- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00002282
A Comparison of the Safety and Effectiveness of Fluconazole or Clotrimazole in the Treatment of Fungal Infections of the Mouth and Throat in Patients With AIDS
A Randomized Multicenter Study of the Efficacy, Safety, and Toleration of Fluconazole or Clotrimazole Troches in the Treatment of Patients With Oropharyngeal Candidiasis in Association With the Acquired Immunodeficiency Syndrome
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Phase
- Not Applicable
Contacts and Locations
Study Locations
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California
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Los Angeles, California, United States, 90033
- Dr Robert Larsen
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Oakland, California, United States, 94609
- Summitt Med Ctr / San Francisco Gen Hosp
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San Francisco, California, United States, 94114
- Davies Med Ctr
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San Francisco, California, United States, 941430654
- UCSF Hosp
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Connecticut
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New Haven, Connecticut, United States, 06511
- Saint Raphael's Hosp
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District of Columbia
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Washington, District of Columbia, United States, 20037
- George Washington Univ Med Ctr
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Maryland
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Baltimore, Maryland, United States, 21205
- Johns Hopkins Hosp
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Massachusetts
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Boston, Massachusetts, United States, 02118
- Univ Hosp
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Missouri
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St. Louis, Missouri, United States, 63108
- Washington Univ School of Medicine
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New Jersey
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Newark, New Jersey, United States, 07102
- Saint Michael's Med Ctr
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New York
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New York, New York, United States, 10021
- Cornell Univ Med Ctr
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New York, New York, United States, 10003
- Cabrini Med Ctr
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Stony Brook, New York, United States, 117948153
- SUNY / Health Sciences Ctr at Stony Brook
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Ohio
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Columbus, Ohio, United States, 43210
- Ohio State Univ Hosp
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Pennsylvania
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Philadelphia, Pennsylvania, United States, 19107
- Buckley Braffman Stern Med Associates
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Texas
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San Antonio, Texas, United States, 78284
- Univ TX San Antonio Health Science Ctr
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Virginia
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Annandale, Virginia, United States, 22203
- Infectious Disease Physicians Inc
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria
Concurrent Medication:
Allowed:
- Cimetidine.
Exclusion Criteria
Co-existing Condition:
Patients with the following are excluded:
- Known history of intolerance or allergy to imidazoles or triazoles, or the non-azole components of clotrimazole troches (dextrose, cellulose, povidone, magnesium stearate).
- Moderate or severe liver disease defined by specified lab values.
Concurrent Medication:
Excluded pending results of phase I studies to determine whether interaction between fluconazole and these agents occurs:
- Barbiturates.
- Phenytoin.
- Coumarin-type anticoagulants.
- Rifampin.
- Oral hypoglycemics.
- Cyclosporin.
Patients with the following are excluded:
- Known history of intolerance or allergy to imidazoles or triazoles, or the non-azole components of clotrimazole troches (dextrose, cellulose, povidone, magnesium stearate).
- Unable to tolerate oral medication.
- Moderate or severe liver disease defined by specified lab values.
- Life expectancy < 4 weeks.
- Unable or unwilling to be followed at the same center for the conduct of this study.
Prior Medication:
Excluded within 3 days of study entry:
- Other antifungal agents.
- Excluded pending results of phase I studies to determine whether interaction between fluconazole and these agents occurs:
- Barbiturates.
- Phenytoin.
- Coumarin-type anticoagulants.
- Rifampin.
- Oral hypoglycemics.
- Cyclosporin.
Patients meeting CDC criteria for diagnosis of AIDS, or having serologic or virologic evidence of HIV infection (but without AIDS-defining opportunistic infections as of yet).
- Patients who have given informed consent in writing to their participation in the study.
- Patients with signs of oropharyngeal candidiasis, i.e., with typical white plaques.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
Collaborators and Investigators
Sponsor
Study record dates
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- RNA Virus Infections
- Virus Diseases
- Blood-Borne Infections
- Communicable Diseases
- Sexually Transmitted Diseases, Viral
- Sexually Transmitted Diseases
- Lentivirus Infections
- Retroviridae Infections
- Immunologic Deficiency Syndromes
- Immune System Diseases
- Stomatognathic Diseases
- Mouth Diseases
- Bacterial Infections and Mycoses
- Mycoses
- Slow Virus Diseases
- HIV Infections
- Infections
- Candidiasis
- Acquired Immunodeficiency Syndrome
- Candidiasis, Oral
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents, Local
- Anti-Infective Agents
- Enzyme Inhibitors
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Cytochrome P-450 CYP3A Inhibitors
- 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
- Clotrimazole
- Miconazole
- Fluconazole
Other Study ID Numbers
- 012M
- 056-171
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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