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

Completed · Not applicable

Conditions studied: Candidiasis, Oral, HIV Infections

In brief

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.

Key facts

Study ID

NCT00002282

Run by

Pfizer

Last updated by the study team

2005-06-24

Who can join

Age: 13 and older. Sex: any. Healthy volunteers: not accepted.

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.
• 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.

Where it is running

• 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

Full record on ClinicalTrials.gov

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