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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.