DUALIS A prospective, multicenter, randomized, open-label trial to assess the safety, tolerability and efficacy of dual therapy with boosted Darunavir + Dolutegravir when switching from standard of care ART in HIV-patients with sustained virological suppression

Registry ID
EUCTR2015-000360-34
Source registry
EUCTR
Status
Prematurely Ended
Phase
PHASE3
Sponsor
Technische Universitaet Muenchen Fakultaet fuer Medizin
Start date
2015-06-26
Last update
2026-08-16

Conditions

Summary

The clinical trial investigates whether a switch strategy of dual therapy with DRV/r + DTG is non-inferior with respect to HIV RNA < 50 cps/ml (ITTe analysis, FDA snapshot analysis (missing, switch or discontinuation of investigational study drugs for any reason = failure; change of NRTI backbone combination will not be classified as failure for primary endpoint analysis)) to a continuous standard of care therapy with DRV/r in combination with 2 NRTIs (ABC/3TC, F/TDF or F/TAF) over 48 weeks in HIV patients, who are on at least 24 weeks prior to randomisation of a stable and fully suppressive ART, consisting of 2 NRTI (ABC/3TC, F/TDF or F/TAF) in combination with DRV/r for a period of at least 28 days prior to randomisation (HIV RNA < 50 cps/ml and within a period of 24 weeks prior to randomisation with one accepted blip of HIV- RNA < 200 cps/ml).

Locations

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