EMERALD

A randomised, active-controlled, open-label study to evaluate the efficacy and safety of switching to a D/C/F/TAF once-daily single-tablet regimen versus continuing the current regimen consisting of a boosted protease inhibitor (bPI) combined with FTC/TDF

Project Summary

This is a randomised, active-controlled, open-label, multicenter study in virologically-suppressed, HIV-1 infected adult participants.

The study will include a Screening Period of approximately 30 days, a controlled Treatment Period of 48 weeks, an Extension Phase of 48 weeks. All eligible participants will be randomly assigned to receive either current treatment regimen - a boosted protease inhibitor (darunavir or atazanavir with low-dose ritonavir or cobicistat, or lopinavir/ritonavir) combined with FTC/TDF, or the experimental treatment regimen comprising the fixed-dose combination of darunavir/cobicistat/FTC/TAF once-daily for 48 weeks.

After completion of week 48, participants assigned to the experimental treatment will continue with D/C/F/TAF in the extension phase up to week 96. Participants who continued their current regimen will receive the experimental treatment (if all criteria are fulfilled) at week 52 up to week 96.

As from Week 96, all participants will be given the option to continue D/C/F/TAF treatment, if they wish and if they continue to benefit from it until D/C/F/TAF becomes commercially available and is reimbursed, or can be accessed through another source in the country where he/she is living, or until the sponsor terminates clinical development.