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To evaluate and estimate the safety and efficacy of the combination of fluconazole and flucytosine as treatment for acute cryptococcal meningitis in patients with AIDS. Fluconazole and flucytosine have different mechanisms of action. Since fluconazole has not been associated with hematologic suppression and does not produce renal impairment that can result in higher serum flucytosine levels, this combination may be better tolerated than is amphotericin B plus flucytosine.
Fluconazole and flucytosine have different mechanisms of action. Since fluconazole has not been associated with hematologic suppression and does not produce renal impairment that can result in higher serum flucytosine levels, this combination may be better tolerated than is amphotericin B plus flucytosine. Patients in each cohort receive a lower dose of fluconazole alone or in combination with flucytosine, or a higher dose of fluconazole alone. Doses in subsequent cohorts are escalated if safety data in the previous cohort is satisfactory. Patients are evaluated weekly for the first 4 weeks and every 2 weeks thereafter. Therapy continues until 8 weeks after the CSF becomes culture negative, up to a maximum of 26 weeks.
Age
13 - No limit years
Sex
ALL
Healthy Volunteers
No
Los Angeles County - USC Med Ctr
Los Angeles, California, United States
UCI Med Ctr
Orange, California, United States
UCSD Med Ctr - Owen Clinic
San Diego, California, United States
Last Updated
June 24, 2005
64
Estimated participants
Flucytosine
DRUG
Fluconazole
DRUG
Lead Sponsor
Pfizer
NCT04142047
NCT06694805
Data Source & Attribution
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View ClinicalTrials.gov Terms and ConditionsNCT07428330