GILD extends study of Ritonavir-Boosted Elvitegravir Versus Raltegravir to 96 weeks
Gilead Sciences, Inc. (Gilead) has decided, per the recommendation of the U.S. Food and Drug Administration (FDA), to amend the design of its ongoing Phase III clinical study of elvitegravir, the company's investigational integrase inhibitor in treatment experienced patients (GS-US-183-0145, "A Multicenter, Randomized, Double-Blind, Double-Dummy, Phase III Study of the Safety and Efficacy of Ritonavir-Boosted Elvitegravir Versus Raltegravir Each Administered With a Background Regimen in HIV-1 Infected, Antitretroviral Treatment Experienced Adults"), to extend the double-blinded study period to up to 96 weeks, rather than the initially planned 48-week duration.
This change will be implemented to allow Gilead to obtain safety and efficacy data from a longer controlled and blinded study, the first clinical trial directly comparing two integrase inhibitors. Gilead has not been informed of any issues with the ongoing study that would cause Gilead to halt or otherwise amend the study design.
Gilead does not expect this planned change to have any impact on timelines for availability of data from ongoing pivotal studies in support of the investigational "Quad" combination of Truvada? (emtricitabine and tenofovir disoproxil fumarate), elvitegravir and cobicistat, or timelines, pending a positive outcome of these studies, for regulatory submissions of the Quad, cobicistat or elvitegravir.
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