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
NCT ID: NCT00001065
Last Updated: 2021-11-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
70 participants
INTERVENTIONAL
1998-04-30
Brief Summary
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Experience with amphotericin B oral suspension for drug-sensitive thrush in HIV-infected patients is limited but encouraging.
Detailed Description
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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.
Conditions
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Keywords
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Study Design
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TREATMENT
Interventions
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Amphotericin B
Eligibility Criteria
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Inclusion Criteria
* HIV infection OR diagnosis of AIDS.
* Diffuse oral candidiasis, symptomatic or asymptomatic, that is resistant to fluconazole.
Exclusion Criteria
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.
13 Years
ALL
No
Sponsors
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Bristol-Myers Squibb
INDUSTRY
National Institute of Allergy and Infectious Diseases (NIAID)
NIH
Responsible Party
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Principal Investigators
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Zingman BS
Role: STUDY_CHAIR
Wheat LJ
Role: STUDY_CHAIR
Locations
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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
Univ. of Rochester ACTG CRS
Rochester, New York, United States
Univ. of Cincinnati CRS
Cincinnati, Ohio, United States
The Ohio State Univ. AIDS CRS
Columbus, Ohio, United States
Hosp. of the Univ. of Pennsylvania CRS
Philadelphia, Pennsylvania, United States
University of Washington AIDS CRS
Seattle, Washington, United States
Puerto Rico-AIDS CRS
San Juan, , Puerto Rico
Mbeya Med. Research Program, Mbeya Referral Hosp. CRS
Mbeya, , Tanzania
Countries
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Other Identifiers
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11271
Identifier Type: REGISTRY
Identifier Source: secondary_id
ACTG 295
Identifier Type: -
Identifier Source: org_study_id