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

NCT07655128 · Status: NOT_YET_RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 87

Last updated 2026-08-20

No results posted yet for this study

Summary

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.

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.

Sponsors & Collaborators

  • University of Stellenbosch

    collaborator OTHER

  • Africa Health Research Institute

    collaborator OTHER

  • PENTA Foundation

    collaborator NETWORK

  • International AIDS Vaccine Initiative

    collaborator NETWORK

  • University of Witwatersrand, South Africa

    collaborator OTHER

  • Enhancing Care Foundation

    collaborator UNKNOWN

  • Radboud University Medical Center

    collaborator OTHER

  • Servicio Madrileño de Salud (SERMAS)

    collaborator UNKNOWN

  • 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

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07655128 on ClinicalTrials.gov