Development of Tests to Measure Medicines in Breast Milk
Research type
Research Study
Full title
Development and validation of assays for quantitation of antiretrovirals in human breastmilk
IRAS ID
208489
Contact name
Catriona Waitt
Contact email
Sponsor organisation
University of Liverpool
Duration of Study in the UK
2 years, 7 months, 21 days
Research summary
Despite the ‘roll out’ of drugs to treat HIV/AIDS in the developing world, HIV continues to be a major cause of illness and death.
Around a third of babies acquiring HIV from their mothers do so as a result of breastfeeding; therefore in well-resourced settings, it is recommended that HIV positive women do not breastfeed their children. However, this is not possible in the developing world, where formula milk is expensive or unavailable and where safe drinking water is scarce. The World Health Organisation therefore suggest that these women exclusively breastfeed their children for six months.
With increasing availability of HIV drugs, there are increasing numbers of women breastfeeding their children whilst on treatment; important questions surrounding the level of drug that breastfed children are exposed to remain unanswered. For example, does a low level of drug in breastmilk lead to ongoing HIV transmission? Does a high level of drug lead to side effects in the baby? More worryingly, does a low level of drug ingested by a child predispose them to develop drug-resistant HIV themselves?
Well-designed clinical studies investigating these issues are few. However, before such studies can be undertaken, it is necessary to ensure that the methods for measuring drug in breastmilk are robust.
This proposal seeks to develop such an assay, in the internationally accredited Bioanalytical Facility at the University of Liverpool. This will ensure that there is a high quality, accurate test available to measure the drugs in both blood and breastmilk, before going on to undertake clinical studies in patients.
REC name
London - City & East Research Ethics Committee
REC reference
16/LO/1394
Date of REC Opinion
29 Jul 2016
REC opinion
Favourable Opinion