Dose-finding Study of GSK2248761 in Antiretroviral Therapy-Naive Subjects (SIGNET)
Status:
Terminated
Trial end date:
2011-07-04
Target enrollment:
Participant gender:
Summary
This 96 week, Phase 2b study in 150 HIV-1 infected antiretroviral (ART) naive adult subjects
consists of a dose-ranging evaluation of GSK2248761 at blinded doses of 100 mg and 200 mg
once daily with a control arm of open-label efavirenz (EFV) 600 mg once daily. The background
ART for all 3 arms will be chosen by the Investigators and will be either abacavir/lamivudine
[ABC/3TC] or tenofovir/emtricitabine [TDF/FTC] fixed dose combination (FDC) tablets.
Antiviral activity, safety, PK, and development of viral resistance will be evaluated.