Infection, Human Immunodeficiency Virus Clinical Trial
Official title:
A Phase IIb Study to Select a Once Daily Dose of GSK1349572 Administered With Either Abacavir/Lamivudine or Tenofovir/Emtricitabine in HIV-1 Infected Antiretroviral Therapy Naive Adult Subjects
This Phase IIb study in HIV-infected antiretroviral naive subjects will select an optimal once daily dose of GSK1349572 from a range of doses for future evaluation.
This Phase IIb study in HIV-infected antiretroviral naive adult subjects will include a
dose-ranging evaluation of GSK1349572 10mg, 25mg and 50mg once daily blinded doses and a
control arm of open label efavirenz 600mg once daily. Background ART for all study subjects
will be chosen by the investigators and will be either Truvada or Epzicom/Kivexa. Data from
the three doses of GSK1349572 will be compared on the basis of antiviral activity,
safety/tolerability and pharmacokinetics over 16-24 weeks.
Several planned interim analyses will evaluate data in real time; any doses considered
inferior will be dropped and subjects on those doses of GSK1349572 will have the option to
switch to either the highest dose still under investigation or the selected dose. Subjects
will be able to remain in the study, unless they reach a stopping criterion, for at least 96
weeks.
ViiV Healthcare is the new sponsor of this study, and GlaxoSmithKline is in the process of
updating systems to reflect the change in sponsorship.
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