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A Trial Comparing GSK1349572 50mg Once Daily to Raltegravir 400mg Twice Daily

NCT01227824 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 828

Last updated 2018-10-09

Study results available
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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.

Conditions

  • Infection, Human Immunodeficiency Virus I

Interventions

DRUG

GSK1349572 (dolutegravir)

GSK1349572 50 mg taken once daily with or without food

DRUG

raltegravir

raltegravir 400mg taken twice daily

OTHER

GSK1349572 Placebo

GSK1349572 placebo taken once daily

OTHER

ABC/3TC

Abacavir/Lamivudine background therapy once daily

OTHER

TDF/FTC

Tenofovir/emtricitabine background therapy once daily

OTHER

raltegravir Placebo

raltegravir placebo taken twice daily

Sponsors & Collaborators

  • Shionogi

    collaborator INDUSTRY

  • GlaxoSmithKline

    collaborator INDUSTRY

  • ViiV Healthcare

    lead INDUSTRY

Principal Investigators

  • GSK Clinical Trials · ViiV Healthcare

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-10-19
Primary Completion
2012-02-06
Completion
2016-12-27

Countries

  • United States
  • Australia
  • Canada
  • France
  • Germany
  • Italy
  • Russia
  • Spain
  • United Kingdom

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 NCT01227824 on ClinicalTrials.gov