Dolutegravir and Darunavir Evaluation in Adults Failing Therapy
Status:
Recruiting
Trial end date:
2023-12-31
Target enrollment:
Participant gender:
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.
Phase:
Phase 4
Details
Lead Sponsor:
Kirby Institute
Collaborators:
Janssen Pharmaceutica National Health and Medical Research Council, Australia National Institute of Allergy and Infectious Diseases (NIAID) UNITAID ViiV Healthcare