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Researchers are evaluating doravirine combined with tenofovir and lamivudine as an alternative to dolutegravir combined with tenofovir and lamivudine or emtricitabine in adults living with HIV-1 who have never received treatment before. This Phase III, open-label, randomized, non-inferiority trial is conducted in multiple countries including Brazil, Cameroon, Côte d'Ivoire, France, Mozambique, and Thailand. The study aims to compare the effectiveness of these regimens by measuring the control of HIV viral load at 48 weeks. Participants will be randomly assigned to receive either doravirine plus tenofovir and lamivudine or dolutegravir plus tenofovir and lamivudine or emtricitabine, all given orally. The study will follow 610 participants for a total of 96 weeks after starting antiretroviral therapy. Primary evaluation focuses on the proportion of participants who achieve a viral load below 50 copies/mL at week 48. Secondary assessments will be performed at weeks 48 and 96. During the trial, participants will undergo regular monitoring including laboratory tests to measure viral load and kidney and liver function. The study will also assess safety and adherence to treatment. Participants must provide informed consent and will be closely followed throughout the study duration to ensure accurate outcome measurements and safety monitoring.

Age: 18Years +All GendersPhase 3
19 locations
Ban Tom Clinical Trials | DecenTrialz