This clinical trial is focused on studying the treatment of HIV-1 infection, a virus that attacks the body’s immune system. The study involves participants who are currently managing their condition with a medication called Biktarvy, which contains the active substances emtricitabine, tenofovir alafenamide, and bictegravir. The trial aims to evaluate the effects of switching to a new combination treatment called Doravirine/Islatravir (also known by the code name MK-8591A), which includes the active substances doravirine and islatravir.
The purpose of the study is to assess the effectiveness and safety of switching from Biktarvy to Doravirine/Islatravir in people who have their HIV-1 under control. Participants will be randomly assigned to either continue their current treatment with Biktarvy or switch to the new combination of Doravirine/Islatravir. Some participants may receive a placebo, which looks like the real medication but does not contain active ingredients. The study will last for a period of 96 weeks, during which participants will have regular check-ups to monitor their health and the virus levels in their blood.
Throughout the study, researchers will collect data to determine how well the new treatment works in keeping the virus suppressed and how safe it is for participants. The trial will also look at any side effects experienced by participants and any changes in their immune system. This information will help in understanding whether the new treatment could be a viable option for people living with HIV-1.
France 
Germany 
Italy 
Spain 
