CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 828 enrolled
Drug / intervention
GSK1349572 (dolutegravir) +5 moredrug
Likely dose
GSK1349572 (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/NCT01227824
NCT01227824Phase 3Completed
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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

ViiV Healthcare·interventional·Posted Oct 25, 2010·Updated Oct 9, 2018

In Brief

A Phase 3 clinical trial evaluating GSK1349572 (dolutegravir), raltegravir, and 4 other interventions for Infection, Human Immunodeficiency Virus I. Completed, enrolled 828 participants across 101 sites in 9 countries.

Detailed 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.

Study Details

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

Timeline

Phase 3CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedOct 25, 2010
Enrollment StartOct 19, 2010
Primary CompletionFeb 6, 2012
Study CompletionDec 27, 2016
TodayJul 2, 2026
Enrollment to primary: 1.3 yearsPosted 15.7 years ago

Interventions

GSK1349572 (dolutegravir)drug

GSK1349572 50 mg taken once daily with or without food

raltegravirdrug

raltegravir 400mg taken twice daily

GSK1349572 Placeboother

GSK1349572 placebo taken once daily

ABC/3TCother

Abacavir/Lamivudine background therapy once daily

TDF/FTCother

Tenofovir/emtricitabine background therapy once daily

raltegravir Placeboother

raltegravir placebo taken twice daily