The study is designed to assess the non-inferiority of ritonavir-boosted elvitegravir, dosed once daily, compared to raltegravir (Isentress), another integrase inhibitor that is dosed twice daily.
The study will enroll 700 HIV-infected, treatment-experienced patients at approximately 125 sites in the US and Puerto Rico. A second Phase III study with a similar design involving 700 HIV-infected, treatment-experienced patients will be initiated later this year in Europe, Canada and Australia.
The primary efficacy endpoint will be the proportion of subjects in both arms of the study who achieve and maintain confirmed viral load of less than 50 copies/ml through 48 weeks. Secondary endpoints will include various additional measures of the efficacy, safety and tolerability of the two treatment regimens.
Norbert Bischofberger, CSO of Gilead Sciences, said: “Advancing novel compounds for the treatment of HIV/AIDS remains a key area of focus for Gilead, and we are very pleased that our integrase inhibitor, elvitegravir, continues to make progress with the initiation of this Phase III clinical trial.”