Last updated 52 days ago

DORAvirine Versus DOlutegravir Based Antiretroviral Regimens in Treatment-naïve People Living With HIV-1 Infection

610 patients around the world

Available in Brazil

Phase III, multicenter, open-label, randomized, non-inferiority clinical trial which aims to assess the non-inferiority of doravirine in association with tenofovir and lamivudine, as compared to dolutegravir in association with tenofovir and lamivudine or emtricitabine. This trial will be implemented in Brazil, Cambodia, Cameroon, Côte d'Ivoire, France and Mozambique. Six hundred and ten patients will be enrolled and followed for 96 weeks after entry in the trial (=ART initiation). Primary endpoint will assess virological 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. Secondary endpoints are planned at W48 and W96.

ANRS, Emerging Infectious Diseases

610Patients around the world

Requirements for the patient

From 18 Years

All Gender

Medical requirements

: 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) including investigational antiretroviral agents
For women of childbearing potential i.e. women 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.

: Has ongoing (pulmonary or extra-pulmonary) tuberculosis (due to rifampin-doravirine drug-drug interaction)
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 documented or known resistance to study drugs (in France and where national guidelines recommend screening for primary resistance before starting first-line ART), as defined below:
Resistance to doravirine: V106A, V106M, Y188L, G190E/S, F227C, M230L, L100I+K103N, K103N+Y181C, K103N+P225H, at least 2 among: A98G, L100I, K101E, V106I, E138K, Y181C/V, G190A or H221Y
Resistance to dolutegravir QD: G118R, F121Y, E138A/K/T, G140A/C/S, N144D, Q148H/K/R, V151L, S153F/Y, N155H, S230R, R263K, T66K+L74M, L74I+E92Q, T66K.
Resistance to lamivudine/emtricitabine: K65R, T69INS, M184V/I, Q151M
Resistance to tenofovir: K65R/E/N, K70E, T69INS, at least 3 mutations among M41L, E44D, D67N, T69D/N/S, L74V/I, L210W, T215A/C/D/E/G/H/I/L/N/S/V/Y/F
Have 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
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
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.
Has a current (active) diagnosis of acute hepatitis, with AST (SGOT) and ALT (SGPT) >4.0 x ULN, due to any cause.
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 procedure.
Is a person under guardianship or deprived of freedom by a judicial or administrative decision.

StudyELDORADO

SponsorANRS, Emerging Infectious Diseases

Requirements

From 18 YearsAll Gender

Unique study IDclinicaltrials.gov

NCT06203132