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A Study to Assess Dolutegravir in HIV-infected Subjects With Treatment Failure on an Integrase Inhibitor Containing Regimen.

NCT01328041 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 183

Last updated 2016-01-07

Study results available
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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.

Conditions

  • Infection, Human Immunodeficiency Virus

Interventions

DRUG

dolutegravir

50 mg twice daily

Sponsors & Collaborators

  • Shionogi

    collaborator INDUSTRY

  • GlaxoSmithKline

    collaborator INDUSTRY

  • ViiV Healthcare

    lead INDUSTRY

Principal Investigators

  • GSK Clinical Trials · ViiV Healthcare

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-05-31
Primary Completion
2012-05-31
Completion
2015-05-31

Countries

  • United States
  • Belgium
  • Canada
  • France
  • Italy
  • Portugal
  • Spain

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01328041 on ClinicalTrials.gov