Low Dose Fluconazole Is Effective for Primary Prophylaxis of Cryptococcal Meningitis

To assess the efficacy and survival benefit of low-dose (400 mg weekly) fluconazole (Diflucan) for primary prophylaxis for cryptococcal meningitis in patients with advanced HIV infection.

A prospective multicentre, randomized, double-blind, placebo-controlled study was carried out in HIV-infected patients with CD4 counts <100 cells/microliter.

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 (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) (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 (P=0.065).

Conclusions

The authors conclude, “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.”

05/26/04