PGT121.414.LS + VRC07-523LS for HIV
What You Need to Know Before You Apply
What is the purpose of this trial?
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.
Do I have to stop taking my current medications for this trial?
The trial information does not specify whether participants need to stop taking their current medications. It is best to discuss this with the study team or your healthcare provider.
What makes the drug PGT121.414.LS + VRC07-523LS unique for treating HIV?
The drug PGT121.414.LS + VRC07-523LS is unique because it involves the use of broadly neutralizing antibodies, which are designed to target and neutralize a wide range of HIV strains, potentially offering a novel approach compared to traditional antiretroviral therapies that focus on inhibiting viral replication.12345
Who Is on the Research Team?
Coleen Cunningham
Principal Investigator
University of California, Irvine
Are You a Good Fit for This Trial?
This trial is for infants exposed to HIV-1, under 72 hours old, generally healthy, with a birth weight of at least 2 kg and born after at least 36 weeks of gestation. Infants must be at increased risk of HIV acquisition. Those breastfeeding or not are included in separate strata. Parents must consent for participation and have confirmed HIV-1 infection.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Initial subcutaneous doses of PGT121.414.LS and VRC07-523LS administered at birth, with a second dose at Week 12 if still breastfeeding
Follow-up
Participants are monitored for safety and pharmacokinetics through Week 24
What Are the Treatments Tested in This Trial?
Interventions
- PGT121.414.LS
- VRC07-523LS
PGT121.414.LS is already approved in United States for the following indications:
- HIV-1 infection
Find a Clinic Near You
Who Is Running the Clinical Trial?
National Institute of Allergy and Infectious Diseases (NIAID)
Lead Sponsor
National Institute of Allergy and Infectious Diseases Vaccine Research Center
Collaborator
National Institute of Mental Health (NIMH)
Collaborator
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Collaborator
National Institute of Allergy and Infectious Diseases Vaccine Research Center (NIAID VRC)
Collaborator