EICHEL M, SCHNEIDER C, JUST-NUEBLING G; Interscience Conference on Antimicrobial Agents and Chemotherapy (41st : 2001 : Chicago, Ill.).

Abstr Intersci Conf Antimicrob Agents Chemother Intersci Conf Antimicrob Agents Chemother. 2001 Dec 16-19; 41: abstract no. J-1624.

University Hospital, Frankfurt/Main, Germany

BACKGROUND: Fluconazole capsules (CAPS) are an effective and safe treatment of oropharyngeal candidiasis. This study aimed at investigating whether the additional topical effect of fluconazole oral suspension (SUSP) leads to an even faster resolution of symptoms. METHODS: A randomized, double-blind/double-dummy study compared the ef-ficacy and safety of highly concentrated fluconazole SUSP (40 mg/ml) with flu-conazole CAPS in the treatment of oropharyngeal candidiasis in HIV-infected patients. Patients received a single dose of 200 mg fluconazole on the first day, and 100 mg od on days 2-10. Clinical and mycological success was evaluated at days 4, 7, 10 and 38. RESULTS: 90 (SUSP: 43; CAPS: 47) out of 93 patients enrolled were included in the ITT analysis. 87% were male; mean age was 41 years. Pathogens iso-lated at baseline were C. albicans (SUSP: 41; CAPS: 43), C. tropicalis (4; 2), C. glabrata (1; 2), C. krusei (2; 1), others (2; 4). Clinical success (cure or improvement) for SUSP and CAPS was 86% and 69% on day 4 (p=0.06), 95% and 89% on day 7 (p=0.28), 93% and 93% on day 10 (p=0.93), 93% and 84% on day 38 (p=0.22). Mycological response (no growth or <10[3] cfu/mL) for SUSP and CAPS was 49% and 60% on day 4 (p=0.33), 58% and 61 % on day 7 (p=0.82), 67% and 71% on day 10 (p=0.72), 57% and 59% on day 38 (p=0.91). Only one patient in each group had a treatment-related adverse event (nausea/vomiting and urticaria). No adverse effects with any possible relationship to concomitant antiretroviral treatment were observed (65% of all patients were on protease inhibitors). CONCLUSION: While the clinical efficacies of fluconazole suspension and capsules in oropharyngeal candidiasis were the same at the end of treatment (93% on day 10), there was a trend towards faster resolution of symptoms in the fluconazole suspension group (p=0.06 on day 4), which warrants further evaluation.

Publication Types:

• Meeting Abstracts

Keywords:

• AIDS Vaccines
• Acquired Immunodeficiency Syndrome
• Candidiasis
• Double-Blind Method
• Fluconazole
• Gastrointestinal Diseases
• HIV Infections
• HIV Seropositivity
• Humans
• Male
• Respiratory Tract Infections
• therapy

Other ID:

• GWAIDS0029327

UI: 102268959

From Meeting Abstracts