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Elvitegravir

Multicenter, Randomized, Double-Blind, Double-Dummy, Phase 3 Study of the Safety and Efficacy of Elvitegravir Versus Raltegravir

Ensayo de GILEAD SCIENCES, INC. en Infeccion por VIH.

Fase

Fase 3

Estado

Completado

Participantes

724

previstos

Centros

180

Fin del objetivo primario

dic 2010

fecha real

Qué significa cada fase y cada estado.

Estudio de intervención, aleatorizado, triple ciego. Comenzó en jul 2008.

Qué mide

Porcentaje de participantes que alcanzaron y mantuvieron ARN del VIH-1 confirmado < 50 copias/mL en la semana 48 (semana 48)

Cómo lo describe el promotor

En el documentoEn inglés, del registroThe purpose of this study is to compare the safety, tolerability and efficacy of a regimen containing once-daily elvitegravir (EVG) versus twice-daily raltegravir (RAL) added to a background regimen (1 fully-active ritonavir (RTV)-boosted protease inhibitor (PI) plus 1 or 2 additional antiretroviral (ARV) agents) in HIV-1 infected, ARV treatment-experienced adults who have documented resistance, or at least six months experience prior to screening with two or more different classes of ARV agents. Participants will be randomized in a 1:1 ratio to receive EVG plus background regimen (Elvitegravir group), or raltegravir plus background regimen (Raltegravir group). Due to known drug interactions, participants in the Elvitegravir group receiving RTV-boosted atazanavir (ATV) or RTV-boosted lopinavir (LPV) as part of their background regimen will receive elvitegravir at a lower dose (85 mg).

Más ensayos de GILD

Todos los de GILD, en su ficha.

Ficha completa en ClinicalTrials.gov (NCT00708162), actualizada en abr 2016.