CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 183 enrolled
Drug / intervention
dolutegravirdrug
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/NCT01328041
NCT01328041Phase 3Completed
CompareCT.gov

A Phase III Study to Demonstrate the Antiviral Activity and Safety of Dolutegravir in HIV-1 Infected Adult Subjects With Treatment Failure on an Integrase Inhibitor Containing Regimen.

ViiV Healthcare·interventional·Posted Apr 4, 2011·Updated Jan 7, 2016

In Brief

A Phase 3 clinical trial evaluating dolutegravir for Infection, Human Immunodeficiency Virus. Completed, enrolled 183 participants across 89 sites in 7 countries.

Detailed Summary

The purpose of this trial is to assess the antiviral activity and safety of a dolutegravir (DTG) containing regimen in HIV-1 infected, antiretroviral therapy (ART)-experienced adults with current or historical failure on an integrase inhibitor (INI) containing regimen. The study will assess DTG 50mg twice daily administered initially with the current failing ART regimen but then with an optimised background ART regimen (OBR) after Day 7. The first analyses will be conducted after the last subject enrolled has completed 24 weeks. Subjects may remain on study after Week 24.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsInfection, Human Immunodeficiency Virus
CountriesBelgium, Canada, France, Italy, Portugal, Spain, United States
CollaboratorsShionogi, GlaxoSmithKline

Timeline

Phase 3CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedApr 4, 2011
Enrollment StartMay 1, 2011
Primary CompletionMay 1, 2012
Study CompletionMay 1, 2015
TodayJul 2, 2026
Enrollment to primary: 1 yearPosted 15.2 years ago

Interventions

dolutegravirdrug

50 mg twice daily