About The Study
This is a Phase III study to compare two antiretroviral therapies in treatment-experienced HIV-1 infected adults. The study will examine the safety, tolerability and efficacy of a treatment regimen containing either the experimental ritonavir-boosted elvitegravir or Health Canada–approved raltegravir. Specifically, the study aims to demonstrate that taking one dose of ritonavir-boosted elvitegravir is as effective as taking two-doses of raltegravir.
The study will be conducted as a multicentre, randomized, active-controlled, double-blind, double-dummy—making both treatment agents similar in appearance. Participants will be randomized into one of two treatment groups and receive either a dosing of elvitegravir once-daily or a twice-daily dosing of raltegravir, each administered with a background regimen containing a fully-active ritonavir-boosted protease inhibitor and a second single agent.
Elvitegravir and ra.ltegravir are integrase inhibitor antiretrovirals. Integrase inhibitors interfere with HIV replication by blocking the ability of the virus to integrate into the genetic material of human cells.
To allow for once daily dosing, Elvitegravir requires a boosting agent, in this case, ritonavir.
This trial is also listed on Clinicaltrials.gov