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- Title
Single-Dose Fluconazole versus Standard 2-Week Therapy for Oropharyngeal Candidiasis in HIV-Infected Patients: A Randomized, Double-Blind, Double-Dummy Trial.
- Authors
Hamza, Omar J. M.; Matee, Mecky I. N.; Brüggemann, Roger J. M.; Moshi, Mainen J.; Simon, Elison N. M.; Mugusi, Ferdinand; Mikx, Frans H. M.; van der Lee, Henrich A. L.; Verweij, Paul E.; van der Ven, André J. A. M.
- Abstract
Background. Oropharyngeal candidiasis is the most common opportunistic infection affecting patients with human immunodeficiency virus (HIV) infection. Because of convenience, cost, and reluctance to complicate antiretroviral treatment regimens, single-dose fluconazole may be a favorable regimen for treatment of moderate to severe oropharyngeal candidiasis. We conducted a prospective, randomized, double-blind, placebo-controlled trial to compare the clinical and mycological responses, relapse rates, and safety of a single 750-mg dose and a 14-day course of treatment with fluconazole. Methods. A total of 220 HIV-infected patients with clinical and mycological evidence of oropharyngeal candidiasis were randomly assigned in a 1:1 ratio to receive either a 750-mg single dose of orally administered fluconazole (110 patients) or 150 mg of orally administered fluconazole once per day for 2 weeks (110 patients). The primary efficacy analysis was based on clinical and mycological responses at the end of treatment. Secondary parameters were safety and relapse rate. Results. Single-dose fluconazole was equivalent to a 14-day course of fluconazole in achieving clinical and mycological cure, with clinical cure rates of 94.5% and 95.5%, respectively (odds ratio, 0.825; 95% confidence interval, 0.244-2.789; P = .99), and mycological cure rates of 84.5% and 75.5%, respectively (odds ratio, 1.780; 95% confidence interval, 0.906-3.496; P = .129). Drug-related adverse events were uncommon and were not different between the treatment groups. Conclusion. A single dose of 750 mg of fluconazole was safe, well tolerated, and as effective as the standard 14-day fluconazole therapy in patients with HIV infection and acquired immunodeficiency syndrome who had oropharyngeal candidiasis coinfection. Trial registration. ClinicalTrials.gov identifier: NCT00553137.
- Subjects
CANDIDIASIS; OPPORTUNISTIC infections; HIV; ANTIRETROVIRAL agents; PLACEBOS; HIV infections; AIDS; ANTIVIRAL agents; LENTIVIRUS diseases; HIV-positive persons
- Publication
Clinical Infectious Diseases, 2008, Vol 47, Issue 10, p1270
- ISSN
1058-4838
- Publication type
Article
- DOI
10.1086/592578