Overview

A Study of GSK1349572 Versus Raltegravir (RAL) With Investigator Selected Background Regimen in Antiretroviral-Experienced, Integrase Inhibitor-Naive Adults

Status:
Completed

Trial end date:
2020-12-15

Target enrollment:

Participant gender:

Summary

ING111762 is a 48 week, randomized, double-blind, active-controlled, multicenter, parallel group, non-inferiority study. The study will be conducted in at least 688 HIV-1 infected antiretroviral experienced, integrase-naïve subjects. Subjects will be randomized 1:1 to receive GSK1349572 50 mg once daily or raltegravir (RAL) 400 mg twice daily, each added to an investigator selected background regimen consisting of at least one fully active agent plus no more than one second single agent which may or may not be active. Antiviral activity, safety, pharmacokinetics (PK), and development of viral resistance will be evaluated.

Phase:

Phase 3

Details

Lead Sponsor:

ViiV Healthcare

Collaborators:

GlaxoSmithKline
Shionogi

Treatments:

Dolutegravir
Integrase Inhibitors
Raltegravir Potassium