Can hashtag#Doravirine provide a safer first-line alternative to hashtag#Dolutegravir without compromising virological efficacy?
The ELDORADO trial aims to answer this question through a large international, open-label, randomised, non-inferiority phase III trial comparing doravirine-based versus dolutegravir-based regimens in 610 treatment-naïve people living with HIV-1, recruited across Brazil, Cameroon, Côte d’Ivoire, France, Mozambique and Thailand.
Beyond viral suppression, ELDORADO will generate evidence on key long-term safety outcomes, including weight gain, obesity, hypertension, diabetes, liver and cardiovascular health, mental health and quality of life — major issues amid growing concerns regarding the cardiometabolic effects associated with dolutegravir-based regimens.
The study also includes innovative components such as pharmacokinetic and pharmacogenetic analyses, echocardiography, FibroScan/CAP assessments, liver and metabolic sub-studies, as well as cost-effectiveness analysis and modelling integrating trial and cohort data.
By generating evidence across high-, middle- and low-resource settings, ELDORADO has the potential to inform future HIV treatment strategies, clinical practice and international treatment guidelines, while expanding therapeutic options for people living with HIV worldwide.
Read the protocol in BMJ Open:
