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

Recruiting Phase 1 Interventional Study
HIV-1
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Healthy Volunteers Welcome You do not need to have the condition being studied to take part.
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At a Glance
Age
Up to 72 Hours
Sex
Any
Trial phase
Phase 1
Study type
Interventional
Purpose
Prevention
Participants needed
48 (estimated)
Sponsor
National Institute of Allergy and Infectious Diseases (NIAID) · NIH
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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.

Trial Locations
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Eligibility Criteria
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 bas…
Contacts

Emily Brown

919-321-3806

embrown@fhi360.org

CONTACT