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
NCT ID: NCT00002282
Last Updated: 2005-06-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
INTERVENTIONAL
Brief Summary
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Detailed Description
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Conditions
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Study Design
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TREATMENT
Interventions
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Clotrimazole
Fluconazole
Eligibility Criteria
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Inclusion Criteria
Allowed:
* Cimetidine.
Exclusion Criteria
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.
13 Years
ALL
No
Sponsors
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Pfizer
INDUSTRY
Locations
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Dr Robert Larsen
Los Angeles, California, United States
Summitt Med Ctr / San Francisco Gen Hosp
Oakland, California, United States
Davies Med Ctr
San Francisco, California, United States
UCSF Hosp
San Francisco, California, United States
Saint Raphael's Hosp
New Haven, Connecticut, United States
George Washington Univ Med Ctr
Washington D.C., District of Columbia, United States
Johns Hopkins Hosp
Baltimore, Maryland, United States
Univ Hosp
Boston, Massachusetts, United States
Washington Univ School of Medicine
St Louis, Missouri, United States
Saint Michael's Med Ctr
Newark, New Jersey, United States
Cabrini Med Ctr
New York, New York, United States
Cornell Univ Med Ctr
New York, New York, United States
SUNY / Health Sciences Ctr at Stony Brook
Stony Brook, New York, United States
Ohio State Univ Hosp
Columbus, Ohio, United States
Buckley Braffman Stern Med Associates
Philadelphia, Pennsylvania, United States
Univ TX San Antonio Health Science Ctr
San Antonio, Texas, United States
Infectious Disease Physicians Inc
Annandale, Virginia, United States
Countries
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Other Identifiers
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056-171
Identifier Type: -
Identifier Source: secondary_id
012M
Identifier Type: -
Identifier Source: org_study_id