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
Information source: NIH AIDS Clinical Trials Information Service
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Candidiasis, Oral; HIV Infections
Intervention: Clotrimazole (Drug); Fluconazole (Drug)
Phase: N/A
Status: Completed
Sponsored by: Pfizer
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.
Clinical Details
Official title: 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 design: Treatment
Eligibility
Minimum age: 13 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
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.
Locations and Contacts
Davies Med Ctr, San Francisco, California 94114, United States
Summitt Med Ctr / San Francisco Gen Hosp, Oakland, California 94609, United States
Dr Robert Larsen, Los Angeles, California 90033, 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, 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
Cornell Univ Med Ctr, New York, New York 10021, United States
Cabrini Med Ctr, New York, New York 10003, 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
Additional Information
Last updated: June 23, 2005
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