Conditions: Infection, Human Immunodeficiency Virus I
Keywords: integrase inhibitor HIV Infection raltegravir GSK1349572
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 828
Healthy volunteers: no

Brief summary:
The purpose of this trial is to assess the non-inferior antiviral activity of GSK1349572 50 mg once daily versus RAL 400mg twice daily over 48 weeks; non-inferiority will also be tested at Week 96. Both GSK1349572 and RAL will be given in combination with fixed-dose dual NRTI therapy (ABC/3TC or TDF/FTC). This study will be conducted in HIV-1 infected ART-naïve adult subjects.

Detailed description:
ING113086 is a Phase 3 randomized, double-blind, double dummy, active-controlled, multicenter, study conducted in approximately 788 HIV-1 infected ART-naïve subjects. Subjects will be randomized 1:1 one of the following treatment arms:

1. GSK1349572 50 mg once daily (approximately 394 subjects) + fixed-dose dual NRTI therapy (either ABC/3TC or TDF/FTC)

   OR
2. 400 mg RAL twice daily (approximately 394 subjects) + fixed-dose dual NRTI therapy (either ABC/3TC or TDF/FTC)

Analyses will be conducted at 48 weeks and 96 weeks. Subjects randomized to receive GSK1349572 and who successfully complete 96 weeks of treatment will continue to have access to GSK1349572 through the study until either it is locally available, as long as they continue to derive clinical benefit.

ViiV Healthcare is the new sponsor of this study, and GlaxoSmithKline is in the process of updating systems to reflect the change in sponsorship

Arms:
arm 1: GSK1349572 50mg once daily + raltegravir placebo twice daily + NRTI background therapy once daily arm 2: raltegravir 400mg twice daily + GSK1349572 placebo once daily + NRTI background therapy once daily

Interventions: intervention 1: GSK1349572 (dolutegravir) intervention 2: raltegravir intervention 3: GSK1349572 Placebo intervention 4: ABC/3TC intervention 5: TDF/FTC intervention 6: raltegravir Placebo
Intervention descriptions: intervention 1: GSK1349572 50 mg taken once daily with or without food intervention 2: raltegravir 400mg taken twice daily intervention 3: GSK1349572 placebo taken once daily intervention 4: Abacavir/Lamivudine background therapy once daily intervention 5: Tenofovir/emtricitabine background therapy once daily intervention 6: raltegravir placebo taken twice daily

Protocol document: