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

This study has been completed.

Sponsor:

Information provided by:

NIH AIDS Clinical Trials Information Service

ClinicalTrials.gov Identifier:

NCT00002339

First received: November 2, 1999

Last updated: June 23, 2005

Last verified: April 1996

History of Changes

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 3


Study Type:	Interventional
Study Design:	Endpoint Classification: Safety Study Primary Purpose: Treatment
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: HIV/AIDS 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 (Child, Adult, Senior)
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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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.


ClinicalTrials.gov Identifier:	NCT00002339 History of Changes
Other Study ID Numbers:	120 R-0220
Study First Received:	November 2, 1999
Last Updated:	June 23, 2005
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

Additional relevant MeSH terms:


Infection HIV Infections Candidiasis Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases Mycoses Fluconazole	Antifungal Agents Anti-Infective Agents 14-alpha Demethylase Inhibitors Cytochrome P-450 Enzyme Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Steroid Synthesis Inhibitors Hormone Antagonists Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs Cytochrome P-450 CYP2C9 Inhibitors Cytochrome P-450 CYP2C19 Inhibitors

ClinicalTrials.gov processed this record on September 26, 2016

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