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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
EU CTIS ID: 2023-508626-10-00
What this study is testing
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.
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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
You likely can't join if
- Has ongoing (pulmonary or extra-pulmonary) active tuberculosis
- Requires or is anticipated to require any of the prohibited or contraindicated medications noted in the trial protocol
- Has significant hypersensitivity or other contraindication to any of the components of the study drugs
- Is pregnant, breastfeeding, or expecting to conceive at any time during the study
- Has any condition, which might, in the investigator’s opinion, compromise the safety of treatment and/or patient’s adherence to study procedures
- Is a person under guardianship or deprived of freedom by a judicial or administrative decision
See the full eligibility criteria
- 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)
- Has ongoing (pulmonary or extra-pulmonary) active tuberculosis
- Requires or is anticipated to require any of the prohibited or contraindicated medications noted in the trial protocol
- Has significant hypersensitivity or other contraindication to any of the components of the study drugs
- Is pregnant, breastfeeding, or expecting to conceive at any time during the study
- Has any condition, which might, in the investigator’s opinion, compromise the safety of treatment and/or patient’s adherence to study procedures
- Is a person under guardianship or deprived of freedom by a judicial or administrative decision
- 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 infected with HIV-2 or co-infected with HIV-1 and HIV-2
- Has received cabotegravir long acting or dapivirine pre-exposure prophylaxis (PrEP)
- 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 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 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
The study team makes the final eligibility decision.
Where it's taking place
- Brazil
- Mozambique
- Côte d’Ivoire
- Thailand
- Cameroon
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Brazil; Mozambique; Côte d’Ivoire; Thailand; Cameroon. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.