02.10.06
Gilead Sciences' results of a Phase I/II dose-escalation study of GS 9137, or JTK-303, a novel oral HIV integrase inhibitor, show significant reductions in viral load among HIV-positive patients receiving GS 9137 as monotherapy or in combination with ritonavir as a boosting agent, compared to placebo.
Integrase inhibitors are a new class of antiretrovirals that interfere with HIV replication by blocking the ability of the virus to integrate into the genetic material of human cells. Novel classes of HIV-fighting drugs are needed as patients live longer and exhaust currently available treatment options.
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. GS 9137 monotherapy demonstrated significant antiviral activity compared to placebo (p less than 0.0001) at all doses.
Integrase inhibitors are a new class of antiretrovirals that interfere with HIV replication by blocking the ability of the virus to integrate into the genetic material of human cells. Novel classes of HIV-fighting drugs are needed as patients live longer and exhaust currently available treatment options.
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. GS 9137 monotherapy demonstrated significant antiviral activity compared to placebo (p less than 0.0001) at all doses.