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

Starting soon · Phase 1/Phase 2 · Has a placebo group

Conditions studied: HIV -1 Infection

In brief

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.

Key facts

Study ID

NCT07655128

Run by

Hospital Universitario 12 de Octubre

People needed

87

Starts

2027-01-01

Expected to finish

2029-12-31

Last updated by the study team

2026-06-17

Who can join

Age: 0 and older, up to 1. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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).
• Clinically stable and can be managed as outpatient (participants identified in-hospital can start the trial at their first routine visit).
• Parent or legal guardian able to provide Informed consent (IC).

You may not qualify if…

• 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.
• Any clinically significant acute or chronic illness or condition at screening that, in the opinion of the principal investigator/designee, renders the participant unfit to participate in the study or jeopardizes the safety or rights of the participant. Including, but not restricted to:
• Evidence of active tuberculosis (TB) disease at the time of enrolment.
• Life-threatening condition associated with a high risk of death within 30 days of enrolment, as determined by the study clinician.
• Severe acute malnutrition with complications.
• Severe neurological illness.
• Hemodynamically significant severe congenital heart disease.
• Active malignancies.
• Life-threatening bleeding disorder.
• Use of systemic immunosuppressive drugs within 30 days before first IMP administration. Not exclusionary: nasal steroid spray, inhaled steroids, topical steroids, a single course of oral/parenteral prednisone or equivalent at 2 mg/kg/day, and length of therapy <14 days.
• Unwillingness to have blood drawn
• Unable to receive SC medications.
• Chronic or recurrent urticaria or any other chronic dermatological condition that may be confused with local Adverse Reactions (ARs).
• Any social or medical condition in the caregivers that, in the judgement of the investigator, would interfere with protocol adherence, completion of the trial or assessment of safety.

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.