www.fdanews.com/articles/73548-gilead-initiates-phase-i-ii-trial-of-hiv-integrase-inhibitor-gs-9137
GILEAD INITIATES PHASE I/II TRIAL OF HIV INTEGRASE INHIBITOR GS 9137
June 22, 2005
Gilead Sciences has begun enrolling patients in a Phase I/II study of the company's oral HIV integrase inhibitor, GS 9137 for the treatment of HIV.
This double-blind, randomized, placebo-controlled Phase I/II dose-escalation study will evaluate the tolerability, safety and antiviral activity of GS 9137 in HIV-positive patients.
GS 9137 is a novel HIV integrase inhibitor discovered by Japan Tobacco (JT) and licensed to Gilead in March. The license granted Gilead exclusive rights to develop and commercialize GS 9137 worldwide, excluding in Japan where JT will retain rights. GS 9137 has been previously evaluated in a Phase I study in Japan to assess pharmacokinetics and safety in healthy volunteers.