- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00002339
A Study of Fluconazole in the Treatment of Fungal Infections of the Throat in Patients With Weakened Immune Systems
June 23, 2005 updated by: Pfizer
An Open Multicenter Trial of Fluconazole Oral Suspension in the Treatment of Esophageal Candidiasis in Immunocompromised Patients
To determine the safety, toleration, and efficacy of fluconazole oral suspension in the treatment of esophageal candidiasis in immunocompromised patients, including those with AIDS.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment
100
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
California
-
Los Angeles, California, United States, 90033
- Los Angeles County - USC Med Ctr
-
-
Texas
-
Houston, Texas, United States, 77030
- Houston Veterans Administration Med Ctr
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
13 years to 70 years (Child, Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
December 7, 2022
Primary Completion
December 7, 2022
Study Completion
December 7, 2022
Study Registration Dates
First Submitted
November 2, 1999
First Submitted That Met QC Criteria
August 30, 2001
First Posted (Estimate)
August 31, 2001
Study Record Updates
Last Update Posted (Estimate)
June 24, 2005
Last Update Submitted That Met QC Criteria
June 23, 2005
Last Verified
April 1, 1996
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Bacterial Infections and Mycoses
- Mycoses
- Infections
- Candidiasis
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Enzyme Inhibitors
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Cytochrome P-450 Enzyme Inhibitors
- Hormone Antagonists
- Antifungal Agents
- Steroid Synthesis Inhibitors
- 14-alpha Demethylase Inhibitors
- Cytochrome P-450 CYP2C9 Inhibitors
- Cytochrome P-450 CYP2C19 Inhibitors
- Fluconazole
Other Study ID Numbers
- 120 (Tumor Vaccine Group)
- R-0220
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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