Phase III Open-label Randomized Trial Comparing Doravirine Versus Dolutegravir Based Antiretroviral Regimens in Treatment-naïve People Living With HIV-1 Infection

What this Trial Is About

Researchers are evaluating doravirine as an alternative to dolutegravir in people living with HIV-1 who have not yet received treatment. This Phase III, open-label, randomized trial aims to determine if doravirine combined with tenofovir and lamivudine is not less effective than dolutegravir combined with tenofovir and lamivudine or emtricitabine. The study will include 610 participants across multiple countries including Brazil, Cameroon, Côte d'Ivoire, France, Mozambique, and Thailand, followed for 96 weeks after starting antiretroviral therapy (ART). Participants are randomly assigned to one of two groups: one receiving doravirine (100 mg) plus tenofovir DF (300 mg) and lamivudine (300 mg) daily, and the other receiving dolutegravir (50 mg) plus tenofovir DF (300 mg) and either lamivudine (300 mg) or emtricitabine (200 mg) daily. The trial is designed to compare these regimens over a period of up to 96 weeks, with a primary focus on viral suppression at Week 48. During the study, participants will have regular assessments including measurements of viral load, drug resistance, metabolic effects, body weight changes, liver and kidney function, and mental health. Researchers will monitor adherence to the treatment and collect blood samples to study drug concentrations and immune cell counts. Safety and tolerability will be evaluated through Week 96, with additional analyses of metabolic and cardiovascular health and quality of life. The total participation duration is up to 96 weeks following treatment start.

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