Efficacy of alcohol-based and alcohol-free melaleuca oral solution for the treatment of fluconazole-refractory oropharyngeal candidiasis in patients with AIDS

HIV Clin Trials. Sep-Oct 2002;3(5):379-85. doi: 10.1310/99dy-8q52-306a-v0aj.

Abstract

Purpose: To evaluate the efficacy of alcohol-based and alcohol-free melaleuca oral solution in patients with AIDS and fluconazole-refractory oropharyngeal candidiasis.

Method: 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.

Conclusion: Both formulations of the melaleuca oral solution appear to be effective alternative regimens for patients with AIDS suffering from oropharyngeal candidiasis refractory to fluconazole.

Publication types

  • Clinical Trial
  • Randomized Controlled Trial

MeSH terms

  • Acquired Immunodeficiency Syndrome / complications*
  • Administration, Oral
  • Adult
  • Aged
  • Alcohols
  • Antifungal Agents / administration & dosage
  • Antifungal Agents / adverse effects
  • Antifungal Agents / therapeutic use
  • Candida albicans / drug effects
  • Candidiasis, Oral / complications*
  • Candidiasis, Oral / drug therapy*
  • Candidiasis, Oral / microbiology
  • Chemistry, Pharmaceutical
  • Drug Resistance, Fungal*
  • Female
  • Fluconazole / pharmacology*
  • Humans
  • Male
  • Melaleuca* / adverse effects
  • Middle Aged
  • Phytotherapy*
  • Tea Tree Oil / administration & dosage
  • Tea Tree Oil / adverse effects
  • Tea Tree Oil / therapeutic use*
  • Time Factors
  • Treatment Outcome

Substances

  • Alcohols
  • Antifungal Agents
  • Tea Tree Oil
  • Fluconazole