EuroCoord – European network of HIV/AIDS cohort studies for a global co-ordination on clinical research

1. EuroCoord – European network of HIV/AIDS cohort studies for a global co-ordination on clinical research Caroline Sabin EuroCoord Scientific Co-ordinator UCL, London

2. Background • EU-funded NoE established by several of the biggest HIV cohorts and collaborations within Europe • Funded for 5 years from January 2011 • Aims to exploit the scientific strength of each participating network, and build on complementarities between them, to enhance the research conducted across Europe, thus providing ‘added value’

3. Founding networks • 23 beneficiaries from 16 countries (> 100 collaborating centres/third parties), ensuring representativeness across Europe.

4. Key research aims • To improve the management and life of HIV-positive individuals, by: • Characterising and modelling HIV-positive populations in Europe; • Improving understanding of pathogenesis; • Documenting uptake of and response to therapy; • Evaluating implications of long-term HIV infection and ART exposure; • Assessing implications of specific management strategies; • Analysing effects and improving management of hepatitis and tuberculosis (TB) co-infection.

5. Key research aims • To improve the management and life of HIV-positive individuals, by: • Characterising and modelling HIV-positive populations in Europe; • Improving understanding of pathogenesis; • Documenting uptake of and response to therapy; • Evaluating implications of long-term HIV infection and ART exposure; • Assessing implications of specific management strategies; • Analysing effects and improving management of hepatitis and tuberculosis (TB) co-infection. 2. To develop and implement novel methodology, research platforms and technologies 3. To establish training programmes to improve clinical management and research skills

6. Workpackage structure

7. Workpackage structure • WP2: Training and outreach • Build on existing training activities (e.g. ACTIVATE, NEAT, CHAIN and within networks) to augment and update skills of health professionals and researchers • Provide clinical management skills and statistical/epidemiological training

8. Workpackage structure • WP3: Scientific oversight • Co-ordinate scientific work to ensure maximal synergy • Facilitate translation of research into policy • Facilitate collaboration with other EU-funded research networks (e.g. CHAIN)

9. Specialist subgroups • Pharmacokinetics and pharmacology • Immunology/HIV virology • Statistical methodology • Improving the management of hepatitis Co-infection

10. Workpackage structure • WP4: Data management • Harmonize collection of data items between cohorts/networks; • Encourage discussion of data formats, SOPs, protocols and quality assurance checks

11. Characterising HIV populations • Timing of diagnosis/presentation in pregnancy • Vertical transmission despite PMTCT • Focus on Eastern European cohorts • Production of assay for incidence testing • Test new diagnoses in C&E Europe and estimate incidence • Contribution of primary infection to propagation of epidemic • Regional differences in populations • Adherence to guidelines and ART outcomes • Standardise definitions of late presentation • Epidemiology and temporal trends

12. Understanding pathogenesis • Drug classes & CD4 cell subset dynamics • CD4 cell subset changes in response to ART/virological failure • Host genetic factors • Predictors of tropism use and change • Long-term non-progression and elite control • HIV resistance and viral tropism • Ultrasensitive genotypic tests • Activated inflammation, coagulation and soluble plasma cancer markers • European registry of HIV controllers • HIV-1 vs. HIV-2 progression

13. Treatment uptake and outcomes • Pharmacokinetics • Treatment in infants • Treatment interruption and outcomes of restarting ART • Pharmacovigilance; ART in pregnancy • Population effectiveness of ART management • Effect of HIV infection duration • Temporal/regional differences in timing of ART • Type of ART and outcomes • Frequency and outcomes of switching • Database of HIV drug resistance mutations • Robust clinical tool for expected CD4 response following cART • Implications of short-term antenatal ART

14. New collaborative themes • HIV and TB (WP 13) • - Monitor incidence, long-term prognosis and temporal changes • - Effects of anti-TB therapy and prophylaxis • - Impact on management of HIV • - Risk factors for IRIS • HIV and Migrants (WP 14) • - Determination of likely country of acquisition • - Identify barriers to prevention, testing and treatment • - Key HIV outcomes and relationship with country of habitation. • Modelling (WP 15) • - Develop existing computer simulation model to provide Europe-wide consensus estimates for rates of diagnosis, treatment usage, resistance, pregnancy, AIDS/death etc.

