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2007 - 2011

Anton Pozniak Deputy Chair NEAT. 2007 - 2011. Coordinated by: Stefano Vella MD ISS - The Italian National Institute of Health - Rome - Italy. 44 core Partner Institutions 16 European Countries National AIDS Research Agencies (ANRS, MRC, NATEC, ISS....) Over 450 researchers

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2007 - 2011

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  1. Anton Pozniak Deputy Chair NEAT 2007 - 2011 Coordinated by: Stefano Vella MD ISS - The Italian National Institute of Health - Rome - Italy

  2. 44 core Partner Institutions • 16 European Countries • National AIDS Research Agencies (ANRS, MRC, NATEC, ISS....) • Over 450 researchers • 357 affiliated Centers

  3. will spread expertise and resources, will provide training and mobility of scientists at all levels and will foster lasting collaborations between west and centre-east Europe. • - will pave the way toward the creation of the European Research Area, capable of integrating and coordinating genuine, independent and interdependent research programmes. • will be able to attract public and private co-funding and positively interact with other non-EU organizations and research agencies.

  4. NEAT MISSION

  5. ACTIVITIES

  6. WORKPACKAGE STRUCTURE • Toovertical • Partnersfelt “stuck” totheirallocated WP • Needto focus more on “activities” ratherthan on workpackages • NeedforSteeringCommitteecontrol

  7. NEW NEAT STRUCTURE:FUSING ACTIVITIES WITH WORKPACKAGES

  8. RESEARCH AGENDA • Addressing the diversity of the European HIV epidemic • Addressing the diversity of European Health Care settings • Examples of possible studies: • Large strategic trials • Rare / specific conditions • Innovative design, new drugs / new combinations • Long term effectiveness studies

  9. ResearchPriorities • Large randomized clinical trial • HIV-HCV co-infection • Integration Grants • NEAT Research Grants • Focused education and training programs

  10. NEAT 001/ANRS 143: Study design Randomisation* 1 : 1 Open-label • Design W96 > 18 years 800 ARV-naïve patients HIV RNA > 1,000 c/mL CD4 cell count ≤ 500/mm3 No major IAS mutations (2009) on genotype Planned study duration : 96 weeks after enrolment of the last patient • * Randomization will be stratified by: • Country • Participation at viro-immunological sub-studyv • § At starting point RTV old formulation will be used, an amendment for the use of heat-stable tablets of RTV will be presented during the trial

  11. Screening/ Randomisation curve* *Last updated:May 2, 2011

  12. Sub-study sites and inclusions Countries Patients Planned Randomised* Target % of Target 467 800 58% Core trial 15 PGx 13 (not participating: DK, GR) 338 800 42% Dynamics 6 (FR, ES, GB, IT, DE, HU) 39 80 49% 100% Bone 8 (FR, ES, IT, IE, DK, BE, NL, GB) 146 142 7 (FR, ES, GB, IE, IT, DE, BE) Neurocog 202 400 51% *Last updated:May 9, 2011

  13. Acknowledgements ANRS: Sandrine Couffin-Cadiergues, Jean-François Delfraissy, Céline Lallemand, Jean-Michel Molina, Juliette Saillard, Alpha Diallo U897 Bordeaux2: Fabien Arnault, Geneviève Chêne, Aurélie Fischer, Laura Richert, Elodie Rouch, Christine Schwimmer, Guillaume Touzeau, Cédrick Wallet CHIP: Bitten Aagaard, Jesper Grarup, Marie-Louise Jakobsen, Per O.Jansson, Karoline Jensen, Mary Pearson MRC: Abdel Babiker, Wendy Dodds, Fiona Ewings, Fleur Hudson, Ischa Kummeling, Nick Paton, Kay Taylor AMC: Remko van Leeuwen, Corry Manting ISS: Lucia Palmisano, Stefano Vella Gesida: Esther Aznar, Manuel Cotarelo Greece: Giota Touloumi Virology working group: Deenan Pillay, Charles Boucher, Vincent Calvez, Carlo Federico Perno, Simon Collins Pharmacology and adherence working group: Marta Boffito, Andrea Ammassari, Andrea Antinori Immunology working group: Brigitte Autran, Reinhold Ernst Schmidt, Michal Odermarsky Toxicity working group: José Arribas, José Bernardino, Hansjakob Furrer, Christoph Fux, Christine Katlama, Peter Reiss, Stephane De Wit, Xavier Franquet Quality of life and pharmaco-economics working group: Rita Murri, Raffaella Bucciardini, Andrea Tramarin, Pythia Nieuwkerk, Brian West, Alain Volny-Anne Neurocognitive function working group: Hélène Amieva, Valerio Tozzi, Alan Winston

