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

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ClinicalTrials.gov Identifier: NCT00002339
Recruitment Status : Completed
First Posted : August 31, 2001
Last Update Posted : June 24, 2005
Sponsor:
Information provided by:
NIH AIDS Clinical Trials Information Service

Study Description
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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.

Condition or disease Intervention/treatment Phase
Candidiasis, Esophageal HIV Infections Drug: Fluconazole Phase 3

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 Design
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Study Type : Interventional  (Clinical Trial)
Enrollment : 100 participants
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 the National Library of Medicine

Drug Information available for: Fluconazole
U.S. FDA Resources

Arms and Interventions
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Outcome Measures
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Eligibility Criteria
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Ages Eligible for Study:   13 Years to 70 Years   (Child, Adult, Senior)
Sexes Eligible for Study:   All
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
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Publications:

ClinicalTrials.gov Identifier: NCT00002339     History of Changes
Other Study ID Numbers: 120
R-0220
First Posted: August 31, 2001    Key Record Dates
Last Update Posted: June 24, 2005
Last Verified: April 1996

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