A Prosp., Multic., Randomized, Open-label Trial to Assess the Safety, Tolerability and Efficacy of Dual Therapy With Boosted Darunavir + Dolutegravir When Switching From SOC ART in HIV-patients With Sustained Virological Suppr. (Dualis)

NCT02486133 Phase 3 COMPLETED

A switch strategy to investigate whether a dual therapy with Ritonavir-boosted (RTV) Darunavir (DRV) + Dolutegravir (DTG) over 48 weeks is non-inferior to a continuous standard of care therapy with RTV-boosted DRV in combination with 2 Nucleosidic Reverse Transcriptase Inhibitors (NRTIs) in HIV patients, who are on a stable antiretroviral therapy (ART) with RTV-boosted DRV in combination with 2 NRTIs.

Details

Lead sponsor	Technical University of Munich
Phase	Phase 3
Status	COMPLETED
Enrolment	269
Start date	2015-07
Completion	2018-05-31

Conditions

• HIV-Infection

Interventions

• Prezista
• Norvir
• Tivicay
• Truvada
• Kivexa
• Descovy

Primary outcomes

• number (%) of patients with fully suppressed HIV RNA < 50 cps/ml at week 48 — 48 weeks
  For primary endpoint, HIV RNA suppression \< 50 cps/ml will be assessed at week 48, using NAT diagnostic.

Countries

Germany