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

Completed · Phase 2

Conditions studied: Candidiasis, Oral, HIV Infections

In brief

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.

Key facts

Study ID

NCT00001065

Run by

National Institute of Allergy and Infectious Diseases (NIAID)

People needed

70

Expected to finish

1998-04-01

Last updated by the study team

2021-11-01

Who can join

Age: 13 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patients must have:
• HIV infection OR diagnosis of AIDS.
• Diffuse oral candidiasis, symptomatic or asymptomatic, that is resistant to fluconazole.

You may not qualify if…

• 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.

Where it is running

• Alabama Therapeutics CRS — Birmingham, Alabama, United States
• USC CRS — Los Angeles, California, United States
• Santa Clara Valley Med. Ctr. — San Jose, California, United States
• San Mateo County AIDS Program — San Mateo, California, United States
• Howard University Hosp., Div. of Infectious Diseases, ACTU — Washington D.C., District of Columbia, United States
• Univ. of Miami AIDS CRS — Miami, Florida, United States
• The Ponce de Leon Ctr. CRS — Atlanta, Georgia, United States
• Queens Med. Ctr. — Honolulu, Hawaii, United States
• Univ. of Hawaii at Manoa, Leahi Hosp. — Honolulu, Hawaii, United States
• Northwestern University CRS — Chicago, Illinois, United States
• Cook County Hosp. CORE Ctr. — Chicago, Illinois, United States
• Weiss Memorial Hosp. — Chicago, Illinois, United States
• Rush Univ. Med. Ctr. ACTG CRS — Chicago, Illinois, United States
• Indiana Univ. School of Medicine, Infectious Disease Research Clinic — Indianapolis, Indiana, United States
• Indiana Univ. School of Medicine, Wishard Memorial — Indianapolis, Indiana, United States
• Methodist Hosp. of Indiana — Indianapolis, Indiana, United States
• Johns Hopkins Adult AIDS CRS — Baltimore, Maryland, United States
• Massachusetts General Hospital ACTG CRS — Boston, Massachusetts, United States
• Bmc Actg Crs — Boston, Massachusetts, United States
• St. Louis ConnectCare, Infectious Diseases Clinic — St Louis, Missouri, United States
• Washington U CRS — St Louis, Missouri, United States
• Univ. of Nebraska Med. Ctr., Durham Outpatient Ctr. — Omaha, Nebraska, United States
• SUNY - Buffalo, Erie County Medical Ctr. — Buffalo, New York, United States
• Beth Israel Med. Ctr. (Mt. Sinai) — New York, New York, United States
• NY Univ. HIV/AIDS CRS — New York, New York, United States

Full record on ClinicalTrials.gov

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