ANRS 0392s ELDORADO: Non-inferiority of doravirine to dolutegravir
The Eldorado trial is a phase III, open-label, randomised, multi-centre trial evaluating the non-inferiority of doravirine versus dolutegravir-based antiretroviral regimens in treatment-naive people living with HIV-1.
Last updated on 13 June 2025
The essential
- The Eldorado trial is designed to compare the virological efficacy and metabolic tolerance of doravirine with that of dolutegravir in treatment-naive people living with HIV-1.
- Conducted in six countries, including France, this phase III trial involves 610 participants followed for 96 weeks.
- The aim is to determine whether doravirine can be a safe and effective therapeutic alternative, particularly in resource-limited settings.
A primary objective of non-inferiority
The aim of this research is to show that doravirine-based antiretroviral therapy (ART) is non-inferior in efficacy to dolutegravir-based ART. The advantage of this combination would be to reduce the side effects associated with dolutegravir, in particular the moderate weight gain observed in patients receiving dolutegravir. If the results of this research are conclusive, doravirin-based treatment could be extended and recommended for HIV-1-infected people who are naive to ART.
The primary objective is to determine whether participants taking doravirine have a non-inferior response to their treatment compared with participants taking dolutegravir. This non-inferiority will be determined after 48 weeks of treatment by comparing the HIV-1 viral load in the blood according to the treatment received.
Secondary objectives of the research include comparison of HIV-1 levels in the blood between the two treatments after 96 weeks of treatment (22 months), assessment of resistance to treatment in the event of failure, and side-effects (notably obesity, hypertension or diabetes).
News
The ANRS0392s ELDORADO trial started in France in the first quarter of 2025. The first trial participant was recruited in France on 10 February 2025 and recruitment for the trial is expected to begin soon in Brazil.
The project has been accepted for co-funding by the EDCTP3 at sites in sub-Saharan Africa. The other sites in other countries (Ivory Coast, Mozambique, Cameroon and Thailand) will be activated from July to November 2025 once the EDCTP3 project has officially started and all the conditions have been met for inclusions to begin in the countries concerned.
The official launch of the EDCTP3 project took place in May 2025.
Find out more
Find out more about the Eldorado trial.
Pathology
VIH-1
Status
Inclusions in progress
Countries
Brasil, Cameroon, France, Ivory Coast, Mozambique, Thailand
