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

Objective: To determine the efficacy and safely of amphotericin B oral susp ension (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 stud y centers within the AIDS Clinical Trials Group. Patients and methods: Individuals with diffuse oral candidiasis after 14 da ys 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 mi 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 plaqu es, the largest being < 3 cm largest dimension. Results: Fifty-eight subjects with a median age of 39 years and a median CD 4 count of 10 x 10(6) cells/l were enrolled. Four subjects were excluded fr om 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 to xicity. Relapse occurred in 16 responders (70%). Conclusions: Amphotericin B oral suspension is well tolerated but has limit ed efficacy for the treatment of fluconazole refractory oral candidiasis. ( C) 2000 Lippincott Williams & Wilkins.