NCT06517693 Safety and Pharmacokinetics Study of PGT121.414.LS Alone and in Combination With VRC07-523LS in Infants Exposed to HIV-1
| NCT ID | NCT06517693 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | National Institute of Allergy and Infectious Diseases (NIAID) |
| Condition | HIV-1 |
| Study Type | INTERVENTIONAL |
| Enrollment | 48 participants |
| Start Date | 2026-01-05 |
| Primary Completion | 2027-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 48 participants in total. It began in 2026-01-05 with a primary completion date of 2027-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The purpose of this study is to evaluate the safety and pharmacokinetics (PK) of the potent, broadly neutralizing anti-HIV monoclonal antibodies (mAb) PGT121.414.LS alone and in combination with VRC07-523LS soon after birth in infants exposed to HIV-1.
Eligibility Criteria
Inclusion Criteria: * Birthing parent is of legal age or circumstance to provide independent informed consent and is willing and able to provide written informed consent for themselves and permission for their infant's participation in this study. * Birthing parent has confirmed HIV-1 infection based on positive test results from two samples collected from two separate blood collection tubes. * Infant was singleton or twin. * Infant's gestational age at birth was at least 36 weeks. * At birth, infant's weight was at least 2 kg. * At entry, infant is less than 72 hours of age and is anticipated to receive study product within 72 hours after birth. * At screening, infant has the following laboratory test results: * Hemoglobin, normal or grade 1 (≥13 g/dL or ≥8.05 mmol/L) * Platelets, normal or grade 1 (≥100,000 cells/mm3 or ≥100.000 x10\^9 cells/L) * Absolute neutrophil count (ANC), normal or grade 1 1. ≤24 hours old (≥4,000 cells/mm3 or ≥4.000 x10\^9 cells/L) 2. \>24 hours old (≥1,250 cells/mm3 or ≥1.250 x10\^9 cells/L) * Alanine transaminase (ALT), normal (\<1.25 x ULN) * At entry, infant is generally healthy as determined by the site investigator based on review of all available medical history information and physical examination findings. * Cohorts 1 and 2, Strata BF only: At entry, infant is breastfeeding or the birthing parent has indicated an intention to initiate breastfeeding. * Cohorts 1 and 2, Strata FF, only: At entry, infant is not breastfeeding and the birthing parent has indicated no intention to breastfeed. * At entry, infant is at increased risk of HIV acquisition. Cohorts 1 and 2, Strata FF only: * Birthing parent had acute HIV during this pregnancy; or * Birthing parent with detectable viral replication (plasma HIV RNA results at least 50 copies/mL) during pregnancy who did not have confirmed viral suppression, defined as at least two consecutive plasma HIV RNA results less than 50 copies/mL from specimens obtained at least four weeks apart with the latest result within four weeks prior to delivery; or * Birthing parent not receiving appropriate ART for at least two weeks, with any part of the two-week period occurring within four weeks prior to delivery, based on birthing parent's report or available medical records. Cohorts 1 and 2, BF only: * Per birthing parent's report, intends to breastfeed Exclusion Criteria: * Birthing parent has received any investigational product during this pregnancy. * Infant has received any active or passive HIV immunotherapy or any investigational product. * At entry, infant with a documented positive HIV Nucleic Acid Test (NAT) result. * Birthing parent or infant has any condition that, in the opinion of the site investigator or designee, would make participation in the study unsafe, complicate interpretation of study outcome data, or otherwise interfere with achieving the study objectives.
Contact & Investigator
Coleen Cunningham
STUDY CHAIR
University of California, Irvine
Frequently Asked Questions
Who can join the NCT06517693 clinical trial?
This trial is open to participants of all sexes, up to 72 Hours, studying HIV-1. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06517693 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT06517693 currently recruiting?
Yes, NCT06517693 is actively recruiting participants. Contact the research team at embrown@fhi360.org for enrollment information.
Where is the NCT06517693 trial being conducted?
This trial is being conducted at Los Angeles, United States, Aurora, United States, Jacksonville, United States, Miami, United States and 11 additional locations.
Who is sponsoring the NCT06517693 clinical trial?
NCT06517693 is sponsored by National Institute of Allergy and Infectious Diseases (NIAID). The principal investigator is Coleen Cunningham at University of California, Irvine. The trial plans to enroll 48 participants.
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