esophageal candidiasis in immunocompromised patients, including those with AIDS.
Status | Completed |
Enrollment | 100 |
Est. completion date | |
Est. primary completion date | |
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. |
Endpoint Classification: Safety Study, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Houston Veterans Administration Med Ctr | Houston | Texas |
United States | Los Angeles County - USC Med Ctr | Los Angeles | California |
Lead Sponsor | Collaborator |
---|---|
Pfizer |
United States,
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
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