NCT06517693 · National Institute of Allergy and Infectious Diseases (NIAID)
Safety and Pharmacokinetics Study of PGT121.414.LS Alone and in Combination With VRC07-523LS in Infants Exposed to HIV-1
What this study is about
The purpose of this study is to evaluate the safety and how the drug moves through the body (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.
View original scientific description
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.
Interventions
DRUG
PGT121.414.LS
Administered SC in the thigh
DRUG
VRC07-523LS
Administered SC in the thigh
Primary outcome measures
Proportion of infants with at least one Grade 3 or higher Adverse Event (AE) (one dose)
Time frame: Day 0 through Week 12
Proportion of infants with at least one Grade 3 or higher AE assessed as related to study product (one dose)
Time frame: Day 0 through Week 12
Proportion of infants with at least one Grade 3 or higher AE (two doses)
Time frame: Day 0 through Week 24
Proportion of infants with at least one Grade 3 or higher AE assessed as related to study product (two doses)
Time frame: Day 0 through Week 24
PGT121.414.LS maximum concentration (Cmax) (single/first dose)
Time frame: Day 0 through Week 48
PGT121.414.LS time of maximum concentration (Tmax) (single/first dose)
Time frame: Day 0 through Week 48
PGT121.414.LS area under the curve (AUC(0-12WK)) (single/first dose)
Time frame: Day 0 through Week 12
PGT121.414.LS concentration at the end of the first dose interval (C(12WK)) (single/first dose)
Time frame: Week 12
PGT121.414.LS concentration at the end of the second dose interval (C(24WK)) (two doses)
Time frame: Week 24
VRC07-523LS maximum concentration (Cmax) (single/first dose)
Time frame: Day 0 through Week 48
VRC07-523LS time of maximum concentration (Tmax) (single/first dose)
Time frame: Day 0 through Week 48
VRC07-523LS area under the curve (AUC(0-12WK))
Time frame: Day 0 through Week 12
VRC07-523LS concentration at the end of the first dose interval (C(12WK)) single/first dose)
Time frame: Week 12
VRC07-523LS concentration at the end of the second dose interval (C(24WK)) (two doses)
Time frame: Week 24
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
- ≤24 hours old (≥4,000 cells/mm3 or ≥4.000 x10\^9 cells/L)
- \>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.
Where
- Los Angeles, California
- Aurora, Colorado
- Jacksonville, Florida
- Miami, Florida
- Atlanta, Georgia
- Chicago, Illinois
- Baltimore, Maryland
- The Bronx, New York
- Memphis, Tennessee
- Houston, Texas
Collaborators
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), National Institute of Mental Health (NIMH)
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Aug 4, 2026 · Source of record for eligibility and locations