Efficacy and safety of etravirine (TMC125) in treatment-experienced HIV-1-infected patients: 48-week results of a phase IIb trial.
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.
Cohen
Calvin J
CJ
Community Research Initiative of New England, Boston, Massachusetts 02215-3319, USA. ccohen@crine.org
Berger
Daniel S
DS
Blick
Gary
G
Grossman
Howard A
HA
Jayaweera
Dushyantha T
DT
Shalit
Peter
P
Thompson
Melanie
M
Peeters
Monika
M
de Béthune
Marie-Pierre
MP
Voorspoels
Ellen
E
Mack
Rebecca
R
Woodfall
Brian
B
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
D019380:Anti-HIV Agents; D009570:Nitriles; D011724:Pyridazines; D011743:Pyrimidines; C451734:etravirine