Trials
Search / Trial NCT00001065

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

Launched by NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES (NIAID) · Aug 30, 2001

Trial Information

Current as of January 15, 2025

Completed

Keywords

Administration, Oral Acquired Immunodeficiency Syndrome Amphotericin B Aids Related Complex Candidiasis, Oral Suspensions

ClinConnect Summary

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 st...

Gender

ALL

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.

Trial Officials

Zingman BS

Study Chair

Wheat LJ

Study Chair

About National Institute Of Allergy And Infectious Diseases (Niaid)

The National Institute of Allergy and Infectious Diseases (NIAID) is a key component of the National Institutes of Health (NIH) dedicated to advancing the understanding, prevention, and treatment of infectious and immune-mediated diseases. Through rigorous clinical trials, NIAID aims to foster innovative research that enhances public health and addresses global health challenges, including emerging infectious diseases and allergies. The institute collaborates with various partners, including academic institutions, industry, and international organizations, to translate scientific discoveries into effective therapies and vaccines. NIAID's commitment to high-quality clinical research is integral to improving health outcomes and informing policy decisions in the realm of infectious diseases and immunology.

Locations

Birmingham, Alabama, United States

Los Angeles, California, United States

San Jose, California, United States

San Mateo, California, United States

Washington, District Of Columbia, United States

Miami, Florida, United States

Honolulu, Hawaii, United States

Chicago, Illinois, United States

Chicago, Illinois, United States

Chicago, Illinois, United States

Indianapolis, Indiana, United States

Indianapolis, Indiana, United States

Baltimore, Maryland, United States

Boston, Massachusetts, United States

Boston, Massachusetts, United States

Saint Louis, Missouri, United States

Saint Louis, Missouri, United States

Omaha, Nebraska, United States

Buffalo, New York, United States

New York, New York, United States

New York, New York, United States

Rochester, New York, United States

Cincinnati, Ohio, United States

Columbus, Ohio, United States

Philadelphia, Pennsylvania, United States

Seattle, Washington, United States

San Juan, , Puerto Rico

Mbeya, , Tanzania

Chicago, Illinois, United States

Atlanta, Georgia, United States

Honolulu, Hawaii, United States

Indianapolis, Indiana, United States

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Discussion 0

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