ObjectivesRash is the most frequent adverse event associated with nevirapine. The use of prednisone has been controversial in this setting. A double-blind placebo-controlled study was performed to evaluate its efficacy in nevirapine-induced rash prevention.DesignMulticentered, randomized, double-blind, placebo-controlled clinical trial with prednisone (30 mg/day × 2 weeks). Inclusion criteria: HIV-1 infection; CD4 count >200 cells/mm3; plasma viral load (PVL) <5 log10copies/ml; nevirapine (200 mg/day × 2 weeks, followed by 200 mg twice daily) plus stavudine and didanosine. Clinical follow-up was performed at 15, 30, and 60 days and thereafter every 2 months.ResultsIn all, 75 evaluable patients were enrolled (39 prednisone/36 placebo). Median baseline CD4+cell count was 390 cells/mm3and PVL, 20,200 copies/ml. Overall, nine cases of rash (12.5%) were detected, seven (18%) in the prednisone group and two (5.5%) in the placebo group (odds ratio [OR], 3.85; 95% confidence interval [CI], 0.65–29.3;p= .11). Incidence of moderate-to-severe rashes leading to nevirapine withdrawal was 13.5% (5 of 37) in the prednisone group and 3% (1 of 35) in the placebo group (p= .2). Median time to rash in both groups was 16 days. Adverse events that motivated withdrawal of therapy appeared in 6 patients from the prednisone group (15.4%) and 3 from the placebo group (8.3%) (p= .3).ConclusionShort-term prednisone administration does not prevent nevirapine rash, but might even increase its incidence.