A Phase III, randomised, multicentre, parallel-group, non-inferiority study evaluating the efficacy, safety, and tolerability of switching to dolutegravir plus lamivudine in HIV-1-infected adults who are virologically suppressed
This study will compare safety, efficacy, and tolerability of a two drug regimen of dolutegravir (DTG) plus lamivudine (3TC) administered once daily with DTG plus two nucleoside reverse transcriptase inhibitors (tenofovir disoproxil fumarate [TDF]/emtricitabine [FTC] as a fixed dose combination) administered once daily in HIV-positive adult subjects that have not previously received antiretroviral therapy.
The study is designed to demonstrate the non-inferior antiviral activity of DTG + 3TC regimen to that of DTG + TDF/FTC and will characterise the long-term antiviral activity, tolerability and safety of DTG + 3TC through Week 148.
Approximately, 700 subjects will be randomised 1:1 to receive DTG + 3TC or DTG + TDF/FTC. Subjects will be stratified by screening HIV viral load and CD4 cell count.
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