Status:
COMPLETED
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
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)
Collaborating Sponsors:
Bristol-Myers Squibb
Conditions:
Candidiasis, Oral
HIV Infections
Eligibility:
All Genders
13+ years
Phase:
PHASE2
Brief Summary
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 ora...
Detailed Description
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...
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.
Key Trial Info
Start Date :
Trial Type :
INTERVENTIONAL
End Date :
April 1 1998
Estimated Enrollment :
70 Patients enrolled
Trial Details
Trial ID
NCT00001065
End Date
April 1 1998
Last Update
November 1 2021
Active Locations (32)
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1
Alabama Therapeutics CRS
Birmingham, Alabama, United States, 35294
2
USC CRS
Los Angeles, California, United States
3
Santa Clara Valley Med. Ctr.
San Jose, California, United States
4
San Mateo County AIDS Program
San Mateo, California, United States