NCT01227824

A Trial Comparing GSK1349572 50mg Once Daily to Raltegravir 400mg Twice Daily

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 828 (actual)
• Sponsor: ViiV Healthcare · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Conditions

• Infection, Human Immunodeficiency Virus I

Interventions

Type	Name	Description
DRUG	GSK1349572 (dolutegravir)	GSK1349572 50 mg taken once daily with or without food
DRUG	raltegravir	raltegravir 400mg taken twice daily
OTHER	GSK1349572 Placebo	GSK1349572 placebo taken once daily
OTHER	ABC/3TC	Abacavir/Lamivudine background therapy once daily
OTHER	TDF/FTC	Tenofovir/emtricitabine background therapy once daily
OTHER	raltegravir Placebo	raltegravir placebo taken twice daily

Timeline

• Start date: 2010-10-19
• Primary completion: 2012-02-06
• Completion: 2016-12-27
• First posted: 2010-10-25
• Last updated: 2018-10-09
• Results posted: 2014-06-23

Locations

101 sites across 9 countries: United States, Australia, Canada, France, Germany, Italy, Russia, Spain, United Kingdom