To assess response and toxicity in patients with fluconazole-resistant oral candidiasis (
thrush ) when given initial induction with amphotericin B oral suspension.
Experience with amphotericin B oral suspension for drug-sensitive thrush in HIV-infected
patients is limited but encouraging.
Patients swish and swallow amphotericin B oral suspension after each meal and at bedtime for
14 days, at which time they are deemed a responder, nonresponder, or failure to induction
therapy. Responders receive maintenance twice daily, while nonresponders receive 14 further
days of initial induction. Failures discontinue the study. Responders after 28 days of
induction are placed on maintenance. After successful completion of initial induction,
patients remain on study for 6 months.
Inclusion Criteria
Patients must have:
- HIV infection OR diagnosis of AIDS.
- Diffuse oral candidiasis, symptomatic or asymptomatic, that is resistant to
fluconazole.
Exclusion Criteria
Co-existing Condition:
Patients with the following symptoms or conditions are excluded:
- Current symptoms of esophageal candidiasis unless there are negative endoscopic
visualization and biopsy for Candida or related yeasts.
- Perioral lesions only (e. g., angular stomatitis, perleche).
- Inability to swish and swallow oral solution.
- Inability to tolerate further oral therapy for thrush.
Concurrent Medication:
Excluded:
- Fluconazole.
- Itraconazole.
- Ketoconazole.
- Flucytosine.
- Intravenous amphotericin or other non-study formulations.
- Nystatin.
- Clotrimazole.
- Other investigational antifungal agents.
- Systemic cytotoxic chemotherapy for malignancy.
Concurrent Treatment:
Excluded:
- Radiation therapy to the mouth, neck, or chest.
Patients with the following prior conditions are excluded:
- Esophageal candidiasis, proven or presumptive, occurring since fluconazole failure.
- Successful treatment of thrush with fluconazole at <= 200 mg/day after original
treatment failure.
- History of oral candidiasis that recurred or persisted despite IV amphotericin B given
once or more weekly.
- History of anaphylaxis to amphotericin B.
- History of hypersensitivity to components in amphotericin B oral suspension.
Prior Medication:
Excluded within 6 weeks prior to study entry:
- Cytotoxic therapy for malignancy.
- Corticosteroids at higher than replacement doses.
Univ of Puerto Rico, San Juan 009365067, Puerto Rico
Univ of Alabama at Birmingham, Birmingham, Alabama 35294, United States
Stanford at Kaiser / Kaiser Permanente Med Ctr, San Francisco, California 94115, United States
Stanford Univ Med Ctr, Stanford, California 943055107, United States
San Mateo AIDS Program / Stanford Univ, Stanford, California 943055107, United States
Howard Univ, Washington, District of Columbia 20059, United States
Emory Univ, Atlanta, Georgia 30308, United States
Queens Med Ctr, Honolulu, Hawaii 96816, United States
Univ of Hawaii, Honolulu, Hawaii 96816, United States
Northwestern Univ Med School, Chicago, Illinois 60611, United States
Univ of Illinois College of Medicine / Pediatrics, Chicago, Illinois 60612, United States
Cook County Hosp, Chicago, Illinois 60612, United States
Illinois Masonic Med Ctr, Chicago, Illinois 606575147, United States
Louis A Weiss Memorial Hosp, Chicago, Illinois 60640, United States
Indiana Univ Hosp, Indianapolis, Indiana 462025250, United States
Methodist Hosp of Indiana / Life Care Clinic, Indianapolis, Indiana 46202, United States
Wishard Hosp / Indiana Univ Hosp, Indianapolis, Indiana 46202, United States
Johns Hopkins Hosp, Baltimore, Maryland 21287, United States
State of MD Div of Corrections / Johns Hopkins Univ Hosp, Baltimore, Maryland 212052196, United States
Harvard (Massachusetts Gen Hosp), Boston, Massachusetts 02114, United States
Boston Med Ctr, Boston, Massachusetts 02118, United States
St Paul Ramsey Med Ctr, St. Paul, Minnesota 55101, United States
St Louis Regional Hosp / St Louis Regional Med Ctr, St. Louis, Missouri 63112, United States
Univ of Nebraska Med Ctr, Omaha, Nebraska 681985130, United States
Univ of New Mexico School of Medicine, Albuquerque, New Mexico 87501, United States
Montefiore Family Health Ctr / Bronx Municipal Hosp, Bronx, New York 10461, United States
Univ of Rochester Medical Center, Rochester, New York 14642, United States
Bellevue Hosp / New York Univ Med Ctr, New York, New York 10016, United States
Mount Sinai Med Ctr, New York, New York 10029, United States
Jack Weiler Hosp / Bronx Municipal Hosp, Bronx, New York 10465, United States
Mount Sinai Med Ctr / Pediatrics, New York, New York 10029, United States
Bronx Municipal Hosp Ctr/Jacobi Med Ctr, Bronx, New York 10461, United States
Montefiore Med Ctr / Bronx Municipal Hosp, Bronx, New York 10467, United States
Bronx Veterans Administration / Mount Sinai Hosp, Bronx, New York 10468, United States
SUNY / Erie County Med Ctr at Buffalo, Buffalo, New York 14215, United States
Beth Israel Med Ctr, New York, New York 10003, United States
SUNY / Health Sciences Ctr at Brooklyn, Brooklyn, New York 112032098, United States
Saint Clare's Hosp and Health Ctr, New York, New York 10019, United States
Comprehensive Health Care Ctr / Bronx Municipal Hosp, Bronx, New York 10461, United States
Montefiore Adolescent AIDS Prog / Bronx Municipal Hosp, Bronx, New York 10461, United States
Carolinas Med Ctr, Charlotte, North Carolina 28203, United States
Univ of North Carolina, Chapel Hill, North Carolina 275997215, United States
Univ of Cincinnati, Cincinnati, Ohio 452670405, United States
Ohio State Univ Hosp Clinic, Columbus, Ohio 432101228, United States
Columbus Children's Hosp, Columbus, Ohio 432052696, United States
Univ of Pennsylvania at Philadelphia, Philadelphia, Pennsylvania 19104, United States
Julio Arroyo, West Columbia, South Carolina 29169, United States
Univ of Tennessee / E Tennessee Comprehensive Hemophilia Ctr, Knoxville, Tennessee 37920, United States
Meharry Med College, Nashville, Tennessee 37203, United States
Univ of Washington, Seattle, Washington 981224304, United States
Youngstown Hemophilia Ctr / Great Lakes Hemophilia Fdn, Wauwatosa, Wisconsin 53213, United States
