Premium
A multicentre, randomized, double‐blind, placebo‐controlled trial of primary cryptococcal meningitis prophylaxis in HIV‐infected patients with severe immune deficiency
Author(s) -
Chetchotisakd P,
Sungkanuparph S,
Thinkhamrop B,
Mootsikapun P,
Boonyaprawit P
Publication year - 2004
Publication title -
hiv medicine
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.53
H-Index - 79
eISSN - 1468-1293
pISSN - 1464-2662
DOI - 10.1111/j.1468-1293.2004.00201.x
Subject(s) - fluconazole , medicine , placebo , meningitis , hazard ratio , randomized controlled trial , cryptococcal meningitis , placebo controlled study , surgery , confidence interval , human immunodeficiency virus (hiv) , immunology , double blind , antifungal , viral disease , pathology , alternative medicine , dermatology
Objectives To assess the efficacy and survival benefit of low‐dose fluconazole (400 mg weekly) for primary prophylaxis for cryptococcal meningitis in patients with advanced HIV infection. Methods A prospective multicentre, randomized, double‐blind, placebo‐controlled study was carried out in HIV‐infected patients with CD4 counts <100 cells/μL. Results Of 90 patients enrolled, 44 received fluconazole and 46 received placebo. The baseline characteristics were similar in the two groups. On an intent‐to‐treat basis, 10 cases of cryptococcal meningitis developed, three (6.8%) in the fluconazole group and seven (15.2%) in the placebo group. Patients in the placebo group were more likely to develop cryptococcal meningitis than those in the fluconazole group [hazard ratio=2.23; 95% confidence interval (CI): 0.58–8.63; P =0.245]. The survival benefit of fluconazole was greater than that of the placebo. The number of deaths per 10 000 person‐days was 2.7 for the fluconazole group (2/7342) and 11.7 for the placebo group (9/7713) (rate difference=9; 95% CI: 0.4–17.5; P =0.046). Based on survival analysis, patients in the placebo group were 4.3 times more likely to die than those in the fluconazole group (95% CI: 0.9–19.8; P =0.065). Conclusion Fluconazole 400 mg once weekly for primary prophylaxis for cryptococcal meningitis in Thailand should be considered in HIV‐infected patients, as our study suggested a survival benefit. However, a larger study should be conducted to confirm our findings.