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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

Primary Purpose

Candidiasis, Oral, HIV Infections

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Amphotericin B
Sponsored by
National Institute of Allergy and Infectious Diseases (NIAID)
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Candidiasis, Oral focused on measuring Administration, Oral, Acquired Immunodeficiency Syndrome, Amphotericin B, AIDS-Related Complex, Candidiasis, Oral, Suspensions

Eligibility Criteria

13 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Alabama Therapeutics CRS
  • USC CRS
  • Santa Clara Valley Med. Ctr.
  • San Mateo County AIDS Program
  • Howard University Hosp., Div. of Infectious Diseases, ACTU
  • Univ. of Miami AIDS CRS
  • The Ponce de Leon Ctr. CRS
  • Queens Med. Ctr.
  • Univ. of Hawaii at Manoa, Leahi Hosp.
  • Northwestern University CRS
  • Cook County Hosp. CORE Ctr.
  • Weiss Memorial Hosp.
  • Rush Univ. Med. Ctr. ACTG CRS
  • Indiana Univ. School of Medicine, Infectious Disease Research Clinic
  • Indiana Univ. School of Medicine, Wishard Memorial
  • Methodist Hosp. of Indiana
  • Johns Hopkins Adult AIDS CRS
  • Massachusetts General Hospital ACTG CRS
  • Bmc Actg Crs
  • St. Louis ConnectCare, Infectious Diseases Clinic
  • Washington U CRS
  • Univ. of Nebraska Med. Ctr., Durham Outpatient Ctr.
  • SUNY - Buffalo, Erie County Medical Ctr.
  • Beth Israel Med. Ctr. (Mt. Sinai)
  • NY Univ. HIV/AIDS CRS
  • Univ. of Rochester ACTG CRS
  • Univ. of Cincinnati CRS
  • The Ohio State Univ. AIDS CRS
  • Hosp. of the Univ. of Pennsylvania CRS
  • University of Washington AIDS CRS
  • Puerto Rico-AIDS CRS
  • Mbeya Med. Research Program, Mbeya Referral Hosp. CRS

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
November 2, 1999
Last Updated
October 28, 2021
Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
Collaborators
Bristol-Myers Squibb
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1. Study Identification

Unique Protocol Identification Number
NCT00001065
Brief Title
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
Official Title
A Phase II Trial of Amphotericin B Oral Suspension for Fluconazole-Resistant Oral Candidiasis in HIV-Infected Patients
Study Type
Interventional

2. Study Status

Record Verification Date
October 2021
Overall Recruitment Status
Completed
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
April 1998 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
Collaborators
Bristol-Myers Squibb

4. Oversight

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Candidiasis, Oral, HIV Infections
Keywords
Administration, Oral, Acquired Immunodeficiency Syndrome, Amphotericin B, AIDS-Related Complex, Candidiasis, Oral, Suspensions

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Enrollment
70 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Amphotericin B

10. Eligibility

Sex
All
Minimum Age & Unit of Time
13 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zingman BS
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Wheat LJ
Official's Role
Study Chair
Facility Information:
Facility Name
Alabama Therapeutics CRS
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294
Country
United States
Facility Name
USC CRS
City
Los Angeles
State/Province
California
Country
United States
Facility Name
Santa Clara Valley Med. Ctr.
City
San Jose
State/Province
California
Country
United States
Facility Name
San Mateo County AIDS Program
City
San Mateo
State/Province
California
Country
United States
Facility Name
Howard University Hosp., Div. of Infectious Diseases, ACTU
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20059
Country
United States
Facility Name
Univ. of Miami AIDS CRS
City
Miami
State/Province
Florida
Country
United States
Facility Name
The Ponce de Leon Ctr. CRS
City
Atlanta
State/Province
Georgia
Country
United States
Facility Name
Queens Med. Ctr.
City
Honolulu
State/Province
Hawaii
ZIP/Postal Code
96816
Country
United States
Facility Name
Univ. of Hawaii at Manoa, Leahi Hosp.
City
Honolulu
State/Province
Hawaii
ZIP/Postal Code
96816
Country
United States
Facility Name
Northwestern University CRS
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
Cook County Hosp. CORE Ctr.
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
Weiss Memorial Hosp.
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60640
Country
United States
Facility Name
Rush Univ. Med. Ctr. ACTG CRS
City
Chicago
State/Province
Illinois
Country
United States
Facility Name
Indiana Univ. School of Medicine, Infectious Disease Research Clinic
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Facility Name
Indiana Univ. School of Medicine, Wishard Memorial
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Facility Name
Methodist Hosp. of Indiana
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Facility Name
Johns Hopkins Adult AIDS CRS
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States
Facility Name
Massachusetts General Hospital ACTG CRS
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
Bmc Actg Crs
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02118
Country
United States
Facility Name
St. Louis ConnectCare, Infectious Diseases Clinic
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63112
Country
United States
Facility Name
Washington U CRS
City
Saint Louis
State/Province
Missouri
Country
United States
Facility Name
Univ. of Nebraska Med. Ctr., Durham Outpatient Ctr.
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68198
Country
United States
Facility Name
SUNY - Buffalo, Erie County Medical Ctr.
City
Buffalo
State/Province
New York
ZIP/Postal Code
14215
Country
United States
Facility Name
Beth Israel Med. Ctr. (Mt. Sinai)
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Facility Name
NY Univ. HIV/AIDS CRS
City
New York
State/Province
New York
Country
United States
Facility Name
Univ. of Rochester ACTG CRS
City
Rochester
State/Province
New York
ZIP/Postal Code
14642
Country
United States
Facility Name
Univ. of Cincinnati CRS
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45267
Country
United States
Facility Name
The Ohio State Univ. AIDS CRS
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Facility Name
Hosp. of the Univ. of Pennsylvania CRS
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
University of Washington AIDS CRS
City
Seattle
State/Province
Washington
ZIP/Postal Code
98122
Country
United States
Facility Name
Puerto Rico-AIDS CRS
City
San Juan
ZIP/Postal Code
00936
Country
Puerto Rico
Facility Name
Mbeya Med. Research Program, Mbeya Referral Hosp. CRS
City
Mbeya
Country
Tanzania

12. IPD Sharing Statement

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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

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