Latency and Early Neonatal Provision of Antiretroviral Drugs Clinical Trial

• Status: Completed
• Trial end date: 2020-04-30
• Target enrollment: 0
• Participant gender: All

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
• Accepts Healthy Volunteers?: No

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
• Treatments: Lamivudine; Lopinavir; Nevirapine; Ritonavir; Zidovudine

Criteria

Inclusion Criteria:

• Point of care (POC) or laboratory-based test positive on a sample collected within 48 hours of birth.

• Mother willing and able to provide informed consent.

Exclusion Criteria:

• Expressed intention to leave the Johannesburg area permanently.

• Co-morbidities, birth defects or other conditions which in the opinion of the clinical team have a greater than 50% risk of mortality in the first days of life.

• Co-morbidities or conditions which in the opinion of the clinical team advise against initiation of ART within the first 48 hours of life.

• Active (uncontrolled) maternal psychiatric illness.