Study to Compare an Oral Weekly Islatravir/Lenacapavir Regimen With Bictegravir/Emtricitabine/Tenofovir Alafenamide in Virologically Suppressed People With HIV-1

To join this study, you need to be an adult (18 years or older) living with HIV. A key requirement is that your HIV must be very well controlled for at least six months before the study starts, meaning the level of the virus in your blood is consistently very low or undetectable. You also need to be taking the specific daily HIV medication called bictegravir/emtricitabine/tenofovir alafenamide for at least six months and be willing to continue it, at least initially.

There are also some reasons why you might not be able to join. For example, if your previous HIV treatment didn't work well in the past, or if you've already taken the new medicines (islatravir or lenacapavir) being tested in this study, you wouldn't be eligible. You also can't have certain other active infections, such as tuberculosis, or uncontrolled hepatitis B or C. Your blood test results also need to be within a healthy range for your kidneys, liver, and blood counts.

If you join this study, you would first have a screening visit to check if you meet all the requirements. If you do, you would then be randomly assigned to one of two groups: either you would switch to taking the new once-a-week tablet, or you would continue taking your current daily tablet. Neither you nor the study doctors will choose which group you are in; this is decided by chance, like flipping a coin.

Throughout the study, which lasts for 48 weeks, you'll have regular visits to the clinic. These visits will include check-ups, blood tests, and discussions with the study team to monitor your health, how the medication is working, and any side effects you might experience. After the 48-week main study period, there might be a follow-up period to continue monitoring your health. The total time you'd be involved in the study would include these visits and follow-up.