NCT06203132

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

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

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 610 (estimated)
• Sponsor: ANRS, Emerging Infectious Diseases · Other Government
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

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, Cameroon, Côte d'Ivoire, France, Mozambique and Thailand. 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.

Conditions

• HIV-1-infection

Interventions

Type	Name	Description
DRUG	Doravirine + tenofovir DF + lamivudine	Oral administration
DRUG	Dolutegravir + tenofovir DF + lamivudine or emtricitabine	Oral administration

Timeline

• Start date: 2025-01-27
• Primary completion: 2026-11-01
• Completion: 2027-11-01
• First posted: 2024-01-12
• Last updated: 2026-01-07

Locations

19 sites across 6 countries: Brazil, Cameroon, Côte d’Ivoire, France, Mozambique, Thailand