This study will look at how well an injectable treatment works for people with detectable levels of HIV who are taking oral antiretroviral therapy (ART). This study will also check if the treatment is safe, how long it lasts, and ask about people’s experience.
The CROWN study is testing a possible new HIV treatment that is given as a shot for people living with HIV. It is for people who still have detectable HIV. If you join this study, you will be placed in a group by chance. You will have a 3 out of 4 chance of being in Group 1 and a 1 out of 4 chance of being in Group 2. Group 1 will get the study shots every 2 months, after getting 2 starter shots (one each month). Group 2 will take oral ART for 6 months, then get the same shots every 2 months, after 2 starter shots (one each month).
At each visit, you will have a physical exam, and vital signs (like blood pressure and heart rate) will be checked. A small amount (1 to 2 tablespoons) of blood will be taken. The blood will be used to check for HIV, STIs, and how safe the treatment is. You will also answer survey questions and get a test called an ECG (short for electrocardiogram). The ECG is a test that shows how your heart is beating. It checks the electrical signals in your heart to make sure everything is working the way it should. You will only get the ECG at 3 visits.
You will have 19 study visits over 2 years. Most visits will take 60 to 90 minutes.
You may be able to join if you are:
Protocol Number: 24-1607
More information available at ClinicalTrials.gov: NCT06694805
Principal Investigator