A Study of Amphotericin B in the Treatment of Fungal Infections of the Mouth in HIV-Infected Patients Who Have Not Had Success With Fluconazole
Candidiasis, Oral, HIV Infections
About this trial
This is an interventional treatment trial for Candidiasis, Oral focused on measuring Administration, Oral, Acquired Immunodeficiency Syndrome, Amphotericin B, AIDS-Related Complex, Candidiasis, Oral, Suspensions
Eligibility Criteria
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.
Sites / Locations
- Alabama Therapeutics CRS
- USC CRS
- Santa Clara Valley Med. Ctr.
- San Mateo County AIDS Program
- Howard University Hosp., Div. of Infectious Diseases, ACTU
- Univ. of Miami AIDS CRS
- The Ponce de Leon Ctr. CRS
- Queens Med. Ctr.
- Univ. of Hawaii at Manoa, Leahi Hosp.
- Northwestern University CRS
- Cook County Hosp. CORE Ctr.
- Weiss Memorial Hosp.
- Rush Univ. Med. Ctr. ACTG CRS
- Indiana Univ. School of Medicine, Infectious Disease Research Clinic
- Indiana Univ. School of Medicine, Wishard Memorial
- Methodist Hosp. of Indiana
- Johns Hopkins Adult AIDS CRS
- Massachusetts General Hospital ACTG CRS
- Bmc Actg Crs
- St. Louis ConnectCare, Infectious Diseases Clinic
- Washington U CRS
- Univ. of Nebraska Med. Ctr., Durham Outpatient Ctr.
- SUNY - Buffalo, Erie County Medical Ctr.
- Beth Israel Med. Ctr. (Mt. Sinai)
- NY Univ. HIV/AIDS CRS
- Univ. of Rochester ACTG CRS
- Univ. of Cincinnati CRS
- The Ohio State Univ. AIDS CRS
- Hosp. of the Univ. of Pennsylvania CRS
- University of Washington AIDS CRS
- Puerto Rico-AIDS CRS
- Mbeya Med. Research Program, Mbeya Referral Hosp. CRS