Early Neutralizing Antibodies in Infants Living With HIV to Enhance Their Life (NCT07655128) | Clinical Trial Compass
Not Yet RecruitingPhase 1/2
Early Neutralizing Antibodies in Infants Living With HIV to Enhance Their Life
87 participantsStarted 2027-01-01
Plain-language 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.
Who can participate
Age range
1 Day – 1 Year
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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).
Exclusion Criteria:
* 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 illn…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial is testing neutralizing antibodies in HIV-positive infants — can you explain what neutralizing antibodies are and how they're different from the antiretroviral medications my child is already on or might start?
2Since this is a Phase 1/2 trial, the researchers are still gathering early safety data — what does that mean for how much we'd know about risks to my infant before enrolling, and how does that compare to the safety record of standard antiretroviral therapy?
3The trial is measuring how quickly and how reliably viral suppression is achieved — can you help me understand what happens if my child doesn't reach viral suppression during the study, and what the backup plan would be?
4The study involves injections, and one of the things being measured is how well infants tolerate those injections — how often would my baby need to come in for these, and is that realistic given our situation?
5Since this trial isn't recruiting yet, what would you recommend my child do in the meantime, and would starting standard treatment now affect whether my child could potentially be considered for this study later?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Safety (Serious adverse events)
Timeframe: 48 weeks
2
Virological suppression (snapshot)
Timeframe: 48 weeks
3
Time to virological suppression
Timeframe: 48 weeks
4
Tolerability of the treatment (participants who discontinue)