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PENTA/ECS
HIV/AIDS
Framework programme: 6
Call: 3
Project number:
LSHP-CT-2006-018865
EC contribution: € 2 000 000
Duration: 48 months
Type: CA
Starting date: March 2006
Graphic element Paediatric European Network for Treatment of AIDS and European Collaborative Study on HIV-infected pregnant women and their children
Keywords: HIV; cohort; vertical transmission; pregnancy; adverse effects; antiretroviral therapy; management; childhood; Eastern Europe

Summary:

The Paediatric European Network for Treatment of AIDS (PENTA), established in 1991, undertakes clinical trials (CTs) to address questions in HIV-infected children where answers cannot be extrapolated from adults. The European Collaborative Study (ECS), a birth cohort study enrolling HIV-infected pregnant women with follow-up of their infected and uninfected infants, was set up in 1985. The PENTA network includes >80 centres in 16 countries and by October 2004, nearly 1 000 children had been enrolled in nine major CTs. The ECS network includes >25 centres in 11 countries and by June 2005 had recruited >6 300 mother-child pairs.

PENTA aims to strengthen and extend the evidence base for the clinical management of HIV-infected children through an integrated programme of CTs and studies. Work plans include design, coordination and analysis of CTs and sub-studies to optimise antiretroviral therapy (ART) use, to enhance knowledge of HIV pathogenesis in children, and improve the standard of care for infected children across Europe by encouraging collaboration between paediatricians. An accredited training programme will also be provided.

ECS objectives include epidemiological investigation of HIV infection in pregnancy and assessment of safety of ART use; monitoring/quantification of MTCT rates, risk factors and interventions across Europe; assessment of disease progression and adverse events in infected children, particularly vertically-infected adolescents; examination of the health of uninfected children, given exposure to maternal HIV and ART in early life, and investigation of feasibility of long-term contact with ART-exposed uninfected children.

In order to integrate their activities, to avoid duplication and to share expertise both in MTCT and paediatric treatment, PENTA and ECS will join and share a common management group for the next four years.

Background:

By the end of 2003, there were an estimated 2.5 million children under the age of 15 living with HIV infection worldwide (UNAIDS 2003). Despite this number, studies on the pathogenesis and treatment of HIV infection in children have been relatively limited. Furthermore, by the end of 2003, 150 000 HIV-infected women were living in Western Europe, with a further 440 000 in Eastern Europe and Central Asia, and HIV seroprevalence in pregnant women was ranging from 0.1 to 1% (UNAIDS 2004). The HIV epidemic in pregnant women in Western Europe has shifted from injecting drug use (IDU) to heterosexually acquired infection, largely among women from sub-Saharan Africa. In contrast, the emerging epidemic in Eastern and Central Europe remains largely focused on IDUs and their sexual partners. Recognising the seriousness of the resurgent epidemic, particularly in Eastern Europe, the European Commission has called for a coordinated and integrated approach to fighting HIV in the enlarged EU.

The Paediatric European Network for Treatment of AIDS (PENTA) was established in 1991 as collaboration between paediatric HIV centres in Europe. The principal aim was to undertake trials to address questions about antiretroviral therapy (ART) in HIV-infected children where answers cannot be extrapolated from trials in adults. Coordination and management activities of the PENTA network have been funded by the European Commission for the last 13 years, through BIOMED 1, BIOMED 2 and the Fifth Framework Programme (including an additional grant to incorporate Romania in 2002). In addition, specific research activities have been funded by governmental and regional bodies in France, the United Kingdom, Italy, Spain and Germany. Support from pharmaceutical companies and the biotechnical industry has also been provided for individual trials and sub-studies.

Through sustained support from the EC, PENTA now has a network of more than 80 clinical centres and research laboratories in 16 countries - 13 in Europe, two in South America and one in Asia. These are able to recruit and follow HIV-infected children, both in clinical trials carried out according to Good Clinical Practice (GCP) and the EU Clinical Trials Legislation, and also in other research activities.

Aim:

As an active research programme, the PENTA scientific objectives include continuation and successful completion of ongoing projects, development and initiation of new trials and sub-studies to address emerging issues in this fast-moving area, and new strategic initiatives to further integrate the work of PENTA trials with that of ongoing and newly developing national and regional cohort collaborations. The following will be carried out:

  • epidemiological investigation of HIV infection in pregnancy
  • assessment of safety of antiretroviral use in pregnancy
  • monitoring/quantification of MTCT rates, risk factors and interventions across Europe
  • assessment of disease progression and adverse events in infected children, particularly vertically-infected  adolescents
  • examination of the health of uninfected, antiretroviral-exposed children, given exposure to maternal HIV and ART in early life investigation of feasibility of long-term contact with ART-exposed uninfected.

The joint collaboration with an integrated management between PENTA and the ECS will allow this CA to consolidate and extend the activities of the ECS. It will be able to continue to evaluate maternal and child health from before delivery into childhood, to assess mother-to-child transmission and therapeutic interventions, and to extend further into Central and Eastern Europe to chart the emerging epidemic while building research capacity. The international advisory and collaborative role of the ECS will also be strengthened through transfer of knowledge.

Expected results:

  • Development of a joint activity plan with other European cohort networks
  • Training programmes based on the PENTA/ECS project’s deliverables
  • Adherence material entitled ‘Support the CD4!’ in German, English and Italian
  • Organisation and implementation of studies on better management of children with HIV infection including evaluation of new drugs, strategies for treatment interruptions, use of Therapeutic Drug Monitoring, use of resistant testing in children, simplification of treatment etc)
  • Preparation of guidelines and scientific manuscripts.

