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| |  Addition of Vicriviroc Allows Treatment-Experienced Patients to Achieve Undetectable HIV Levels: Presented at CROI By Ed Susman BOSTON, MA -- February 4, 2008 -- Treatment-experienced patients with HIV were able to achieve undetectable bloodstream levels of the virus in a phase 2 clinical trial if the chemokine receptor 5 (CCR5) antagonist vicriviroc was added to their background regimen. In the 48-week study, 56% of 39 patients who were randomized to receive 30 mg of vicriviroc achieved undetectable viral loads using the 50-copy assay; 52% of 40 patients who were randomized to receive 20 mg vicriviroc were able to achieve undetectable viral loads; and 14% of 35 patients who received placebo in addition to an optimized antiretroviral regimen were able to achieve an undetectable viral load. The difference between vicriviroc 30 mg (P =.0002) and 20 mg (P =.0004) was statistically significant compared with placebo, said Barry Zingman, MD, Medical Director, AIDS Center, and Associate Professor of Clinical Medicine, Montefiore Medical Center, University Hospital, Albert Einstein College of Medicine, The Bronx, New York, New York. "There were no apparent dose- or drug-related toxicities," Dr. Zingman said at an opening press briefing here on February 3 at the 15th Conference on Retrovirus and Opportunistic Infections (CROI). He said that there were no malignancies in this study. Several cases of cancer in earlier trials were individually examined, Dr. Zingman said, and the drug was ruled out as the cause of the disease. Patients who received vicriviroc 30 mg achieved reductions in viral loads of 1.77log10; those who received 20 mg of the drug had an average reduction in viral loads of 1.75log10; the average reduction for patients on placebo plus optimized background medication had an average reduction of 0.79log10. All patients in the study were eligible for enrollment if their HIV RNA viral load exceeded 1000 copies/mL despite being on a stable antiretroviral regimen for at least 6 weeks. Vicriviroc was dosed with 100 mg of ritonavir. Funding for this study was provided by the drug's developer, Schering-Plough.
[Presentation title: Vicriviroc, a Next Generation CCR5 Antagonist, Exhibits Potent, Sustained Suppression of Viral Replication in Treatment-Experienced Adults: VICTOR-E1 48-Week Results. Abstract 39LB]
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