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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.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00001065
First Posted: August 31, 2001
Last Update Posted: May 2, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Bristol-Myers Squibb
Information provided by (Responsible Party):
National Institute of Allergy and Infectious Diseases (NIAID)
November 2, 1999
August 31, 2001
May 2, 2012
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Complete list of historical versions of study NCT00001065 on ClinicalTrials.gov Archive Site
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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
A Phase II Trial of Amphotericin B Oral Suspension for Fluconazole-Resistant Oral Candidiasis in HIV-Infected Patients

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.

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.

Interventional
Phase 2
Primary Purpose: Treatment
  • Candidiasis, Oral
  • HIV Infections
Drug: Amphotericin B
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
70
April 1998
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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.
Sexes Eligible for Study: All
13 Years and older   (Child, Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Puerto Rico,   Tanzania,   United States
 
 
NCT00001065
ACTG 295
11271 ( Registry Identifier: DAIDS ES Registry Number )
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National Institute of Allergy and Infectious Diseases (NIAID)
National Institute of Allergy and Infectious Diseases (NIAID)
Bristol-Myers Squibb
Study Chair: Zingman BS
Study Chair: Wheat LJ
National Institute of Allergy and Infectious Diseases (NIAID)
May 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP