Amphotericin B oral suspension for fluconazole-refractory oral candidiasis in persons with HIV infection. Adult AIDS Clinical Trials Group Study Team 295

AIDS. 2000 May 5;14(7):845-52. doi: 10.1097/00002030-200005050-00011.


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 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.

Publication types

  • Clinical Trial
  • Multicenter Study
  • Research Support, U.S. Gov't, P.H.S.

MeSH terms

  • AIDS-Related Opportunistic Infections / drug therapy*
  • AIDS-Related Opportunistic Infections / microbiology
  • Adult
  • Amphotericin B / therapeutic use*
  • Antifungal Agents / pharmacology
  • Antifungal Agents / therapeutic use*
  • Candida / drug effects*
  • Candida / isolation & purification
  • Candidiasis, Oral / drug therapy*
  • Candidiasis, Oral / microbiology
  • Drug Resistance, Microbial
  • Female
  • Fluconazole / pharmacology
  • Fluconazole / therapeutic use*
  • Humans
  • Male
  • Microbial Sensitivity Tests
  • Middle Aged
  • Prospective Studies
  • Treatment Outcome


  • Antifungal Agents
  • Amphotericin B
  • Fluconazole