Antiviral activity and safety of aplaviroc, a CCR5 antagonist, in combination with lopinavir/ritonavir in HIV-infected, therapy-naïve patients: Results of the EPIC study (CCR100136)

P. Yeni, A. Lamarca, D. Berger, P. Cimoch, A. Lazzarin, P. Salvato, F. M. Smaill, E. Teofilo, S. J. Madison, W. G. Nichols, K. K. Adkison, T. Bonny, J. Millard, Debra Mccarty

Research output: Contribution to journalArticle

Abstract

Background: This phase IIb study explored the antiviral activity and safety of the investigational CC chemokine receptor 5 (CCR5) antagonist aplaviroc (APL) in antiretroviral-naïve patients harbouring R5- or R5X4-tropic virus. Methods: A total of 191 patients were randomized 2:2:2:1 to one of three APL dosing regimens or to lamivudine (3TC)/zidovudine (ZDV) twice daily (bid), each in combination with lopinavir/ritonavir (LPV/r) 400 mg/100 mg bid. Efficacy, safety and pharmacokinetic parameters were assessed. Results: This study was terminated prematurely because of APL-associated idiosyncratic hepatotoxicity. A total of 141 patients initiated treatment early enough to have been able to complete 12 weeks on treatment [modified intent-to-treat (M-ITT) population]; of these, 133 completed the 12-week treatment phase. The proportion of subjects in the M-ITT population with HIV-1 RNA

Original languageEnglish
Pages (from-to)116-124
Number of pages9
JournalHIV Medicine
Volume10
Issue number2
DOIs
Publication statusPublished - 2009

Fingerprint

Lopinavir
Ritonavir
Antiviral Agents
Lamivudine
HIV
Safety
Zidovudine
Population
HIV-1
Therapeutics
Pharmacokinetics
RNA
Viruses
aplaviroc
CCR5 Receptor Antagonists

Keywords

  • 873140
  • Aplaviroc
  • CC chemokine receptor (CCR) 5-tropic virus
  • HIV infection

ASJC Scopus subject areas

  • Infectious Diseases
  • Pharmacology (medical)
  • Health Policy

Cite this

Antiviral activity and safety of aplaviroc, a CCR5 antagonist, in combination with lopinavir/ritonavir in HIV-infected, therapy-naïve patients : Results of the EPIC study (CCR100136). / Yeni, P.; Lamarca, A.; Berger, D.; Cimoch, P.; Lazzarin, A.; Salvato, P.; Smaill, F. M.; Teofilo, E.; Madison, S. J.; Nichols, W. G.; Adkison, K. K.; Bonny, T.; Millard, J.; Mccarty, Debra.

In: HIV Medicine, Vol. 10, No. 2, 2009, p. 116-124.

Research output: Contribution to journalArticle

Yeni, P, Lamarca, A, Berger, D, Cimoch, P, Lazzarin, A, Salvato, P, Smaill, FM, Teofilo, E, Madison, SJ, Nichols, WG, Adkison, KK, Bonny, T, Millard, J & Mccarty, D 2009, 'Antiviral activity and safety of aplaviroc, a CCR5 antagonist, in combination with lopinavir/ritonavir in HIV-infected, therapy-naïve patients: Results of the EPIC study (CCR100136)', HIV Medicine, vol. 10, no. 2, pp. 116-124. https://doi.org/10.1111/j.1468-1293.2008.00660.x
Yeni, P. ; Lamarca, A. ; Berger, D. ; Cimoch, P. ; Lazzarin, A. ; Salvato, P. ; Smaill, F. M. ; Teofilo, E. ; Madison, S. J. ; Nichols, W. G. ; Adkison, K. K. ; Bonny, T. ; Millard, J. ; Mccarty, Debra. / Antiviral activity and safety of aplaviroc, a CCR5 antagonist, in combination with lopinavir/ritonavir in HIV-infected, therapy-naïve patients : Results of the EPIC study (CCR100136). In: HIV Medicine. 2009 ; Vol. 10, No. 2. pp. 116-124.
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