Schering-Plough Reports Long-Term Vicriviroc Data From Phase II Open-Label Extension Study in Treatment-Experienced HIV-Infecte...(eptor. Approximately 50-60 percent of t...),Health

About the Study

This ongoing, open-label extension of the VICTOR-E1 Phase II study was designed to provide continued therapy with vicriviroc and to collect safety data. Evidence for sustained viral suppression and CD4 cell count improvement was monitored. After completing 48 weeks of treatment in the double-blind phase of the VICTOR-E1 study, patients (including patients in the placebo arm) were offered open-label vicriviroc 30 mg once daily plus an optimized antiretroviral regimen containing a ritonavir-boosted protease inhibitor. The mean duration of vicriviroc treatment in the open-label phase was 13 months.

Vicriviroc Phase III Studies in Treatment-Experienced Patients

Patient enrollment has been completed in two large Phase III registration studies, known as VICTOR-E3 and VICTOR-E4 (Vicriviroc in Combination Treatment with an Optimized Antiretroviral Therapy Regimen in HIV-Infected Treatment-Experienced Subjects), evaluating vicriviroc 30 mg once daily in combination with an optimized background antiretroviral regimen containing a ritonavir-boosted protease inhibitor compared to a control group receiving new optimized background therapy alone. The optimized background therapy must include at least two drugs to which the patient's HIV is susceptible. Patients coinfected with hepatitis B or C may be included in these studies and there are few exclusions of commonly prescribed drugs or need for dose adjustments based on the known vicriviroc drug-drug interaction profile. The two studies involve a total of more than 850 patients at more than 160 sites in North America, Latin America, Europe and South Africa.

Vicriviroc Phase II Studies in Treatment-Naive Patients

Patient enrollment also has been completed in an ongoing Phase
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