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, Antiretroviral 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."