Efficacy and safety of etravirine (TMC125) in treatment-experienced HIV-1-infected patients: 48-week results of a phase IIb trial

AIDS. 2009 Jan 28;23(3):423-6. doi: 10.1097/QAD.0b013e32831c5040.

Abstract

Forty-eight-week results from a randomized, multicentre, part-blinded, phase IIb clinical trial assessing the efficacy and safety of 400 and 800 mg etravirine twice daily (phase IIb formulation) and optimized background regimen versus standard-of-care regimen are presented. Both etravirine doses demonstrated sustained virological suppression at 48 weeks and a favourable tolerability profile. Etravirine demonstrated higher efficacy than control, irrespective of the number of detectable nonnucleoside reverse transcriptase inhibitor-resistance-associated mutations at baseline or active background antiretrovirals.

Publication types

  • Clinical Trial, Phase II
  • Multicenter Study
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Anti-HIV Agents / administration & dosage*
  • Anti-HIV Agents / adverse effects
  • Anti-HIV Agents / therapeutic use
  • Dose-Response Relationship, Drug
  • HIV Infections / drug therapy*
  • HIV Infections / virology
  • HIV-1 / isolation & purification*
  • Humans
  • Nitriles
  • Pyridazines / administration & dosage*
  • Pyridazines / adverse effects
  • Pyridazines / therapeutic use
  • Pyrimidines
  • Single-Blind Method
  • Treatment Outcome
  • Viral Load

Substances

  • Anti-HIV Agents
  • Nitriles
  • Pyridazines
  • Pyrimidines
  • etravirine