Efficacy and Safety of Tenofovir Plus Lamivudine Plus Efavirenz Regimen as First-line Antiretroviral Therapy

• Percentage of Participants With HIV-1 RNA < 400 Copies/mL at Week 48 [ Time Frame: 48 weeks ] [ Designated as safety issue: No ]
  

• Percentage of Participants With HIV-1 RNA < 400 Copies/mL at Week 96 [ Time Frame: 96 weeks ] [ Designated as safety issue: No ]
  
• Percentage of Participants With HIV-1 RNA < 40 Copies/mL at Week 96 [ Time Frame: 96 weeks ] [ Designated as safety issue: No ]
  
• Change From Baseline in CD4 count at Week 48 [ Time Frame: Baseline and 48 weeks ] [ Designated as safety issue: No ]
  
• Change From Baseline in CD4 count at Week 96 [ Time Frame: Baseline and 96 weeks ] [ Designated as safety issue: No ]
  
• Incidence of adverse events and laboratory abnormalities from baseline to week 48 [ Time Frame: 48 weeks ] [ Designated as safety issue: Yes ]
  
• Incidence of adverse events and laboratory abnormalities from baseline to week 96 [ Time Frame: 96 weeks ] [ Designated as safety issue: Yes ]
  

This study is a prospective, open-label, multi-centered clinical trial to assess the virologic suppression and immune recovery rates as well as tolerability of the regimen 3TC+TDF+EFV in ARV-naive Chinese population.

500 eligible participants will be recruited to take the regimen If the patient fails to tolerate EFV, it can be substituted by NVP when CD4 < 250/μL, and by LPV/r when CD4 > 250/uL. If the patient fails to tolerate TDF, AZT will be an alternative, except when Hb < 90/L or neutrophil count < 0.75×109/L. The participants will be followed up by months 0.5, 1, 2 ,3 and every 3 months subsequently for 2 years.

The efficacy of the regimen will be evaluated by comparison between different points along the time line and previous regimens. The safety of the regimen will be assessed by monitoring kidney function, bone density, cardiovascular profile, lipid profile, liver function etc as well as other adverse events.