Vicriviroc in combination therapy with an optimized regimen for treatment-experienced subjects

48-Week results of the VICTOR-El phase 2 trial

Jamal Suleiman, Barry S. Zingman, Ricardo Sobhie Diaz, Jose Valdez Ramalho Madruga, Edwin Dejesus, Jihad Slim, Carmen Mak, Erin Lee, Michael C. McCarthy, M. Dunkle, Sharon Walmsley

Research output: Contribution to journalArticle

38 Citations (Scopus)

Abstract

Background. Agents that block the CCR5 coreceptor for human immunodeficiency virus (HIV) have demonstrated potent antiretroviral activity. In early clinical studies, the CCR5 antagonist vicriviroc proved to be a safe and effective component of combination antiretroviral therapy. Methods. This double-blind, dose-ranging, phase 2 trial randomized subjects to receive 30 mg or 20 mg of vicriviroc or placebo once daily plus re-optimized background therapy containing a protease inhibitor with ritonavir. Subjects were adults infected with CCR5-tropic HIV who were experiencing failure of triple antiretroviral regimens. The primary end point was mean change in baseline log10 HIV RNA level at 48 weeks, based on an intent-to-treat analysis. Results. One hundred fourteen persons received vicriviroc at 30 mg (n = 39), vicriviroc at 20 mg (n = 40), or placebo (n = 35). The mean change in baseline HIV RNA level at week 48 was -1.77 log10 copies/mL for 30 mg of vicriviroc and -1.75 log10 copies/mL for 20 mg of vicriviroc, compared with -0.79 log10 copies/mL for placebo (P = .002 and P = .003, respectively, compared with placebo). Mean CD4 counts increased by 102, 136, and 63 cells/mm3 for 30 mg vicriviroc, 20 mg vicriviroc, and placebo, respectively (P = .260 and P = .039, respectively, compared with placebo). Rates of adverse events (mostly mild-to-moderate) were 111.4, 112.5, and 147.4 events per 100 subject-years, respectively. Conclusions. Vicriviroc administered with a protease inhibitor plus ritonavir-containing regimen shows potent antiretroviral and immunologic activity sustained over 48 weeks in treatment-experienced patients.

Original languageEnglish (US)
Pages (from-to)590-599
Number of pages10
JournalJournal of Infectious Diseases
Volume201
Issue number4
DOIs
StatePublished - Feb 15 2010

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Placebos
HIV
Ritonavir
Therapeutics
Protease Inhibitors
RNA
vicriviroc
CD4 Lymphocyte Count

ASJC Scopus subject areas

  • Infectious Diseases
  • Immunology and Allergy

Cite this

Vicriviroc in combination therapy with an optimized regimen for treatment-experienced subjects : 48-Week results of the VICTOR-El phase 2 trial. / Suleiman, Jamal; Zingman, Barry S.; Diaz, Ricardo Sobhie; Madruga, Jose Valdez Ramalho; Dejesus, Edwin; Slim, Jihad; Mak, Carmen; Lee, Erin; McCarthy, Michael C.; Dunkle, M.; Walmsley, Sharon.

In: Journal of Infectious Diseases, Vol. 201, No. 4, 15.02.2010, p. 590-599.

Research output: Contribution to journalArticle

Suleiman, J, Zingman, BS, Diaz, RS, Madruga, JVR, Dejesus, E, Slim, J, Mak, C, Lee, E, McCarthy, MC, Dunkle, M & Walmsley, S 2010, 'Vicriviroc in combination therapy with an optimized regimen for treatment-experienced subjects: 48-Week results of the VICTOR-El phase 2 trial', Journal of Infectious Diseases, vol. 201, no. 4, pp. 590-599. https://doi.org/10.1086/650342
Suleiman, Jamal ; Zingman, Barry S. ; Diaz, Ricardo Sobhie ; Madruga, Jose Valdez Ramalho ; Dejesus, Edwin ; Slim, Jihad ; Mak, Carmen ; Lee, Erin ; McCarthy, Michael C. ; Dunkle, M. ; Walmsley, Sharon. / Vicriviroc in combination therapy with an optimized regimen for treatment-experienced subjects : 48-Week results of the VICTOR-El phase 2 trial. In: Journal of Infectious Diseases. 2010 ; Vol. 201, No. 4. pp. 590-599.
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abstract = "Background. Agents that block the CCR5 coreceptor for human immunodeficiency virus (HIV) have demonstrated potent antiretroviral activity. In early clinical studies, the CCR5 antagonist vicriviroc proved to be a safe and effective component of combination antiretroviral therapy. Methods. This double-blind, dose-ranging, phase 2 trial randomized subjects to receive 30 mg or 20 mg of vicriviroc or placebo once daily plus re-optimized background therapy containing a protease inhibitor with ritonavir. Subjects were adults infected with CCR5-tropic HIV who were experiencing failure of triple antiretroviral regimens. The primary end point was mean change in baseline log10 HIV RNA level at 48 weeks, based on an intent-to-treat analysis. Results. One hundred fourteen persons received vicriviroc at 30 mg (n = 39), vicriviroc at 20 mg (n = 40), or placebo (n = 35). The mean change in baseline HIV RNA level at week 48 was -1.77 log10 copies/mL for 30 mg of vicriviroc and -1.75 log10 copies/mL for 20 mg of vicriviroc, compared with -0.79 log10 copies/mL for placebo (P = .002 and P = .003, respectively, compared with placebo). Mean CD4 counts increased by 102, 136, and 63 cells/mm3 for 30 mg vicriviroc, 20 mg vicriviroc, and placebo, respectively (P = .260 and P = .039, respectively, compared with placebo). Rates of adverse events (mostly mild-to-moderate) were 111.4, 112.5, and 147.4 events per 100 subject-years, respectively. Conclusions. Vicriviroc administered with a protease inhibitor plus ritonavir-containing regimen shows potent antiretroviral and immunologic activity sustained over 48 weeks in treatment-experienced patients.",
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N2 - Background. Agents that block the CCR5 coreceptor for human immunodeficiency virus (HIV) have demonstrated potent antiretroviral activity. In early clinical studies, the CCR5 antagonist vicriviroc proved to be a safe and effective component of combination antiretroviral therapy. Methods. This double-blind, dose-ranging, phase 2 trial randomized subjects to receive 30 mg or 20 mg of vicriviroc or placebo once daily plus re-optimized background therapy containing a protease inhibitor with ritonavir. Subjects were adults infected with CCR5-tropic HIV who were experiencing failure of triple antiretroviral regimens. The primary end point was mean change in baseline log10 HIV RNA level at 48 weeks, based on an intent-to-treat analysis. Results. One hundred fourteen persons received vicriviroc at 30 mg (n = 39), vicriviroc at 20 mg (n = 40), or placebo (n = 35). The mean change in baseline HIV RNA level at week 48 was -1.77 log10 copies/mL for 30 mg of vicriviroc and -1.75 log10 copies/mL for 20 mg of vicriviroc, compared with -0.79 log10 copies/mL for placebo (P = .002 and P = .003, respectively, compared with placebo). Mean CD4 counts increased by 102, 136, and 63 cells/mm3 for 30 mg vicriviroc, 20 mg vicriviroc, and placebo, respectively (P = .260 and P = .039, respectively, compared with placebo). Rates of adverse events (mostly mild-to-moderate) were 111.4, 112.5, and 147.4 events per 100 subject-years, respectively. Conclusions. Vicriviroc administered with a protease inhibitor plus ritonavir-containing regimen shows potent antiretroviral and immunologic activity sustained over 48 weeks in treatment-experienced patients.

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