Amphotericin B oral suspension for fluconazole-refractory oral candidiasis in persons with HIV infection

Carl J. Fichtenbaum, Robert Zackin, Natasa Rajicic, William G. Powderly, L. Joseph Wheat, Barry S. Zingman

Research output: Contribution to journalArticle

19 Citations (Scopus)

Abstract

Objective: To determine the efficacy and safety of amphotericin B oral suspension (ABOS) for the treatment of fluconazole refractory oral candidiasis in persons with HIV infection. Design and setting: A prospective, multicenter, open label trial at 25 study centers within the AIDS Clinical Trials Group. Patients and methods: Individuals with diffuse oral candidiasis after 14 days of treatment with 200 mg of fluconazole daily (more than five plaques or a single plaque > 3 cm largest length) were treated with ABOS, 100 mg/ml, 5 ml swish and swallow, four times daily for 14 days. Thereafter incomplete or non-responders received an additional 14 days of therapy and responders received maintenance ABOS twice daily for up to 6 months. Relapses during maintenance ABOS were treated by increasing the dose to four times daily. Main outcome measures: To demonstrate an ABOS clinical response rate > 33% and a treatment-limiting toxicity rate < 50%. Clinical response was defined as the absence of mouth pain and the presence of less than five oral plaques, the largest being < 3 cm largest dimension. Results: Fifty-eight subjects with a median age of 39 years and a median CD4 count of 10 x 106 cells/l were enrolled. Four subjects were excluded from the analysis because of inadequate follow-up after randomization (n = 3) or the presence of active esophageal disease (n = 1). Of the remaining 54 subjects, 23 (42.6%; 95% lower confidence interval, 31.1%) were classified as responders after 28 days. Five subjects (9%) stopped treatment due to toxicity. Relapse occurred in 16 responders (70%). Conclusions: Amphotericin B oral suspension is well tolerated but has limited efficacy for the treatment of fluconazole refractory oral candidiasis. (C) 2000 Lippincott Williams and Wilkins.

Original languageEnglish (US)
Pages (from-to)845-852
Number of pages8
JournalAIDS
Volume14
Issue number7
DOIs
StatePublished - 2000

Fingerprint

Oral Candidiasis
Fluconazole
Amphotericin B
HIV Infections
Suspensions
Maintenance
Esophageal Diseases
Therapeutics
Recurrence
CD4 Lymphocyte Count
Deglutition
Random Allocation
Mouth
Acquired Immunodeficiency Syndrome
Outcome Assessment (Health Care)
Clinical Trials
Confidence Intervals
Safety
Pain

Keywords

  • AIDS
  • Amphotericin B
  • Candida
  • Fluconazole
  • Oral candidiasis
  • Refractory candidiasis
  • Resistant candidiasis

ASJC Scopus subject areas

  • Immunology and Allergy
  • Immunology

Cite this

Amphotericin B oral suspension for fluconazole-refractory oral candidiasis in persons with HIV infection. / Fichtenbaum, Carl J.; Zackin, Robert; Rajicic, Natasa; Powderly, William G.; Joseph Wheat, L.; Zingman, Barry S.

In: AIDS, Vol. 14, No. 7, 2000, p. 845-852.

Research output: Contribution to journalArticle

Fichtenbaum, Carl J. ; Zackin, Robert ; Rajicic, Natasa ; Powderly, William G. ; Joseph Wheat, L. ; Zingman, Barry S. / Amphotericin B oral suspension for fluconazole-refractory oral candidiasis in persons with HIV infection. In: AIDS. 2000 ; Vol. 14, No. 7. pp. 845-852.
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AU - Rajicic, Natasa

AU - Powderly, William G.

AU - Joseph Wheat, L.

AU - Zingman, Barry S.

PY - 2000

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N2 - Objective: To determine the efficacy and safety of amphotericin B oral suspension (ABOS) for the treatment of fluconazole refractory oral candidiasis in persons with HIV infection. Design and setting: A prospective, multicenter, open label trial at 25 study centers within the AIDS Clinical Trials Group. Patients and methods: Individuals with diffuse oral candidiasis after 14 days of treatment with 200 mg of fluconazole daily (more than five plaques or a single plaque > 3 cm largest length) were treated with ABOS, 100 mg/ml, 5 ml swish and swallow, four times daily for 14 days. Thereafter incomplete or non-responders received an additional 14 days of therapy and responders received maintenance ABOS twice daily for up to 6 months. Relapses during maintenance ABOS were treated by increasing the dose to four times daily. Main outcome measures: To demonstrate an ABOS clinical response rate > 33% and a treatment-limiting toxicity rate < 50%. Clinical response was defined as the absence of mouth pain and the presence of less than five oral plaques, the largest being < 3 cm largest dimension. Results: Fifty-eight subjects with a median age of 39 years and a median CD4 count of 10 x 106 cells/l were enrolled. Four subjects were excluded from the analysis because of inadequate follow-up after randomization (n = 3) or the presence of active esophageal disease (n = 1). Of the remaining 54 subjects, 23 (42.6%; 95% lower confidence interval, 31.1%) were classified as responders after 28 days. Five subjects (9%) stopped treatment due to toxicity. Relapse occurred in 16 responders (70%). Conclusions: Amphotericin B oral suspension is well tolerated but has limited efficacy for the treatment of fluconazole refractory oral candidiasis. (C) 2000 Lippincott Williams and Wilkins.

AB - Objective: To determine the efficacy and safety of amphotericin B oral suspension (ABOS) for the treatment of fluconazole refractory oral candidiasis in persons with HIV infection. Design and setting: A prospective, multicenter, open label trial at 25 study centers within the AIDS Clinical Trials Group. Patients and methods: Individuals with diffuse oral candidiasis after 14 days of treatment with 200 mg of fluconazole daily (more than five plaques or a single plaque > 3 cm largest length) were treated with ABOS, 100 mg/ml, 5 ml swish and swallow, four times daily for 14 days. Thereafter incomplete or non-responders received an additional 14 days of therapy and responders received maintenance ABOS twice daily for up to 6 months. Relapses during maintenance ABOS were treated by increasing the dose to four times daily. Main outcome measures: To demonstrate an ABOS clinical response rate > 33% and a treatment-limiting toxicity rate < 50%. Clinical response was defined as the absence of mouth pain and the presence of less than five oral plaques, the largest being < 3 cm largest dimension. Results: Fifty-eight subjects with a median age of 39 years and a median CD4 count of 10 x 106 cells/l were enrolled. Four subjects were excluded from the analysis because of inadequate follow-up after randomization (n = 3) or the presence of active esophageal disease (n = 1). Of the remaining 54 subjects, 23 (42.6%; 95% lower confidence interval, 31.1%) were classified as responders after 28 days. Five subjects (9%) stopped treatment due to toxicity. Relapse occurred in 16 responders (70%). Conclusions: Amphotericin B oral suspension is well tolerated but has limited efficacy for the treatment of fluconazole refractory oral candidiasis. (C) 2000 Lippincott Williams and Wilkins.

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KW - Candida

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