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drugset / Trial / NCT06203132

DORAvirine Versus DOlutegravir Based Antiretroviral Regimens in Treatment-naïve People Living With HIV-1 Infection

NCT06203132 ↗

Phase 3 Recruiting 610 enrolled ANRS, Emerging Infectious Diseases European and Developing Countries Clinical Trials Partnership (EDCTP) · collab MSD France · collab

RandomizedParallel-groupOpen-labelTreatment

Summary

Phase III trial evaluating doravirine as an alternative to dolutegravir in treatment naïve people living with HIV-1 infection.

Timeline

Start: 2025-01-27
Primary completion: 2026-11
Completion: 2027-11

Publications

L'hostellier A, Kouanfack C, Chazallon C, Wagner-Cardoso S, Eholie SP, Banze N, Halue G, Capeau J, Delaugerre C, Moh R, Bonnet F, Mfeukeu Kuate L, Jaquet A, Perazzo H, Bernard C, Bastard JP, Goldwirt L, Vilquin P, Nhassengo PP, Lavalee M, Minvielle N, Dodd PJ, Marcy O, Molina JM, Grinsztejn B, Sellier PO. Doravirine versus dolutegravir-based regimen in antiretroviral treatment-naive people living with HIV-1 (ANRS0392s ELDORADO): protocol for an international, open-label, randomised, non-inferiority, phase III trial. BMJ Open. 2026 Feb 5;16(2):e110560. doi: 10.1136/bmjopen-2025-110560.

Drugs

Evaluation	Drug	Modality	Dose	Route
Comparator	Dolutegravir	Other / unclassified	50 mg	Oral
Subject	Doravirine	Small molecule	100 mg	Oral
Background	Lamivudine	Other / unclassified	300 mg	Oral
Background	Tenofovir disoproxil fumarate	Small molecule	300 mg	Oral
Comparator	emtricitabine	Other / unclassified	200 mg	Oral

Indications