15. Summary • HIV EuroCoord will strengthen European HIV cohort research, by bringing it within a single pan-European network of cohort studies • A multidisciplinary approach, and access to data from >250,000 HIV-positive individuals, will allow us to address key areas of research aimed at improving the management and life of HIV-positive individuals • By utilising a common research platform, we will ensure that the most complementary, collaborative and competitive science is untaken

16. Acknowledgements • Executive Board: GenevièveChêne, University of Bordeaux II, France; Dominique Costagliola, Institut National de la Santé et de la RechercheMédicale, France Julia Del Amo, Instituto de Salud Carlos III, Spain; Carlo Giaquinto, Fondazione PENTA, Italy; Di Gibb, Medical Research Council, UK; JesperGrarup, KøbenhavnsUniversitet, Denmark; Ole Kirk, KøbenhavnsUniversitet, Denmark; Bruno Ledergerber, University of Zurich, Switzerland; Laurence Meyer, Institut National de la Santé et de la RechercheMédicale, France; Alex Panteleev, St. Petersburg City AIDS Centre, Russian Federation; Andrew Phillips, University College London, UK, Kholoud Porter (Chair), Medical Research Council, UK; Caroline Sabin (Scientific Coordinator), University College London, UK, Claire Thorne, University College London, UK; Stephen Welch, Fondazione PENTA, UK. • Council of Partners: Jean-Pierre Aboulker, Institut National de la Santé et de la RechercheMédicale, France; Jan Albert, Karolinska Institute, Sweden; Silvia Asandi , Romanian Angel Appeal Foundation, Romania; GenevièveChêne, University of Bordeaux II, France; Dominique Costagliola, INSERM, France; Antonellad’ArminioMonforte, ICoNA Foundation, Italy; Stéphane De Wit, St. Pierre University Hospital, Belgium; Frank De Wolf (Chair), Stichting HIV Monitoring, Netherlands; Julia Del Amo, Instituto de Salud Carlos III, Spain; José Gatell, FundacióPrivadaClínic per a la RecercaBíomèdica, Spain; Carlo Giaquinto, Fondazione PENTA, Italy; OsamahHamouda, Robert Koch Institut, Germany; Igor Karpov, University of Minsk, Belarus; Bruno Ledergerber, University of Zurich, Switzerland; Jens Lundgren, KøbenhavnsUniversitet, Denmark; RuslanMalyuta, Perinatal Prevention of AIDS Initiative, Ukraine; Claus Møller, Cadpeople A/S, Denmark; Andrew Phillips , University College London, UK; Kholoud Porter, Medical Research Council, United Kingdom; Maria Prins, Academic Medical Centre, Netherlands; AzaRakhmanova, St. Petersburg City AIDS Centre, Russian Federation; JürgenRockstroh, University of Bonn, Germany; MagdaRosinska, National Institute of Public Health, National Institute of Hygiene, Poland; Claire Thorne, University College London, UK; GiotaTouloumi, National and Kapodistrian University of Athens, Greece; Alain Volny Anne, European AIDS Treatment Group, France. • External Advisory Board: David Cooper, University of New South Wales, Australia; Nikos Dedes, Positive Voice, Greece; Kevin Fenton, Centers for Disease Control and Prevention, USA; David Pizzuti, Gilead Sciences, USA; Marco Vitoria, World Health Organisation, Switzerland. • Secretariat: Kate Coughlin, MRC Clinical Trials Unit, UK; Michelle Ellefson, KøbenhavnsUniversitet, Denmark; Silvia Faggion, Fondazione PENTA, Italy; Richard Frost, MRC Regional Centre London, UK; Marie Reynolds, MRC Clinical Trials Unit, UK; Christine Schwimmer, University of Bordeaux II, France; Martin Scott, UCL European Research & Development Office, UK.

17. www.etudes.isped.u-bordeaux2.fr/cohere/ www.cphiv.dk/EuroSIDA/tabid/59.aspx www.cascade-collaboration.org www.pentatrials.org www.EuroCoord.net or Contact info@EuroCoord.net