Malignancies found in Schering-Plough phase 2 trial of vicriviroc for HIV

By Lisa Kerner

Erie, Pa., March 3 - The Study Monitoring Committee of the ACTG (NIH-sponsored Adult AIDS Clinical Trials Group) has notified Schering-Plough Corp. that five cases of malignancy have been observed in the company's ongoing phase 2 clinical study of vicriviroc, a CCR5 receptor antagonist.

The five cases included four patients with lymphoma and one patient with gastric adenocarcinoma (stomach cancer), according to a company news release.

A total of 118 U.S. treatment-experienced patients with HIV disease and low CD4 counts are participating in the trial. Patients and investigators are immediately being informed of the malignancy results, the company said.

The ACTG has concluded that a causal association between vicriviroc and the lymphoma cases could not be established.

Furthermore, since vicriviroc, at the two highest doses tested, together with an optimized background antiretroviral regimen showed evidence of virologic activity and CD4 count increases, the ACTG has determined the trial will continue.

To assure the safety of patients in the trial, the ACTG is introducing long-term follow-up of three to five years, and unblinding the patients so they may make more informed decisions about treatment options.

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

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