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Analysis of Long-Term Vicriviroc Data Provides Evidence of Sustained Viral Suppression, Increased CD4 Cell Counts and Tolerability in Treatment-Experienced HIV-Infected Patients
Date:10/26/2008

at more than 160 sites in North America, Latin America, Europe and South Africa.

For more information about the VICTOR-E3 and VICTOR-E4 clinical studies, please visit http://www.clinicaltrials.gov, search term: vicriviroc.

Status of Vicriviroc Phase II Study in Treatment-Naive Patients

Schering-Plough also has completed patient enrollment in the first part of an ongoing Phase II study of vicriviroc in a novel nucleoside-sparing regimen for first-line therapy of adult treatment-naive HIV-infected patients with R5-tropic virus only. Approximately 80-90 percent of treatment-naive patients have virus that uses the CCR5 co-receptor.(5) The study evaluates vicriviroc 30 mg once-daily in combination with ritonavir-boosted atazanavir,(6) compared to a control group receiving Truvada (emtricitabine and tenofovir disoproxil fumarate)(7) plus ritonavir-boosted atazanavir, which is a currently recommended option for first-line therapy. This novel nucleoside-sparing vicriviroc regimen is designed to help avoid the risk of toxicities associated with the nucleoside class of HIV drugs, 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.(8-10) This approach represents a potential opportunity to preserve nucleoside and non-nucleoside reverse transcriptase inhibitors (NRTIs, NNRTIs), integrase inhibitors, fusion inhibitors and most protease inhibitors for later lines of HIV treatment. The full study will involve approximately 200 patients and is ongoing at more than 20 sites in North America, Central America, Europe and South Africa.

For more information about the study, please visit http://www.clinicaltrials.gov, search term: vicriviroc.

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