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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

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. Identifier: NCT00001065
Recruitment Status : Completed
First Posted : August 31, 2001
Last Update Posted : May 2, 2012
Bristol-Myers Squibb
Information provided by (Responsible Party):
National Institute of Allergy and Infectious Diseases (NIAID)

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 oral suspension for drug-sensitive thrush in HIV-infected patients is limited but encouraging.

Condition or disease Intervention/treatment Phase
Candidiasis, Oral HIV Infections Drug: Amphotericin B Phase 2

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 70 participants
Primary Purpose: Treatment
Official Title: A Phase II Trial of Amphotericin B Oral Suspension for Fluconazole-Resistant Oral Candidiasis in HIV-Infected Patients
Study Completion Date : April 1998

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Information from the National Library of Medicine

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Ages Eligible for Study:   13 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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:


  • Fluconazole.
  • Itraconazole.
  • Ketoconazole.
  • Flucytosine.
  • Intravenous amphotericin or other non-study formulations.
  • Nystatin.
  • Clotrimazole.
  • Other investigational antifungal agents.
  • Systemic cytotoxic chemotherapy for malignancy.

Concurrent Treatment:


  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00001065

  Show 32 Study Locations
Sponsors and Collaborators
National Institute of Allergy and Infectious Diseases (NIAID)
Bristol-Myers Squibb
Study Chair: Zingman BS
Study Chair: Wheat LJ

Responsible Party: National Institute of Allergy and Infectious Diseases (NIAID) Identifier: NCT00001065     History of Changes
Other Study ID Numbers: ACTG 295
11271 ( Registry Identifier: DAIDS ES Registry Number )
First Posted: August 31, 2001    Key Record Dates
Last Update Posted: May 2, 2012
Last Verified: May 2012

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

Additional relevant MeSH terms:
HIV Infections
Candidiasis, Oral
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Mouth Diseases
Stomatognathic Diseases
Amphotericin B
Liposomal amphotericin B
Antifungal Agents
Anti-Infective Agents
14-alpha Demethylase Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Steroid Synthesis Inhibitors
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Cytochrome P-450 CYP2C9 Inhibitors
Cytochrome P-450 CYP2C19 Inhibitors