A Phase 2B Multicenter, Randomized, Comparative Trial Of UK-453,061 Versus Etravirine In Combination With Darunavir/Ritonavir And A Nucleos(t)Ide Reverse Transcriptase Inhibitor For The Treatment Of Antiretroviral Experienced HIV-1 Infected Subjects With Evidence Of NNRTI Resistant HIV-1

• Percentage of subjects with HIV-1 RNA <50 copies/mL at 24 weeks. [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  

• The percentage of subjects with HIV-1 RNA <50 copies/mL and <400 copies/mL at various time points [ Time Frame: 24-96 weeks ] [ Designated as safety issue: No ]
  
• The change from baseline in log10 transformed HIV 1 RNA levels [ Time Frame: 24-96 weeks ] [ Designated as safety issue: No ]
  
• Assessment of Genotypic and phenotypic resistance at various time points [ Time Frame: TBD ] [ Designated as safety issue: No ]
  
• The time-averaged difference (TAD) in log10 transformed HIV 1 RNA levels at various time points. [ Time Frame: 24-96 weeks ] [ Designated as safety issue: No ]
  
• The percentage of subjects with virologic response at different time points. [ Time Frame: 48-96 weeks ] [ Designated as safety issue: No ]
  
• Change from baseline in CD4+ cell counts (absolute and percentage). [ Time Frame: 24-96 weeks ] [ Designated as safety issue: No ]
  
• Safety and tolerability as measured by spontaneous adverse event reports, serious adverse events and safety laboratory tests. [ Time Frame: 96 weeks ] [ Designated as safety issue: Yes ]
  
• Pharmacokinetic (PK) and pharmacokinetic/pharmacodynamic (PK/PD) analyses (to be reported separately). [ Time Frame: 48 weeks ] [ Designated as safety issue: No ]
  

The trial was terminated on 12 April, 2012 due to lack of efficacy at the Week 24 analysis. The decision to terminate the trial was not based on any safety concerns.