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
Launched by NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES (NIAID) · Aug 30, 2001
Trial Information
Current as of January 15, 2025
Completed
Keywords
ClinConnect Summary
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 st...
Gender
ALL
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.
Trial Officials
Zingman BS
Study Chair
Wheat LJ
Study Chair
About National Institute Of Allergy And Infectious Diseases (Niaid)
The National Institute of Allergy and Infectious Diseases (NIAID) is a key component of the National Institutes of Health (NIH) dedicated to advancing the understanding, prevention, and treatment of infectious and immune-mediated diseases. Through rigorous clinical trials, NIAID aims to foster innovative research that enhances public health and addresses global health challenges, including emerging infectious diseases and allergies. The institute collaborates with various partners, including academic institutions, industry, and international organizations, to translate scientific discoveries into effective therapies and vaccines. NIAID's commitment to high-quality clinical research is integral to improving health outcomes and informing policy decisions in the realm of infectious diseases and immunology.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Birmingham, Alabama, United States
Los Angeles, California, United States
San Jose, California, United States
San Mateo, California, United States
Washington, District Of Columbia, United States
Miami, Florida, United States
Honolulu, Hawaii, United States
Chicago, Illinois, United States
Chicago, Illinois, United States
Chicago, Illinois, United States
Indianapolis, Indiana, United States
Indianapolis, Indiana, United States
Baltimore, Maryland, United States
Boston, Massachusetts, United States
Boston, Massachusetts, United States
Saint Louis, Missouri, United States
Saint Louis, Missouri, United States
Omaha, Nebraska, United States
Buffalo, New York, United States
New York, New York, United States
New York, New York, United States
Rochester, New York, United States
Cincinnati, Ohio, United States
Columbus, Ohio, United States
Philadelphia, Pennsylvania, United States
Seattle, Washington, United States
San Juan, , Puerto Rico
Mbeya, , Tanzania
Chicago, Illinois, United States
Atlanta, Georgia, United States
Honolulu, Hawaii, United States
Indianapolis, Indiana, United States
People applied
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
Discussion 0
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