Fluconazole Prophylaxis of Thrush in AIDS (NCT00001542) | Clinical Trial Compass
CompletedPhase 4
Fluconazole Prophylaxis of Thrush in AIDS
United States80 participantsStarted 1996-07
Plain-language summary
This is a placebo-controlled trial of intermittent fluconazole prophylaxis (200 mg orally three times a week) in the prevention of thrush.
Who can participate
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HIV infection previously documented by ELISA test kit and confirmed by either Western Blot, HIV antigen, HIV culture, or a second antibody test other than ELISA.
Age 18 years or older.
CD4 count of less than or equal to 150 cells/mm(3).
At least one prior episode of health care provider diagnosed oropharyngeal candidiasis in the 6 months preceding enrollment.
No allergy or intolerance to azoles.
Less than 3 episodes of oropharyngeal candidiasis within the last 3 months.
No history of esophageal candidiasis.
No presence of systemic fungal infection requiring continuous antifungal therapy.
No use of continuous azole treatment (i.e. daily, weekly, every other day, twice weekly fluconazole, itraconazole, ketoconazole or coltrimazole) for the prevention of fungal infections greater than or equal to 1 month within the past 6 months.
No severe liver disease (ALT or AST greater than 5 times the upper limit of normal).
No history of poorly responsive mucosal infection (i.e., requiring more than 200 mg of fluconazole daily or more than 14 days of therapy).
Females may not be pregnant or lactating. Must have a negative pregnancy test within 2 weeks of enrollment.
No one unlikely to survive more than 6 months.
Must have ability to tolerate oral medications.
No presence of active mucosal infection or symptoms of OPC/EC at time of initial assessment. (Note: Can enroll 2 weeks after resolution of the active episode).
No patients currently being treated with azole for recent m…
Trial details
NCT IDNCT00001542
SponsorNational Institute of Allergy and Infectious Diseases (NIAID)