Taking people in FrancePhase 3
Compares two HIV treatment combinations in people starting HIV medicine
Tests doravirine against dolutegravir, each with two other HIV medicines, in adults new to treatment.
Key facts
- Who runs it
- Inserm
- Where
- Bordeaux, Montpellier, Nantes, Paris, and Paris Cedex 12, FranceSee the 9 sites
- Trial code
- Registry title
- ANRS0392s ELDORADO : Phase III, open-label, randomized, multicenter trial EvaLuating the non-inferiority of DORAvirine versus DOlutegravir based antiretroviral regimens in treatment-naïve people living with HIV-1 infection
- Status
- Recruiting
- Phase
- Phase 3
- People taking part
- 60 people, planned
- Started
- 8 Jan 2025
- Expected to end
- 1 Dec 2027
- Type of study
- Interventional, 2 groupsOne group gets an existing treatment, for comparison.
- Record updated
- 25 September 2026
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with HIV-1 who have never taken HIV medicine and have a viral load of at least 1,000 copies/mL. It compares two HIV drug combinations.
- Age
- 18 years or older
- Sex
- All sexes can join.
- Disease stage
- HIV-1 infection with plasma HIV-1 RNA of 1000 copies/mL or more within 30 days before randomization, and a doctor's decision that HIV treatment is needed.
- Earlier treatment
- Must never have taken antiretroviral therapy (ART) for HIV. Cannot have had oral PrEP or PEP in the past three months, or lenacapavir, long-acting cabotegravir or dapivirine PrEP.
- Biomarker or test result
- HIV-1 positive test. No known or possible resistance to the study drugs.
Main reasons for not taking part
- Active tuberculosis
- HIV-2 infection, or HIV-1 and HIV-2 together
- Kidney function below 60 mL/min/1.73m² or liver tests (AST, ALT) above 4.0 x the upper limit of normal
- Pregnant, breastfeeding, or planning to conceive during the study
- Recent use of immune-suppressing therapy or an investigational drug within 30 days
The registry criteria, word for word
Show all 23 criteriaShow less
Who can take part
- Be at least 18 years of age on the day of signing the informed consent
- Be HIV-1 positive as determined according to national testing strategies
- Have a plasma HIV-1 RNA ≥1000 copies/mL within 30 days prior to the randomization
- Have HIV treatment indication based on physician assessment according to local treatment guidelines
- Be naïve to antiretroviral therapy (ART) for the treatment of HIV infection including investigational antiretroviral agents
- For cisgender women or transgender men of childbearing potential i.e. of childbearing age who are not menopausal, or permanently sterilized (e.g. tubal occlusion, hysterectomy, bilateral salpingectomy) or not refraining from sexual activity: negative urinary test for pregnancy and acceptance to use contraceptive methods
- Understand the study procedures and voluntarily agree to participate by giving written informed consent for the trial
- For participants in France, be affiliated to a Social Security program or CMU (Universal Health Cover)
Who cannot take part
- Has received oral pre-exposure prophylaxis (PrEP) or post-exposure prophylaxis (PEP) in the past three months or has had no negative HIV-1 serology performed
- Has documented or known resistance or possible resistance to study drugs as defined by the ANRS MIE AC43 Resistance group
- Has participated in a study with an investigational compound/device within 30 days prior to signing informed consent or anticipates participating in such a study involving an investigational compound/device during the course of this study
- Has used systemic immunosuppressive therapy or immune modulators within 30 days prior to treatment in this study or is anticipated to need them during the course of the study
- Requires or is anticipated to require any of the prohibited or contraindicated medications noted in the trial protocol
- Has received lenacapavir or cabotegravir long acting or dapivirine pre-exposure prophylaxis (PrEP)
- Has ongoing (pulmonary or extra-pulmonary) active tuberculosis
- For participants in Cameroon, infection with HIV-1 subtype O
- Has significant hypersensitivity or other contraindication to any of the components of the study drugs
- Has any condition, which might, in the investigator’s opinion, compromise the safety of treatment and/or patient’s adherence to study procedures
- Is infected with HIV-2 or co-infected with HIV-1 and HIV-2
- Has the following laboratory values at screening visit, within 30 days prior to the randomization: AST (SGOT) and ALT (SGPT) >4.0 x upper limit of normal (ULN) - estimated glomerular filtration rate at time of screening <60 mL/min/1.73m², based on the CKD-EPI equation
- Has any other history or current evidence of any condition, therapy, laboratory abnormality or other circumstance that might confound the results of the study or interfere with the subject’s participation for the full duration of the study, such that it is not in the best interest of the subject to participate
- Is pregnant, breastfeeding, or expecting to conceive at any time during the study
- Is a person under guardianship or deprived of freedom by a judicial or administrative decision
Where in France
- Hôpital Saint-AndréBordeaux, FranceTaking people
- Pellegrin HospitalBordeaux, FranceTaking people
- Hopital la ColombiereMontpellier, FranceTaking people
- CHU NantesNantes, FranceTaking people
- APHP Bichat-Claude BernardParis, FranceTaking people
- Hôpital de la Pitié-SalpêtrièreParis, FranceTaking people
- Hôpital Lariboisière APHPParis, FranceTaking people
- Hopital Saint LouisParis, FranceTaking people
- Hopital Saint AntoineParis Cedex 12, FranceTaking people
About the trial
What the trial wants to find out
To assess the non-inferiority of doravirine (DOR) in association with tenofovir (TDF) and lamivudine (3TC), compared to dolutegravir (DTG) in association with tenofovir (TDF) and lamivudine (3TC) or emtricitabine (FTC), in terms of virologic efficacy at week 48, measured by the proportion of subjects achieving HIV 1 RNA <50 copies/mL, in HIV-1 infected, treatment-naive subjects with pre-treatment viral load (HIV-1 RNA) ≥ 1,000 copies/mL.
The 2 groups in the trial
- Doravirine armTreatment being tested
Doravirine (100 mg) + tenofovir DF (300 mg) + lamivudine (300mg) administered daily
Treatment: Doravirine + tenofovir DF + lamivudine
- Dolutegravir armExisting treatment, for comparison
Dolutegravir (50 mg) + tenofovir DF 300 mg + XTC (300 mg if lamivudine or 200 mg if emtricitabine) administered daily
Treatment: Dolutegravir + tenofovir DF + lamivudine or emtricitabine
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov and on the EU's official list of trials (CTIS).
- Official title
- ANRS0392s ELDORADO : Phase III, open-label, randomized, multicenter trial EvaLuating the non-inferiority of DORAvirine versus DOlutegravir based antiretroviral regimens in treatment-naïve people living with HIV-1 infection
- Plain-language title
- Compares two HIV treatment combinations in people starting HIV medicineGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 9 November 2026.
- Publications
- Record updated
- 25 September 2026