Project description
Rethinking HIV treatment to safeguard health
Dolutegravir (DTG) is widely used as a first-line HIV treatment, but growing evidence links it to serious side effects, including obesity, diabetes, and hypertension, particularly among women in sub-Saharan Africa. These health risks, alongside mental health and quality-of-life concerns, demand urgent attention. With this in mind, the EU-funded ELDORADO project is investigating doravirine (DOR), a promising but underused alternative. Through a major clinical trial spanning Africa, Asia, Europe, and South America, the project will compare the safety and effectiveness of DOR-based therapies against DTG. It also explores long-term organ effects, mental health, and economic impact, aiming to inform global HIV treatment guidelines and improve outcomes for millions of people living with HIV worldwide.
Objective
The integrase inhibitors dolutegravir (DTG) is recommended by the World Health Organization (WHO) for 1st line antiretroviral therapy (ART) in people living with HIV (PLHIV) since 2018. Despite its high virologic efficacy, there is growing evidence showing massive weight gain and high incidence of metabolic disorders (obesity, type 2 diabetes) and hypertension under DTG, notably among women from sub-Saharan Africa (SSA) women, along with mental health and quality of life issues. The non-nucleoside reverse transcriptase inhibitor doravirine (DOR) is a potent novel ART, recommended in European and North-American guidelines, but not used so far in Southern countries despite interesting virological, safety and resistance profiles. In this context, the ELDORADO project will generate high-quality data on DTG-based ART toxicity and evaluate DOR as an alternative for 1st-line HIV-1 treatment in order to support national and international policymakers in updating national and international guidelines and practices aimed to improve patient outcomes and reduce disease burden of HIV in sub-Saharan Africa and worldwide. The project includes i) a randomized clinical trial assessing the non-inferiority of DOR-based ART as compared to DTG-based ART in terms of virologic efficacy, and its superiority in terms of key safety endpoints (obesity, diabetes, hypertension) in 610 PLHIV from diverse ethnic backgrounds across in SSA (Cameroon, Côte d’Ivoire, Mozambique), Brazil, Thailand, and France, ii) innovative assessments of organ lesions, iii) assessments of mental health and quality of life, iv) health impact and economics modelling based on the trial results as well as that of other trials (NAMSAL) and cohorts (IeDEA West Africa and Brazil). The project will also prioritize capacity building for junior investigators and community advisory board. The ELDORADO trial will be confounded in non-SSA countries by the ANRS|MIE (trial sponsor) and MSD, and benefits from support from the WHO.
Fields of science (EuroSciVoc)
CORDIS classifies projects with EuroSciVoc, a multilingual taxonomy of fields of science, through a semi-automatic process based on NLP techniques. See: The European Science Vocabulary.
CORDIS classifies projects with EuroSciVoc, a multilingual taxonomy of fields of science, through a semi-automatic process based on NLP techniques. See: The European Science Vocabulary.
- medical and health sciences clinical medicine endocrinology diabetes
- medical and health sciences health sciences infectious diseases RNA viruses HIV
- medical and health sciences health sciences nutrition obesity
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Keywords
Project’s keywords as indicated by the project coordinator. Not to be confused with the EuroSciVoc taxonomy (Fields of science)
Project’s keywords as indicated by the project coordinator. Not to be confused with the EuroSciVoc taxonomy (Fields of science)
Programme(s)
Multi-annual funding programmes that define the EU’s priorities for research and innovation.
Multi-annual funding programmes that define the EU’s priorities for research and innovation.
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HORIZON.2.1 - Health
MAIN PROGRAMME
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Topic(s)
Calls for proposals are divided into topics. A topic defines a specific subject or area for which applicants can submit proposals. The description of a topic comprises its specific scope and the expected impact of the funded project.
Calls for proposals are divided into topics. A topic defines a specific subject or area for which applicants can submit proposals. The description of a topic comprises its specific scope and the expected impact of the funded project.
Funding Scheme
Funding scheme (or “Type of Action”) inside a programme with common features. It specifies: the scope of what is funded; the reimbursement rate; specific evaluation criteria to qualify for funding; and the use of simplified forms of costs like lump sums.
Funding scheme (or “Type of Action”) inside a programme with common features. It specifies: the scope of what is funded; the reimbursement rate; specific evaluation criteria to qualify for funding; and the use of simplified forms of costs like lump sums.
HORIZON-JU-RIA - HORIZON JU Research and Innovation Actions
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Call for proposal
Procedure for inviting applicants to submit project proposals, with the aim of receiving EU funding.
Procedure for inviting applicants to submit project proposals, with the aim of receiving EU funding.
(opens in new window) HORIZON-JU-GH-EDCTP3-2024-01-two-stage
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Net EU financial contribution. The sum of money that the participant receives, deducted by the EU contribution to its linked third party. It considers the distribution of the EU financial contribution between direct beneficiaries of the project and other types of participants, like third-party participants.
33000 BORDEAUX
France
The total costs incurred by this organisation to participate in the project, including direct and indirect costs. This amount is a subset of the overall project budget.