Dual Therapy With Boosted Darunavir + Dolutegravir
NCT02486133 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 269
Last updated 2023-11-29
Summary
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.
Conditions
- HIV-Infection
Interventions
- DRUG
-
Prezista
once daily
- DRUG
-
Norvir
once daily
- DRUG
-
Tivicay
once daily
- DRUG
-
Truvada
once daily
- DRUG
-
Kivexa
once daily
- DRUG
-
Descovy
once daily
Sponsors & Collaborators
-
Technical University of Munich
lead OTHER
Principal Investigators
-
Christoph Spinner, MD · Dep. of Medicine II & IZAR, Klinikum rechts der Isar der TUM
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2015-07-31
- Primary Completion
- 2018-05-31
- Completion
- 2018-05-31
Countries
- Germany
Study Locations
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