A Pilot Study Assessing the Integrase Inhibitor GSK1349572 in HIV-infected Persons With Virus Resistant to Raltegravir
Status:
Completed
Trial end date:
2015-01-01
Target enrollment:
Participant gender:
Summary
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.