CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 844 enrolled
Drug / intervention
Dolutegravir +5 moredrug
Likely dose
Dolutegravir 50 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01263015
NCT01263015Phase 3Completed
CompareCT.gov

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

ViiV Healthcare·interventional·Posted Dec 20, 2010·Updated Apr 4, 2018

In Brief

A Phase 3 clinical trial evaluating Dolutegravir, Atripla, and 4 other interventions for Infection, Human Immunodeficiency Virus I. Completed, enrolled 844 participants across 145 sites in 12 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsInfection, Human Immunodeficiency Virus I
CountriesAustralia, Belgium, Canada, Denmark, France, Germany, Italy, Netherlands, Romania, Spain, United Kingdom, United States
CollaboratorsShionogi, GlaxoSmithKline

Timeline

Phase 3CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedDec 20, 2010
Enrollment StartFeb 1, 2011
Primary CompletionMay 14, 2012
Study CompletionDec 3, 2015
TodayJul 2, 2026
Enrollment to primary: 1.3 yearsPosted 15.5 years ago

Interventions

Dolutegravirdrug

Dolutegravir (also known as GSK1349572) 50 mg taken once daily

Atripladrug

Atripla once daily on an empty stomach

Abacavir/Lamivudinedrug

taken once daily; also known as EPZICOM

Abacavir/Lamivudine Placebodrug

matching placebo taken once daily

Dolutegravir placebodrug

matching placebo taken once daily

Atripla placebodrug

matching placebo taken once daily on an empty stomach