Incidence of resistance in a double-blind study comparing lopinavir/ritonavir plus stavudine and lamivudine to nelfinavir plus stavudine and lamivudine

J Infect Dis. 2004 Jan 1;189(1):51-60. doi: 10.1086/380509. Epub 2003 Dec 31.

Abstract

Study M98-863 was a double-blind, randomized, phase 3 study that compared lopinavir/ritonavir with nelfinavir, each coadministered with stavudine and lamivudine, in 653 antiretroviral therapy-naive human immunodeficiency virus (HIV) type 1-infected subjects. The incidence of HIV drug resistance was analyzed using baseline and rebound virus isolates from subjects with plasma HIV RNA >400 copies/mL from weeks 24 to 108 of therapy. No evidence of genotypic or phenotypic resistance to lopinavir/ritonavir, defined as any active site or primary mutation in HIV protease, was detected in virus isolates from 51 lopinavir/ritonavir-treated subjects with available genotypes. Primary mutations related to nelfinavir resistance (D30N and/or L90M) were observed in 43 (45%) of 96 nelfinavir-treated subjects. Resistance to lamivudine and stavudine was also significantly higher in nelfinavir-treated versus lopinavir/ritonavir-treated subjects. These differences suggest substantially different genetic and pharmacological barriers to resistance for these 2 protease inhibitors and may have implications for strategies for initiating antiretroviral therapy.

Publication types

  • Clinical Trial
  • Clinical Trial, Phase III
  • Comparative Study
  • Multicenter Study
  • Randomized Controlled Trial

MeSH terms

  • Double-Blind Method
  • Drug Resistance, Viral* / genetics
  • Drug Therapy, Combination
  • Global Health
  • HIV Infections / blood
  • HIV Infections / drug therapy*
  • HIV Protease Inhibitors / therapeutic use*
  • HIV-1* / genetics
  • HIV-1* / isolation & purification
  • Humans
  • Lamivudine / therapeutic use*
  • Lopinavir
  • Mutation
  • Nelfinavir / therapeutic use*
  • Patient Compliance
  • Pyrimidinones / administration & dosage
  • Pyrimidinones / therapeutic use*
  • RNA, Viral / blood
  • Reverse Transcriptase Inhibitors / therapeutic use*
  • Ritonavir / administration & dosage
  • Ritonavir / therapeutic use*
  • Stavudine / therapeutic use*
  • Time Factors
  • Viral Load

Substances

  • HIV Protease Inhibitors
  • Pyrimidinones
  • RNA, Viral
  • Reverse Transcriptase Inhibitors
  • Lopinavir
  • Lamivudine
  • Stavudine
  • Nelfinavir
  • Ritonavir