HIV Infections Clinical Trial
Official title:
Multi-center Comparison of Fluconazole (UK-49,858) and Amphotericin B as Treatment for Acute Cryptococcal Meningitis
To compare the safety and effectiveness of fluconazole (FCZ) and amphotericin B (AMB), alone
or in combination with flucytosine (FLC), as treatment for acute cryptococcal meningitis in
patients who have not been treated previously or who have relapsed after a previous
successful treatment.
Cryptococcal meningitis is an important cause of disease and death among patients with AIDS.
Usually AMB is given either alone or with FLC to patients with this infection, but these
treatments are not always effective and both have toxic effects. Animal studies and
preliminary studies in humans show that FCZ is active in cryptococcal meningitis and suggest
that it may be less toxic than either AMB or FLC.
Cryptococcal meningitis is an important cause of disease and death among patients with AIDS.
Usually AMB is given either alone or with FLC to patients with this infection, but these
treatments are not always effective and both have toxic effects. Animal studies and
preliminary studies in humans show that FCZ is active in cryptococcal meningitis and suggest
that it may be less toxic than either AMB or FLC.
Patients accepted into the study are randomly assigned to FCZ or AMB. Patients assigned to
FCZ take FCZ by mouth daily for 10 weeks. Patients assigned to AMB are given intravenous
injections of AMB daily for 6-10 weeks. Non-AIDS patients assigned to AMB also take FLC by
mouth daily. The use of FLC in patients with AIDS is decided on an individual basis.
Patients with AIDS who respond satisfactorily to FCZ receive maintenance therapy to prevent
relapse for an additional 12 months. Patients with AIDS who respond to AMB may qualify for
another Pfizer Central Research protocol. Patients without AIDS who respond to therapy are
observed for 6 months for relapse. During therapy, samples of blood and cerebrospinal fluid
(by lumbar puncture) are taken periodically in order to evaluate the effectiveness of the
drug treatments and to identify possible toxic effects.
;
Intervention Model: Parallel Assignment, Primary Purpose: Treatment
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