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Vicriviroc Demonstrates Potent and Sustained Viral Suppression Through 48 Weeks of Therapy in Treatment-Experienced HIV-Infected Patients
Date:2/6/2008

regardless of the number of active HIV drugs in a patient's background therapy."

The study, known as VICTOR-E1 (Vicriviroc in Combination Treatment with Optimized Antiretroviral Therapy Regimen in Experienced Subjects), evaluated the safety and efficacy of vicriviroc (30 mg or 20 mg once daily) in combination with an optimized ritonavir-boosted, protease inhibitor-containing antiretroviral regimen compared to a control group receiving new OBT alone. The primary endpoint of the study was change in HIV-RNA at week 48. A total of 116 treatment-experienced adult HIV-infected patients with R5-type virus at screening were randomized in this placebo-controlled, double-blind study at 37 sites throughout Europe, South Africa and North and South America.

Results of the study through 48 weeks demonstrated potent and sustained viral suppression in the vicriviroc arms, with significantly greater decreases in mean HIV-RNA, as well as greater increases in mean CD4 counts, compared to the control arm. At 48 weeks, patients in the 30 mg and 20 mg vicriviroc treatment groups achieved mean decreases from baseline in viral load of -1.77 and -1.75 (log10 copies/mL), respectively, compared to -0.79 for the control group (p=0.0017 and p=0.0026, respectively). Mean increases from baseline in CD4 cell counts in the vicriviroc groups were +102 and +134 (cells/mm3), respectively, compared to +65 in the control group. Fewer patients in the vicriviroc groups discontinued from the study due to virologic failure compared to those in the control group (13 percent and 8 percent vs. 38 percent, respectively).

No clinically relevant differences in safety profile between the vicriviroc and control groups were observed in this study, including liver toxicity, opportunistic infections, malignancies or other conditions. There were no cases of grade 3/4 elevated ALT reported in the vicriviroc groups compared to one case in the control group, and there were one, two and one cases of g
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SOURCE Schering-Plough Corporation
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