HVTN 807: 426c.Mod.Core-C4b adjuvanted with 3M-052-AF + Alum immunization in combination with an antiretroviral analytical treatment interruption (ATI) in people living with HIV for elicitation of VRC01-lineage antibodies
Sponsor: |
NIH |
Enrolling: |
Male and Female Patients |
Study Length: |
1 Years |
IRB Number: |
AAAU7022 |
U.S. Govt. ID: |
NCT06006546 |
Contact: |
Brittany Rose: 347-770-2201 / br2731@cumc.columbia.edu |
The HIV Vaccine Trials Network (HVTN), Division of AIDS (DAIDS), and Columbia University Irving Medical Center (CUIMC) are conducting a trial to learn about the safety and effectiveness of a new experimental HIV vaccine. The goal is to understand if the study products are safe to use in people living with HIV, and whether they can get the study products without being too uncomfortable. We also want to understand how people's immune systems respond to the study products, and whether stopping HIV medications changes these immune responses. There will be 2 groups in this study. Both groups will receive the study products. Participants in group 2 will take their HIV medicine for the whole study. Participants in group 1, however, will stop using their HIV medicines and have frequent monitoring to ensure their health. If you are aged 18-55, in overall good health and living with HIV, you may be able to participate. Your participation in this study will be for about a year and 2 months of clinic visits, with a follow-up contact about a month later to check on your health. Study procedures will include blood draws, injections, and leukapheresis. Leukapheresis is a procedure to collect your white blood cells. The main risks of this procedure includes pain, bruising, bleeding, and infection where the needle is inserted. You will be compensated for taking part in this study. If you choose to participate in Group 1, you will receive a minimum compensation of $1650. If you choose to participate in Group 2, you will receive a minimum compensation of $800 in total for the completion of all required study visits. You will not receive compensation for any study visits that you do not attend.
Investigator
Magdalena Sobieszczyk, MD
Are you currently living with HIV? |
Yes |
No |
Are you between the ages of 18 to 55? |
Yes |
No |
Have you been taking antiretroviral therapy (ART) for at least 48 weeks? |
Yes |
No |