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Schering-Plough Expands Vicriviroc Phase II Study in Treatment-Naive Patients With HIV
Date:7/15/2009

seline in viral load (log10 HIV RNA) at week 48 of treatment. A key secondary efficacy endpoint is the proportion of patients with plasma HIV RNA less than 50 copies/mL at week 48 of treatment.

Atazanavir boosted by ritonavir was selected for use in this study because it is recommended as an option for first-line therapy in both the International AIDS Society and Department of Health and Human Services guidelines for antiretroviral therapy. Additionally, like vicriviroc, it is administered as a once daily dose and it has been shown to have a more favorable lipid safety profile than other drugs in the PI class.

The study is being sponsored by Schering-Plough with support from Bristol-Myers Squibb.

Vicriviroc also is being studied in two large ongoing Phase III clinical studies in treatment-experienced HIV patients. For more information about vicriviroc clinical studies, please visit www.clinicaltrials.gov, search term: vicriviroc.

Key Safety Findings with Vicriviroc

A pooled data analysis was conducted for two vicriviroc Phase II studies involving 205 treatment-experienced HIV-infected patients who continued on vicriviroc at the completion of 48 weeks of treatment in an open-label extension for each study. Patients received vicriviroc for up to 216 weeks of total treatment duration as part of an optimized antiretroviral regimen. AIDS-associated opportunistic infections and conditions were observed infrequently and sporadically. Infections involving the upper and lower respiratory tract were the only other infections or adverse events that occurred in 5 percent or more of patients. Elevations of liver enzymes and bilirubin were noted, but were not characteristic of drug-induced liver injury and were judged to be not related to vicriviroc. These infections and other adverse eve
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