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HIV drug designed for children wins FDA approval
HIV drug designed for children wins FDA approval
10 October 2007
A pill containing 3 anti-HIV drugs designed specifically
for children has been given tentative approval by the United States
Food and Drug Administration (FDA). Its use in Sub-Saharan Africa
will benefit thousands of children living with HIV.The Medical
Research Council sponsored the trial that helped to develop the
right combination of drug doses in the pills.
The expense and difficulty of giving anti-HIV drugs in syrups
formulated for children has meant that they have often been treated
with divided adult tablets. This can lead to inadequate dosing and
increases the risk of rapid development of drug resistance. The
malnutrition experienced by many children may also affect dosing
and efficiency of drug treatment. The European and Developing
Countries Clinical Trials Partnerships (EDCTP) helped to address
these problems by funding a pharmacokinetic (dosing) study which
MRC scientists managed in collaboration with colleagues in Zambia.
The tablets are manufactured by CIPLA pharmaceuticals, who provided
the tablets for this study.
The pill, known as Triomune Baby and Junior, has the advantage
of being scored so that they can easily be snapped in half. It is
also water soluble so can be dissolved in water or other semi
solids like porridge and given to children who are too young to
swallow tablets. The ease of use of the pill is enhanced by simple
prescription guidelines that are based on a weight-based table. In
addition, the three drugs are layered to ensure equal distribution
when it is snapped in half
The fact that there are three different drugs combined in one
tablet and that tablets can be stored, distributed, and
administered easily to children represents a significant advance in
HIV treatment for children in resource-limited settings.
Information from the EDCTP study contributed to the FDA granting
tentative approval for the registration of Triomune Baby and Junior
for use in children.The pharmacokinetic study was undertaken by
Professor Chintu from the School of Medicine and Department of
Paediatrics, University Teaching Hospital, Lusaka, and his Zambian
team, along with research collaborators from the Netherlands (Dr
David Burger) who undertook the drug testing and the UK based
Medical Research Council (MRC) Clinical Trials Unit.
Read this
press release in full on the MRC website
Last Update Date : 7/6/2009
