Health Trials

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

ConditionHIV-1
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
AgeUp to 72
SponsorNational Institute of Allergy and Infectious Diseases (NIAID)

About 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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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.

Disqualifiers

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 design

Design model

Sequential

Treatments tested in this trial

  • PGT121.414.LS

    Drug

    Administered SC in the thigh

  • VRC07-523LS

    Drug

    Administered SC in the thigh

Treatment groups

48 Participants
are divided into 4 treatment groups
Group A: Cohort 1 Stratum Formula Fed (FF)Experimental treatment 1 intervention
Group B: Cohort 1 Stratum Breastfed (BF)Experimental treatment 1 intervention
Group C: Cohort 2 Stratum FFExperimental treatment 2 interventions
Group D: Cohort 2 Stratum BFExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

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

Time frame
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)

Time frame
Day 0 through Week 12
3

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

Time frame
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)

Time frame
Day 0 through Week 24

Secondary outcomes

1

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

Time frame
Day 0 through Week 96
2

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
3

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

Time frame
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)

Time frame
Day 0 through Week 12

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

National Institute of Allergy and Infectious Diseases (NIAID)

Lead sponsor

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

Collaborator

National Institute of Mental Health (NIMH)

Collaborator

Source ClinicalTrials.gov
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