Infection, Human Immunodeficiency Virus Clinical Trial
Official title:
A Pilot Study to Assess the Antiviral Activity of GSK1349572 Containing Regimen in Antiretroviral Therapy (ART)-Experienced, HIV-1-infected Adult Subjects With Raltegravir Resistance
Integrase is an enzyme produced by HIV so that the virus can multiply in the human body.
GSK1349572 is a new drug in the integrase inhibitor class that prevents the enzyme from
working properly and therefore prevents the virus from multiplying.
GSK1349572 has shown to be effective against viruses in a short-term monotherapy study in
adults with no previous exposure to integrase inhibitors. The purpose of this study is to
determine whether GSK1349572 is effective in the treatment of HIV-infected patients who no
longer respond to treatment with the approved integrase inhibitor raltegravir and carry
viruses with resistance to this drug. The safety and efficacy of GSK1349572 50mg once daily
in combination with the background HIV drugs previously administered (unless discontinuation
of a particular drug is required) will be assessed over 10 days (functional monotherapy
phase), followed by the evaluation of the safety and efficacy of GSK1349572 given with a new
optimised background regimen from Day 11 through at least Week 24.
Study (ING112961) is a Phase IIb, multicentre, open-label, single arm, two cohorts, pilot
study to assess the antiviral activity of GSK1349572 containing regimen in HIV-1 infected
ART-experienced adults with raltegravir (RAL) resistance. The study will include
approximately 50 ART-experienced subjects with either current or past virologic failure to
RAL. All subjects must harbour isolates with RAL resistance mutations at Screening. Subjects
should also have documented genotypic and/or phenotypic resistance to at least one compound
from each of three or more of the approved classes of ART (including integrase inhibitors
[INIs]). Subjects with current RAL virologic failure will substitute RAL with GSK1349572
50mg once daily and continue the remaining components of their failing regimen through Day
10. Subjects with historical RAL virologic failure will add GSK1349572 50mg once daily to
their failing regimen through Day 10. On Day 11 all subjects will continue GSK1349572 and
optimize their background therapy. Antiviral activity, safety and tolerability of GSK1349572
will be evaluated at Day 11 and over time through at least Week 24.
ViiV Healthcare is the new sponsor of this study, and GlaxoSmithKline is in the process of
updating systems to reflect the change in sponsorship.
;
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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