Institute for Global Health



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

Project Summary

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.

Links to other research

Other research from the UCL Centre for Clinical Research in Infection and Sexual Health

Other research from IGH on Randomised Controlled TrialsHIV and Treatment

Other research from IGH in the UK