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Published on 8/17/2006 in the Prospect News Biotech Daily.

Schering-Plough study shows vicriviroc decreases viral load in treatment-experienced HIV patients

By Lisa Kerner

Charlotte, N.C., Aug. 17 - Schering-Plough said in an ongoing phase 2 clinical trial of vicriviroc, a CCR5 receptor antagonist, results showed potent and sustained viral suppression after 24 weeks of therapy in 118 treatment-experienced HIV patients.

Vicriviroc was administered in once-daily doses in combination with an optimized ritonavir-boosted protease inhibitor-containing antiretroviral regimen.

Viral load decrease was significantly greater for patients in each vicriviroc group compared to the control group at day 14 and at week 24, the company said.

No difference was reported between the vicriviroc groups.

Schering-Plough said that while here was no statistical difference in the viral load reductions between the three vicriviroc arms, a higher rate of virologic failure and emergence of X4 virus was observed at the lowest dose of 5 mg.

Researchers from the National Institute of Health-sponsored Adult AIDS Clinical Trial Group (ACTG) presented the data at the XVI International AIDS Conference.

"We are encouraged by the durability of viral suppression observed through 24 weeks in this study of patients with significantly advanced HIV disease," principal investigator Roy Gulick said in a company news release.

Based on the ACTG study, as well as pharmacokinetic and pharmacodynamic data, Schering-Plough Research Institute began a new phase 2 clinical trial of higher doses of vicriviroc in treatment-experienced HIV patients.

The goal of this trial, known as Victor-E1, is to achieve incremental improvement in viral suppression. A total of 120 patients who are currently failing an antiretroviral treatment regimen will be enrolled in the 48-week trial.

Schering-Plough is a global science-based health care company based in Kenilworth, N.J.


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