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

Hernando Knobel*, José M. Miró, Beatriz Mahillo, Pere Domingo, Antonio Rivero, Esteban Ribera, Juan Gonzalez, José Sanz, Alicia González, José Luis Blanco, Vicente Boix, Luis Force, Josep M. Llibre, David Dalmau, Juan A. Arroyo, Julián De La Torre, Dolors Rodriguez, María Luisa Montes, Alberto Arranz, María Sarasa

*Corresponding author for this work

Research output: Contribution to journalArticleResearchpeer-review

20 Citations (Scopus)

Abstract

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/mm3 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.

Original languageAmerican English
Pages (from-to)1276-1281
Number of pages6
JournalJournal of Acquired Immune Deficiency Syndromes
Volume37
Issue number2
DOIs
Publication statusPublished - 1 Oct 2004

Keywords

  • Adverse drug reaction
  • Cetirizine
  • Double-blind method
  • Exanthema
  • Nevirapine
  • Randomized trial

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