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Schering-Plough Initiates Phase II Study With Vicriviroc in Treatment-Naive HIV-Infected Patients
Date:4/15/2008

class," said Joseph C. Gathe, Jr., M.D., F.A.C.P., clinical instructor, department of internal medicine, Baylor College of Medicine, Houston, and lead investigator for the study. "This treatment strategy could also prove beneficial for the growing number of patients who already have primary resistance to NRTIs prior to any treatment."

In previous studies in treatment-experienced HIV-infected patients, vicriviroc in combination with an optimized ritonavir-boosted PI-containing regimen demonstrated potent and sustained viral suppression through 48 weeks of treatment.(4, 5)

The standard of care for treatment-naive HIV-infected individuals is to combine three drugs from two classes to initiate antiretroviral therapy. The combinations characteristically use two NRTIs with either a non-nucleoside reverse transcriptase inhibitor (NNRTI) or a ritonavir-boosted PI.(6) While these combinations have been demonstrated to be highly effective, long-term tolerance may be limited by the toxicity specifically associated with nucleosides, which can include neuropathy, myopathy, renal toxicity, hepatic steatosis, lactic acidosis, bone marrow suppression, fat atrophy and, with certain agents, increased risk of myocardial infarction.(7-9)

"As a next-generation HIV entry inhibitor, vicriviroc has the potential to benefit a broad range of patients by offering potent and sustained viral suppression, and a single once-daily dose for use in combination with other antiretroviral agents," said Robert J. Spiegel, M.D., chief medical officer and senior vice president, Schering-Plough Research Institute. "CCR5 antagonists such as vicriviroc have a novel mechanism of action in fighting HIV, and may play a unique role as physicians seek to construct new regimens to meet the specific needs of their patients, whether they are starting treatment or have been treated with several different combinations over a period of time."

About the Phase II Naive Study

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