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

Summary

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.

Conditions

• HIV -1 Infection

Interventions

DRUG

Broadly neutralizing antibody (bNAb) ePGT121v1-LS

Administration of subcutaneous ePGT121v1LS, 4 doses, separate 12 weeks away.

DRUG

Saline (0.9% NaCl)

Administration of subcutaneous saline, 4 doses, separate 12 weeks away.

DRUG

Broadly neutralizing antibody (bNAb) VRC07-523-LS

Administration of subcutaneous ePGT121v1LS, 4 doses, separate 12 weeks away.

Sponsors & Collaborators

• Africa Health Research Institute

  collaborator OTHER

• PENTA Foundation

  collaborator NETWORK

• International AIDS Vaccine Initiative

  collaborator NETWORK

• University of Witwatersrand, South Africa

  collaborator OTHER

• Radboud University Medical Center

  collaborator OTHER

• Servicio Madrileño de Salud (SERMAS)

  collaborator UNKNOWN

• Eduardo Mondlane University

  collaborator OTHER

• Fundaçao Ariel Glaser contra o SIDA Pediatrico

  collaborator UNKNOWN

• Centro de Investigação em Saúde de Manhiça

  collaborator OTHER

• University of Rome Tor Vergata

  collaborator OTHER

• Centre Pasteur du Cameroun

  collaborator OTHER

• Barcelona Institute for Global Health

  collaborator OTHER

• Hospital Universitario 12 de Octubre

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

1 Day

Max Age

1 Year

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2027-01-01

Primary Completion

2029-07-01

Completion

2029-12-31

FDA Drug

Yes