Week 24 efficacy and safety of TMC114/ritonavir in treatment-experienced HIV patients.

Academic Article

Abstract

  • BACKGROUND: Agents for the treatment of HIV-1-infected patients with resistance to current antiretroviral (ART) drugs are needed. METHODS: TMC114-C202 was a randomized, partially blinded, dose-finding study in treatment-experienced HIV-1-infected patients with one or more primary protease inhibitor (PI) mutations and HIV-1 RNA > 1000 copies/ml. Patients were randomized to receive one of four TMC114 doses given with ritonavir (TMC114/r) or investigator-selected control PI drug(s) (CPI); all received an optimized background regimen. The primary intent-to-treat analysis compared the proportion of patients achieving a >or= 1 log10 copies/ml HIV-1 RNA reduction at week 24 between the treatment arms using the time-to-loss of virological response algorithm. RESULTS: For 278 patients at baseline, mean HIV-1 RNA was 4.7 log10 copies/ml, median CD4 cell count was 106 cells/mul; HIV-1 isolates had a median of three primary PI mutations and a median fold change in lopinavir susceptibility of 80. Discontinuation rates were 23% for TMC114/r versus 64% for CPI. More patients in each TMC114/r dose group achieved >or= 1.0 log10 copies/ml reduction in HIV-1 RNA than in the CPI group (45-62% versus 14%; P
  • Published In

  • AIDS  Journal
  • Keywords

  • CD4 Lymphocyte Count, Drug Administration Schedule, Drug Resistance, Viral, Drug Therapy, Combination, Female, HIV Infections, HIV Protease Inhibitors, HIV-1, Humans, Male, Middle Aged, Mutation, RNA, Viral, Reverse Transcriptase Inhibitors, Ritonavir, Treatment Outcome
  • Digital Object Identifier (doi)

    Author List

  • Haubrich R; Berger D; Chiliade P; Colson A; Conant M; Gallant J; Wilkin T; Nadler J; Pierone G; Saag M
  • Start Page

  • F11
  • End Page

  • F18
  • Volume

  • 21
  • Issue

  • 6