Latency and Early Neonatal Provision of Antiretroviral Drugs Clinical Trial (LEOPARD)

NCT02431975 Phase 4 COMPLETED

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.

Details

Lead sponsor	Columbia University
Phase	Phase 4
Status	COMPLETED
Enrolment	73
Start date	2015-08
Completion	2020-04-30

Conditions

• HIV

Interventions

• Nevirapine
• Zidovudine
• Lamivudine
• LPV/r

Primary outcomes

• Percent of patients with initial viral suppression — 24 weeks
  Suppression is defined as patients with plasma HIV RNA \<50 copies/mL.

Countries

South Africa