This double-blind, randomized, placebo-controlled study will evaluate the tolerability, safety and antiviral activity of GS 9137 (also known as JTK-303), in HIV-positive patients. The drug will be administered in a dose-escalating regime to thoroughly evaluate the potential of the compound.
GS 9137 is a novel HIV integrase inhibitor discovered by Japan Tobacco, who licensed the product to Gilead in March 2005. The license granted Gilead exclusive rights to develop and commercialize GS 9137 in all countries excluding Japan where Japan Tobacco will retain rights. GS 9137 has been previously evaluated in a phase I study in Japan to assess pharmacokinetics and safety in healthy volunteers.
“The initiation of this trial underscores Gilead’s ongoing commitment to HIV and efforts to advance novel compounds with the potential to address unmet medical needs of people living with HIV,” said Dr Norbert Bischofberger, executive vice president, research and development, Gilead Sciences.
Dr Bischofberger continued: “HIV continues to be a major focus for Gilead, and integrase inhibitors represent a promising novel class of agents with the potential to inhibit HIV replication, particularly for patients whose HIV has developed resistance to other agents.”
As an investigational compound, GS 9137 has not yet been determined safe or efficacious in humans for its ultimate intended use.