Infection, Human Immunodeficiency Virus I Clinical Trial
Official title:
A Randomized, Double Blind Study of the Safety and Efficacy of GSK1349572 50mg Once Daily to Raltegravir 400mg Twice Daily Both Administered With Fixed-dose Dual Nucleoside Reverse Transcriptase Inhibitor Therapy Over 96 Weeks in HIV-1 Infected Antiretroviral Therapy Naive Adult Subjects
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.
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
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