Full Text View
Tabular View
No Study Results Posted
Related Studies
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
This study has been completed.
First Received: November 2, 1999   Last Updated: August 25, 2008   History of Changes
Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
Collaborator: Bristol-Myers Squibb
Information provided by: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier: NCT00001065
  Purpose

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.


Condition Intervention Phase
Candidiasis, Oral
HIV Infections
Drug: Amphotericin B
Phase II

Study Type: Interventional
Study Design: Treatment
Official Title: A Phase II Trial of Amphotericin B Oral Suspension for Fluconazole-Resistant Oral Candidiasis in HIV-Infected Patients

Resource links provided by NLM:


Further study details as provided by National Institute of Allergy and Infectious Diseases (NIAID):

Estimated Enrollment: 70
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 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.

  Eligibility

Ages Eligible for Study:   13 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00001065

  Hide Study Locations
Locations
United States, Alabama
Univ of Alabama at Birmingham
Birmingham, Alabama, United States, 35294
United States, California
Stanford at Kaiser / Kaiser Permanente Med Ctr
San Francisco, California, United States, 94115
Stanford Univ Med Ctr
Stanford, California, United States, 943055107
San Mateo AIDS Program / Stanford Univ
Stanford, California, United States, 943055107
United States, District of Columbia
Howard Univ
Washington, District of Columbia, United States, 20059
United States, Georgia
Emory Univ
Atlanta, Georgia, United States, 30308
United States, Hawaii
Queens Med Ctr
Honolulu, Hawaii, United States, 96816
Univ of Hawaii
Honolulu, Hawaii, United States, 96816
United States, Illinois
Northwestern Univ Med School
Chicago, Illinois, United States, 60611
Univ of Illinois College of Medicine / Pediatrics
Chicago, Illinois, United States, 60612
Cook County Hosp
Chicago, Illinois, United States, 60612
Illinois Masonic Med Ctr
Chicago, Illinois, United States, 606575147
Louis A Weiss Memorial Hosp
Chicago, Illinois, United States, 60640
United States, Indiana
Indiana Univ Hosp
Indianapolis, Indiana, United States, 462025250
Methodist Hosp of Indiana / Life Care Clinic
Indianapolis, Indiana, United States, 46202
Wishard Hosp / Indiana Univ Hosp
Indianapolis, Indiana, United States, 46202
United States, Maryland
Johns Hopkins Hosp
Baltimore, Maryland, United States, 21287
State of MD Div of Corrections / Johns Hopkins Univ Hosp
Baltimore, Maryland, United States, 212052196
United States, Massachusetts
Harvard (Massachusetts Gen Hosp)
Boston, Massachusetts, United States, 02114
Boston Med Ctr
Boston, Massachusetts, United States, 02118
United States, Minnesota
St Paul Ramsey Med Ctr
St Paul, Minnesota, United States, 55101
United States, Missouri
St Louis Regional Hosp / St Louis Regional Med Ctr
St Louis, Missouri, United States, 63112
United States, Nebraska
Univ of Nebraska Med Ctr
Omaha, Nebraska, United States, 681985130
United States, New Mexico
Univ of New Mexico School of Medicine
Albuquerque, New Mexico, United States, 87501
United States, New York
Montefiore Family Health Ctr / Bronx Municipal Hosp
Bronx, New York, United States, 10461
Univ of Rochester Medical Center
Rochester, New York, United States, 14642
Bellevue Hosp / New York Univ Med Ctr
New York, New York, United States, 10016
Mount Sinai Med Ctr
New York, New York, United States, 10029
Jack Weiler Hosp / Bronx Municipal Hosp
Bronx, New York, United States, 10465
Mount Sinai Med Ctr / Pediatrics
New York, New York, United States, 10029
Bronx Municipal Hosp Ctr/Jacobi Med Ctr
Bronx, New York, United States, 10461
Montefiore Med Ctr / Bronx Municipal Hosp
Bronx, New York, United States, 10467
Comprehensive Health Care Ctr / Bronx Municipal Hosp
Bronx, New York, United States, 10461
SUNY / Erie County Med Ctr at Buffalo
Buffalo, New York, United States, 14215
Beth Israel Med Ctr
New York, New York, United States, 10003
SUNY / Health Sciences Ctr at Brooklyn
Brooklyn, New York, United States, 112032098
Saint Clare's Hosp and Health Ctr
New York, New York, United States, 10019
Bronx Veterans Administration / Mount Sinai Hosp
Bronx, New York, United States, 10468
Montefiore Adolescent AIDS Prog / Bronx Municipal Hosp
Bronx, New York, United States, 10461
United States, North Carolina
Carolinas Med Ctr
Charlotte, North Carolina, United States, 28203
Univ of North Carolina
Chapel Hill, North Carolina, United States, 275997215
United States, Ohio
Univ of Cincinnati
Cincinnati, Ohio, United States, 452670405
Ohio State Univ Hosp Clinic
Columbus, Ohio, United States, 432101228
Columbus Children's Hosp
Columbus, Ohio, United States, 432052696
United States, Pennsylvania
Univ of Pennsylvania at Philadelphia
Philadelphia, Pennsylvania, United States, 19104
United States, South Carolina
Julio Arroyo
West Columbia, South Carolina, United States, 29169
United States, Tennessee
Univ of Tennessee / E Tennessee Comprehensive Hemophilia Ctr
Knoxville, Tennessee, United States, 37920
Meharry Med College
Nashville, Tennessee, United States, 37203
United States, Washington
Univ of Washington
Seattle, Washington, United States, 981224304
United States, Wisconsin
Youngstown Hemophilia Ctr / Great Lakes Hemophilia Fdn
Wauwatosa, Wisconsin, United States, 53213
Puerto Rico
Univ of Puerto Rico
San Juan, Puerto Rico, 009365067
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
Study Chair: Zingman BS
Study Chair: Wheat LJ
  More Information

Additional Information:
No publications provided

Study ID Numbers: ACTG 295
Study First Received: November 2, 1999
Last Updated: August 25, 2008
ClinicalTrials.gov Identifier: NCT00001065     History of Changes
Health Authority: United States: Federal Government

Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):
Administration, Oral
Acquired Immunodeficiency Syndrome
Amphotericin B
AIDS-Related Complex
Candidiasis, Oral
Suspensions

Additional relevant MeSH terms:
Mouth Diseases
Abelcet
Anti-Infective Agents
Communicable Diseases
Sexually Transmitted Diseases, Viral
Candidiasis, Oral
Antiprotozoal Agents
Slow Virus Diseases
Candidiasis
Infection
Liposomal amphotericin B
Anti-Bacterial Agents
Mycoses
Antiparasitic Agents
Antifungal Agents
Therapeutic Uses
Antibiotics, Antifungal
Amebicides
Retroviridae Infections
Fluconazole
Amphotericin B
RNA Virus Infections
Immune System Diseases
Acquired Immunodeficiency Syndrome
Pharmacologic Actions
Immunologic Deficiency Syndromes
Virus Diseases
HIV Infections
Sexually Transmitted Diseases
Lentivirus Infections

ClinicalTrials.gov processed this record on November 30, 2009