This clinical trial is focused on studying the treatment of HIV-1 infection, a virus that attacks the immune system. The study involves two different treatment groups. One group will receive a combination of medications called doravirine and islatravir, known together as MK-8591A. The other group will receive a combination of bictegravir, emtricitabine, and tenofovir alafenamide, which are combined in a medication called Biktarvy. The purpose of the study is to evaluate the effectiveness, safety, and tolerability of these treatments in people who have not previously taken antiretroviral therapy, which is a type of medication used to treat HIV.
Participants in the study will be randomly assigned to one of the two treatment groups. The study is designed to be double-blind, meaning neither the participants nor the researchers will know which treatment each participant is receiving. This helps to ensure that the results are not biased. The study will last for a period of 96 weeks, with regular check-ups to monitor the participants’ health and the effectiveness of the treatment. The main goal is to see how well the treatments can reduce the amount of HIV in the blood to very low levels, specifically less than 50 copies per milliliter, by Week 48.
Throughout the study, the safety and side effects of the treatments will be closely monitored. Participants will have regular visits with healthcare professionals to review their health status and any potential side effects. The study will also look at changes in the participants’ immune system, specifically the number of CD4+ T-cells, which are a type of white blood cell that plays a crucial role in the immune response. The study aims to provide valuable information on the best treatment options for people living with HIV-1 who are new to antiretroviral therapy.



France
Germany
Spain