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ECS
HIV/AIDS
Framework programme: 5
Project number:
QLK2-2000-00002
EC contribution: € 627 441
Duration: 36 months
Type: CA
Starting date: 1 September 2000
Graphic element European Collaborative Study on Pregnant HIV Infected Women and Their Children
Keywords: Mother-to-child transmission; HIV infection; paediatric; interventions; epidemiology

Summary:

The European Collaborative Study aims to investigate the consequences of HIV infection in pregnancy and its outcome in infected and uninfected children born to HIV infected mothers. Interventions to reduce the risk of mother-to-child transmission are now widely available, which has resulted in substantially reduced rates of transmission. However, these interventions may have potential long-term adverse effects, in particular for uninfected children exposed to antiretroviral therapy in utero or early in life. Monitoring the rates of transmission and the occurrence of such adverse events is vital on a European basis.

Problem:

By the end of 1998, nearly 40 000 women had been diagnosed with AIDS in Europe, and there were an estimated 400 000 women living with HIV infection, mostly of child-bearing age, and the number of infants at risk of vertically acquired HIV infection continues to rise. Although interventions are now available to reduce the risk of vertical transmission (such as anti-retroviral therapy with zidovudine, elective caesarean section and refraining from breastfeeding), important new questions have emerged regarding the effect of such interventions on the health of HIV-infected women and their infected and uninfected children. The European Collaborative Study is a unique prospective cohort study, which, over the past decade, has provided an epidemiological assessment of the issues relating to HIV infection in pregnancy and childhood.

Aim:

The aim of this project is to investigate the consequences of HIV infection in pregnancy and after delivery in women and their children, in the area of anti-retroviral therapy and other interventions for treatment and prophylaxis. This includes:

1. monitoring demographic and biological characteristics of HIV- infected pregnant women in Europe, and the extent and type of anti-retroviral treatment and other interventions to reduce mother-to-child transmission given before, during and after pregnancy

2. monitoring pregnancy outcome, such as prematurity and the association with anti-retroviral combination therapy

3. estimating the rate of vertical transmission in Europe

4. evaluating further interventions to reduce the risk of vertical transmission, such as Nevirapine, in a randomised trial

5. elucidating the progression of vertically acquired HIV infection, allowing for exposure to prophylactic and therapeutic anti-retroviral therapy

6. acting as a public health resource on a European basis.

Expected results: Much of current knowledge about HIV infection in pregnancy and mother-to-child transmission of HIV infection was acquired prior to the widespread introduction of anti-retroviral therapy, which both delays the progression of disease and acts as a prophylaxis to reduce the risk of vertical transmission. An increasing number of HIV-infected women receive combination anti-retroviral therapy before and during pregnancy, and it is recommended that HIV-infected women should be offered an elective caesarean section delivery and be given advice to refrain from breastfeeding. New questions have therefore arisen as to the medium and long-term effect of these intervention strategies on the health and quality of life of HIV-infected women and their children. In particular, concerns have been recently expressed about the possible serious adverse effects of ART exposure for uninfected children.

HIV infection in women was initially mostly restricted to easily identifiable groups, such as those with a history of injecting drugs or those from an area where HIV infection is highly prevalent. However, in recent years there has been a shift towards heterosexual acquisition of infection, which is less easily identifiable. In many European centres, therefore, all pregnant women are now offered an HIV test, so that those identified as being infected can benefit from the available interventions. The risk of vertical transmission may increase or decrease depending on the characteristics of the HIV-infected pregnant women and the uptake of interventions, which aim to prevent mother-to-child transmission. The aim and objectives of the ECS project proposed here focus on the further identification of factors that influence vertical transmission of HIV infection, and the progression of HIV disease in women and children in this changing environment. The evaluation of interventions to reduce the risk of mother-to-child transmission of disease will contribute to knowledge on interventions in general, and mechanisms and timing of mother-to-child transmission in particular.

Use of anti-retroviral therapy by women before and during pregnancy will be assessed and issues relating to quality of life will be explored. Possible adverse pregnancy outcomes associated with anti-retroviral therapy will be monitored. Little is known about the medium to long-term adverse effect of exposure to anti-retroviral drugs in intra-uterine or early life, an issue especially important for the large numbers of uninfected children born to infected mothers. It is extremely important, therefore, to develop systems to enable any events to be identified. Evaluation of the efficacy of alternative interventions to reduce or prevent mother-to-child transmission may aid the identification of safer or cheaper approaches. Infants born to mothers who received anti-retroviral therapy but who were nevertheless infected may have acquired a resistant virus. Options for the management of these children may be limited, and a standard clinical approach will be developed. The quality of life of infected children and factors that influence therapy adherence in infected children will be explored.

The proposed development of common and shared databases across the network will enable individual centres to monitor in a standard fashion their case-load and clinical burden of HIV in women and children and facilitate the management of HIV infection in pregnant women and their infected children in Europe. Findings from the ECS will provide the basis for public health guidelines for the management of HIV infection in women and children across Europe, and will be translated into a standard approach to clinical care.

