NCT01263015

A Trial Comparing GSK1349572 50mg Plus Abacavir/Lamivudine Once Daily to Atripla (Also Called The SINGLE Trial)

A Randomized, Double-Blind Study of the Safety and Efficacy of GSK1349572 Plus Abacavir/Lamivudine Fixed-Dose Combination Therapy Administered Once Daily Compared to Atripla Over 96 Weeks in HIV-1 Infected Antiretroviral Therapy Naive Adult Subjects

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 844 (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 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

Conditions

• Infection, Human Immunodeficiency Virus I

Interventions

Type	Name	Description
DRUG	Dolutegravir	Dolutegravir (also known as GSK1349572) 50 mg taken once daily
DRUG	Atripla	Atripla once daily on an empty stomach
DRUG	Abacavir/Lamivudine	taken once daily; also known as EPZICOM
DRUG	Abacavir/Lamivudine Placebo	matching placebo taken once daily
DRUG	Dolutegravir placebo	matching placebo taken once daily
DRUG	Atripla placebo	matching placebo taken once daily on an empty stomach

Timeline

• Start date: 2011-02-01
• Primary completion: 2012-05-14
• Completion: 2015-12-03
• First posted: 2010-12-20
• Last updated: 2018-04-04
• Results posted: 2014-07-02

Locations

145 sites across 12 countries: United States, Australia, Belgium, Canada, Denmark, France, Germany, Italy, Netherlands, Romania, Spain, United Kingdom