  14. ACTORS OF NEAT 001/ANRS 143 François Raffi / Anton Pozniak / Stefano Vella / Laura Richert / Geneviève Chêne / Clotilde Allavena / Christine Schwimmer / Abdel Babiker /Andrea Antinori / José Arribas / Nikos Dedes / Andrzej Horban / Deenan Pillay / Brigitte Autran / Marta Boffito / Andrea Tramarin / Rita Murri / Raffaella Bucciardini / Jesper Grarup / Remko Van Leeuwen / Jens Lundgren / Nick Paton / JF Delfraissy / Juliette Saillard / Lucia Palmisano / Christine Katlama / Georg Behrens / Alan Winston / Jan Prins / Patrick Mallon / Francisco Antunes / Juan Gonzalez-Garcia / Stéphane de Wit /Andrzej Horban / Angelos Hatzakis /Denes Banhegyi / Anders Sönnerborg / Jan Gerstoft / Brigitte Schmied / Eric Sandström/ Hans-Juergen Stellbrink/ Markus Flepp / Jean-Michel Molina / José Gatell / Christiane Moecklinghoff / Gillian Pearce / Bach-Yen Nguyen / Xavier Franquet + 100 affiliated clinical centers

  15. ResearchPriorities • Large randomized clinical trial • HIV-HCV co-infection • Integration Grants • NEAT Research Grants • Focused education and training programs

  16. ACTORS OF THE HIV-HCV COINFECTION COHORTProbe-C Study Juergen Rockstroh / Mark Nelson / Martin Vogel / Brigitte Autran / Sanjay Bhagani / Francisco Blanco / Sònia Clemares / Bonaventura Clotet Nathan Clumeck / Stephanie Dominguez / Martin Fisher / Massimo Galli Diego Garcia / Jose Gatell / Richard Gilson / Andrzej Horban / Jose Mallolas / Lars Peters / Anton Pozniak / Massimo Puoti / Peter Reiss / Marek Radkowski / Vicente Soriano

  17. ResearchPriorities • Large randomized clinical trial • HIV-HCV co-infection • Integration Grants • NEAT Research Grants • Focused education and training programs

  18. IG 2009 Title:Study of the Pharmacokinetics of Efavirenz and Rifampicin (SPhEAR) study Applicant: UCD-Mallon / Co-applicants: Frank-HIV-Stephan; OWS-Zagler Title:Interferon-based treatment of hepatitis C in HIV-coinfection Applicant: UKB-Rockstroh / Co-applicants: SSAT-Pozniac; FLS-Clotet; Frank-Hiv-Bickel Title: Finding new treatments based on host factors involved in HIV-1 infection Applicant: AMC-Van leewen / Co-applicants: SCHS-Telenti; AMC-Paxton Title: Evaluation of efficacy and safety of a strategy of switching well suppressed HIV−infected patients to an unboosted atazanavir−based regimen and to identify baseline risk factors for virologic failure. Applicant: AP-HP-Molina / Co-applicants: FCSR-Lazzarin; UNIMI-Rusconi; HCIII-Soriano; SSAT-Nelson

