About this trial
The goal of this clinical trial is to learn if subcutaneous ePGT121v1-LS added to standard antiretroviral therapy (ART) is safe and helps improve HIV viral suppression in infants living with HIV in South Africa. The study will also learn how the body processes ePGT121v1-LS and whether caregivers and health workers find this treatment approach acceptable.
The main questions it aims to answer are:
* Is ePGT121v1-LS safe and well tolerated in infants living with HIV? * Does adding ePGT121v1-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 to achieve viral suppression compared with standard treatment alone? * How does ePGT121v1-LS behave in the body after repeated subcutaneous injections?
Researchers will compare infants receiving ePGT121v1-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 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.
Eligibility criteria
Qualifiers
Infants from 1 to 365 days old at the time of enrolment.
Living with HIV-1, diagnosed with an approved assay detecting HIV nucleic acids in blood.
Weight > 2.5 kg at enrolment.
ART-naïve or ≤ 30 days of triple ART at screening (not including prophylaxis in HIV-exposed).
Disqualifiers
Participation in other concurrent research studies that, in the opinion of the principal investigator and central team, would interfere with the objectives of this study.
Previous receipt of bNAbs against HIV.
Serious Adverse Reactions (SARs) to the investigational medicinal product (IMP) or its components.
Intravenous (IV) immunoglobulins received within 90 days before IMP administration.
Trial design
Treatments tested in this trial
- Broadly neutralizing antibody (bNAb) ePGT121v1-LS
- Saline (0.9% NaCl)
Treatment groups
Locations
Sponsors and collaborators
Hospital Universitario 12 de Octubre
Lead sponsor
University of Stellenbosch
Collaborator
Africa Health Research Institute
Collaborator
PENTA Foundation
Collaborator
International AIDS Vaccine Initiative
Collaborator
University of Witwatersrand, South Africa
Collaborator
Enhancing Care Foundation
Collaborator
Faculty of Medical Sciences, Radboud University of Medical Center
Collaborator
Servicio Madrileño de Salud (SERMAS)
Collaborator