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HIV-1Phase 1NCT06517693

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

A Phase 1 study testing PGT121.414.LS and VRC07-523LS in people with HIV-1, run by National Institute of Allergy and Infectious Diseases (NIAID) at 19 sites in 6 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages Up to 72 hoursHealthy volunteers can take part
Conditions the study is for
HIV-1
What is being tested?
PGT121.414.LS and VRC07-523LS
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
48 participants
Where
19 sitesin 6 countries
Study dates
5 Jan 2026to 31 May 2029
Phase
Phase 1
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Up to 72 hours
  • All sexes
  • Healthy volunteers accepted
  • Child

Who may be able to join

  • 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.
Show all 23Show fewer
  • 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

Who cannot join

  • 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.

Trial locations and contacts

19 sites in 6 countries. Contact the study team or a site near you to ask about taking part.

Emily Brown contact

919-321-3806

embrown@fhi360.org

19 sites in 6 countries

United States13 sites, 11 recruiting

  • Site 5030, Emory University School of Medicine NICHD CRS

    Atlanta, Georgia, 30322

    Not yet recruiting

  • Site 5052, University of Colorado Denver NICHD CRS

    Aurora, Colorado, 80045

    Recruiting

  • Site 5092, Johns Hopkins University Baltimore

    Baltimore, Maryland, 21287

    Recruiting

  • Site 32515, Rush Univ./Cook County Hosp. Chicago CRS

    Chicago, Illinois, 60612

    Not yet recruiting

  • Site 5083, Rush University Cook County Hospital Chicago

    Chicago, Illinois, 60612

    Withdrawn

  • Site 5128, Baylor College of Medicine/Texas Children's Hospital NICHD CRS

    Houston, Texas, 77030

    Recruiting

  • Site 5051, University of Florida Jacksonville NICHD CRS

    Jacksonville, Florida, 32209

    Recruiting

  • Site 5112, David Geffen School of Medicine at UCLA

    Los Angeles, California, 90095

    Not yet recruiting

  • Site 6501, St. Jude Children's Research Hospital CRS

    Memphis, Tennessee, 38105

    Not yet recruiting

  • Site 32512, Pediatric Perinatal HIV CRS

    Miami, Florida, 33136

    Not yet recruiting

  • Site 5127, Pediatric Perinatal HIV

    Miami, Florida, 33136

    Withdrawn

  • Site 5114, Bronx-Lebanon Hospital Center

    The Bronx, New York, 10457

    Recruiting

  • Site 5013, Jacobi Med. Ctr Bronx NICHD CRS

    The Bronx, New York, 10461

    Not yet recruiting

Other trials in United States

Brazil2 sites, 1 recruiting

  • Site 5072, Hospital Federal dos Servidores do Estado

    Rio de Janeiro, Brazil, CEP 20221-903

    Withdrawn

  • Site 5097, Hospital Geral De Nova Iguacu Brazil NICHD CRS

    Rio de Janeiro, 26030

    Not yet recruiting

Other trials in Brazil

Kenya1 site, 1 recruiting

  • Site 5121, Kenya Medical Research Institute/Walter Reed Project Clinical Research Center, Kericho CRS

    Kericho, 20200

    Recruiting

Other trials in Kenya

Puerto Rico1 site, 1 recruiting

  • Site 32513, IMPAACT/Gamma Project/UPR Pediatric HIV/AIDS Research Network CRS

    San Juan, Puerto Rico, 00935

    Not yet recruiting

Other trials in Puerto Rico

South Africa1 site, 1 recruiting

  • Site 8950, FAMCRU

    Cape Town, Parrow Valley, 7505

    Not yet recruiting

Other trials in South Africa

Zimbabwe1 site, 1 recruiting

  • Site 31890, Harare Family Care CRS

    Harare

    Not yet recruiting

Other trials in Zimbabwe

About this study

Official title: 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.

Read the 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.

Conditions
HIV-1
Being tested
PGT121.414.LS, VRC07-523LS

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PGT121.414.LSDrug

    Administered SC in the thigh

  • VRC07-523LSDrug

    Administered SC in the thigh

Study groups in NCT06517693
Study groupRoleWhat they receive
Cohort 1 Stratum Formula Fed (FF)ExperimentalSingle subcutaneous (SC) dose of PGT121.414.LS at birth, based on weight.
Receives: Drug: PGT121.414.LS
Cohort 1 Stratum Breastfed (BF)ExperimentalInitial 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.
Receives: Drug: PGT121.414.LS
Cohort 2 Stratum FFExperimentalSingle SC doses of PGT121.414.LS and VRC07-523LS at birth, based on weight.
Receives: Drug: PGT121.414.LS; Drug: VRC07-523LS
Cohort 2 Stratum BFExperimentalInitial 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.
Receives: Drug: PGT121.414.LS; Drug: VRC07-523LS

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Proportion of infants with at least one Grade 3 or higher Adverse Event (AE) (one dose)

