A multicentre, randomized, double‐blind, placebo‐controlled trial of primary cryptococcal meningitis prophylaxis in HIV‐infected patients with severe immune deficiency

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Abstract
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 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.