PGT121.414.LS + VRC07-523LS for HIV

Recruiting at 17 trial locations

Age: < 18

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Waitlist Available

Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)

No Placebo Group

Trial Summary

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.

Research Team

Coleen Cunningham

Principal Investigator

University of California, Irvine

Eligibility Criteria

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

For Cohorts 1 and 2, Strata BF: At entry, infant is breastfeeding or the birthing parent has indicated an intention to initiate breastfeeding

I plan to breastfeed, according to my own decision.

My newborn is less than 3 days old and can start the study within 3 days after birth.

Exclusion Criteria

Birthing parent has received any investigational product during this pregnancy

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

At entry, infant with a documented positive HIV Nucleic Acid Test (NAT) result

Treatment Details

Interventions

• PGT121.414.LS (Monoclonal Antibodies)
• VRC07-523LS (Monoclonal Antibodies)

Trial Overview The study tests the safety and how the body processes two anti-HIV antibodies (PGT121.414.LS alone and combined with VRC07-523LS) administered soon after birth to infants exposed to HIV-1.

Participant Groups

Group I: Cohort 2 Stratum FF Experimental Treatment 2 Interventions

Single SC doses of PGT121.414.LS and VRC07-523LS at birth, based on weight.

Group II: Cohort 2 Stratum BF Experimental Treatment 2 Interventions

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.

Group III: Cohort 1 Stratum Formula Fed (FF) Experimental Treatment 1 Intervention

Single subcutaneous (SC) dose of PGT121.414.LS at birth, based on weight.

Group IV: Cohort 1 Stratum Breastfed (BF) Experimental Treatment 1 Intervention

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.

Who Is Running the Clinical Trial?

National Institute of Allergy and Infectious Diseases (NIAID)

Lead Sponsor

Trials

3,361

Recruited

5,516,000+

Dr. Jeanne Marrazzo

National Institute of Allergy and Infectious Diseases (NIAID)

Chief Executive Officer since 2023

MD, MPH

Dr. H. Clifford Lane

National Institute of Allergy and Infectious Diseases (NIAID)

Chief Medical Officer

MD

National Institute of Allergy and Infectious Diseases Vaccine Research Center

Collaborator

Trials

1

Recruited

50+

National Institute of Mental Health (NIMH)

Collaborator

Trials

3,007

Recruited

2,852,000+

Dr. Joshua A. Gordon

National Institute of Mental Health (NIMH)

Chief Executive Officer since 2016

MD, PhD

Dr. Shelli Avenevoli

National Institute of Mental Health (NIMH)

Chief Medical Officer

PhD

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Collaborator

Trials

2,103

Recruited

2,760,000+

Dr. Diana W. Bianchi

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Chief Executive Officer since 2016

MD from Stanford University

Dr. Alison Cernich

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Chief Medical Officer since 2020

PhD in Clinical Psychology from University of Maryland

National Institute of Allergy and Infectious Diseases Vaccine Research Center (NIAID VRC)

Collaborator

Trials

1

Recruited

50+