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www.fdanews.com/articles/96258-vicriviroc-demonstrates-viral-suppression-in-phase-ii-study

Vicriviroc Demonstrates Viral Suppression in Phase II Study

July 24, 2007

Schering-Plough said that results from a Phase II clinical trial showed vicriviroc, its investigational CCR5 antagonist, demonstrated viral suppression through 48 weeks of therapy in treatment-experienced HIV patients, when administered in once-daily doses in combination with an optimized ritonavir-boosted protease inhibitor-containing antiretroviral regimen.

Vicriviroc is an extracellular inhibitor of HIV infection designed to block entry of infectious virions into uninfected CD4 cells via antagonism of the CCR5 coreceptor, Schering-Plough said.

More patients in the vicriviroc groups had undetectable virus at 48 weeks compared with those in the placebo group and fewer patients in the vicriviroc groups experienced virological failure compared with those in the placebo group, the company added.

According to the company, there was no significant difference in grade 3 or 4 adverse events across the vicriviroc and placebo groups. Eight patients randomized to vicriviroc and two patients randomized to placebo developed malignancies.