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Efficacy of short-term monotherapy with maraviroc, a new CCR5 antagonist, in patients infected with HIV-1

Nature Medicine volume 11, pages 1170–1172 (2005)Cite this article

Abstract

We assessed the efficacy and safety of 10-d monotherapy with the orally administered CCR5 antagonist maraviroc in 63 HIV-1-positive individuals prescreened for the absence of CXCR4-using virus. Maximum reduction in viral load occurred at a median of 10–15 d, with a mean reduction of ≥1.6 log10 copies/ml at all twice daily doses ≥100 mg. These results provide proof of concept that CCR5 antagonism is a viable antiretroviral therapeutic approach.

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Figure 1: Change in viral load over time and its correlation with maraviroc steady state AUC0–24.

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Acknowledgements

We thank all the patients, study-site staff and Pfizer Global Research and Development staff for their contributions, which made this study possible.

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Authors and Affiliations

  1. Department of Internal Medicine, Division of Infectious Diseases, Haus 11, University of Cologne, Joseph-Stelzmann-Strasse 9, Cologne, D-50924, Germany

    Gerd Fätkenheuer

  2. Chelsea and Westminster Hospital, 369 Fulham Road, London, SW10 974, UK

    Anton L Pozniak

  3. Department of Thoracic Medicine, Royal Free Hospital, Pond Street, Garrett Anderson Ward, 11th floor, London, NW3 2QG, UK

    Margaret A Johnson & Mike Youle

  4. St Georg Hospital, ifi-Institut für interdisziplinäre Infektiologie und Immunologie, Lohmühlenstr. 5, Hamburg, D-20099, Germany

    Andreas Plettenberg

  5. Klinikum der Johann Wolfgang Goethe-Universität, Zentrum der Inneren Medizin, Infektionsambulanz, Haus 68, Theodor-Stern-Kai 7, Frankfurt, D-60596, Germany

    Schlomo Staszewski

  6. Head Division Infectious Diseases & AIDS, University Hospital, P.O. Box 85500, Utrecht, 3508 GA, The Netherlands

    Andy I M Hoepelman

  7. University of Alabama at Birmingham, Birmingham, 35294-2050, Alabama, USA

    Michael S Saag

  8. Ludwig-Maximilian-Universität, Med. Poliklinik der LMU, München, Germany

    Frank D Goebel

  9. University of Bonn, Sigmund-Freudstr. 25, Bonn, D-53105, Germany

    Jürgen K Rockstroh

  10. Beth Israel Deaconess Medical Center, Harvard Medical School, 330 Brookline Ave. CC-913, Boston, 02215, Massachusetts, USA

    Bruce J Dezube

  11. Pfizer Global Research and Development, Sandwich, CT13 9NJ, Kent, UK

    Tim M Jenkins, Christine Medhurst, John F Sullivan, Caroline Ridgway, Samantha Abel, Ian T James & Elna van der Ryst

Authors
  1. Gerd Fätkenheuer
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  14. Caroline Ridgway
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  15. Samantha Abel
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  16. Ian T James
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  17. Mike Youle
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  18. Elna van der Ryst
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Corresponding author

Correspondence to Elna van der Ryst.

Ethics declarations

Competing interests

G.F. has received speaker fees and honoraria for expert advice from Pfizer.

A.L.P. has no competing financial interest or conflict of interest in the publication of this manuscript.

M.A.J. has received honoraria and traveling scholarships and has acted as an advisor to or received research funding from the following companies: Abbott, Boehringer Ingelheim, Bristol-Myers Squibb, Gilead Sciences, GlaxoSmithKline and Roche.

A.P. has no conflict of interest and no financial interests.

S.S. has been a member of several national and international scientific advisory boards founded by the pharmaceutical companies including GlaxoSmithKline, DuPont, Abbott, Gilead, Boehringer Ingelheim, Bristol-Meyers Squibb and Roche and has received honoraria for participation in the advisory boards and for lectures at satellite symposia.

A.I.M.H. has no competing financial interests other than the receipt grants for studies in the past and also for this study.

M.S.S. is a consultant to Pfizer and has grant support from Pfizer.

F.D.G. received a grant from Pfizer for this study. There is no additional support from Pfizer.

J.K.R. has received consultation or lecture fees from Abbott, Boehringer-Ingelheim, Bristol-Myers-Squibb, Gilead, GlaxoSmith-Kline, Pfizer, Roche and Schering-Plough.

B.J.D. is on Pfizer's speakers bureau but falls below the $10,000 amount and has no stock or other interests to declare.

T.M.J., C.M., J.F.S., C.R., S.A., I.T.J. and E.v.d.R. are employees of Pfizer Ltd.

M.Y. has no personal financial interests in Pfizer, has not been employed by Pfizer and has received no funding from Pfizer concerning this study.

Supplementary information

Supplementary Table 1

Mean maraviroc pharmacokinetic parameters on day 1 and day 10. (PDF 20 kb)

Supplementary Methods (PDF 43 kb)

Supplementary Note (PDF 26 kb)

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Fätkenheuer, G., Pozniak, A., Johnson, M. et al. Efficacy of short-term monotherapy with maraviroc, a new CCR5 antagonist, in patients infected with HIV-1. Nat Med 11, 1170–1172 (2005). https://doi.org/10.1038/nm1319

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  • DOI: https://doi.org/10.1038/nm1319

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