Potential applications: The ECS network provides a range of expertise in areas ranging from medical caretosocial services, with epidemiological expertise provided centrally. The ECS cohort provides a unique opportunity to address these new research and clinical questions for HIV-infected pregnant women and their children. It is fundamental to investigate more fully the occurrence of adverse events associated with exposure to ART in foetal and neonatal life in uninfected children born to HIV-infected women, using the ECS cohort, which follows up both infected and uninfected children, and in collaboration with other prospective studies. Collaborating clinicians make an important contribution to dissemination locally, in addition to their vital role in translating ECS research findings into evidence-based clinical management. ECS findings have informed the development of clinical guidelines.

Coordinator:

ML Newell with C.Thome, CS.Peckham
Centre for Paediatric Epidemiology, Institute of Child Health
30 Guilford Street
WC1N 1EH London
United Kingdom
Tel: +44 20 7905 2105
Fax: +44 20 7813 8145
E-mail: m.newell@ich.ucl.ac.uk

Partners:

Principal
Scientific
Participants
Official Address Other Information
2Carlo GiaquintoInstituto di Clinica Pediatrica
Via Giustiniani 3
IT-35128 Padova
Italy
Tel: +39 049 8213585
Fax: +39 049 8753865
E-mail: carlog@child.pedi.unipd.it
3I Grosch WörnerKinderklinik Medizinische Fakultat der Humboldt
Mittelallee 8, Station 63, Augestenburger Platz 1
DE-13353 Berlin
Germany
Tel: +49 30 45066501
Fax: +49 30 45066956
E-mail: ilse.grosch-woerner@charite.de
4JYQ MokPaediatric HIV service, Edinburgh Sick Children’s NHS Trust
10 Chalmers Crescent
UK-EH9 1TS Edinburgh
United Kingdom
Tel: +44 131 536 0971
Fax: +44 131 536 0570
E-mail: jyqm@srv2.med.ed.ac.uk
5MI de JoseS Pediatria, Hospital Infantil ‘La Paz’
P Castellana 261
ES-28046 Madrid
Spain
Tel: +34 1 358 4454
Fax: +34 1 729 1179
E-mail: maribelj@arrakis.es
6F Asensi-BotetDepartment Medicine Pediatria, Hospital de la Seguridad Social ‘La Fe’
Avenida de Campanar 21
ES-46009 Valencia
Spain
Tel + Fax: +34 96 386 2791
E-mail: asensi_fra@gva.es
7H ScherpbierAcademisch Medisch Centrum
Meibergdreef 9
NL-1105 AZ Amsterdam Zuidoost
The Netherlands
Tel: +31 20 566 9111
Fax: +31 20 566 4440
E-mail: H.J.Scherpbier@amc.uva.nl
8AB BohlinDepartment of Paediatrics, Huddinge Hospital
SE-141 86 Huddinge
Sweden
Tel: +46 8 58587308
Fax: +46 8 58581410
E-mail: ann.britt.bohlin@klinvet.ki.se
9A Ferrazin
A De Maria
Department of Internal Medicine, Ospedale ‘S Martino’
Largo R Benzi 10
IT-16134 Genoa
Italy
Tel: +39 010 3538933
Fax: +39 010 3538904
E-mail: demaria@ermes.cba.unige.it
10Graham TaylorDepartment of GU Medicine and Communicable Diseases
St Mary’s Hospital
Norfolk Place
UK-W2 1PG London
United Kingdom
Tel: +44 20 7594 6581
E-mail: g.p.taylor@ic.ac.uk
11J LevyHospital St Pierre, Paediatric Infectious Diseases Unit
322 Rue Haute
BE-1000 Bruxelles
Belgium
Tel: +32 2 535 4344
Fax: +32 2 535 4563
E-mail: Jack.Levy@stpierre-bru.be
12Brunella GuerraInstituto Clinica Ginecologia e Ostetrica
Cattedra Fisiopatalogia Prenatala, Policlinico S. Orsola Malpighi
Via Massarenti 13
IT-40138 Bologna
Italy
Tel: +39 051 397637
Fax: +39 051 6446508
13Pasquale MartinelliIstituto di Clinica Ostetrica, II Policlinico
Via S Pansini 5
IT- 80131 Napoli
Italy
Tel: +39 081 74662966
Fax: +39 081 74662966
E-mail: Martinel@unina.it
14A MurDepartamento de Pediatria, Hospital Del Mar
Passeig Maritim 25-29
ES-08003 Barcelona
Spain
Tel: +34 93 221 1010
Fax: +34 93 221 0541
E-mail: 17028@imas.imim.es
15O CollDepartamento de Obstetica-Ginecologia, Hospital Clinic
University of Barcelona
Calle VillaRroel 170
ES-08028 Barcelona
Spain
Tel: +34 93 2275436
Fax: +34 93 4510332
E-mail: ocoll@jet.es
16T NiemiecDepartment of Family Health,
National research Institute of Mother and Child
Kasprzaka 17a
PL-01-211 Warsaw
Poland
Tel: +48 22 63211548
Fax: +48 22 63211548
E-mail: tniemiec@zigzag.pl
17M MarczynskaDepartment of Children’s Infectious Diseases
Medica University of Warsaw
37 Wolska Street
PL-01-2001 Warsaw
Poland
Tel: +48 22 632 0683
Fax: +48 22 632 0683
E-mail: mmarczynska@poczta.onet.pl
18Ruslan MalyutaOdessa Oblast Clinical Hospital
Zabolotnogo Street 26
270117 Odessa,
Ukraine
Tel: +380 48 731 2502
Fax: +380 48 777 6434
E-mail: ru_doc@mail.ru

 
 
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