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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.

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

MedlinePlus related topics:   AIDS    Esophagus Disorders    Yeast Infections   

ChemIDplus related topics:   Fluconazole   

U.S. FDA Resources

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

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:

Study ID Numbers:   120, R-0220
First Received:   November 2, 1999
Last Updated:   June 23, 2005
ClinicalTrials.gov Identifier:   NCT00002339
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
Sexually Transmitted Diseases, Viral
Esophageal disorder
Candidiasis
Clotrimazole
Gastrointestinal Diseases
Miconazole
Acquired Immunodeficiency Syndrome
Tioconazole
Immunologic Deficiency Syndromes
Virus Diseases
Mycoses
Esophagitis
Digestive System Diseases
HIV Infections
Sexually Transmitted Diseases
Esophageal Diseases
Retroviridae Infections

Additional relevant MeSH terms:
Anti-Infective Agents
Communicable Diseases
RNA Virus Infections
Slow Virus Diseases
Immune System Diseases
Therapeutic Uses
Antifungal Agents
Lentivirus Infections
Infection
Pharmacologic Actions

ClinicalTrials.gov processed this record on October 07, 2008




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