A phase IIIb/IV randomized open-label trial to compare Dolutegravir + pharmaco-enhanced Darunavir versus recommended standard of care antiretroviral regimens in patients with HIV infection who have failed recommended first line therapy

Project no.: HIV-NAT 246/ D2EFT: Dolutegravir and Darunavir Evaluation in adults Failing Therapy (NCT03017872)

This is a phase IIIB/IV randomised open-label trial to compare dolutegravir + pharmaco-enhanced darunavir versus recommended standard of care antiretroviral regimens in patients with HIV infection who have failed recommended first line therapy.

Brief Summary: D²EFT is a randomised, open-label study in HIV-1 infected patients failing first-line antiretroviral therapy (ART). The study compares 2 regimens of second-line ART (dolutegravir and darunavir pharmaco-enhanced with ritonavir and dolutegravir and 2 prespecified NRTIs) with the WHO recommended regimen of 2NRTIs plus a ritonavir-boosted PI (Standard of Care (SOC)). 1,010 participants from 14 predominantly low-middle income countries will be followed for 96 weeks with the primary endpoint at week 48. The design is based on the hypothesis that one or both of the new regimens will be non-inferior to SOC in terms of virologic control while being easier to take, economically viable and affording simplification of treatment programs.