Actively Recruiting
Safety and Pharmacokinetics Study of PGT121.414.LS Alone and in Combination With VRC07-523LS in Infants Exposed to HIV-1
Led by National Institute of Allergy and Infectious Diseases (NIAID) · Updated on 2026-03-17
48
Participants Needed
17
Research Sites
129 weeks
Total Duration
On this page
Sponsors
N
National Institute of Allergy and Infectious Diseases (NIAID)
Lead Sponsor
E
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Safety and Pharmacokinetics Study of PGT121.414.LS Alone and in Combination With VRC07-523LS in Infants Exposed to HIV-1
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Birthing parent is legally able and willing to provide informed consent for themselves and permission for their infant to participate.
- Birthing parent has confirmed HIV-1 infection from two separate positive blood tests.
- Infant was a singleton or twin birth.
- Infant was born at a gestational age of at least 36 weeks.
- Infant weighed at least 2 kg at birth.
- Infant is less than 72 hours old at study entry and expected to receive the study product within 72 hours after birth.
- Infant has normal or mild (grade 1) hemoglobin levels (≥13 g/dL or ≥8.05 mmol/L).
- Infant has normal or mild (grade 1) platelet count (≥100,000 cells/mm3).
- Infant has normal or mild (grade 1) absolute neutrophil count (ANC):
- ≥4,000 cells/mm3 if ≤24 hours old
- ≥1,250 cells/mm3 if >24 hours old
- Infant has normal alanine transaminase (ALT) levels (<1.25 times upper limit of normal).
- Infant is generally healthy based on medical history and physical exam.
- For Cohorts 1 and 2, breastfeeding (BF) strata: infant is breastfeeding or birthing parent intends to breastfeed.
- For Cohorts 1 and 2, formula feeding (FF) strata: infant is not breastfeeding and birthing parent does not intend to breastfeed.
- Infant is at increased risk of HIV acquisition.
- For Cohorts 1 and 2, FF only: birthing parent had acute HIV during pregnancy, or had detectable viral replication during pregnancy without confirmed viral suppression, or was not on appropriate antiretroviral therapy (ART) for at least two weeks within four weeks prior to delivery.
- For Cohorts 1 and 2, BF only: birthing parent intends to breastfeed.
You will not qualify if you...
- Birthing parent has received any investigational product during pregnancy.
- Infant has received any active or passive HIV immunotherapy or any investigational product.
- Infant has a documented positive HIV Nucleic Acid Test (NAT) at entry.
- Birthing parent or infant has any condition that would make study participation unsafe, affect study results, or interfere with study goals as determined by the investigator.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 17 locations
1
Site 5112, David Geffen School of Medicine at UCLA
Los Angeles, California, United States, 90095
Not Yet Recruiting
2
Site 5052, University of Colorado Denver
Aurora, Colorado, United States, 80045
Actively Recruiting
3
Site 5051, University of Florida Jacksonville
Jacksonville, Florida, United States, 32209
Actively Recruiting
4
Site 5127, Pediatric Perinatal HIV
Miami, Florida, United States, 33136
Not Yet Recruiting
5
Site 5030, Emory University School of Medicine
Atlanta, Georgia, United States, 30322
Not Yet Recruiting
6
Site 5083, Rush University Cook County Hospital Chicago
Chicago, Illinois, United States, 60612
Not Yet Recruiting
7
Site 5092, Johns Hopkins University Baltimore
Baltimore, Maryland, United States, 21287
Actively Recruiting
8
Site 5114, Bronx-Lebanon Hospital Center
The Bronx, New York, United States, 10457
Actively Recruiting
9
Site 5013, Jacobi Medical Center Bronx
The Bronx, New York, United States, 10461
Not Yet Recruiting
10
Site 6501, St. Jude Children's Research Hospital
Memphis, Tennessee, United States, 38105
Not Yet Recruiting
11
Site 5128, Baylor College of Medicine/Texas Children's Hospital
Houston, Texas, United States, 77030
Actively Recruiting
12
Site 5072, Hospital Federal dos Servidores do Estado
Rio de Janeiro, Brazil, CEP 20221-903
Not Yet Recruiting
13
Site 5097, Hospital Geral De Nova Iguacu Brazil
Rio de Janeiro, Brazil, CEP 26030-380
Not Yet Recruiting
14
Site 5121, Kenya Medical Research Institute/Walter Reed Project Clinical Research Center, Kericho
Kericho, Kenya, 20200
Not Yet Recruiting
15
Site 5129, IMPAACT/Gamma Project/UPR Pediatric HIV/AIDS Research
San Juan, Puerto Rico, 00935
Not Yet Recruiting
16
Site 8950, FAMCRU
Cape Town, Parrow Valley, South Africa, 7505
Not Yet Recruiting
17
Site 31890, Harare Family Care
Harare, Zimbabwe
Not Yet Recruiting
Research Team
E
Emily Brown
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
PREVENTION
Number of Arms
4
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