title: Amphotericin B oral suspension for fluconazole-refractory oral candidiasis in persons with HIV infection. Adult AIDS Clinical Trials Group Study Team 295.
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.
  
  
  METHODS
  A prospective, multicenter, open label trial at 25 study centers within the AIDS Clinical Trials Group.
  
  
  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.
  
  
  METHODS
  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 10(6) 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.
authors.affiliation: Washington University School of Medicine, St Louis, Missouri, USA. carl.fichtenbaum@uc.edu
authors.forename: C J
authors.initials: CJ
authors.lastname: Fichtenbaum
authors.forename: R
authors.initials: R
authors.lastname: Zackin
authors.forename: N
authors.initials: N
authors.lastname: Rajicic
authors.forename: W G
authors.initials: WG
authors.lastname: Powderly
authors.forename: L J
authors.initials: LJ
authors.lastname: Wheat
authors.forename: B S
authors.initials: BS
authors.lastname: Zingman
mesh_terms: D017088:AIDS-Related Opportunistic Infections / Q000188:drug therapy* / Q000382:microbiology; D000328:Adult; D000666:Amphotericin B / Q000627:therapeutic use*; D000935:Antifungal Agents / Q000494:pharmacology / Q000627:therapeutic use*; D002175:Candida / Q000187:drug effects* / Q000302:isolation & purification; D002180:Candidiasis, Oral / Q000188:drug therapy* / Q000382:microbiology; D004352:Drug Resistance, Microbial; D005260:Female; D015725:Fluconazole / Q000494:pharmacology / Q000627:therapeutic use*; D006801:Humans; D008297:Male; D008826:Microbial Sensitivity Tests; D008875:Middle Aged; D011446:Prospective Studies; D016896:Treatment Outcome
chemical_list: D000935:Antifungal Agents; D000666:Amphotericin B; D015725:Fluconazole