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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:

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:

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:
HIV Infections
Acquired Immunodeficiency Syndrome
Candidiasis
Esophageal Diseases
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
 Slow Virus Diseases
Mycoses
Gastrointestinal Diseases
Digestive System Diseases
Fluconazole
Antifungal Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
14-alpha Demethylase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on March 07, 2013