Safety and Pharmacokinetics Study of PGT121.414.LS Alone and in Combination With VRC07-523LS in Infants Exposed to HIV-1

August 24, 2026 updated by: National Institute of Allergy and Infectious Diseases (NIAID)

Open-Label, Phase I Study of the Safety and Pharmacokinetics of PGT121.414.LS Alone and in Combination With VRC07-523LS in Infants Exposed to HIV-1

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

This is an open-label, phase I study of the potent, broadly neutralizing anti-HIV monoclonal antibodies (mAb) PGT121.414.LS alone and in combination with VRC07-523LS administered soon after birth in infants exposed to HIV-1. The study is designed to assess the safety and pharmacokinetics (PK) profile of one and two subcutaneous (SC) doses of PGT121.414.LS alone or in combination with VRC07-523LS through Week 12 and Week 24, respectively.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
48

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Brazil
      • Rio de Janeiro, Brazil, CEP 26030-380
        • Not yet recruiting
        • Site 5097, Hospital Geral De Nova Iguacu Brazil
    • Brazil
      • Rio de Janeiro, Brazil, Brazil, CEP 20221-903
        • Withdrawn
        • Site 5072, Hospital Federal dos Servidores do Estado
  • Kenya
      • Kericho, Kenya, 20200
        • Not yet recruiting
        • Site 5121, Kenya Medical Research Institute/Walter Reed Project Clinical Research Center, Kericho
  • Puerto Rico
    • Puerto Rico
      • San Juan, Puerto Rico, Puerto Rico, 00935
        • Not yet recruiting
        • Site 32513, IMPAACT/Gamma Project/UPR Pediatric HIV/AIDS Research Network CRS
  • South Africa
    • Parrow Valley
      • Cape Town, Parrow Valley, South Africa, 7505
        • Not yet recruiting
        • Site 8950, FAMCRU
  • United States
    • California
      • Los Angeles, California, United States, 90095
        • Not yet recruiting
        • Site 5112, David Geffen School of Medicine at UCLA
    • Colorado
      • Aurora, Colorado, United States, 80045
        • Recruiting
        • Site 5052, University of Colorado Denver
    • Florida
      • Jacksonville, Florida, United States, 32209
        • Recruiting
        • Site 5051, University of Florida Jacksonville
      • Miami, Florida, United States, 33136
        • Withdrawn
        • Site 5127, Pediatric Perinatal HIV
    • Georgia
      • Atlanta, Georgia, United States, 30322
        • Not yet recruiting
        • Site 5030, Emory University School of Medicine
    • Illinois
      • Chicago, Illinois, United States, 60612
        • Withdrawn
        • Site 5083, Rush University Cook County Hospital Chicago
    • Maryland
      • Baltimore, Maryland, United States, 21287
        • Recruiting
        • Site 5092, Johns Hopkins University Baltimore
    • New York
      • The Bronx, New York, United States, 10457
        • Recruiting
        • Site 5114, Bronx-Lebanon Hospital Center
        • Contact:
      • The Bronx, New York, United States, 10461
        • Not yet recruiting
        • Site 5013, Jacobi Medical Center Bronx
    • Tennessee
      • Memphis, Tennessee, United States, 38105
        • Not yet recruiting
        • Site 6501, St. Jude Children's Research Hospital
    • Texas
      • Houston, Texas, United States, 77030
        • Recruiting
        • Site 5128, Baylor College of Medicine/Texas Children's Hospital
  • Zimbabwe
      • Harare, Zimbabwe
        • Not yet recruiting
        • Site 31890, Harare Family Care

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Non-Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Cohort 1 Stratum Formula Fed (FF)
Single subcutaneous (SC) dose of PGT121.414.LS at birth, based on weight.
Drug: PGT121.414.LS
Administered SC in the thigh
Experimental: Cohort 1 Stratum Breastfed (BF)
Initial SC dose of PGT121.414.LS at birth, based on weight. Second SC dose of 100 mg PGT121.414.LS at Week 12, if still breastfeeding. Dosing at Week 12 is not based on weight.
Drug: PGT121.414.LS
Administered SC in the thigh
Experimental: Cohort 2 Stratum FF
Single SC doses of PGT121.414.LS and VRC07-523LS at birth, based on weight.
Drug: PGT121.414.LS
Administered SC in the thigh
Drug: VRC07-523LS
Administered SC in the thigh
Experimental: Cohort 2 Stratum BF
Initial SC doses of PGT121.414.LS and VRC07-523LS at birth, based on weight. Second SC doses of 100 mg of PGT121.414.LS and 100 mg VRC07-523LS at Week 12, if still breastfeeding. Dosing at Week 12 is not based on weight.
Drug: PGT121.414.LS
Administered SC in the thigh
Drug: VRC07-523LS
Administered SC in the thigh

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Proportion of infants with at least one Grade 3 or higher Adverse Event (AE) (one dose)
Time Frame: Day 0 through Week 12
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
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
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
Day 0 through Week 24
PGT121.414.LS maximum concentration (Cmax) (single/first dose)
Time Frame: Day 0 through Week 48
Day 0 through Week 48
PGT121.414.LS time of maximum concentration (Tmax) (single/first dose)
Time Frame: Day 0 through Week 48
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
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
Week 12
PGT121.414.LS concentration at the end of the second dose interval (C(24WK)) (two doses)
Time Frame: Week 24
Week 24
VRC07-523LS maximum concentration (Cmax) (single/first dose)
Time Frame: Day 0 through Week 48
Day 0 through Week 48
VRC07-523LS time of maximum concentration (Tmax) (single/first dose)
Time Frame: Day 0 through Week 48
Day 0 through Week 48
VRC07-523LS area under the curve (AUC(0-12WK))
Time Frame: Day 0 through Week 12
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
Week 12
VRC07-523LS concentration at the end of the second dose interval (C(24WK)) (two doses)
Time Frame: Week 24
Week 24

