A Study to Assess Dolutegravir in HIV-infected Subjects With Treatment Failure on an Integrase Inhibitor Containing Regimen. (VIKING-3)
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 Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||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.|
- The mean change from Baseline in plasma HIV-1 RNA at Day 8 [ Time Frame: Baseline and Day 8 ] [ Designated as safety issue: No ]
- The proportion of subjects with HIV-1 RNA <50copies/mL at Week 24 [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
- The number of subjects with clinical or laboratory adverse events and the severity of such events over time [ Time Frame: 24 weeks and beyond ] [ Designated as safety issue: No ]
- The proportion of subjects with HIV-RNA <400copies/mL and <50copies/mL over time as well as changes from Baseline in HIV-RNA [ Time Frame: Baseline, Weeks 24, 48 ] [ Designated as safety issue: No ]
- The absolute values and change from baseline in CD4+ and CD8+ cell counts over time [ Time Frame: Baseline and Weeks 24, 48 ] [ Designated as safety issue: No ]
- The incidence of HIV-1 disease progression (AIDS and death) [ Time Frame: Weeks 24, 48 ] [ Designated as safety issue: No ]
- Pharmacokinetic parameters of DTG over time as measured by Area Under the Curve, maximum and minimum concentrations of DTG [ Time Frame: Day 8, Weeks 4, 24 ] [ Designated as safety issue: No ]
- Development of genotypic and phenotypic viral resistance to DTG, raltegravir and other on study ARTs [ Time Frame: throughout the study at time of virological failure and up to Week 48 ] [ Designated as safety issue: No ]
|Study Start Date:||May 2011|
|Estimated Study Completion Date:||January 2016|
|Primary Completion Date:||May 2012 (Final data collection date for primary outcome measure)|
dolutegravir plus background antiretroviral therapy optimised at Day 8
50 mg twice daily
ING112574 is a Phase 3, multicentre, open-label, single arm study to assess the antiviral activity and safety of DTG containing regimen in HIV-1 infected ART-experienced adults with historical or current evidence of resistance to RAL or ELV. Initially, a minimum of 100 subjects will be enrolled to receive DTG 50mg twice daily with the current failing regimen for 7 days but with OBR from Day 8. Subjects must also have documented genotypic and/or phenotypic resistance to at least one compound in two or more of the other approved classes of ART but must also be able to include at least one fully active drug in the OBR to be started Day 8. The first data cut will take place after the (approximate) 100th subject enrolled completes the Week 24 visit. Enrollment will continue until a further 50 to 100 subjects have been recruited. All subjects who successfully complete 24 weeks of treatment will continue to have access to DTG until it is locally available as long as they continue to derive clinical benefit.
ViiV Healthcare is the sponsor of this study.
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|Study Director:||GSK Clinical Trials||ViiV Healthcare|