Study Assessing Dolutegravir in HIV-1 Infected Subjects With Virus Resistant to Raltegravir and/or Elivitegravir

PHASE3CompletedINTERVENTIONAL
Enrollment

30

Participants

Timeline

Start Date

April 18, 2012

Primary Completion Date

October 31, 2012

Study Completion Date

December 16, 2013

Conditions
HIV Infections
Interventions
DRUG

Dolutegravir 50 mg twice daily

Active dolutegravir plus failing background regimen (Day 1 to Day 7). Open label dolutegravir plus optimized background regimen (from Day 8)

DRUG

Dolutegravir placebo twice daily

Dolutegravir placebo plus failing background regimen (Day 1 to Day 7)

Trial Locations (25)

10011

GSK Investigational Site, New York

10467

GSK Investigational Site, The Bronx

10595

GSK Investigational Site, Valhalla

14215

GSK Investigational Site, Buffalo

19140

GSK Investigational Site, Philadelphia

20007

GSK Investigational Site, Washington D.C.

20009

GSK Investigational Site, Washington D.C.

22003

GSK Investigational Site, Annandale

27710

GSK Investigational Site, Durham

30912

GSK Investigational Site, Augusta

31401

GSK Investigational Site, Savannah

32803

GSK Investigational Site, Orlando

33316

GSK Investigational Site, Fort Lauderdale

34982

GSK Investigational Site, Ft. Pierce

60153

GSK Investigational Site, Maywood

72207

GSK Investigational Site, Little Rock

75246

GSK Investigational Site, Dallas

78705

GSK Investigational Site, Austin

90069

GSK Investigational Site, Los Angeles

90211

GSK Investigational Site, Beverly Hills

93301

GSK Investigational Site, Bakersfield

92103-8208

GSK Investigational Site, San Diego

06850

GSK Investigational Site, Norwalk

02115

GSK Investigational Site, Boston

08844

GSK Investigational Site, Hillsborough

Sponsors

Lead Sponsor

Collaborators (2)

All Listed Sponsors
collaborator

Shionogi

INDUSTRY

collaborator

GlaxoSmithKline

INDUSTRY

lead

ViiV Healthcare

INDUSTRY

NCT01568892 - Study Assessing Dolutegravir in HIV-1 Infected Subjects With Virus Resistant to Raltegravir and/or Elivitegravir | Biotech Hunter | Biotech Hunter