Dose-finding Study of GSK2248761 in Antiretroviral Therapy-Naive Subjects (SIGNET)

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.

Timeline

Start

2010-11-18

Primary completion

2011-07-04

Completion

2011-07-04

Publications

• Background 1993 revised classification system for HIV infection and expanded surveillance case definition for AIDS among adolescents and adults. MMWR Recomm Rep. 1992 Dec 18;41(RR-17):1-19.

Drugs

Indications