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

Tracking Information
First Received Date ^ICMJE	November 2, 1999
Last Updated Date	June 23, 2005
Start Date ^ICMJE
Primary Completion Date
Current Primary Outcome Measures ^ICMJE
Original Primary Outcome Measures ^ICMJE
Change History	Complete list of historical versions of study NCT00002339 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE
Original Secondary Outcome Measures ^ICMJE

Descriptive Information
Brief Title ^ICMJE	A Study of Fluconazole in the Treatment of Fungal Infections of the Throat in Patients With Weakened Immune Systems
Official Title ^ICMJE	An Open Multicenter Trial of Fluconazole Oral Suspension in the Treatment of Esophageal Candidiasis in Immunocompromised Patients
Brief 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.
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.
Study Phase	Phase III
Study Type ^ICMJE	Interventional
Study Design ^ICMJE	Treatment, Safety Study
Condition ^ICMJE	Candidiasis, Esophageal HIV Infections
Intervention ^ICMJE	Drug: Fluconazole
Study Arms / Comparison Groups
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.
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	100
Completion Date
Primary Completion Date
Eligibility Criteria ^ICMJE	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.
Gender	Both
Ages	13 Years to 70 Years
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT ID ^ICMJE	NCT00002339
Responsible Party
Study ID Numbers ^ICMJE	120, R-0220
Study Sponsor ^ICMJE	Pfizer
Collaborators ^ICMJE
Investigators ^ICMJE
Information Provided By	NIH AIDS Clinical Trials Information Service
Verification Date	April 1996
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP