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.
aCommunity Research Initiative of New England, Boston, Massachusetts, USA
bNorthstar Medical Center, Chicago, Illinois, USA
cCircle Medical LLC, Norwalk, Connecticut, USA
dFenway Community Health, Boston, Massachusetts, USA
eUniversity of Miami, Miami, Florida, USA
fSwedish Medical Center, Seattle, Washington, USA
gAIDS Research Consortium of Atlanta, Atlanta, Georgia, USA
hTibotec BVBA, Mechelen, Belgium
iTibotec Inc., Yardley, Pennsylvania, USA.
Received 13 December, 2007
Revised 30 July, 2008
Accepted 13 August, 2008
Correspondence to Calvin J. Cohen, Community Research Initiative of New England, 23 Miner Street, Boston, New England, MA 02215-3319, USA. Tel: +1 617 502 1740; fax: +1 617 504 1701; e-mail: firstname.lastname@example.org