Assessment of cetirizine, an antihistamine, to prevent cutaneous reactions to nevirapine therapy: results of the viramune-zyrtec double-blind, placebo-controlled trial.
We conducted a 12-week, multicenter, randomized, double-blind, placebo-controlled trial of cetirizine to assess the ability of antihistamines to prevent nevirapine-associated rash in patients infected with human immunodeficiency virus type 1. Patients initiating treatment with nevirapine were randomized to receive either cetirizine, 10 mg q.d. (104 patients), or placebo (96 patients) during the first 6 weeks of therapy. Rash occurred in 22 (11%) of 200 patients; 10 (9.6%) were in the cetirizine group and 12 (12.5%) were in the placebo group (odds ratio [OR], 0.75; 95% confidence interval [CI], 0.31-1.81; P=.5). Five of 22 rashes were cases of hypersensitivity syndrome. The rate of nevirapine discontinuation due to rash was similar in the 2 groups (7.7% and 6.25% in the cetirizine and placebo groups, respectively; P=.4). Multivariate analysis showed no treatment-group effect but indicated that age >40 years (OR, 3.83; 95% CI, 1.4-10.46; P=.008) was associated with an increased risk of rash. Cetirizine has no preventive effect on nevirapine-associated rash.
Launay
O
O
Service de Medecine Interne, Hopital Cochin-Port Royal-Saint-Vincent de Paul, AP-HP, Paris, France. odile.launay@cch.ap-hop-paris.fr
Roudière
L
L
Boukli
N
N
Dupont
B
B
Prévoteau du Clary
F
F
Patey
O
O
David
F
F
Lortholary
O
O
Devidas
A
A
Piketty
C
C
Rey
E
E
Urbinelli
R
R
Allaert
F A
FA
Tréluyer
J M
JM
Caumes
E
E
D000328:Adult; D019380:Anti-HIV Agents / Q000009:adverse effects* / Q000097:blood / Q000627:therapeutic use; D017332:Cetirizine / Q000627:therapeutic use*; D004311:Double-Blind Method; D005076:Exanthema / Q000139:chemically induced / Q000453:epidemiology / Q000517:prevention & control*; D005260:Female; D015658:HIV Infections / Q000150:complications / Q000188:drug therapy / Q000276:immunology; D015497:HIV-1 / Q000187:drug effects; D006634:Histamine H1 Antagonists / Q000627:therapeutic use*; D006801:Humans; D015994:Incidence; D008297:Male; D015999:Multivariate Analysis; D019829:Nevirapine / Q000009:adverse effects* / Q000097:blood / Q000627:therapeutic use; D010919:Placebos
D019380:Anti-HIV Agents; D006634:Histamine H1 Antagonists; D010919:Placebos; D019829:Nevirapine; D017332:Cetirizine