A Study of Fluconazole in the Treatment of Fungal Infections of the Throat in Patients With Weakened Immune Systems
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT00002339 |
Recruitment Status
:
Completed
First Posted
: August 31, 2001
Last Update Posted
: June 24, 2005
|
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Candidiasis, Esophageal HIV Infections | Drug: Fluconazole | Phase 3 |
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 |


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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 |
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.

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
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 |
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 |