A randomized, double blind, controlled, phase 2 clinical trial to evaluate the safety, tolerability, pharmacokinetics, and neutralization of VRC07-523LS, PGT121.414.LS, and PGDM1400LS broadly neutralizing monoclonal antibodies given intravenously in adult participants without HIV
Sponsor: |
National Institute of Allergy and Infectious Diseases |
Enrolling: |
Male and Female Patients |
Study Length: |
12 Months |
Clinic Visits: |
9 |
IRB Number: |
AAAV8729 |
U.S. Govt. ID: |
NCT06812494 |
Contact: |
Brittany Rose: 212-305-2201 / br2731@cumc.columbia.edu |
This clinical research study is seeking healthy individuals ages 18 to 65 who do not have HIV to help researchers understand how the body's immune system responds to three investigational antibodies (VRC07-523LS, PGT121.414.LS, and PGDM1400LS) against HIV when given in different combinations and doses. This is a Phase 2 study, which means that the combination of these antibodies has been previously studied in humans at similar or higher doses than what would be given in this study. The study involves two intravenous (IV) infusions of the study antibodies at two different timepoints; the first infusion takes place at the time of enrollment, and the second infusion takes place 6 months later. You will be randomly assigned into one of two groups, with one group receiving the lower dose of the infusions, and the other group receiving a higher dose. Blood samples will be collected at each visit to measure safety, comfort, and immune response. Individuals who are pregnant, breastfeeding, have previously received an HIV vaccine, or have certain medical conditions may not be eligible. Your participation in this study will last about 12 months. You will be compensated for participating in this study.
Investigator
Magdalena Sobieszczyk, MD
Are you living with HIV? |
Yes |
No |
Are you between the ages of 18 and 65? |
Yes |
No |