Gemini: A study evaluating the efficacy, safety and tolerability of dolutegravir plus lamiduvine compared to dolutegravir plus tenofovir/emtricitabine in HIV-1-infected treatment-naïve adults

Q: To demonstrate the non-inferiority of DTG plus 3TC once daily compared to DTG plus tenofovir disoproxil fumerate/emtricitabine (TDF/FTC) fixed-dose combination (FDC) once daily at 48 weeks
POP: 700 HIV-1 infected treatment-naive men and women 18 years of age or older. HIV VL > 1000
MED: Dolutegravir 50mg daily open label + either blinded 3tc 300mg daily OR blinded TDF/FTC 300/200mg daily
DUR: 148 weeks planned with a continuation phase for Dolutegravir/3tc arm providing drug until FDC available or development terminated
CALL: Erin Hoffman 919-843-0720 or Donna Pittard, RN 919- 843-6512