TANGO

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.

Key Project Information

Dates: 11th April 2018 - (ongoing)

UCL lead/Principal Investigator: Dr Sarah Pett

Lead organisation: MRC Clinical Trials Unit at UCL

Partners: Central and North West London NHS Foundation Trust

Location: UK

Funding: GSK/ViiV Healthcare

Contact: mmc-research-cnwl@nhs.net

Website: www.clinicaltrials.gov/ct2/show/NCT02831764

Research Team

Dr Lewis Haddow

Gaynor Lawrenson