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

Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorANRS, Emerging Infectious Diseases

About this trial

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

Eligibility criteria

Qualifiers

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

Disqualifiers

None

Trial design

Treatments tested in this trial

  • Doravirine + tenofovir DF + lamivudine
  • Dolutegravir + tenofovir DF + lamivudine or emtricitabine

Treatment groups

610 Participants
are divided into 2 treatment groups

Locations

19
Brazil
Hospital Geral de Nova Iguaçu26030-380, Nova IguaçuRio de Janeiro, Brazil
Laboratory on Clinical research on AIDS-INI FIOCRUZ21040-900, Rio de JaneiroRio de Janeiro, Brazil
Cameroon
Hôpital Central de Yaoundé Yaoundé Cameroon
Côte d’Ivoire
Centre de prise en charge de Recherche et de Formation (CEPREF) Abidjan Côte d’Ivoire

Sponsors and collaborators

ANRS, Emerging Infectious Diseases

Lead sponsor

MSD France

Collaborator

European and Developing Countries Clinical Trials Partnership (EDCTP)

Collaborator