Locations
Burkina Faso: Centre Hospitalier Universitaire Blaise Compraore Ouagadougou
South Africa: Cecilia Makiwane hospital, East London
Uganda: PROMISE M&S site Mbale
Zambia: Paediatric Center Of Excellence, Lusaka
Sponsor
French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS)
General objective
- To assess the long-term safety and efficacy of one-year infant prophylaxis using lamivudine (3TC) or lopinavir/ritonavir (LPV/r) to prevent post-natal transmission through breastfeeding.
- To investigate the biological mechanisms involved in postnatal HIV transmission.
Specific objectives
- To compare the long-term safety of infant prophylaxis using either 3TC versus LPV/r on child development (growth, somatic and mental health), mortality, adrenal function, liver function, full blood count and mitochondrial toxicity.
- To estimate the final efficacy data of 50 weeks of infant prophylaxis using either LPV/r or 3TC, since some mothers may have resumed breastfeeding after the trial.
- To profile miRNA in breast milk according to maternal HIV status and HIV transmission.
- To determine the influence of maternal milk on infant gut inflammation in an in vitro 3D-intestinal model (CACO-2 cells)
Study Population
The study population will comprise all ANRS 12174 PROMISE-PEP trial participants who completed the 50 week follow-up and are not HIV infected. There are 1101 children fulfilling the inclusion criteria over the four African sites with an estimation of 80% of them being recruited on PROMISE M&S study (N=881).