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

Part of paid clinical trials in Los Angeles, California.

Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
Study ID
NCT06517693
Phase
PHASE1
Status
Recruiting
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Conditions

  • HIV-1

Eligibility Criteria

Sex
ALL
Age
N/A - 72 Hours
Healthy Volunteers
Accepted

Interventions

  • PGT121.414.LS — DRUG
    Administered SC in the thigh
  • VRC07-523LS — DRUG
    Administered SC in the thigh

Study Details

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.

Key Dates

Start date
Jan 5, 2026
Status verified
May 2026
Primary completion
Dec 31, 2027
Completion
Jun 30, 2028

Study Design

Enrollment
48 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
PREVENTION

Arms

  • Experimental: Cohort 1 Stratum Formula Fed (FF)
    Single subcutaneous (SC) dose of PGT121.414.LS at birth, based on weight.
  • 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.
  • Experimental: Cohort 2 Stratum FF
    Single SC doses of PGT121.414.LS and VRC07-523LS at birth, based on weight.
  • 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.

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 ]

Central Contacts

Locations (11)

FacilityCityStateZIPSite coordinators
Site 5112, David Geffen School of Medicine at UCLALos AngelesCalifornia90095-
Site 5052, University of Colorado DenverAuroraColorado80045-
Site 5051, University of Florida JacksonvilleJacksonvilleFlorida32209-
Site 5127, Pediatric Perinatal HIVMiamiFlorida33136-
Site 5030, Emory University School of MedicineAtlantaGeorgia30322-
Site 5083, Rush University Cook County Hospital ChicagoChicagoIllinois60612-
Site 5092, Johns Hopkins University BaltimoreBaltimoreMaryland21287-
Site 5013, Jacobi Medical Center BronxThe BronxNew York10461-
Site 5114, Bronx-Lebanon Hospital CenterThe BronxNew York10457-
Site 6501, St. Jude Children's Research HospitalMemphisTennessee38105-
Site 5128, Baylor College of Medicine/Texas Children's HospitalHoustonTexas77030-

Find similar trials in Los Angeles, CA

By research site
Site 5112, David Geffen School of Medicine at UCLA· Los Angeles, CASite 5052, University of Colorado Denver· Aurora, COSite 5051, University of Florida Jacksonville· Jacksonville, FLSite 5127, Pediatric Perinatal HIV· Miami, FLSite 5030, Emory University School of Medicine· Atlanta, GASite 5083, Rush University Cook County Hospital Chicago· Chicago, IL

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