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Brussels, 14 September 2007

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.

In 2006, an estimated 2.3 million children worldwide were living with HIV, 9 out of 10 of them in Sub-Saharan Africa, and 380000 children below the age of 15 years died of AIDS-related causes. 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 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.

The European and Developing Countries Clinical Trials Partnerships (EDCTP), helped to address this problem by funding a pharmacokinetic (dosing) study and a trial. EDCTP, launched in 2004, is a research programme designed to pool resources from the European Union research budget and European national research programmes to conduct clinical trials in the area of HIV/AIDS, malaria and tuberculosis. Information obtained from the study contributed to the FDA granting tentative approval for the registration of this drug, Triomune, 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 and the Medical Research Council (MRC) Clinical Trials Unit, United Kingdom. The study was presented at the Conference for Retroviruses and Opportunistic Infections (CROI) meeting in February 2007 in Los Angeles and is a sub-study of a larger ongoing randomised trial (the CHAPAS1 trial – Children with HIV in Africa - Pharmacokinetics and Adherence of Simple Antiretroviral Regimens) that is evaluating the necessity of “lead-in” treatment for nevirapine, one of the anti-HIV drugs in the triple combination pill. Data generated from this pharmacokinetic sub-study of CHAPAS 1 were included in the submission for drug registration and contributed to the FDA granting tentative approval for the registration of this drug for use in children.

Triomune Baby and Junior tablets are scored, crushable and water soluble for children who cannot swallow tablets. The fact that all three drugs are combined in one tablet (which is layered to ensure equal distribution of drugs if snapped in half), 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.

This will be the first FDC anti-HIV drug specifically designed for children to be registered by the FDA.

The tentative FDA registration paves the way for the drug to receive WHO prequalification status. Additionally, it will allow programmes such as PEPFAR and the Clinton Foundation which make antiretroviral drugs available in many resource-constrained countries, to purchase the drug for widespread use in HIV-infected children.
See also:
FDA press release:

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