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PENTA
HIV/AIDS
Framework programme: 5
Project number:
QLK2-CT-2000-00150
EC contribution: € 957 000
Duration: 48 months
Type: CA
Starting date: 1 October 2000
Website: http://www.ctu.mrc.ac.uk/penta
Graphic element Paediatric European Network for the Treatment of AIDS
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.

Aim:

  • To initiate and undertake trials, which address questions about antiretroviral therapy (ART) in HIV infected children, particularly those that cannot be answered by trials in adults.
  • To undertake trials, which explore other issues related to the clinical management of HIV infected children, including HIV resistance tests, therapeutic drug monitoring of levels of ART, immune-based therapies in the newborn, and in older children and adherence support methodologies.
  • To combine existing data from PENTA and other cohort studies in Europe and US in order to undertake analyses to determine the relationships between HIV RNA viral load and CD4 count better, and how these vary with age in untreated and treated children.
  • To strengthen and extend the existing highly successful PENTA network to include centres from Romania, the country reporting the highest number of HIV-infected children in Europe.

Expected results:

  • By encouraging collaboration and contact between paediatricians, particularly in those centres treating small numbers of children, the standard of clinical care for HIV-infected children will improve throughout Europe.
  • Design and implementation of high quality independent clinical trials in children with HIV infection
  • Combining trials and cohort data into a dataset for undertaking meta-analysis of virological and immunological markers of HIV infection.
  • Expansion of the network to other Eastern European countries.

Potential applications:

HIV prevention, care and treatment of infected individuals requires a multi-faceted approach and has been the task of several European Community Action Programmes. PENTA aims to develop new and better strategies for the treatment and care of children with HIV infection across Europe. Due to interventions to reduce mother-to-child transmission of HIV, the number of HIV-infected children has decreased. However, there remain significant numbers of infected children in Europe, whose life-expectancy has increased with the advent of more potent antiretroviral therapies. The outcome of the paediatric clinical trials carried out in Europe will have an impact, particularly in middle-income countries (such as Romania and Brazil), where HIV/AIDS is a crucial problem, and some antiretroviral therapies are affordable and beginning to be used.

Exchange of information, and training in research methods and in the management of HIV-infected children through exchanges will contribute to improved management of children across all participating countries. The collaboration established by the PENTA network with drug companies has resulted in the development of innovative methods for drug distribution and monitoring, leading to faster availability of products for trials throughout the participating Member States, which should contribute to the rapid availability of new products throughout the European Union. In addition, the collaboration with other European networks involved in paediatric HIV research extends the scope of the work carried out by PENTA to the social field.

Coordinator:

Carlo Giaquinto
Azienda Ospedaliera di Padova
Dipartimento di Pediatria
via Giustiniani 3
35128 Padova
Italy
Tel: +39 049 8213585
Fax: +39 049 8773865
E-mail: carlog@child.pedi.unipd.it

Partners:

Principal
Scientific
Participants
Official Address Other Information
2 J.Pierre Aboulker Agence National pour la Recherche de la Sida
(ANRS)/INSERM
16 Avenue Paul Vaillant Couturier
FR-94807 Villejuif
France
Tel: +33 1 45 59 51 07
Fax: +33 1 45 59 51 80
E-mail: jp.aboulker@bjf.inserm.fr
Website: http://www.inserm.fr
3 Diana Gibb Medical Research Council
HIV Division - Clinical Trials Unit
222 Euston Road
UK-NW1 2BZ London
United Kingdom
Tel: +44 20 7670 4700
Fax: +44 20 7670 4818
E-mail: Di.Gibb@ctu.mrc.ac.uk
Website: http://www.ctu.mrc.ac.uk
4 European Aids Treatment Group
 
