Failure of cetirizine to prevent nevirapine-associated rash: a double-blind placebo-controlled trial for the GESIDA 26/01 Study.

Author(s): Knobel H, Miro JM, Mahillo B, Domingo P, Rivero A, Ribera E, Gonzalez J, Sanz J, Gonzalez A, Blanco JL, Boix V, Force L, Llibre JM, Dalmau D, Arroyo JA, De la Torre J, Rodriguez D, Montes ML, Arranz A, Sarasa M, Grupo Estudio Syndrome Immunodeficiencies Adquirida 26/02 Study Group

Affiliation(s): Department of Internal Medicine, Infectious Diseases, Hospital del Mar, Barcelona, Spain. hknobel@telefonica.net

Publication date & source: 2004-10-01, J Acquir Immune Defic Syndr., 37(2):1276-81.

Publication type: Clinical Trial; Multicenter Study; Randomized Controlled Trial

OBJECTIVES: Rash is the most frequent adverse event associated with nevirapine. The use of antihistamines remains unclear in this setting. A double-blind placebo-controlled study was performed to evaluate the efficacy of cetirizine in the prevention of nevirapine rash. METHODS: A multicenter, randomized, double-blind, placebo-controlled clinical trial with cetirizine (10 mg/d x 30 days) was conducted. Inclusion criteria were HIV-1 infection and nevirapine therapy started with any CD4 cell count or plasma viral load and without simultaneous use of abacavir, cotrimoxazole, or rifampin. Clinical follow-up was performed at 15, 30, and 90 days. RESULTS: Two hundred seventeen evaluable patients were enrolled (107 patients receiving cetirizine and 110 patients receiving placebo), 32.3% of whom were women. The median baseline CD4 cell count and plasma viral load were 341 cells/mm and 11,000 copies/mL, respectively. Overall, 29 rashes (13.4%) were detected: 16 (15.0%) in the cetirizine group and 13 (11.8%) in the placebo group (odds ratio [OR] = 1.31, 95% confidence interval [CI]: 0.60-2.88; P = 0.50). The incidence of moderate to severe rashes leading to nevirapine withdrawal was 10.3% (11 of 107 patients) in the cetirizine group and 7.3% (8 of 110 patients) in the placebo group (OR = 1.46, 95% CI: 0.52-4.18; P = 0.43). Adverse events leading to withdrawal of therapy appeared in 14 patients (13.1%) from the cetirizine group and 10 (9.1%) from the placebo group (P = 0.34). CONCLUSION: Cetirizine does not prevent the incidence or affect the severity of nevirapine-associated rash.