Journal Article

Single-Dose Fluconazole versus Standard 2-Week Therapy for Oropharyngeal Candidiasis in HIV-Infected Patients: A Randomized, Double-Blind, Double-Dummy Trial

Omar J. M. Hamza, Mecky I. N. Matee, Roger J. M. Brüggemann, Mainen J. Moshi, Elison N. M. Simon, Ferdinand Mugusi, Frans H. M. Mikx, Henrich A. L. van der Lee, Paul E. Verweij and André J. A. M. van der Ven

in Clinical Infectious Diseases

Published on behalf of Infectious Diseases Society of America

Volume 47, issue 10, pages 1270-1276
Published in print November 2008 | ISSN: 1058-4838
Published online November 2008 | e-ISSN: 1537-6591 | DOI: http://dx.doi.org/10.1086/592578
Single-Dose Fluconazole versus Standard 2-Week Therapy for Oropharyngeal Candidiasis in HIV-Infected Patients: A Randomized, Double-Blind, Double-Dummy Trial

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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.

Journal Article.  4199 words.  Illustrated.

Subjects: Infectious Diseases ; Immunology ; Public Health and Epidemiology ; Microbiology

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