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

Cohen, Calvin Ja; Berger, Daniel Sb; Blick, Garyc; Grossman, Howard Ad; Jayaweera, Dushyantha Te; Shalit, Peterf; Thompson, Melanieg; Peeters, Monikah; de Béthune, Marie-Pierreh; Voorspoels, Ellenh; Mack, Rebeccai; Woodfall, Brianh

doi: 10.1097/QAD.0b013e32831c5040
Research Letters

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: ccohen@crine.org

© 2009 Lippincott Williams & Wilkins, Inc.