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Single-dose fluconazole versus standard 2-week therapy for oropharyngeal candidiasis in HIV-infected patients: a randomized, double-blind, double-dummy trial.
Clin Infect Dis. 2008 Nov 15; 47(10):1270-6.CI

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.

Authors+Show Affiliations

Department of Oral Surgery and Oral Pathology, Muhimbili University of Health and Allied Sciences, Dar es Salaam, Tanzania. dromar20@yahoo.comNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Comparative Study
Journal Article
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

18840077

Citation

Hamza, Omar J M., et al. "Single-dose Fluconazole Versus Standard 2-week Therapy for Oropharyngeal Candidiasis in HIV-infected Patients: a Randomized, Double-blind, Double-dummy Trial." Clinical Infectious Diseases : an Official Publication of the Infectious Diseases Society of America, vol. 47, no. 10, 2008, pp. 1270-6.
Hamza OJ, Matee MI, Brüggemann RJ, et al. Single-dose fluconazole versus standard 2-week therapy for oropharyngeal candidiasis in HIV-infected patients: a randomized, double-blind, double-dummy trial. Clin Infect Dis. 2008;47(10):1270-6.
Hamza, O. J., Matee, M. I., Brüggemann, R. J., Moshi, M. J., Simon, E. N., Mugusi, F., Mikx, F. H., van der Lee, H. A., Verweij, P. E., & van der Ven, A. J. (2008). Single-dose fluconazole versus standard 2-week therapy for oropharyngeal candidiasis in HIV-infected patients: a randomized, double-blind, double-dummy trial. Clinical Infectious Diseases : an Official Publication of the Infectious Diseases Society of America, 47(10), 1270-6. https://doi.org/10.1086/592578
Hamza OJ, et al. Single-dose Fluconazole Versus Standard 2-week Therapy for Oropharyngeal Candidiasis in HIV-infected Patients: a Randomized, Double-blind, Double-dummy Trial. Clin Infect Dis. 2008 Nov 15;47(10):1270-6. PubMed PMID: 18840077.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Single-dose fluconazole versus standard 2-week therapy for oropharyngeal candidiasis in HIV-infected patients: a randomized, double-blind, double-dummy trial. AU - Hamza,Omar J M, AU - Matee,Mecky I N, AU - Brüggemann,Roger J M, AU - Moshi,Mainen J, AU - Simon,Elison N M, AU - Mugusi,Ferdinand, AU - Mikx,Frans H M, AU - van der Lee,Henrich A L, AU - Verweij,Paul E, AU - van der Ven,André J A M, PY - 2008/10/9/pubmed PY - 2008/12/17/medline PY - 2008/10/9/entrez SP - 1270 EP - 6 JF - Clinical infectious diseases : an official publication of the Infectious Diseases Society of America JO - Clin Infect Dis VL - 47 IS - 10 N2 - 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. SN - 1537-6591 UR - https://www.unboundmedicine.com/medline/citation/18840077/Single_dose_fluconazole_versus_standard_2_week_therapy_for_oropharyngeal_candidiasis_in_HIV_infected_patients:_a_randomized_double_blind_double_dummy_trial_ L2 - https://academic.oup.com/cid/article-lookup/doi/10.1086/592578 DB - PRIME DP - Unbound Medicine ER -