Conditions: Infection, Human Immunodeficiency Virus I
Keywords: GSK1349572 Abacavir/Lamivudine Treatment-naive HIV Infection Dolutegravir integrase inhibitor Atripla
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 844
Healthy volunteers: no

Brief summary:
The purpose of this trial is to assess the non-inferior antiviral activity of GSK1349572 50 mg plus Abacavir/Lamivudine once daily versus Efavirenz/Emtricitabine/Tenofovir disoproxil fumarate (ATRIPLA® a trade mark of Bristol-Myers Squibb and Gilead Sciences LLC) over 48 weeks; non-inferiority will also be tested at Week 96. This study will be conducted in HIV-1 infected ART-naïve adult subjects. Long term antiviral activity, tolerability, safety, and development of viral resistance will be evaluated.

Detailed description:
ING114467 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:

GSK1349572 50 mg plus abacavir/lamivudine fixed-dose combination once daily (approximately 394 subjects)

OR

Atripla once daily (approximately 394 subjects)

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 plus abacavir/lamivudine fixed-dose combination through the study until it is locally available-as long as they continue to derive clinical benefit, until they meet a protocol-defined reason for discontinuation, or until development of the compound is terminated.

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: Dolutegravir 50mg once daily + abacavir/lamivudine as the fixed-dose combination once daily + Atripla placebo once daily arm 2: Atripla once daily + Dolutegravir placebo once daily + abacavir/lamivudine as the fixed-dose combination placebo once daily

Interventions: intervention 1: Dolutegravir intervention 2: Atripla intervention 3: Abacavir/Lamivudine intervention 4: Abacavir/Lamivudine Placebo intervention 5: Dolutegravir placebo intervention 6: Atripla placebo
Intervention descriptions: intervention 1: Dolutegravir (also known as GSK1349572) 50 mg taken once daily intervention 2: Atripla once daily on an empty stomach intervention 3: taken once daily; also known as EPZICOM intervention 4: matching placebo taken once daily intervention 5: matching placebo taken once daily intervention 6: matching placebo taken once daily on an empty stomach

Protocol document: