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

NCT00001065 | Completed Phase 2

• 2 other identifiers: ACTG 29511271
• Study Type: interventional
• Target: 70
• Locations: 3 countries
• Sites: 32

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.

Conditions

Candidiasis, Oral; HIV Infections

Keywords

Administration, Oral; Acquired Immunodeficiency Syndrome; Amphotericin B; AIDS-Related Complex; Candidiasis, Oral; Suspensions

Interventions

Amphotericin B DRUG

Eligibility Criteria

• Age: 13 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients must have:
• HIV infection OR diagnosis of AIDS.
• Diffuse oral candidiasis, symptomatic or asymptomatic, that is resistant to fluconazole.

You may not qualify if:

• 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.

Sponsors & Collaborators

• National Institute of Allergy and Infectious Diseases (NIAID): lead
• Bristol-Myers Squibb: collaborator

Study Sites (32)

Alabama Therapeutics CRS

Birmingham, Alabama, 35294, United States

Location

USC CRS

Los Angeles, California, United States

Location

Santa Clara Valley Med. Ctr.

San Jose, California, United States

Location

San Mateo County AIDS Program

San Mateo, California, United States

Location

Howard University Hosp., Div. of Infectious Diseases, ACTU

Washington D.C., District of Columbia, 20059, United States

Location

Univ. of Miami AIDS CRS

Miami, Florida, United States

Location

The Ponce de Leon Ctr. CRS

Atlanta, Georgia, United States

Location

Queens Med. Ctr.

Honolulu, Hawaii, 96816, United States

Location

Univ. of Hawaii at Manoa, Leahi Hosp.

Honolulu, Hawaii, 96816, United States

Location

Northwestern University CRS

Chicago, Illinois, 60611, United States

Location

Cook County Hosp. CORE Ctr.

Chicago, Illinois, 60612, United States

Location

Weiss Memorial Hosp.

Chicago, Illinois, 60640, United States

Location

Rush Univ. Med. Ctr. ACTG CRS

Chicago, Illinois, United States

Location

Indiana Univ. School of Medicine, Infectious Disease Research Clinic

Indianapolis, Indiana, 46202, United States

Location

Indiana Univ. School of Medicine, Wishard Memorial

Indianapolis, Indiana, 46202, United States

Location

Methodist Hosp. of Indiana

Indianapolis, Indiana, 46202, United States

Location

Johns Hopkins Adult AIDS CRS

Baltimore, Maryland, 21287, United States

Location

Massachusetts General Hospital ACTG CRS

Boston, Massachusetts, 02114, United States

Location

Bmc Actg Crs

Boston, Massachusetts, 02118, United States

Location

St. Louis ConnectCare, Infectious Diseases Clinic

St Louis, Missouri, 63112, United States

Location

Washington U CRS

St Louis, Missouri, United States

Location

Univ. of Nebraska Med. Ctr., Durham Outpatient Ctr.

Omaha, Nebraska, 68198, United States

Location

SUNY - Buffalo, Erie County Medical Ctr.

Buffalo, New York, 14215, United States

Location

Beth Israel Med. Ctr. (Mt. Sinai)

New York, New York, 10029, United States

Location

NY Univ. HIV/AIDS CRS

New York, New York, United States

Location

Univ. of Rochester ACTG CRS

Rochester, New York, 14642, United States

Location

Univ. of Cincinnati CRS

Cincinnati, Ohio, 45267, United States

Location

The Ohio State Univ. AIDS CRS

Columbus, Ohio, 43210, United States

Location

Hosp. of the Univ. of Pennsylvania CRS

Philadelphia, Pennsylvania, 19104, United States

Location

University of Washington AIDS CRS

Seattle, Washington, 98122, United States

Location

Puerto Rico-AIDS CRS

San Juan, 00936, Puerto Rico

Location

Mbeya Med. Research Program, Mbeya Referral Hosp. CRS

Mbeya, Tanzania

Location

MeSH Terms

Conditions

Candidiasis, Oral; HIV Infections; Acquired Immunodeficiency Syndrome; AIDS-Related Complex

Interventions

Amphotericin B

Condition Hierarchy (Ancestors)

Candidiasis; Mycoses; Bacterial Infections and Mycoses; Infections; Mouth Diseases; Stomatognathic Diseases; Blood-Borne Infections; Communicable Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Slow Virus Diseases

Intervention Hierarchy (Ancestors)

Macrolides; Polyketides; Lactones; Organic Chemicals

Study Officials

• Zingman BS

  STUDY CHAIR

• Wheat LJ

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Purpose: TREATMENT
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 2, 1999
• First Posted: August 31, 2001
• Study Completion: April 1, 1998
• Last Updated: November 1, 2021

Record last verified: 2021-10

Locations

US (30); TA (1); PR (1)