Clin Infect Dis. 1994 Oct;19(4):741-5. Unique Identifier : AIDSLINE
Treatment of cryptococcal meningitis with amphotericin B or fluconazole
is often unsuccessful; in only 35%-40% of cases do CSF cultures become
negative by 10 weeks after initiation of such therapy. We conducted a
prospective, open-label clinical trial involving persons with AIDS to
determine whether the rate of clinical success would improve when
fluconazole (400 mg daily) was combined with flucytosine (150 mg/kg
daily). At the conclusion of 10 weeks of therapy, 75% (95% confidence
interval, 58%-87%) of 32 subjects' CSF cultures were negative. The
Kaplan-Meier estimate of clinical success at 10 weeks was 63% (95%
confidence interval, 48%-82%). The median time to negativity of the CSF
culture was 23 days. Toxic side effects that were sufficiently severe to
lead to the withdrawal of flucytosine were observed in nine subjects
(28%). In this pilot study of fluconazole combined with flucytosine, the
rate of clinical success at 10 weeks was greater than that previously
reported with regard to the use of fluconazole alone or amphotericin B
alone.
Adult AIDS-Related Opportunistic Infections/*DRUG THERAPY
Cerebrospinal Fluid/MICROBIOLOGY Cryptococcus neoformans/ISOLATION &
PURIF Drug Therapy, Combination Female Fluconazole/ADMINISTRATION &
DOSAGE/*THERAPEUTIC USE Flucytosine/ADMINISTRATION & DOSAGE/ADVERSE
EFFECTS/*THERAPEUTIC USE Human Male Meningitis,
Cryptococcal/CEREBROSPINAL FLUID/*DRUG THERAPY Pilot Projects
Prospective Studies Support, Non-U.S. Gov't Survival Analysis
CLINICAL TRIAL JOURNAL ARTICLE