Comparison of Fluconazole (UK-49,858) and Amphotericin B for Maintenance Treatment of Cryptococcal Meningitis in Patients With Acquired Immunodeficiency Syndrome
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.
Interventional
Intervention Model: Parallel Assignment, Primary Purpose: Treatment
Armstrong D
Study Chair
Unspecified
ACTG 026
NCT00001017
Name | Location |
---|---|
Bellevue Hosp / New York Univ Med Ctr | New York, New York 10016 |
Mem Sloan - Kettering Cancer Ctr | New York, New York 10021 |
Saint Luke's - Roosevelt Hosp Ctr | New York, New York 10025 |
Univ of Rochester Medical Center | Rochester, New York 14642 |
Julio Arroyo | West Columbia, South Carolina 29169 |
UCLA CARE Ctr | Los Angeles, California 90095 |
Univ of Miami School of Medicine | Miami, Florida 331361013 |
Indiana Univ Hosp | Indianapolis, Indiana 462025250 |
Tulane Univ School of Medicine | New Orleans, Louisiana 70112 |
Harvard (Massachusetts Gen Hosp) | Boston, Massachusetts 02114 |
Beth Israel Deaconess - West Campus | Boston, Massachusetts 02215 |
Jack Weiler Hosp / Bronx Municipal Hosp | Bronx, New York 10465 |
Bronx Veterans Administration / Mount Sinai Hosp | Bronx, New York 10468 |
Montefiore Med Ctr / Bronx Municipal Hosp | Bronx, New York 10467 |
SUNY / Erie County Med Ctr at Buffalo | Buffalo, New York 14215 |
City Hosp Ctr at Elmhurst / Mount Sinai Hosp | Elmhurst, New York 11373 |
Cornell Univ Med Ctr | New York, New York 10021 |
Mount Sinai Med Ctr | New York, New York 10029 |
Beth Israel Med Ctr / Peter Krueger Clinic | New York, New York 10003 |
SUNY - Stony Brook | Stony Brook, New York 117948153 |
Univ of North Carolina | Chapel Hill, North Carolina 275997215 |
Duke Univ Med Ctr | Durham, North Carolina 27710 |
Holmes Hosp / Univ of Cincinnati Med Ctr | Cincinnati, Ohio 452670405 |
Univ Hosp of Cleveland / Case Western Reserve Univ | Cleveland, Ohio 44106 |
Ohio State Univ Hosp Clinic | Columbus, Ohio 432101228 |
Johns Hopkins Hosp | Baltimore, Maryland 21287 |
North Central Bronx Hosp / Bronx Municipal Hosp | Bronx, New York 10467 |
Louisiana State Univ School of Medicine | New Orleans, Louisiana 70112 |