Schering-Plough says vicriviroc well tolerated; dosing, background regimen need further study

By Lisa Kerner

Erie, Pa., Feb. 10 - Schering-Plough Corp. presented data from clinical studies in the ongoing development of vicriviroc, its investigational CCR5 receptor antagonist, at the 13th Conference on Retroviruses and Opportunistic Infections in Denver.

Vicriviroc is being evaluated in an ongoing phase 2 clinical study in treatment-experienced HIV patients, according to a company news release.

In the study of 92 treatment-naive patients, vicriviroc was shown to be well tolerated, with no evidence of hepatotoxicity. The endpoints of this 48-week trial included mean change in the decline of viral load (HIV RNA) from baseline at two weeks.

The optimal dose and background regimen for use with vicriviroc in this patient population requires further study, the company said.

Schering-Plough had terminated this study in October when patients who received vicriviroc in combination with Combivir experienced virologic breakthrough, compared to those who received the control regimen of Combivir and efavirenz, a current standard of care for treatment-naïve patients living with HIV.

"These results have proven instructive to the further development of vicriviroc and will inform our plans for designing additional studies," Wayne Greaves, M.D., senior director of global clinical development, Schering-Plough Research Institute and results presenter.

Vicriviroc was also studied in combination with ritonavir-boosted atazanavir, fosamprenavir, indinavir, nelfinavir, and saquinavir. There were no significant changes in vicriviroc plasma concentrations when combined with the protease inhibitor combinations, according to the release.

All three-agent combinations were well tolerated, and as a result, vicriviroc may be studied further for use in ritonavir-boosted protease inhibitor-containing regimens, the company said.

Schering-Plough said it continues its development of vicriviroc with an ongoing and fully enrolled phase 2 study in U.S. treatment-experienced patients, being conducted by the NIH-sponsored Adult AIDS Clinical Trials Group.

Schering-Plough is a global science-based health care company with leading prescription, consumer and animal health products based in Kenilworth, N.J.

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