Conditions: Infection, Human Immunodeficiency Virus
Keywords: GSK1349572 emtricitabine tenofovir efavirenz abacavir antiretroviral therapy naive dose selection HIV-1 Infection integrase inhibitor HIV infection once daily lamivudine
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 208
Healthy volunteers: no

Brief summary:
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.

Detailed description:
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.

Arms:
arm 1: subjects will receive GSK1349572 10mg once daily blinded to dose arm 2: subjects will receive GSK1349572 25mg once daily blinded to dose arm 3: subjects will receive GSK1349572 50mg once daily blinded to dose arm 4: efavirenz will serve as the internal control arm

Interventions: intervention 1: GSK1349572 intervention 2: efavirenz
Intervention descriptions: intervention 1: investigational HIV-1 integrase inhibitor intervention 2: approved therapy for HIV-1 infection, used as an internal study control

Protocol document: