www.fdanews.com/articles/84476-gilead-reports-hiv-study-data
GILEAD REPORTS HIV STUDY DATA
February 10, 2006
Gilead Sciences has announced the results of a Phase I/II dose-escalation study of GS 9137, or JTK-303, a novel oral HIV integrase inhibitor.
This Phase I/II study was a double-blind, randomized, placebo-controlled monotherapy study to evaluate the safety, tolerability and antiviral activity of GS 9137 in HIV-infected treatment-naive and treatment-experienced patients. Forty patients were randomized and received one of five doses of GS 9137 or placebo with food for 10 days. The primary efficacy endpoint was the maximum reduction in viral load from baseline.