Phase II double blind randomised placebo-controlled clinical trial to evaluate the safety & pharmacokinetics ofVRC07-523LS in breastfed HIV-exposed uninfected and HIV-infected neonates and infants in South-Africa

South African Medical ResearchCouncil0 sites129 target enrollmentNovember 11, 2022

Overview

No summary available.

Registry

who.int

Start Date

November 11, 2022

End Date

TBD

Last Updated

2 years ago

Study Type

Interventional

Sex

All

Sponsor

South African Medical ResearchCouncil

•Eligibility criteria
•Maternal inclusion criteria
•1\) Documented HIV\-1infection antenatally or at delivery and receiving ART as per national guidelines
•2\) Greater than or equal to18 years of age
•3\) Breastfeeding at the time of enrolment or willing to initiate breastfeeding in the immediate post\-partum period
•INFANT ELIGIBILITY CRITERIA
•1\) Gestational age greater or equal to36 weeks, assessed using dual methods of early sonar AND birth Ballard Score (done up to 42 hours after birth)
•2\) Birth weight greater than or equal to 2\.0 kg and lower than or equal to 4\.5kg
•3\) Written consent of one or both parents (according to South African regulation)

•Mother exclusion criteria
•1\) Prior participation in anyHIV\-1 vaccine trial
•2\) Receipt of another active or passive HIVimmunotherapy or investigational product concurrently
•3\) Documented or suspected serious medical illness with fatal compromise or immediate life\-threatening condition (other than HIV\-infection as judged by the examining clinician)
•4\) Unable or unwilling to provide a signed informed consent to participate to the study for herself and her infant
•5\) Known active tuberculosis or other opportunistic infection
•6\.Plan to relocate in 1 year or do not have a local address
•7\)Does not have her own cell phone
•8\)Not able to provide three alternate contact phone numbers
•9\) Multiple pregnancies, i.e. twins, triplets, quadruplets, etc.