HIV Infections Clinical Trial
Official title:
A Pilot Study of Fluconazole Plus Flucytosine for the Treatment of AIDS Patients With Acute Cryptococcal Meningitis.
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.
;
Allocation: Randomized, Endpoint Classification: Safety Study, Primary Purpose: Treatment
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