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Schering-Plough Initiates Phase III Studies with Vicriviroc in Treatment- Experienced HIV Patients
Date:9/17/2007

s or need for dose adjustments based on the known vicriviroc drug-drug interaction profile. The studies will enroll approximately 375 patients each at more than 160 sites in North America, South America, Europe, Australia and South Africa.

"As a next-generation HIV entry inhibitor, vicriviroc has the potential to benefit a broad range of patients by offering a potent, sustained viral response and a single once-daily dose in combination with optimized background therapy," said Robert J. Spiegel, M.D., chief medical officer and senior vice president, Schering-Plough Research Institute. "There is an urgent need for new antiretroviral agents with novel mechanisms of action and we look forward to the further clinical evaluation of vicriviroc in these large global studies."

About the VICTOR-E3 and VICTOR-E4 Phase III Studies

VICTOR-E3 and VICTOR-E4 are identically designed, randomized, double- blind, placebo-controlled, parallel group, multicenter studies of vicriviroc in adult treatment-experienced patients infected with CCR5-tropic HIV virus (no detectable CXCR4-tropic or dual/mixed CCR5/CXCR4-tropic virus at screening).

The primary efficacy endpoint of the studies will be the proportion of patients with plasma HIV-1 RNA less than 50 copies/mL at week 48. Key secondary endpoints, each measured at 48 weeks, include the proportion of patients with less than 400 copies/mL of plasma HIV-1 RNA, mean change from baseline in plasma HIV-1 RNA (log10 copies/mL) and mean change from baseline CD4+ count. All efficacy endpoints will also be evaluated at week 24.

Patients in VICTOR-E3 and VICTOR-E4 must have documented resistance to at least two of the three antiretroviral drug classes (NRTI, NNRTI or PI)(2-4) or 6 months or more of experience with at least two of the following: one NRTI, one NNRTI or two PIs (excluding low-dose ritonavir); and must have plasma HIV- 1 RNA levels above 1000 copies/mL. The optimized background therapy must include a prote
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SOURCE Schering-Plough Corporation
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