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
2 other identifiers
interventional
N/A
1 country
17
Brief Summary
To compare the efficacy, safety, and tolerance of fluconazole single daily capsule for 14 days versus clotrimazole troche 5 x daily for 14 days in the treatment of oropharyngeal candidiasis in patients with AIDS.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
17 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 2, 1999
CompletedFirst Posted
Study publicly available on registry
August 31, 2001
CompletedJune 24, 2005
February 1, 1990
November 2, 1999
June 23, 2005
Conditions
Keywords
Interventions
Eligibility Criteria
You may qualify if:
- Concurrent Medication:
- Allowed:
- Cimetidine.
You may not qualify if:
- 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.
- +16 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Pfizerlead
Study Sites (17)
Dr Robert Larsen
Los Angeles, California, 90033, United States
Summitt Med Ctr / San Francisco Gen Hosp
Oakland, California, 94609, United States
Davies Med Ctr
San Francisco, California, 94114, United States
UCSF Hosp
San Francisco, California, 941430654, United States
Saint Raphael's Hosp
New Haven, Connecticut, 06511, United States
George Washington Univ Med Ctr
Washington D.C., District of Columbia, 20037, United States
Johns Hopkins Hosp
Baltimore, Maryland, 21205, United States
Univ Hosp
Boston, Massachusetts, 02118, United States
Washington Univ School of Medicine
St Louis, Missouri, 63108, United States
Saint Michael's Med Ctr
Newark, New Jersey, 07102, United States
Cabrini Med Ctr
New York, New York, 10003, United States
Cornell Univ Med Ctr
New York, New York, 10021, United States
SUNY / Health Sciences Ctr at Stony Brook
Stony Brook, New York, 117948153, United States
Ohio State Univ Hosp
Columbus, Ohio, 43210, United States
Buckley Braffman Stern Med Associates
Philadelphia, Pennsylvania, 19107, United States
Univ TX San Antonio Health Science Ctr
San Antonio, Texas, 78284, United States
Infectious Disease Physicians Inc
Annandale, Virginia, 22203, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Purpose
- TREATMENT
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
November 2, 1999
First Posted
August 31, 2001
Last Updated
June 24, 2005
Record last verified: 1990-02