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

Prior treatment

• 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)

Other illness

• 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

Lab values

• 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

Other

• 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

• 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)