Potential applications:

  • Clinical guidelines for the management of pregnant HIV-infected women
  • Evidence on which to base clinical guidelines for management of paediatric HIV infection
  • Early identification of potential adverse events associated with use of antiretrovirals in pregnancy and childhood
  • Training of researchers and clinicians from Europe and other countries to improve the care of HIV-infected children and their families
  • Evaluation of adherence factors and provision of tools to improve adherence
  • Standardised procedures for anthropometric measurements in children for the definition of the lipodystrophy syndrome
  • Integrated dynamic immunological and virological model of paediatric HIV-1 response to therapy, in order to guide and develop future optimal treatment strategies
  • Improvement of the management and use of antiretrovirals in children
  • Reliable age specific data of relevance to the natural history and treatment of HIV infection in resource-limited countries
  • Production of age-related population pharmacokinetic models for PIs and NNRTIs used in children.

Coordinator:

Carlo Gianquito
FONDAZIONE PENTA - ONLUS
Via Giustiniani 3, 35128 Padova
Tel: +39 049 8213585
Fax: +39 049 8753865
Website: http://www.ctu.mrc.ac.uk/penta/

Partners:

Principal
Scientific
Participants
Official Address Other Information
2
Institute of Child Health, University College London
United Kingdom
3
MRC - Clinical Trials Unit
United Kingdom
4
ANRS/INSERM SC10 Clinical Trial Centre
France
5
AOPD- Dip di Pediatria
Italy
6
Romanian Angel Appeal
Romania
7
IRD Unit 054 – PHPT
France
Thailand
8
Hospital St Pierre
Belgium
9
Instituto Emilio Ribas
Brazil
10
Universitats Kinderklinik
Switzerland
11
Kinderspital Zurich University
Switzerland
12
Universitats Kinderkliniken
Germany
13
Hvidovre Hospital
Denmark
14
Hospital Carlos III
Spain
15
Hospital 12 de Octubre
Spain
16
Hospital Gregorio Marañon
Spain
17
Hospital Necker Enfants Malades
France
18
Hospital Robert Debre
France
19
Institute Gustave Roussy
France
20
Our Lady’s Hospital
Ireland
21
Osp Ped. Bambino Gesù
Italy
22
Dpt Scienze Pediatriche –Uni.To
Italy
23
Azienda Osp San Martino
Italy
24
Istituto Superiore di Sanità
Italy
25
Istituto di Oncologia-Univ.Pd
Italy
26
Osp Luigi Sacco
Italy
27
Emma Children Hospital AMC
Netherlands
28
University Medical Center Nijmegen
Netherlands
29
University.Medical Center Utrecht
Netherlands
30
Spitalul Victor Babes
Romania
31
Karolinska University Hospital
Sweden
32
St Mary’s NHS Trust
United Kingdom
33
St George’s Hospital
United Kingdom
34
UCL - Institute Child Health
United Kingdom
35
University of Liverpool
United Kingdom
36
Chelsea & West Hospital
United Kingdom
37
Univ. Klinik fur Kinder
Austria
38
Univ. Düsseldorf Kinderklinik
Germany
39
Hospital d’Enfants A Trousseau
France
40
Hospital Cochin Port-Royal
France
41
Hospital Louis Mourier
France
42
Osp Bambini Umberto I
Italy
43
Osp Ped Meyer, University of Florence
Italy
44
UNIMI – Ist. Clinica Pediatrica
Italy
45
UNINA- Federico II
Italy
46
Ospedale dei Bambini
Italy
47
San Matteo – Uni Pavia
Italy
48
Ospedale S. Chiara
Italy
49
Medical University of Warsaw
Poland
50
Inst Boli Infect Matei Bals
Romania
51
Spit Boli Infect Costanta
Romania
52
Univeristy Hospital Lewisham
United Kingdom
53
Newham General Hospital
United Kingdom
54
Caldecot Centre, King’s College Hospital
United Kingdom
55
Great Ormond Street Hospital
United Kingdom
56
John Radcliffe Hospital
United Kingdom
57
Ealing Hospital NHS Trust
United Kingdom
58
University Hospital
north Staffordshire
United Kingdom
59
Fundacion Huesped
Argentina
60
Hospital Dr JP Garrahan
Argentina
61
Hospital Dra Cecilia Grierson
Argentina
62
USP Sao Paolo
Brazil
63
School of Med. Minas Gerais
Brazil
64
HIVNAT - Bangkok
Thailand
65
Projet Enfant Yopougon, IRD
Ivory Coast
66
Sidney Children’s Hospital
Australia
67
Hospital Miguel Servet
Spain
68
Spitalul Boli Infect Craiova
Romania
69
Spitalul Boli Infect Cluj
Romania
70
Spitalul Boli Infect Iasi
Romania
71
Spitalul Judeatean Braila
Romania
72
Spitalul Boli Infect Galati
Romania
73
Ziekenhuis Netwerk Antwerpen
Belgium
74
Azienda Ospedaliera S. Anna
Italy
75
NHS Lothian
University Hospital Division
United Kingdom
76
Primagen
Netherlands
77
Fundacio Clinic
Spain
78
Hospital Universitari ‘La Fe’
Spain
79
‘La Paz’ Children’s University Hospital
Spain
80
National Research Institute of Mother & Child
Poland
81
‘Perinatal Prevention of AIDS Initiative’ Voluntary Society
Ukraine
82
Hospital del Mar
Spain

 
 
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