Schering-Plough Initiates Phase II Study With Vicriviroc in Treatment-Naive HIV-Infecte...(mized controlled open-label study is pro...),Health

The primary efficacy endpoint of the study is the mean change from baseline 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.

The study will be conducted in two stages. In the first stage, 80 patients will be randomized (40 per treatment arm) into the study. When the 80 subjects from the first stage have completed 24 weeks of treatment, a formal interim analysis will be conducted and the results presented to an independent Data Safety Monitoring Board (DSMB) to assure the safety of the study participants. The study will be extended to stage 2 based on the results of the 24-week interim analysis; at which time an additional 120 patients (60 per treatment arm) will be enrolled. The final analysis will be conducted at week 48 of treatment for all patients.

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, it has been shown to have a more favorable lipid profile than other drugs in the PI class.

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

About Vicriviroc Ongoing Phase III Studies in Treatment-Experienced Patients

Schering-Plough is currently enrolling patients in two large global Phase III clinical studies with vicriviroc in adult treatment-experienced HIV-infected patients with R5-type virus only.

The two studies, known as VICTOR-E3 and VICTOR-E4 (Vicriviroc in
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