Efficacy of melaleuca oral solution for the treatment of fluconazole refractory oral candidiasis in AIDS patients

Objective: To evaluate the efficacy of melaleuca oral solution in AIDS patients with fluconazole-resistant oropharyngeal candida infections. Design: A prospective, single center, open-labeled study. Setting: A university-based inner-city HIV/AIDS clinic. Patients: Thirteen patients with AIDS and oral candidiasis documented to be clinically refractory to fluconazole, as defined by failure to respond to a minimum of 14 days of ≤ 400 mg fluconazole per day. Additionally, patients had in vitro resistance to fluconazole, defined by minimal inhibitory concentrations of ≤ 20 μg/ml. Interventions: Patients were given 15 ml melaleuca oral solution four times daily to swish and expel for 2-4 weeks. Main outcome measures: Resolution of clinical lesions of oral pseudomembranous candidiasis lesions. Evaluations were performed weekly for 4 weeks and at the end of therapy for clinical signs of oral candidiasis. Quantitative yeast cultures were performed at each evaluation. Results: A total of 13 patients were entered into the study, 12 were evaluable. At the 2-week evaluation, seven out of 12 patients had improved, none were cured, and six were unchanged. At the 4-week evaluation, eight out of 12 patients showed a response (two cured, six improved), four were non-responders, and one had deteriorated. A mycological response was seen in seven out of 12 patients. A followup evaluation 2-4 weeks after therapy was discontinued revealed that there were no clinical relapses in the two patients who were cured. Conclusions: Melaleuca oral solution appears to be effective as an alternative regimen for AIDS patients with oropharyngeal candidiasis refractory to fluconazole.