HVTN 130/HPTN 089: A phase 1 clinical trial to evaluate the safety, tolerability, pharmacokinetics, and antiviral activity of combinations of monoclonal antibodies PGT121, PGDM1400, 10-1074, and VRC07-523LS administered via intravenous infusion in healthy, HIV-uninfected adult participants. (CUIMC)
Sponsor: |
NIH, NIAID, DAIDS |
Enrolling: |
Male and Female Patients |
Study Length: |
19 Months |
Clinic Visits: |
16 |
IRB Number: |
AAAS4038 |
U.S. Govt. ID: |
NCT03928821 |
Contact: |
Jorge Benitez: 212-305-2201 / jb2226@columbia.edu |
Antibodies are one of the natural ways that our bodies fight or prevent infection. Were testing an antibody to find out if its safe, if they don't make people feel uncomfortable, how these study antibodies move throughout the body, and to measure antiviral activity. You cannot get HIV from the study antibody. Firstly, request to be contacted by our study team. We'll follow up by asking you to complete a brief electronic pre-screen questionnaire to find out if you meet basic study criteria. If you meet basic criteria, we'll invite you to our clinic to review the study for which you may be eligible and possibly draw blood to find out if you meet additional medical criteria. You'll receive $20-25 for each screening visit. If you're eligible, consent to participate, and are assigned into Group 1, 2, or 3, you'll will receive IV infusions of the antibodies at 1 visit only for which you'll be compensated $200 for completing the visit. We'll also ask you to return to the clinic another 10 times to complete follow up visits that require blood to be drawn for which you'll be compensated $75 for each visit. If you're eligible, consent to participate, and are assigned into Group 4, you'll receive IV infusions of the antibodies at 2 visits for which you'll be compensated $300 per visit. We'll also ask you to return to the clinic another 13 times to complete follow up visits that require blood to be drawn for which you'll be compensated $75 per visit. Your participation will help end HIV by informing medical science and HIV prevention efforts.
This study is closed
Investigator
Magdalena Sobieszczyk, MD
Are you between the ages of 18 to 50? |
Yes |
No |
Are you HIV negative (HIV-)? |
Yes |
No |