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

This study has been completed.

First Received: November 2, 1999 Last Updated: June 23, 2005 History of Changes

Sponsored by:	Pfizer
Information provided by:	NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier:	NCT00002339

Purpose

To determine the safety, toleration, and efficacy of fluconazole oral suspension in the treatment of esophageal candidiasis in immunocompromised patients, including those with AIDS.

Condition	Intervention	Phase
Candidiasis, Esophageal HIV Infections	Drug: Fluconazole	Phase III

Study Type:	Interventional
Study Design:	Treatment, Safety Study
Official Title:	An Open Multicenter Trial of Fluconazole Oral Suspension in the Treatment of Esophageal Candidiasis in Immunocompromised Patients

Resource links provided by NLM:

MedlinePlus related topics: AIDS Esophagus Disorders Yeast Infections

Drug Information available for: Fluconazole

U.S. FDA Resources

Further study details as provided by NIH AIDS Clinical Trials Information Service:

Estimated Enrollment:

100

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

Ages Eligible for Study:	13 Years to 70 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00002339

Locations

United States, California
Los Angeles County - USC Med Ctr
Los Angeles, California, United States, 90033
United States, Texas
Houston Veterans Administration Med Ctr
Houston, Texas, United States, 77030

Sponsors and Collaborators

Pfizer

More Information

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.

Study ID Numbers:	120, R-0220
Study First Received:	November 2, 1999
Last Updated:	June 23, 2005
ClinicalTrials.gov Identifier:	NCT00002339 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by NIH AIDS Clinical Trials Information Service:

Esophagitis
Fluconazole
Acquired Immunodeficiency Syndrome
Candidiasis
Immunocompromised Host

Study placed in the following topic categories:

Fluconazole
Anti-Infective Agents
Sexually Transmitted Diseases, Viral
Candidiasis
Gastrointestinal Diseases
Acquired Immunodeficiency Syndrome
Immunologic Deficiency Syndromes
Virus Diseases
Mycoses

Esophagitis
Digestive System Diseases
Esophageal Disorder
HIV Infections
Antifungal Agents
Sexually Transmitted Diseases
Esophageal Diseases
Retroviridae Infections

Additional relevant MeSH terms:

Fluconazole
Anti-Infective Agents
Communicable Diseases
RNA Virus Infections
Sexually Transmitted Diseases, Viral
Slow Virus Diseases
Immune System Diseases
Candidiasis
Gastrointestinal Diseases
Acquired Immunodeficiency Syndrome
Infection
Pharmacologic Actions

Immunologic Deficiency Syndromes
Virus Diseases
Mycoses
Digestive System Diseases
HIV Infections
Therapeutic Uses
Antifungal Agents
Sexually Transmitted Diseases
Lentivirus Infections
Esophageal Diseases
Retroviridae Infections

ClinicalTrials.gov processed this record on September 02, 2009