    Measured: Day 0 through Week 12

  2. Proportion of infants with at least one Grade 3 or higher AE assessed as related to study product (one dose)

    Measured: Day 0 through Week 12

  3. Proportion of infants with at least one Grade 3 or higher AE (two doses)

    Measured: Day 0 through Week 24

  4. Proportion of infants with at least one Grade 3 or higher AE assessed as related to study product (two doses)

    Measured: Day 0 through Week 24

  5. PGT121.414.LS maximum concentration (Cmax) (single/first dose)

    Measured: Day 0 through Week 48

  6. PGT121.414.LS time of maximum concentration (Tmax) (single/first dose)

    Measured: Day 0 through Week 48

  7. PGT121.414.LS area under the curve (AUC(0-12WK)) (single/first dose)

    Measured: Day 0 through Week 12

  8. PGT121.414.LS concentration at the end of the first dose interval (C(12WK)) (single/first dose)

    Measured: Week 12

  9. PGT121.414.LS concentration at the end of the second dose interval (C(24WK)) (two doses)

    Measured: Week 24

  10. VRC07-523LS maximum concentration (Cmax) (single/first dose)

    Measured: Day 0 through Week 48

  11. VRC07-523LS time of maximum concentration (Tmax) (single/first dose)

    Measured: Day 0 through Week 48

  12. VRC07-523LS area under the curve (AUC(0-12WK))

    Measured: Day 0 through Week 12

  13. VRC07-523LS concentration at the end of the first dose interval (C(12WK)) single/first dose)

    Measured: Week 12

  14. VRC07-523LS concentration at the end of the second dose interval (C(24WK)) (two doses)

    Measured: Week 24

Secondary outcomes (29)

  1. Proportion of infants with at least one Grade 3 or higher AE

    Measured: Day 0 through Week 96

  2. Proportion of infants with at least one Grade 3 or higher AE assessed as related to study product

    Measured: Day 0 through Week 96

  3. Proportion of infants with at least one Grade 2 or higher AE (one dose)

    Measured: Day 0 through Week 12

  4. Proportion of infants with at least one Grade 2 or higher AE assessed as related to study product (one dose)

    Measured: Day 0 through Week 12

  5. Proportion of infants with at least one Grade 2 or higher AE (two doses)

    Measured: Day 0 through Week 24

  6. Proportion of infants with at least one Grade 2 or higher AE assessed as related to study product (two doses)

    Measured: Day 0 through Week 24

  7. Proportion of infants with any AEs that lead to study product discontinuation

    Measured: Day 0 through Week 12

  8. PGT121.414.LS AUC(0-48WK) after single dose administration

    Measured: Week 48

  9. PGT121.414.LS concentration after single dose administration

    Measured: Week 48

  10. PGT121.414.LS concentration after two dose administration

    Measured: Week 60

  11. PGT121.414.LS apparent clearance (CL/F)

    Measured: Day 0 through Week 60

  12. PGT121.414.LS half-life (T1/2) following single dose administration

    Measured: Day 0 through Week 48

  13. PGT121.414.LS half-life (T1/2) following two dose administration

    Measured: Day 0 through Week 60

  14. VRC07-523LS AUC(0-48WK) after single dose administration

    Measured: Week 48

  15. VRC07-523LS concentration after single dose administration

    Measured: Week 48

  16. VRC07-523LS concentration after two dose administration

    Measured: Week 60

  17. VRC07-523LS apparent clearance (CL/F)

    Measured: Day 0 through Week 60

  18. VRC07-523LS half-life (T1/2) following single dose administration

    Measured: Day 0 through Week 48

  19. VRC07-523LS half-life (T1/2) following tow dose administration

    Measured: Day 0 through Week 60

  20. Proportion of infants with PGT121.414.LS concentrations > 20 and > 50 mcg/mL following single/first dose administration

    Measured: Week 12

  21. Proportion of infants with PGT121.414.LS concentrations > 20 and > 50 mcg/mL following two dose administration

    Measured: Week 24

  22. Proportion of infants with VRC07-523LS concentrations > 10 and > 20 mcg/mL following single/first dose administration

    Measured: Week 12

  23. Proportion of infants with PGT121.414.LS concentrations > 10 and > 20 mcg/mL following two dose administration

    Measured: Week 24

  24. Proportion of infants with anti-PGT121.414.LS antibodies detected

    Measured: Week 24

  25. Proportion of infants with anti-VRC07-523LS antibodies detected

    Measured: Week 24

  26. Proportion of infants with anti-PGT121.414.LS antibodies detected

    Measured: Week 48

  27. Proportion of infants with anti-VRC07-523LS antibodies detected

    Measured: Week 48

  28. Proportion of infants with confirmed HIV infection following receipt of study product

    Measured: Day 0 through Week 96

  29. 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

    Measured: Day 0 through Week 13

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Jul 2024
  2. Study start5 Jan 2026
  3. Primary completion30 Nov 2027 (estimated)
  4. Study completion31 May 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Prevention
Allocation
Non-randomised
Intervention model
Sequential
Masking
None (open label)
Enrolment
48 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06517693
Sponsor's protocol ID
IMPAACT 2037
Other IDs
38962
Status last verified
Oct 2026
First submitted
18 Jul 2024
Last updated
3 Nov 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: Individual participant data that underlie results in the publication, after deidentification

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing PGT121.414.LS and VRC07-523LS in people with HIV-1, run by National Institute of Allergy and Infectious Diseases (NIAID) at 19 sites in 6 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 23 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 3 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 19 sites in United States, Brazil, Kenya, Puerto Rico, South Africa and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Emily Brown (919-321-3806, embrown@fhi360.org), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Proportion of infants with at least one Grade 3 or higher Adverse Event (AE) (one dose) (time frame: Day 0 through Week 12). The study lists 14 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06517693.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Nov 2026.

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