Latency and Early Neonatal Provision of Antiretroviral Drugs Clinical Trial
Status:
Completed
Trial end date:
2020-04-30
Target enrollment:
Participant gender:
Summary
The investigators propose a non-randomized clinical trial of 60 HIV-infected infants
identified within 48 hours of birth and their mothers to investigate the consequences of very
early ART on the establishment and maintenance of the viral reservoir.
The first phase (early ART initiation within 48 hours of birth) will examine the trajectory
i.e. changes over time of the viral reservoir and detection of HIV-specific antibody
responses in infants testing HIV-positive within 48 hours of birth and initiating early ART.
Secondary pathogenesis aims will test whether markers of neonatal immune quiescence are
associated with the extent of seeding and rate of decline of the viral reservoir when ART is
started at a young age and investigate whether markers in infant stool samples can be used as
a non-invasive method of defining relevant immune and HIV-specific parameters associated with
viral reservoir size.
The investigators hypothesize that developmental characteristics of newborn immunity may make
this period the optimal time to begin ART and influence the seeding of the viral reservoir.
Phase:
Phase 4
Details
Lead Sponsor:
Columbia University
Collaborators:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) National Institutes of Health (NIH) University of Witwatersrand, South Africa