Université de Liège
Belgium
 
5   Instituto de Infectologia E. Ribas - Sao Paolo
Brazil
 
6   Hvidore Hospital -Dept. Paediatrics 531
EATN/EATG (European AIDS Treatment Group)
Denmark
 
7   Hopital Jean Verdier,
France
 
8   Hopital Necker Enfants Malades,
France
 
9   Hopital Arnaud de Villeneuve,
France
 
10   Hopital Robert Debre,
France
 
11   Hopital Necker Enfants Malades,
France
 
12   Hopital Edouard Henriot,
France
 
13   Hopital de la Timone,
France
 
14   C.H.U: de Nice- Hopital de l’Archet,
France
 
15   Hopital Armand Trouseeau,
France
 
16   Hopital Pourpan, Institute Goustave – Roussy,
France
 
17   Centre Hospitalier Intercommunal-Creteil,
France
 
18   Hopital Jeanne de Flandres.
France
 
19   Charite-Virchow-Klinikum- Humboldt Universitat,
Germany
 
20   Universitats – Kinderklinik – Heidelberg,
Germany
 
21   Universitat zu Koln,
Germany
 
22   Universitat of Dusseldorf,
Germany
 
23   KinderKlinik St Anna Stift,
Germany
 
24   Universitat of Munchen, Universitie Kinderklinik – Ulm.
Germany
 
25   Our Lady’s Hospital for Sick Children.
Ireland
 
26   Università di Napoli Federico II,
Italy
 
27   Istituto per l’Infanzia B. Garofolo,
Italy
 
28   Ospedale Bambin Gesù,
Italy
 
29   Ospedale G. Salesi,
Italy
 
30   IRCSS Policlinico S. Matteo,
Italy
 
31   Ospedale Infantile R. Margherita,
Italy
 
32   Ospedale Luigi Sacco,
Italy
 
33   Università di Milano,
Italy
 
34   Ospedale Niguarda Ca’Grande,
Italy
 
35   Istituto Giannina Gaslini,
Italy
 
36   Università Cattolica Sacro Cuore,
Italy
 
37   Ospedale dei Bambini Umberto I,
Italy
 
38   Ospedale Infantile di Trento,
Italy
 
39   Università di Firenze,
Italy
 
40   Istituto Superiore di Sanità,
Italy
 
41   Università degli Studi di Padova,
Italy
 
42   Ospedale SS Annunziata,
Italy
 
43   Ospedale regionale di Bolzano,
Italy
 
44   Ospedale Policlinico di Modena,
Italy
 
45   Ospedale Maggiore di Parma,
Italy
 
46   Ospedale dei bambini di Palermo.
Italy
 
47   Academisch Ziekenhuis Univ. Amsterdam
The Netherlands
 
48   University Hospital Utrecht,
The Netherlands
 
49   Slotervaart Hospital,
The Netherlands
 
50   University Hospital of Rotterdam.
The Netherlands
 
51   Hospital de D. Estefania.
Portugal
 
52   Clinical Municipal Hospital Constanta
Romania
 
53   Institutul de Boli Infectioase “Matei bals” Bucaresti
Romania
 
54   Romanian Appeal Fondation
Romania
 
55   Spitalul Clinic de Boli Infectioase si Tropicale “Victor Babes” Bucaresti
Romania
 
56   Hospital General Universitario Gregorio Maranon,
Spain
 
57   Hospital Infantil La Paz,
Spain
 
58   Hospital de Basurto,
Spain
 
59   Hospital 12 Octubre,
Spain
 
60   Hospital Clinic-Saint Joan de Deu,
Spain
 
61   Hospital de Aranzazu,
Spain
 
62   Hospital La Fe,
Spain
 
63   Hospital Del Mar,
Spain
 
64   Instituto de Salud Carlos III,
Spain
 
65   Hospital Son Dureta,
Spain
 
66   Hospital General Universitario Gregorio Maranon,
Spain
 
67   Hospital Virgen de la Macarena,
Spain
 
68   Hospital Materno Infantil Vall d’Hebron.
Spain
 
69   Huddinge Hospital.
Sweden
 
70   Chefartzt Pediatrische Klinik,
Switzerland
 
71   Universitats Kinderklinik - Basel,
Switzerland
 
72   Kinderspital - Zurich,
Switzerland
 
73   CHU Vaudois,
Switzerland
 
74   Hopital Cantonal Universitaire – Geneve.
Switzerland
 
75   University of London, Ealing Hospital,
United Kingdom
 
76   ICSTM St. Mary’s Hospital,
United Kingdom
 
77   St George’s Hospital Medical School,
United Kingdom
 
78   Royal Free Hospital - Department of Child Health,
United Kingdom
 
79   Lewisham University Hospital,
United Kingdom
 
80   UCLMS, Royal Hospital for Sick Children,
United Kingdom
 
81   London King’s, St Thomas’s Hospital,
United Kingdom
 
82   Royal Free Hospital - Department of Retrovirology,
United Kingdom
 
83   Chelsea and Westminster Hospital,
United Kingdom
 
84   John Radcliffe Hospital,
United Kingdom
 
85   Newham General Hospital,
United Kingdom
 
86   Sheffield Children Hospital,
United Kingdom
 
87   University of Birmingham Medical School,
United Kingdom
 
88   University of Liverpool,
United Kingdom
 
89   Great Ormond Street Hospital - University of London.
United Kingdom
 
90      

 
 
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