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

NCT06203132 | Recruiting Phase 3 DMC

• 1 other identifier: ANRS 0392s ELDORADO
• Study Type: interventional
• Target: 610
• Locations: 6 countries
• Sites: 19

Brief Summary

Phase III trial evaluating doravirine as an alternative to dolutegravir in treatment naïve people living with HIV-1 infection.

Conditions

HIV-1-infection

Keywords

HIV-1; ART-naïve; doravirine; dolutegravir; non-inferiority

Outcome Measures

Primary Outcomes (1)

• Non-inferiority of doravirine in combination with tenofovir and lamivudine as compared to dolutegravir in combination with tenofovir and lamivudine or emtricitabine in terms of virological efficacy at week 48

  The non-inferiority will be assessed in terms of virologic efficacy at week 48 under allocated treatment using the FDA snapshot algorithm (window period of 42-54 weeks), and measured by the proportion of subjects achieving a rate of 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 rate of HIV 1 RNA will be measured by RT-PCR.

  Week 48

Secondary Outcomes (38)

• Occurrence of obesity

  Week 48; Week 96

• Occurrence of insulin resistance

  Week 48; Week 96

• Occurrence of hypertension

  Week 48; Week 96

• Non-inferiority of DOR in association with TDF and 3TC, compared to DTG in association with TDF and 3TC or FTC, in terms of virologic efficacy

  Week 96

• Occurrence of virological failures

  Virological failure

Study Arms (2)

Doravirine arm

EXPERIMENTAL

Doravirine (100 mg) + tenofovir DF (300 mg) + lamivudine (300mg) administered daily

Drug: Doravirine + tenofovir DF + lamivudine

Dolutegravir arm

ACTIVE COMPARATOR

Dolutegravir (50 mg) + tenofovir DF 300 mg + XTC (300 mg if lamivudine or 200 mg if emtricitabine) administered daily

Drug: Dolutegravir + tenofovir DF + lamivudine or emtricitabine

Interventions

Doravirine + tenofovir DF + lamivudine DRUG

Oral administration

Also known as: Delstrigo

Doravirine arm

Dolutegravir + tenofovir DF + lamivudine or emtricitabine DRUG

Oral administration

Dolutegravir arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify 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) including investigational antiretroviral agents
• For 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.
• Has ongoing (pulmonary or extra-pulmonary) tuberculosis
• 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 (in France and where national guidelines recommend screening for primary resistance before starting first-line ART) 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

Sponsors & Collaborators

• ANRS, Emerging Infectious Diseases: lead
• MSD France: collaborator
• European and Developing Countries Clinical Trials Partnership (EDCTP): collaborator

Study Sites (19)

Hospital Geral de Nova Iguaçu

Nova Iguaçu, Rio de Janeiro, 26030-380, Brazil

RECRUITING

Laboratory on Clinical research on AIDS-INI FIOCRUZ

Rio de Janeiro, Rio de Janeiro, 21040-900, Brazil

RECRUITING

Hôpital Central de Yaoundé

Yaoundé, Cameroon

RECRUITING

Centre de prise en charge de Recherche et de Formation (CEPREF)

Abidjan, Côte d’Ivoire

NOT YET RECRUITING

Centre Médical de Suivi des Donneurs de Sang (CMSDS) - Centre National de Transfusion Sanguine (CNTS)

Abidjan, Côte d’Ivoire

NOT YET RECRUITING

CHU de Treichville, Service des Maladies Infectieuses et Tropicales (SMIT)

Abidjan, Côte d’Ivoire

RECRUITING

CHU Bordeaux Pellegrin - Service des Maladies Infectieuses et Tropicales

Bordeaux, 33075, France

RECRUITING

CHU Bordeaux St André - Service de Médecine Interne

Bordeaux, 33075, France

RECRUITING

CHU Montpellier - Hôpital La Colombière - Service des Maladies Infectieuses et Tropicales

Montpellier, 34295, France

RECRUITING

CHU Nantes Hôtel Dieu - Service des Maladies infectieuses et tropicales

Nantes, 44093, France

RECRUITING

AP-HP Hôpital Lariboisière - Service de Maladies Infectieuses et Tropicales

Paris, 75010, France

RECRUITING

AP-HP Hôpital Saint Louis - Service des Maladies Infectieuses et Tropicales

Paris, 75010, France

RECRUITING

AP-HP Hôpital Saint Antoine - Service des Maladies Infectieuses et Tropicales

Paris, 75012, France

RECRUITING

AP-HP Hôpital Pitié Salpêtrière - Service des Maladies Infectieuses et Tropicales

Paris, 75013, France

RECRUITING

AP-HP Bichat Claude Bernard - Service des Maladies Infectieuses et Tropicales

Paris, 75018, France

RECRUITING

Centro de Saúde 1o de Maio

Maputo, Mozambique

RECRUITING

Chiangrai Prachanukroh

Chiang Rai, 57000, Thailand

NOT YET RECRUITING

Lampang Hospital Internal Medicine department

Lampang, 52000, Thailand

NOT YET RECRUITING

Phayao Hospital Internal Medicine department

Phayao, 56000, Thailand

NOT YET RECRUITING

Related Publications (1)

• L'hostellier A, Kouanfack C, Chazallon C, Wagner-Cardoso S, Eholie SP, Banze N, Halue G, Capeau J, Delaugerre C, Moh R, Bonnet F, Mfeukeu Kuate L, Jaquet A, Perazzo H, Bernard C, Bastard JP, Goldwirt L, Vilquin P, Nhassengo PP, Lavalee M, Minvielle N, Dodd PJ, Marcy O, Molina JM, Grinsztejn B, Sellier PO. Doravirine versus dolutegravir-based regimen in antiretroviral treatment-naive people living with HIV-1 (ANRS0392s ELDORADO): protocol for an international, open-label, randomised, non-inferiority, phase III trial. BMJ Open. 2026 Feb 5;16(2):e110560. doi: 10.1136/bmjopen-2025-110560.

  PMID: 41644158 DERIVED

MeSH Terms

Interventions

doravirine; Tenofovir; Lamivudine; dolutegravir; Emtricitabine

Intervention Hierarchy (Ancestors)

Organophosphonates; Organophosphorus Compounds; Organic Chemicals; Adenine; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Zalcitabine; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Dideoxynucleosides

Study Officials

• Pierre SELLIER, Dr

  Assistance Publique - Hôpitaux de Paris

  PRINCIPAL INVESTIGATOR

• Beatriz GRINSZTEJN, Pr

  INI-FIOCRUZ

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Anthony L'HOSTELLIER

CONTACT

33 (0)5 57 57 47 11; anthony.lhostellier@u-bordeaux.fr

Olivier MARCY, Dr

CONTACT

33 (0)5 57 57 13 93; olivier.marcy@u-bordeaux.fr

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 6, 2023
• First Posted: January 12, 2024
• Study Start: January 27, 2025
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): November 1, 2027
• Last Updated: January 7, 2026

Record last verified: 2026-01

Locations

FR (9); CA (1); BR (2); MO (1); TH (3); CÔ (3)