Early DOlutegravir/LAmivudine Switching After Virological Suppression (EDOLAS Study)
NCT04979468 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 440
Last updated 2021-07-28
Summary
Phase III, randomized, open-label, multicentre, active-controlled, non-inferiority study evaluating the efficacy and safety of early switching to dolutegravir/lamivudine (DTG/3TC) in single-pill, in HIV-1 infected individuals currently taking an INSTI-based three-drug first-line regimen for less than 18 months and who have been virologically suppressed with HIV-1 RNA \<50 copies/mL
Conditions
Interventions
- DRUG
-
DOVATO
Dovato is a medicine for treating infection with human immunodeficiency virus type 1 (HIV-1), a virus that causes acquired immune deficiency syndrome (AIDS).
Sponsors & Collaborators
-
Societa' Italiana Di Malattie Infettive E Tropicali
lead OTHER
Principal Investigators
-
Andrea Andreoni, P.I. · Policlinico Universitario Tor Vergata
-
Alessandra Bandera, P.I. · Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
-
Alessandro Bartoloni, P.I. · Azienda Ospedaliero-Universitaria Careggi
-
Stefano Bonora, P.I. · Ospedale Amedeo di Savoia
-
Antonio Cascio, P.I. · A.O.U. Policlinico "Paolo Giaccone"
-
Antonella Castagna, P.I. · IRCCS Ospedale San Raffaele
-
Annamaria Cattelan, P.I. · Azienda Ospedaliera di Padova
-
Roberto Cauda, P.I. · Fondazione Policlinico Universitario A. Gemelli, IRCCS
-
Benedetto Maurizio Celesia, P.I. · ARNAS Garibaldi
-
Antonella d'Arminio Monforte, P.I. · ASST Santi Paolo e Carlo - Presidio San Paolo
-
Antonio Di Biagio, P.I. · Ospedale Policlinico San Martino di Genova
-
Massimo Antonio Di Pietro, P.I. · Azienda Ospedaliero-Universitaria Careggi
-
Massimiliano Fabbiani, P.I. · Azienda Ospedaliera Universitaria Senese
-
Roberto Gulminetti, P.I. · Fondazione IRCCS Policlinico San Matteo
-
Giuseppe Lapadula, P.I. · Ospedale San Gerardo di Monza
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Giordano Madeddu, P.I. · Strutture Ospedaliere - Cliniche San Pietro - AOU Sassari
-
Franco Maggiolo, P.I. · ASST Papa Giovanni XXIII
-
Cristina Mussini, P.I. · Azienda Ospedaliero-Universitaria di Modena
-
Massimo Puoti, P.I. · ASST Grande Ospedale Metropolitano Niguarda
-
Giuliano Rizzardini, P.I. · ASST Fatebenefratelli Sacco
-
Stefano Rusconi, P.I. · ASST Fatebenefratelli Sacco
-
Annalisa aracino, P.I. · Azienda Ospedaliera Universitaria Policlinico di Bari
-
Laura Sighinolfi, P.I. · Azienda Ospedaliera Universitaria Ferrara
-
Gabriella d'Ettorre, P.I. · A.O.U. Policlinico Umberto I
Study Design
- Allocation
- RANDOMIZED
- Purpose
- OTHER
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2021-03-23
- Primary Completion
- 2023-04-01
- Completion
- 2024-04-01
Countries
- Italy
Study Locations
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