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, which are taken as a single pill once a day. The other group will receive a different combination of medications known as bictegravir, emtricitabine, and tenofovir alafenamide, also taken as a single pill once a day. These medications are designed to help control the virus in people who have not previously received antiretroviral therapy, which is the standard treatment for HIV.
The purpose of this study is to compare the effectiveness, safety, and tolerability of the two treatment options over a period of time. Participants will be randomly assigned to one of the two groups and will not know which treatment they are receiving, as the study is double-blind. This means that neither the participants nor the researchers will know who is receiving which treatment, to ensure unbiased results. The study will last for a total of 96 weeks, with regular check-ups and assessments to monitor the participants’ health and the virus’s response to the treatment.
Throughout the study, the main focus will be on how well the treatments reduce the amount of HIV-1 RNA in the blood, which is a measure of the virus’s activity. Safety will also be closely monitored by reviewing any side effects or adverse events that participants may experience. The study aims to provide valuable information on the best treatment options for people newly diagnosed with HIV-1, helping to improve their health outcomes and quality of life.



France
Germany
Italy
Poland
Spain
The Netherlands