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Proportion of infants with at least one Grade 3 or higher AE
Time Frame: Day 0 through Week 96
Day 0 through Week 96
Proportion of infants with at least one Grade 3 or higher AE assessed as related to study product
Time Frame: Day 0 through Week 96
Day 0 through Week 96
Proportion of infants with at least one Grade 2 or higher AE (one dose)
Time Frame: Day 0 through Week 12
Day 0 through Week 12
Proportion of infants with at least one Grade 2 or higher AE assessed as related to study product (one dose)
Time Frame: Day 0 through Week 12
Day 0 through Week 12
Proportion of infants with at least one Grade 2 or higher AE (two doses)
Time Frame: Day 0 through Week 24
Day 0 through Week 24
Proportion of infants with at least one Grade 2 or higher AE assessed as related to study product (two doses)
Time Frame: Day 0 through Week 24
Day 0 through Week 24
Proportion of infants with any AEs that lead to study product discontinuation
Time Frame: Day 0 through Week 12
Day 0 through Week 12
PGT121.414.LS AUC(0-48WK) after single dose administration
Time Frame: Week 48
Week 48
PGT121.414.LS concentration after single dose administration
Time Frame: Week 48
Week 48
PGT121.414.LS concentration after two dose administration
Time Frame: Week 60
Week 60
PGT121.414.LS apparent clearance (CL/F)
Time Frame: Day 0 through Week 60
Day 0 through Week 60
PGT121.414.LS half-life (T1/2) following single dose administration
Time Frame: Day 0 through Week 48
Day 0 through Week 48
PGT121.414.LS half-life (T1/2) following two dose administration
Time Frame: Day 0 through Week 60
Day 0 through Week 60
VRC07-523LS AUC(0-48WK) after single dose administration
Time Frame: Week 48
Week 48
VRC07-523LS concentration after single dose administration
Time Frame: Week 48
Week 48
VRC07-523LS concentration after two dose administration
Time Frame: Week 60
Week 60
VRC07-523LS apparent clearance (CL/F)
Time Frame: Day 0 through Week 60
Day 0 through Week 60
VRC07-523LS half-life (T1/2) following single dose administration
Time Frame: Day 0 through Week 48
Day 0 through Week 48
VRC07-523LS half-life (T1/2) following tow dose administration
Time Frame: Day 0 through Week 60
Day 0 through Week 60
Proportion of infants with PGT121.414.LS concentrations > 20 and > 50 mcg/mL following single/first dose administration
Time Frame: Week 12
Week 12
Proportion of infants with PGT121.414.LS concentrations > 20 and > 50 mcg/mL following two dose administration
Time Frame: Week 24
Week 24
Proportion of infants with VRC07-523LS concentrations > 10 and > 20 mcg/mL following single/first dose administration
Time Frame: Week 12
Week 12
Proportion of infants with PGT121.414.LS concentrations > 10 and > 20 mcg/mL following two dose administration
Time Frame: Week 24
Week 24
Proportion of infants with anti-PGT121.414.LS antibodies detected
Time Frame: Week 24
Week 24
Proportion of infants with anti-VRC07-523LS antibodies detected
Time Frame: Week 24
Week 24
Proportion of infants with anti-PGT121.414.LS antibodies detected
Time Frame: Week 48
Week 48
Proportion of infants with anti-VRC07-523LS antibodies detected
Time Frame: Week 48
Week 48
Proportion of infants with confirmed HIV infection following receipt of study product
Time Frame: Day 0 through Week 96
Day 0 through Week 96
Frequency of study product injection site local reactions for one and two SC doses of PGT121.414.LS alone or in combination with VRC07-523LS
Time Frame: Day 0 through Week 13
Day 0 through Week 13

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
National Institute of Allergy and Infectious Diseases (NIAID)

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
National Institute of Mental Health (NIMH)

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: Coleen Cunningham, University of California, Irvine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 5, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 30, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 18, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 18, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 24, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 25, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 24, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2026

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • IMPAACT 2037
  • 38962 (Other Identifier: DAIDS Study ID)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Individual participant data that underlie results in the publication, after deidentification

IPD Sharing Time Frame

Beginning 3 months following publication and available throughout period of funding of the International Maternal Pediatric Adolescent AIDS Clinical Trial (IMPAACT) Network by NIH.

IPD Sharing Access Criteria

With whom?

  • Researchers who provide a methodologically sound proposal for use of the data that is approved by the IMPAACT Network.
  • For what types of analyses?
  • To achieve aims in the proposal approved by the IMPAACT Network.
  • By what mechanism will data be made available?
  • Researchers may submit a request for access to data using the IMPAACT "Data Request" form at: https:// www.impaactnetwork.org/ resources/study-proposals.htm. Researchers of approved proposals will need to sign an IMPAACT Data Use Agreement before receiving the data.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings