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

On 13 August 2007, the United States Federal Drug Administration (FDA) gave tentative approval for a fixed-dose combination (FDC) anti-HIV drug specifically formulated for paediatric use. EDCTP, the European and Developing Countries Clinical Trials Partnership, funded the pharmacokinetic study leading to this major breakthrough in the treatment of children infected by HIV/AIDS. The FDC is manufactured by CIPLA pharmaceuticals. It is administered twice daily, according to a simple weight-based table, allowing for easy prescribing. It can also be dissolved in water for young children who cannot swallow tablets. As a result of this tentative approval, this FDC antiretroviral drug will also be included in the World Health Organisation (WHO) Prequalification Programme and will become available for distribution under the President’s Emergency Plan for AIDS Relief (PEPFAR) and Clinton Foundation programmes. Under the trade names of Triomune Baby and Junior, the drug has already been approved and is in use in Zambia.