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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Page 1 of 8 (32 locations)

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