title: Failure of cetirizine to prevent nevirapine-associated rash: a double-blind placebo-controlled trial for the GESIDA 26/01 Study.
abstract: OBJECTIVE
  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).
  
  
  CONCLUSIONS
  Cetirizine does not prevent the incidence or affect the severity of nevirapine-associated rash.
authors.affiliation: Department of Internal Medicine, Infectious Diseases, Hospital del Mar, Barcelona, Spain. hknobel@telefonica.net
authors.forename: Hernando
authors.initials: H
authors.lastname: Knobel
authors.forename: José M
authors.initials: JM
authors.lastname: Miró
authors.forename: Beatriz
authors.initials: B
authors.lastname: Mahillo
authors.forename: Pere
authors.initials: P
authors.lastname: Domingo
authors.forename: Antonio
authors.initials: A
authors.lastname: Rivero
authors.forename: Esteban
authors.initials: E
authors.lastname: Ribera
authors.forename: Juan
authors.initials: J
authors.lastname: Gonzalez
authors.forename: José
authors.initials: J
authors.lastname: Sanz
authors.forename: Alicia
authors.initials: A
authors.lastname: González
authors.forename: José Luis
authors.initials: JL
authors.lastname: Blanco
authors.forename: Vicente
authors.initials: V
authors.lastname: Boix
authors.forename: Luis
authors.initials: L
authors.lastname: Force
authors.forename: Josep M
authors.initials: JM
authors.lastname: Llibre
authors.forename: David
authors.initials: D
authors.lastname: Dalmau
authors.forename: Juan A
authors.initials: JA
authors.lastname: Arroyo
authors.forename: Julián
authors.initials: J
authors.lastname: De la Torre
authors.forename: Dolors
authors.initials: D
authors.lastname: Rodriguez
authors.forename: María Luisa
authors.initials: ML
authors.lastname: Montes
authors.forename: Alberto
authors.initials: A
authors.lastname: Arranz
authors.forename: María
authors.initials: M
authors.lastname: Sarasa
mesh_terms: D017332:Cetirizine / Q000627:therapeutic use*; D004311:Double-Blind Method; D005076:Exanthema / Q000139:chemically induced / Q000517:prevention & control*; D005260:Female; D015658:HIV Infections / Q000150:complications* / Q000188:drug therapy / Q000276:immunology; D015497:HIV-1 / Q000187:drug effects; D006801:Humans; D008297:Male; D008875:Middle Aged; D019829:Nevirapine / Q000009:adverse effects* / Q000097:blood / Q000627:therapeutic use; D017211:Treatment Failure
chemical_list: D019829:Nevirapine; D017332:Cetirizine