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Home > "A" Clinical Trials Conditions > 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

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



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

For Condition: Candidiasis, Oral,HIV Infections
Status: Completed
Sponsor(s): National Institute of Allergy and Infectious Diseases (NIAID) , Bristol-Myers Squibb
Synopsis: 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.
Details: 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.
Eligibility:
Study Type:
  Interventional, Treatment
Minimum Age/Maximum Age: 13 Years/
Genders: Both
Protocol Entry 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.
Total Enrollment: 70

Location and Contact Information:

Overall Study Official:
ZingmanBS,  Study Chair, 

Univ of Illinois College of Medicine / Pediatrics
Chicago,  Illinois,  60612
United States
 

Univ of North Carolina
Chapel Hill,  North Carolina,  275997215
United States
 

Montefiore Med Ctr / Bronx Municipal Hosp
Bronx,  New York,  10467
United States
 

Emory Univ
Atlanta,  Georgia,  30308
United States
 

Louis A Weiss Memorial Hosp
Chicago,  Illinois,  60640
United States
 

Univ of Hawaii
Honolulu,  Hawaii,  96816
United States
 

Montefiore Family Health Ctr / Bronx Municipal Hosp
Bronx,  New York,  10461
United States
 

Comprehensive Health Care Ctr / Bronx Municipal Hosp
Bronx,  New York,  10461
United States
 

Cook County Hosp
Chicago,  Illinois,  60612
United States
 

Bellevue Hosp / New York Univ Med Ctr
New York City,  New York,  10016
United States
 

Illinois Masonic Med Ctr
Chicago,  Illinois,  606575147
United States
 

Johns Hopkins Hosp
Baltimore,  Maryland,  21287
United States
 

Univ of Tennessee / E Tennessee Comprehensive Hemophilia Ctr
Knoxville,  Tennessee,  37920
United States
 

Univ of Washington
Seattle,  Washington,  981224304
United States
 

Stanford Univ Med Ctr
Stanford,  California,  943055107
United States
 

Montefiore Adolescent AIDS Prog / Bronx Municipal Hosp
Bronx,  New York,  10461
United States
 

Bronx Municipal Hosp Ctr/Jacobi Med Ctr
Bronx,  New York,  10461
United States
 

Columbus Children's Hosp
Columbus,  Ohio,  432052696
United States
 

SUNY / Erie County Med Ctr at Buffalo
Buffalo,  New York,  14215
United States
 

Queens Med Ctr
Honolulu,  Hawaii,  96816
United States
 

Julio Arroyo
West Columbia,  South Carolina,  29169
United States
 

Bronx Veterans Administration / Mount Sinai Hosp
Bronx,  New York,  10468
United States
 

Stanford at Kaiser / Kaiser Permanente Med Ctr
San Francisco,  California,  94115
United States
 

Univ of Rochester Medical Center
Rochester,  New York,  14642
United States
 

Univ of Pennsylvania at Philadelphia
Philadelphia,  Pennsylvania,  19104
United States
 

Methodist Hosp of Indiana / Life Care Clinic
Indianapolis,  Indiana,  46202
United States
 

State of MD Div of Corrections / Johns Hopkins Univ Hosp
Baltimore,  Maryland,  212052196
United States
 

Wishard Hosp / Indiana Univ Hosp
Indianapolis,  Indiana,  46202
United States
 

SUNY / Health Sciences Ctr at Brooklyn
Brooklyn,  New York,  112032098
United States
 

Harvard (Massachusetts Gen Hosp)
Boston,  Massachusetts,  02114
United States
 

St Louis Regional Hosp / St Louis Regional Med Ctr
St. Louis,  Missouri,  63112
United States
 

Univ of Alabama at Birmingham
Birmingham,  Alabama,  35294
United States
 

Saint Clare's Hosp and Health Ctr
New York City,  New York,  10019
United States
 

Mount Sinai Med Ctr
New York City,  New York,  10029
United States
 

Northwestern Univ Med School
Chicago,  Illinois,  60611
United States
 

Univ of New Mexico School of Medicine
Albuquerque,  New Mexico,  87501
United States
 

Jack Weiler Hosp / Bronx Municipal Hosp
Bronx,  New York,  10465
United States
 

Beth Israel Med Ctr
New York City,  New York,  10003
United States
 

Univ of Cincinnati
Cincinnati,  Ohio,  452670405
United States
 

Mount Sinai Med Ctr / Pediatrics
New York City,  New York,  10029
United States
 

Univ of Nebraska Med Ctr
Omaha,  Nebraska,  681985130
United States
 

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

Boston Med Ctr
Boston,  Massachusetts,  02118
United States
 

St Paul Ramsey Med Ctr
St. Paul,  Minnesota,  55101
United States
 

Carolinas Med Ctr
Charlotte,  North Carolina,  28203
United States
 

Ohio State Univ Hosp Clinic
Columbus,  Ohio,  432101228
United States
 

Univ of Puerto Rico
San Juan,  ,  009365067
Puerto Rico
 

Indiana Univ Hosp
Indianapolis,  Indiana,  462025250
United States
 

Meharry Med College
Nashville,  Tennessee,  37203
United States
 

Youngstown Hemophilia Ctr / Great Lakes Hemophilia Fdn
Wauwatosa,  Wisconsin,  53213
United States
 

San Mateo AIDS Program / Stanford Univ
Stanford,  California,  943055107
United States
 


Additional Information:
Study ID Numbers:
  ACTG 295; 
Study Start Date: 
Record last reviewed: April 1999
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00001065

Other Hiv Infections Studies:
1. Nystatin Pastilles for the Prevention of Oral Candidiasis in Patients With AIDS or ARC

2. Safety and Effectiveness of Giving Lamisil to HIV-Positive Subjects With Thrush Who Have Not Responded to Fluconazole Treatment

3. A Study of Nystatin in the Prevention of Fungal Infections of the Mouth in Patients with AIDS or AIDS-Related Syndromes

4. An Open Study of the Effect of Itraconazole Oral Solution for the Treatment of Fluconazole Refractory Oropharyngeal Candidiasis in HIV-Positive Subjects.

5. A Study to Compare the Use of Fluconazole as Continuous Therapy Versus Periodic Therapy in HIV-Positive Patients with Recurrent Thrush

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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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