Schering-Plough begins phase III vicriviroc study

Schering-Plough has announced that it has initiated two phase III clinical trials of vicriviroc as a therapy for treatment-experienced HIV patients in combination with an optimized background therapy containing at a protease inhibitor boosted by ritonavir.

This study programme aims to build upon previous trials of vicriviroc in treatment-experienced HIV patients, including a phase II study where the compound showed both strong and sustained viral suppression in patients throughout 48 weeks of treatment.

Dubbed the Victor-E3 and Victor E-4 studies, these phase III trials will assess the virologic benefit of adding 30 mg of the compound to optimized background therapy for HIV, in addition to investigating the safety and tolerability of the compound when compared to placebo.

Robert J Spiegel, chief medical officer and senior vice-president of Schering-Plough Research Institute, said: “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 optimised background therapy.”

He added that there is an immediate need for new antiretrovirals with innovative methods of action, with the company anticipating the further evaluation of the compound during these large phase III trials.

In July 2007, Schering-Plough announced positive phase II clinical trial results for vicriviroc when administered in a once-daily dose in combination with an optimised background regimen of antretroviral therapy containing a ritonavir-boosted protease inhibitor.