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1 December 2009

Volume 200, Number 11
The Journal of Infectious Diseases 2009;200:1724–1728
© 2009 by the Infectious Diseases Society of America. All rights reserved.
0022-1899/2009/20011-0015$15.00
DOI: 10.1086/648090
BRIEF REPORT

Response to Vicriviroc in Treatment‐Experienced Subjects, as Determined by an Enhanced‐Sensitivity Coreceptor Tropism Assay: Reanalysis of AIDS Clinical Trials Group A5211

Zhaohui Su,1

Roy M. Gulick,4

Amy Krambrink,1

Eoin Coakley,5

Michael D. Hughes,1

Dong Han,5

Charles Flexner,6

Timothy J. Wilkin,4

Paul R. Skolnik,3

Wayne L. Greaves,7

Daniel R. Kuritzkes,2 and

Jacqueline D. Reeves,5 for the

AIDS Clinical Trials Group A5211 Team

1Harvard School of Public Health, 2Brigham and Women’s Hospital, Harvard Medical School, and 3Boston University Medical Center, Boston, Massachusetts; 4Weill‐Cornell Medical College, New York, New York; 5Monogram Biosciences, South San Francisco, California; 6Johns Hopkins University, Baltimore, Maryland; 7Schering‐Plough Research Institute, Kenilworth, New Jersey

The enhanced‐sensitivity Trofile assay (Monogram Biosciences) was used to retest coreceptor use at both study screening and study entry for 118 treatment‐experienced subjects in AIDS Clinical Trials Group A5211 who had CCR5‐tropic (R5) virus detected by the original Trofile assay at study screening. Among 90 recipients of vicriviroc, a significantly ( ) greater mean reduction in HIV‐1 RNA was observed in 72 subjects with R5 virus versus 15 subjects reclassified as having dual/mixed‐tropic viruses at screening: −1.11 versus −0.09 log10 copies/mL at day 14 and −1.91 versus −0.57 log10 copies/mL at week 24, respectively. Results suggest that the enhanced‐sensitivity assay is a better screening tool for determining patient eligibility for CCR5 antagonist therapy.

Received 31 March 2009; accepted 12 June 2009; electronically published 29 October 2009.

Reprints or correspondence: Zhaohui Su, Harvard School of Public Health, 651 Huntington Ave., FXB Bldg., Rm. 515, Boston, MA 02115 ().

  • Potential conflicts of interest: J.D.R. and E.C. are employed by Monogram Biosciences. M.D.H. is a paid member of the data and safety monitoring board of Boehringer Ingelheim, Tibotec Pharmaceuticals, and Virionyx. C.F. has served on a scientific advisory board for Schering‐Plough. W.L.G. is employed by Schering‐Plough Research Institute. D.R.K. is a consultant to Schering‐Plough and Monogram Biosciences and has received research funding from Schering‐Plough. R.M.G. receives research grant support from Pfizer and Schering‐Plough and has served as an ad hoc consultant for Monogram Biosciences, Pathway, Pfizer and Schering‐Plough. T.J.W. is an ad hoc consultant for Pfizer. All other authors: no conflicts.

  • Financial support: AIDS Clinical Trials Group (ACTG)/National Institute of Allergy and Infectious Diseases/National Institutes of Health (grant AI‐68636) and Statistical Data Management Center (grant AI68634), Cornell Clinical Trials Unit (grant AI‐69419), Cornell Clinical and Translational Science Center (grant RR024996), K24 AI51966 (to R.M.G.), and K23 AI55038 (to T.J.W.), Johns Hopkins AIDS Clinical Trial Unit (ACTU; grant AI27668), Penn AIDS Clinical Trials Unit (grant U01‐AI32783), Penn Center for AIDS Research (grant P30‐AI45008), and Harvard–Boston Medical Center ACTU (grant AI27659). Tropism testing performed using the enhanced Trofile assay was supported by Monogram Biosciences.

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