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news.Schering-Plough has initiated two phase III clinical studies with vicriviroc, its investigational CCR5 antagonist, administered once-daily as a single 30mg tablet in combination with an optimized background therapy that must include a protease inhibitor boosted by ritonavir in adult treatment-experienced HIV patients with R5-type virus only.
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Vicriviroc is a next-generation extracellular inhibitor of HIV infection designed to block entry of infectious virions into uninfected CD4 cells via antagonism of the CCR5 co-receptor.
The vicriviroc phase III clinical program builds upon previous studies in HIV treatment-experienced patients, including a phase II study (ACTG 5211) in which vicriviroc demonstrated potent and sustained viral suppression through 48 weeks of therapy.
The two phase III studies, known as VICTOR-E3 and VICTOR-E4 (Vicriviroc in Combination Treatment with an Optimized Antiretroviral Therapy Regimen in HIV- Infected Treatment-Experienced Subjects), will evaluate the virologic benefit of adding vicriviroc 30 mg once daily to an optimized background therapy compared to a control group receiving new optimized background therapy alone. The studies will also evaluate the safety and tolerability of vicriviroc compared to placebo. The optimized background therapy must include at least two drugs that are active, based on susceptibility testing. Patients coinfected with hepatitis C may be included in the studies and there are no exclusions of commonly prescribed drugs or need for dose adjustments based on the known vicriviroc drug-drug interaction profile. The studies will enroll approximately 375 patients each at more than 160 sites in North America, South America, Europe, Australia and South Africa.
Robert Spiegel, CMO and senior vice president said: “As a next-generation HIV entry inhibitor, vicriviroc has the potential to benefit a broad range of patients by offering a potent, sustained viral response and a single once-daily dose in combination with optimized background therapy. There is an urgent need for new antiretroviral agents with novel mechanisms of action and we look forward to the further clinical evaluation of vicriviroc in these large global studies.”