title: Efficacy and safety of etravirine (TMC125) in treatment-experienced HIV-1-infected patients: 48-week results of a phase IIb trial.
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.
authors.affiliation: Community Research Initiative of New England, Boston, Massachusetts 02215-3319, USA. ccohen@crine.org
authors.forename: Calvin J
authors.initials: CJ
authors.lastname: Cohen
authors.forename: Daniel S
authors.initials: DS
authors.lastname: Berger
authors.forename: Gary
authors.initials: G
authors.lastname: Blick
authors.forename: Howard A
authors.initials: HA
authors.lastname: Grossman
authors.forename: Dushyantha T
authors.initials: DT
authors.lastname: Jayaweera
authors.forename: Peter
authors.initials: P
authors.lastname: Shalit
authors.forename: Melanie
authors.initials: M
authors.lastname: Thompson
authors.forename: Monika
authors.initials: M
authors.lastname: Peeters
authors.forename: Marie-Pierre
authors.initials: MP
authors.lastname: de Béthune
authors.forename: Ellen
authors.initials: E
authors.lastname: Voorspoels
authors.forename: Rebecca
authors.initials: R
authors.lastname: Mack
authors.forename: Brian
authors.initials: B
authors.lastname: Woodfall
mesh_terms: D019380:Anti-HIV Agents / Q000008:administration & dosage* / Q000009:adverse effects / Q000627:therapeutic use; D004305:Dose-Response Relationship, Drug; D015658:HIV Infections / Q000188:drug therapy* / Q000821:virology; D015497:HIV-1 / Q000302:isolation & purification*; D006801:Humans; D009570:Nitriles; D011724:Pyridazines / Q000008:administration & dosage* / Q000009:adverse effects / Q000627:therapeutic use; D011743:Pyrimidines; D016037:Single-Blind Method; D016896:Treatment Outcome; D019562:Viral Load
chemical_list: D019380:Anti-HIV Agents; D009570:Nitriles; D011724:Pyridazines; D011743:Pyrimidines; C451734:etravirine