Early Neutralizing Antibodies in Infants Living With HIV to Enhance Their Life (2)

The goal of this clinical trial is to learn if subcutaneous ePGT121v1-LS and VRC07-523-LS added to standard antiretroviral therapy (ART) is safe and helps improve HIV viral suppression in infants living with HIV in Mozambique and Cameroon. The study will also learn how the body processes ePGT121v1-LS and VRC07-523-LS and whether caregivers and health workers find this treatment approach acceptable. The main questions it aims to answer are: * Are ePGT121v1-LS and and VRC07-523-LS safe and well tolerated in infants living with HIV? * Does adding ePGT121v1-LS and VRC07-523-LS to standard ART increase the number of infants who achieve HIV viral suppression by week 48? * How long does it take participants receiving ePGT121v1-LS and VRC07-523-LS to achieve viral suppression compared with standard treatment alone? * How does ePGT121v1-LS and VRC07-523-LS behave in the body after repeated subcutaneous injections? Researchers will compare infants receiving ePGT121v1-LS and VRC07-523-LS plus ART to infants receiving standard ART plus placebo (saline) to see if ePGT121v1-LS improves HIV viral suppression. Participants will: * Continue taking standard oral ART. * Receive 4 subcutaneous injections of ePGT121v1-LS and VRC07-523-LS or placebo every 12 weeks. * Attend regular clinic visits for safety checks, blood tests, and HIV viral load monitoring. * Have follow-up visits for 48 weeks. * Participate in evaluations of treatment adherence and acceptability from the perspective of caregivers and health workers.

NCT Number	NCT07655141
Lead Sponsor	Hospital Universitario 12 de Octubre Collaborators: Africa Health Research Institute, PENTA Foundation, International AIDS Vaccine Initiative, University of Witwatersrand, South Africa, Radboud University Medical Center, Servicio Madrileño de Salud (SERMAS), Eduardo Mondlane University, Fundaçao Ariel Glaser contra o SIDA Pediatrico, Centro de Investigação em Saúde de Manhiça, University of Rome Tor Vergata, Centre Pasteur du Cameroun, Barcelona Institute for Global Health
Conditions	HIV -1 Infection
Enrollment	73 participants
Start Date	2027-01-01
Primary Completion	2029-07-01 (estimated)
Study Completion	2029-12-31 (estimated)
Updated on ClinicalTrials.gov	2026-06-17