title: Efficacy of alcohol-based and alcohol-free melaleuca oral solution for the treatment of fluconazole-refractory oropharyngeal candidiasis in patients with AIDS.
abstract: OBJECTIVE
  To evaluate the efficacy of alcohol-based and alcohol-free melaleuca oral solution in patients with AIDS and fluconazole-refractory oropharyngeal candidiasis.
  
  
  METHODS
  We performed a prospective, single-center, open-label study in a university-based inner city HIV/AIDS clinic. The study included 27 patients with AIDS and oral candidiasis clinically refractory to fluconazole. Patients were randomized 1:1 to receive either alcohol-based or alcohol-free melaleuca oral solution four times daily for 2-4 weeks. Thirteen patients were enrolled into cohort 1, and 14 patients were enrolled into cohort 2. The main outcome measure was resolution of clinical lesions of oral candidiasis. Evaluations were performed at 2 and 4 weeks for clinical signs and symptoms of oral candidiasis and quantitative yeast cultures.
  
  
  RESULTS
  All C. albicans isolates showed some degree of in vitro resistance to fluconazole. Overall, using a modified intent-to-treat analysis, 60% of patients demonstrated a clinical response to the melaleuca oral solution (7 patients cured and 8 patients clinically improved) at the 4-week evaluation.
  
  
  CONCLUSIONS
  Both formulations of the melaleuca oral solution appear to be effective alternative regimens for patients with AIDS suffering from oropharyngeal candidiasis refractory to fluconazole.
authors.affiliation: Division of Infectious Diseases, Wayne State University School of Medicine, Detroit, Michigan, USA. jvazquez@intmed.wayne.edu
authors.forename: Jose A
authors.initials: JA
authors.lastname: Vazquez
authors.forename: Ahmad A
authors.initials: AA
authors.lastname: Zawawi
mesh_terms: D000163:Acquired Immunodeficiency Syndrome / Q000150:complications*; D000284:Administration, Oral; D000328:Adult; D000368:Aged; D000438:Alcohols; D000935:Antifungal Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use; D002176:Candida albicans / Q000187:drug effects; D002180:Candidiasis, Oral / Q000150:complications* / Q000188:drug therapy* / Q000382:microbiology; D002626:Chemistry, Pharmaceutical; D025141:Drug Resistance, Fungal; D005260:Female; D015725:Fluconazole / Q000494:pharmacology*; D006801:Humans; D008297:Male; D031650:Melaleuca / Q000009:adverse effects; D008875:Middle Aged; D008517:Phytotherapy; D020947:Tea Tree Oil / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D013997:Time Factors; D016896:Treatment Outcome
chemical_list: D000438:Alcohols; D000935:Antifungal Agents; D020947:Tea Tree Oil; D015725:Fluconazole