HIV Infections Clinical Trial
Official title:
Comparison of Fluconazole (UK-49,858) and Amphotericin B for Maintenance Treatment of Cryptococcal Meningitis in Patients With Acquired Immunodeficiency Syndrome
To compare the safety and effectiveness of a new drug, fluconazole, with that of the usual
therapy, amphotericin B, in the prevention of a relapse of cryptococcal meningitis (CM) in
patients with AIDS who have been successfully treated for acute CM in the last 6 months.
Cryptococcal meningitis is a life-threatening infectious complication of AIDS. Because
relapse after treatment occurs in over 50 percent of cases, chronic maintenance therapy with
intravenous (IV) amphotericin B is usually given. However, amphotericin B is not always
effective, has toxic effects, and must be given by the intravenous route. Fluconazole is an
antifungal agent that can be given orally and has been shown to be effective against
cryptococcal infections in animals and against acute CM in a few AIDS patients. Also, the
side effects experienced by over 2000 patients or volunteers given fluconazole have seldom
been severe enough to require withdrawal of the drug.
Cryptococcal meningitis is a life-threatening infectious complication of AIDS. Because
relapse after treatment occurs in over 50 percent of cases, chronic maintenance therapy with
intravenous (IV) amphotericin B is usually given. However, amphotericin B is not always
effective, has toxic effects, and must be given by the intravenous route. Fluconazole is an
antifungal agent that can be given orally and has been shown to be effective against
cryptococcal infections in animals and against acute CM in a few AIDS patients. Also, the
side effects experienced by over 2000 patients or volunteers given fluconazole have seldom
been severe enough to require withdrawal of the drug.
Patients accepted in the trial are randomly assigned to fluconazole or amphotericin B.
Fluconazole is given orally once a day and amphotericin B is given intravenously once a
week. Dosages depend on body weight. Medications may be given with amphotericin B to prevent
or reduce discomfort from associated side effects. Patients are treated for 12 months and
may continue to receive antiviral therapy, radiation therapy for mucocutaneous Kaposi's
sarcoma, or preventive therapy for Pneumocystis carinii pneumonia (PCP) during the study.
;
Intervention Model: Parallel Assignment, Primary Purpose: Treatment
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