Delavirdine in combination with zidovudine in treatment of human immunodeficiency virus type 1-infected patients: evaluation of efficacy and emergence of viral resistance in a randomized, comparative phase III trial. The M/3331/0013B Study Group.

Author(s): Joly V, Moroni M, Concia E, Lazzarin A, Hirschel B, Jost J, Chiodo F, Bentwich Z, Love WC, Hawkins DA, Wilkins EG, Gatell AJ, Vetter N, Greenwald C, Freimuth WW, de Cian W

Affiliation(s): Department of Internal Medicine, Hopital Bichat, Paris, France. veronique.joly@bch.ap-hop-paris.fr

Publication date & source: 2000-11, Antimicrob Agents Chemother., 44(11):3155-7.

Publication type: Clinical Trial; Clinical Trial, Phase III; Randomized Controlled Trial

We compared the activity of delavirdine (DLV) plus zidovudine (AZT) (n = 300) with that of AZT (n = 297) against human immunodeficiency virus type 1 in a randomized, double-blind, placebo-controlled trial. DLV exerted a transient antiviral effect, and mutations for resistance to DLV were found in more than 90% of subjects at week 12. The K103N mutation, which confers nonnucleoside reverse transcriptase inhibitor cross-resistance, was found in 85% of the patients.