Condition: HIV · Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
This study is testing a lab-made antibody called ePGT121v1-LS that targets a specific part of HIV. Researchers will give it by vein (IV) and under the skin (SC), both on its own and together with two other antibodies, VRC07-523LS and PGDM1400LS, which target different parts of the virus. They will assess safety and side effects, determine the right dose, study how the body processes the drug (pharmacokinetics or PK), and measure how well it neutralizes HIV in the blood (serum neutralizing activity). The expectation is that ePGT121v1-LS, whether given alone or with PGDM1400LS and VRC07-523LS, by IV or SC, will be safe in generally healthy adults and that the antibodies will not interfere with each other when used together. Approximately 83 volunteers in overall good health and without HIV-1 will be enrolled into two parts (A and B). Part A has six groups. In Groups 1-3, participants will get ePGT121v1-LS given by IV at one of three dose levels: 5 mg/kg, 20 mg/kg, or 40 mg/kg. In Groups 4-6, participants will receive three antibodies-first ePGT121v1-LS, then PGDM1400LS and VRC07-523LS-given by IV at two separate visits that are 24 weeks apart. The total study duration for participants in Part A is 48 weeks of scheduled clinic visits. Part B has two groups. In Group 7, people will get ePGT121v1-LS as SC shots at two visits 12 weeks apart. Each visit will give a total of 375 mg, split into three injections of 125 mg each. In Group 8, people will also have two visits 12 weeks a…
This description comes directly from the study's public registry record.
Contact details are listed per location below or on the registry record.
Always discuss trial participation with your own doctor first.
| Alabama CRS (Site ID: 31788) | Birmingham, Alabama, United States | Recruiting |
| Bridge HIV CRS (Site ID: 30305) | San Francisco, California, United States | Recruiting |
| The Ponce de Leon Center CRS (Site ID: 5802) | Atlanta, Georgia, United States | Not Yet Recruiting |
| Brigham and Women's Hospital Vaccine CRS (BWH VCRS) (Site ID: 30007) | Boston, Massachusetts, United States | Not Yet Recruiting |
| Penn Prevention CRS (Site ID: 30310) | Philadelphia, Pennsylvania, United States | Recruiting |
| Vanderbilt Vaccine (VV) CRS (Site ID: 30352) | Nashville, Tennessee, United States | Recruiting |
| Houston Advancing Research Team CRS (Site ID: 31473) | Houston, Texas, United States | Not Yet Recruiting |
| Via Libre CRS (Site ID: 31909) | Lima Cercado, Lima region, Peru | Not Yet Recruiting |
| Centro de Investigaciones Tecnológicas, Biomédicas y Medioambientales CRS (CITBM) - Unidad de Ensayos Clínicos (UNIDEC) (Site ID: 31970) | Bellavista, Provincia Constitucional del Callao, Peru | Not Yet Recruiting |
| Seke South CRS (Site ID: 30294) | Harare, Zimbabwe | Not Yet Recruiting |
| Spilhaus CRS (Site ID: 30314) | Harare, Zimbabwe | Not Yet Recruiting |
Get one email when the public record changes — results posted, or the study's status changes. Nothing else, ever.
We email about this public record only. Unsubscribe anytime with one click. Never medical advice.
This page is independently generated by Eichor from the public ClinicalTrials.gov record and re-synced daily. It is not the sponsor's official website unless claimed. Nothing here is medical advice; eligibility is always determined by the study team — talk to your own doctor first.
Source record: clinicaltrials.gov/study/NCT07390955