Phase III Trial Comparing Doravirine and Dolutegravir-based Treatments for People Living with HIV-1 Who Have Never Received Antiretroviral Therapy

What this Trial Is About

Researchers are evaluating doravirine as an alternative to dolutegravir in people newly diagnosed with HIV-1 infection who have not yet received treatment. This Phase III, open-label, randomized clinical 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 be conducted across multiple countries including Brazil, Cameroon, Cte dIvoire, France, Mozambique, and Thailand, enrolling 610 participants. Participants will be 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 or emtricitabine daily. The treatment period will last for 96 weeks after starting antiretroviral therapy ART, with primary assessment at week 48 to measure viral suppression. During the study, participants will undergo evaluations to monitor viral load, drug resistance, metabolic health, body weight changes, liver and kidney function, cardiovascular status, and mental health. Adherence to ART will be tracked, and blood samples will be taken to measure drug levels and immune cell counts. The research team will review virological efficacy and safety outcomes at weeks 48 and 96, supporting a comprehensive understanding of the treatments effects over nearly two years of participation.

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