Gilead recruits for Ph III elvitegravir HIV trial

California, USA-based Gilead Sciences has started the enrollment of patients in a Phase III clinical trial of elvitegravir, an investigational oral integrase inhibitor that is being evaluated for the treatment of HIV-1 infection.

The randomized, double-blind, 48-week clinical trial will test the non-inferiority of ritonavir-boosted elvitegravir (n=350) versus raltegravir (n=350) in 700 HIV-infected, treatment-experienced patients at approximately 125 sites in the USA and Puerto Rico. Patients will have documented viral resistance or at least six months of treatment experience with two or more different classes of antiretroviral agents prior to screening. Patients who have previously taken an integrase inhibitor will be excluded from the trial.

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. 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.