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PENTA


HIV/AIDS

Paediatric European Network for the Treatment of AIDS
Framework programme:
5
Project number:
QLK2-CT-2000-00150
EC contribution:
€ 957 000
Duration:
48 months
Type:
CA
Starting date:
1 October 2000

Keywords: HIV; children; clinical trials; antiretroviral therapy (ART); pharmacokinetic studies

Summary:

The Paediatric European Network for Treatment AIDS (PENTA) was established in 1991 as a collaboration between paediatric HIV centres in Europe. PENTA aims to undertake trials in HIV-infected children addressing questions on antiretroviral drugs specific to children, which cannot be answered in adults. PENTA has established a network of over 90 paediatric centres and collaborating laboratories from 13 European countries able to recruit and follow up HIV-infected children in clinical trials to good clinical practice (GCP) standards. More than 700 children have been enrolled in eight major studies coordinated by the MRC Clinical Trial Unit in London, the INSERM/ANRS HIV trial centre in Paris and the Department of Paediatrics at the University of Padova.

Problem:

With the prolongation of disease-free life associated with potent antiretroviral therapy (ART), new therapies are evaluated in adult trials using endpoints of viral load reduction and immune response. However, there are important differences between adults and children in these parameters. Pharmacokinetic studies are essential as some drugs, such as the protease inhibitors, are metabolised faster in children and extrapolating from adult data would result in under-dosing, which could increase the risk of developing resistance to HIV.

It was recognised that a network of paediatric centres in Europe was required to evaluate therapeutic questions specific to children with HIV infection, as there were insufficient numbers of children to address questions in a timely manner in any single country. PENTA was set up and has been funded by the EU and Member States since 1991. Trials have been planned in close communication with researchers undertaking trials in adults, and are designed to complement questions being addressed by trials undertaken through the Paediatric AIDS Clinical Trials Group (PACTG) in the US.

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