HIV/AIDS infected children can now benefit from a European and Developing Countries Clinical Trials Partnership funded trial

In August, the United States (US) Federal Drug Administration (FDA) gave a tentative approval to a fixed-dose anti-HIV drug specifically formulated for paediatric use. The fixed-dose combination scored tablet of lamivudine 30mg, stavudine 6mg and nevirapine 50mg (Triomune Baby) and double this strength (Triomune Junior) is manufactured by CIPLA pharmaceuticals.

EDCTP, the funder of the pharmacokinetic study leading to this tentative approval, congratulates Professor Chifumbe 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 and the Medical Research Council (MRC) Clinical Trials Unit, United Kingdom on their work. Triomune Baby and Junior have already been approved in Zambia and are currently being used to treat children there.

Treatment of HIV/AIDS in children is a great challenge in resource-constrained settings. One of the reasons for this is the difficulty and cost of giving paediatric formulations, particularly syrups, of anti-HIV drugs to children. The absence of appropriate paediatric formulations often necessitates administering divided adult tablets to HIV-infected children. This can lead to incorrect dosing, especially under dosing, and increases the risk of the rapid development of resistance to the drugs. The problem is compounded by underlying malnutrition in these children, and the lack of knowledge about how malnutrition affects drug levels in the body. read more