CLINICAL STUDY |
Results from an on-going Phase II study showed that antiretroviral suppression was sustained after 48-weeks of treatment with drug (raltegravir), an investigational oral integrase inhibitor, in combination with optimized background therapy (OBT) versus placebo plus OBT in treatment-experienced HIV-infected patients failing therapy and who had virus resistant to three classes of oral antiretroviral drugs. The results from this ongoing Phase II study also showed that drug dosed at 200 mg, 400 mg, 600 mg orally twice daily in combination with OBT was generally well tolerated in these patients (n=133).
These results were presented today at the American Society for Microbiology s 47th Annual Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC).
"The findings at 48 weeks are consistent with the 24 week results and what we know to date about the drug s efficacy and tolerability profile," said Jose M. Gatell, M.D., Ph.D., senior consultant and head, Infectious Diseases and AIDS Units, Clinical Institute of Medicine and Dermatology; hospital clinic professor of medicine, University of Barcelona, Spain. "These results reinforce the drug s potential as the first in a promising new class of antiretroviral agents."
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