PROMISE M & S
Infant Peri-Exposure Prophylaxis to Prevent HIV-1 Transmission by Breastfeeding: Mechanisms & Safety
Hovedinnhold
The Centre for International Health has been engaged in the follow up study of the large prevention of mother to child transmission trial PROMISE PEP: Prevention of mother to child transmission of HIV.
Important aims of the follow up were:
- 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 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.
The study was structured in two parts. The 'clinical & biological safety' component involved a cross sectional survey. A clinical and neuropsychological examination of participants were conducted. In addition biological samples were collected.
In 2018, the research group had their final PROMISE M and S consortium meeting and the current work involves data analysis and dissemination.
About the project
Project name: PROMISE M & S: Infant Peri-Exposure Prophylaxis to Prevent HIV-1 Transmission by Breastfeeding: Mechanisms & Safety
Period: 2017-2019
UiB coordinator: Thorkild Tylleskär
Funding: French National Institute for Health and Medical Research - French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS)
Partners: Université de Montepellier, France / Centre Hospitalier Universitaire Blaise Compraore, Burkina Faso / Cecilia Makiwane hospital, South Africa / PROMISE M & S site, Uganda / Paediatric Center Of Excellence, Zambia
Relevant links: Clinicaltrials.gov: NCT03519503
