Research Article| Volume 19, ISSUE 3, P471-480, May 1997

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Itraconazole oral solution versus clotrimazole troches for the treatment of oropharyngeal candidiasis in immunocompromised patients

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      This multicenter, open-label, third-party—masked trial compared the efficacy and safety of itraconazole oral solution (200 mg once daily) and clotrimazole troches (10 mg five times daily) in a population of immunocompromised subjects composed primarily of patients with human immunodeficiency virus (HIV)/acquired immunodeficiency syndrome (AIDS). Patients were treated for 14 days; patients who exhibited a clinical response were followed up for an additional month to document the occurrence of relapse. Efficacy was judged by changes from baseline in symptoms of oropharyngeal candidiasis (erythema, soreness/burning), extent of oral lesions, and the presence/absence of Candida species on fungal culture. A total of 162 patients were randomized, and 149 were evaluated for efficacy. The percentage of patients with negative cultures at the end of treatment was significantly greater in the itraconazole group than in the clotrimazole group (60% vs 32%, respectively). Negative culture plus clinical response was achieved in significantly more itraconazole-treated patients (53%) than clotrimazole-treated patients (30%); results were similar in the subgroup of patients with HIV/AIDS. Both drugs were well tolerated, with the most frequently reported adverse events for both agents involving the gastrointestinal system. In conclusion, systemic therapy with itraconazole oral solution is efficacious and well tolerated in immunocompromised patients, including those with HIV/AIDS, when administered once daily for 14 days for the treatment of oral candidiasis.


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        • Greenspan D
        Treatment of oropharyngeal candidiasis in HIV-positive patients.
        J Am Acad Dermatol. 1994; 31 (3 Pt 2): S51-S55
        • Van Meter F
        • Gallo JW
        • Garcia-Rojas G
        • et al.
        A study of oral candidiasis in HIV-positive patients.
        J Dent Hyg. 1994; 68: 30-34
        • Klein RS
        • Harris CA
        • Butkus Small C
        • et al.
        Oral candidiasis in high-risk patients as the initial manifestation of the acquired immunodeficiency syndrome.
        NEJM. 1984; 311: 354-358
        • Lifson AR
        • Hilton JF
        • Westenhouse JL
        • et al.
        Time from HIV seroconversion to oral candidiasis or hairy leukoplakia among homosexual and bisexual men enrolled in three prospective cohorts.
        AIDS. 1994; 8: 73-79
        • Koletar SL
        • Russell JA
        • Fass RJ
        • Plouffe JF
        Comparison of oral fluconazole and clotrimazole troches as treatment for oral candidiasis in patients with human immunodeficiency virus.
        Antimicrob Agents Chemother. 1990; 34: 2267-2268
        • Pons V
        • Greenspan D
        • Debruin M
        Therapy for oropharyngeal candidiasis in HIV-infected patients: A randomized, prospective multicenter study of oral fluconazole versus clotrimazole troches.
        J Acquired Immune Defic Syndr. 1993; 6 (Multicenter Study Group): 1311-1316
        • Sangeorzan JA
        • Bradley SF
        • He X
        • et al.
        Epidemiology of oral candidiasis in HIV-infected patients: Colonization, infection, treatment, and emergence of fluconazole resistance.
        Am J Med. 1994; 97: 339-346
        • De Wit S
        • Goossens H
        • Weerts D
        • Clumeck N
        Comparison of fluconazole and ketoconazole for oropharyngeal candidiasis in AIDS.
        Lancet. 1989; 1: 746-748
        • Cleary JD
        • Taylor JW
        • Chapman SW
        Itraconazole in antifungal therapy.
        Ann Pharmacother. 1992; 26: 502-509
        • Lake-Bakaar G
        • Tom W
        • Lake-Bakaar D
        • et al.
        Gastropathy and ketoconazole malabsorption in the acquired immunodeficiency syndrome (AIDS).
        Ann Intern Med. 1988; 109: 471-473
        • Boken DJ
        • Swindells S
        • Rinaldi MG
        Fluconazole-resistant Candida albicans.
        Clin Infect Dis. 1993; 17: 1018-1021
        • Goff DA
        • Koletar SL
        • Buesching WJ
        • et al.
        Isolation of fluconazole-resistant Candida albicans from human immunodeficiency virus-negative patients never treated with azoles.
        Clin Infect Dis. 1995; 20: 77-83
        • Newman SL
        • Flanigan TP
        • Ficher A
        • et al.
        Clinically significant mucosal candidiasis resistant to fluconazole treatment in patients with AIDS.
        Clin Infect Dis. 1994; 19: 684-686
        • Rex JH
        • Rinaldi MG
        • Pfaller MA
        Resistance of Candida species to fluconazole.
        Antimicrob Agents Chemother. 1995; 39: 1-8
        • Hay RJ
        • Dupont B
        • Graybill JR
        First international symposium on itraconazole: A summary.
        Rev Infect Dis. 1987; 9 (Suppl 1): S1-S3
        • Barchiesi F
        • Colombo AL
        • McGough DA
        • et al.
        In vitro activity of itraconazole against fluconazole-susceptible and -resistant Candida albicans isolates from oral cavities of patients infected with human immunodeficiency virus.
        Antimicrob Agents Chemother. 1994; 38: 1530-1533
        • Blatchford NR
        Treatment of oral candidosis with itraconazole: A review.
        J Am Acad Dermatol. 1990; 23: 565-567
        • Barone JA
        • Koh JG
        • Bierman RH
        • et al.
        Food interaction and steady-state pharmacokinetics of itraconazole capsules in healthy male volunteers.
        Antimicrob Agents Chemother. 1993; 37: 778-784
        • Hardin TC
        • Graybill JR
        • Fetchick R
        • et al.
        Pharmacokinetics of itraconazole following oral administration to normal volunteers.
        Antimicrob Agents Chemother. 1988; 32: 1310-1313
        • Smith DE
        • Midgley J
        • Allan M
        • et al.
        Itraconazole versus ketoconazole in the treatment of oral and oesophageal candidosis in patients infected with HIV.
        AIDS. 1991; 5: 1367-1371
        • Hostetler JS
        • Hanson LH
        • Stevens DA
        Effect of cyclodextrin on the pharmacology of antifungal oral azoles.
        Antimicrob Agents Chemother. 1992; 36: 477-480
        • Barone JA
        • Moskovitz BL
        • Guarnieri J
        • et al.
        Enhanced bioavailability of itraconazole (ITR) solution compared with capsules in healthy volunteers.
        Presented at the Annual Meeting of the American College of Clinical Pharmacy. 691997; (Panama City, Florida)
        • Desmet P
        • Kayembe K
        • Stoffels P
        • et al.
        Treatment of oral candidosis in AIDS patients with itraconazole oral solution.
        Presented at the Third Symposium, Topics in Mycology: Mycoses in AIDS Patients. 20231989; (Paris, France)
        • Powderly WG
        • Finkelstein DM
        • Feinberg J
        • et al.
        A randomized trial comparing fluconazole with clotrimazole troches for the prevention of fungal infections in patients with advanced human immunodeficiency virus infection.
        NEJM. 1995; 332: 700-705