  19. IG 2009 Title: Development of hypersensitive quantification assay for cell activation membrane markers Applicant:AP-HP-Autran / Co-applicants: FCSR-Poli; CI-MHH; FLS-Clotet; SSAT-Pozniac Title: Efficay of treatment Intensification with Maraviroc on HIV−1 Viral Latency in recently infected HIV−1 Naïve Patients Starting Raltegravir plus Tenofovir/Emtricitabine. Applicant: FLS-Clotet / Co-applicants: HCPB-Miro; SSAT-Pozniac Title: Kinetic of coagulation and inflammation biomarkers in advanced multiexperienced HIV patients under ART Applicant:FCSR-CSL-Tambussi / Co-applicants: AP-HP-Autran; FLS-Clotet Title: PAPHIV: Response of quadrivalent Human Papilloma Virus (HPV) vaccination in Human Immunodeficiency Virus (HIV) infected adolescents and young adults and impact on virological and immunological response to Anti-Retroviral Therapy (ART) Applicant:PENTA-Giaquinto / Co-applicants: UTV-Rossi; HCPB-Gatell

  20. IG 2010 Title:Study of Inflammatory, endothelial function and hypercoagulability markers in recently infected HIV-1 patients randomized to start intensified treatment with Maraviroc vs Raltegravir plus tenofovir/emtricitabine. From the Maraviboost study: A 48 week randomized, controlled, open-label, proof-of-concept pilot clinical trial Applicant: FLS-Clotet / Co-applicants:HCPB-Miro; UKB-Rockstroh Title: Molecular mechanisms and epigenetic modifications involved in HIV-1 latency : implications for the development of new anti-HIV-1 therapeutic strategies Applicant:HSP-Clumek / Co-applicants:AP-HP-Katlama Title:Outcome of liver Transplantation in HCV-HIV-1 coinfected patients in en the cART era. Applicant:HCPB-Miro / Co-applicants:UKB-Rockstroh; Hôpital Paul Brousse, Paris; University Hospital “Ospedale di Circolo -Fondazione Macchi”, Varese; King’s College Hospital, London; Bern University Hospital, Bern Title: Longitudinal study of 25-hydroxyvitamin D and relationship with deaths, AIDS-defining and non-AIDS events in EuroSIDA : a case-control study Applicant: HH-Jens-Lundgren / Co-applicants: UCL-Andrew Phillips; Centre de Diagnostic et de Thérapeutique, Hôtel-Dieu; Hôpital Necker, Service d’Explorations Fonctionnelles

  21. IG 2010 Title: A study of cognitive function, sexual risk behaviours and attitudes to HIV transmission and antiretroviral treatment, among HIV-infected patients in the UK, Denmark, Italy and Belarus. Applicant:UCL-Phillips/Rodger / Co-applicants:WSZ-Horban ; INMI-Antinori; UCPH-Lundgren; Minsk State Medical University Title:Genetic markers predisposing to non-cirrhotic portal hypertension in HIV-infected patients Applicant:HCIII-Soriano / Co-applicants: UNI-BS-Puoti; UKB-Rockstroh; SSAT-Nelson Title: Kinetic of coagulation and inflammation biomarkers in advanced, multiexperienced  HIV patients under ART Applicant:FCSR−CSL-Tambussi / Co-applicants:AP-HP-Autran; FLS-Clotet Title: The HIV Reverse Cholesterol Transport Study Applicant: UCD-Mallon / Co-applicants: AMC-Reiss; SSAT-Pozniak

  22. ACTORS OF INTEGRATION GRANTS 2008 - 2010 Academisch Medisch Centrum-AMC National University of Ireland University College Dublin - School of Medicine and Medical Sciences -UCD Hospital Clinic i Provincial de Barcelona-HCPB Fundacio Lluita contra la SIDA -FLS Hospital Carlos III - Service of Infectious Diseases-HCII Hospital La Paz HIV-UNIT-HULP Saint Pierre University Hospital HSP Department of Infectious Diseases-HSP Wojewodzki Szpital Zakazny WSZ AIDS - Diagnosis and Therapy Center-WSZ Assistance Publique – Hopitaux de Paris-AP-HP University of Bonn - Department of Medicine -UKB Abteilung Klinische Immunologie Medizinische Hochschule Hannover –CI-MHH Hospital of the Johann Wolfang Goethe University  -FRANK-HIV National Institute for Infectious Diseases “L.Spallanzani” (IRCCS)-INMI Universita degli Studi di Brescia - Institute of Infectious and tropical diseases-UNI-BS Fondazione Centro San Raffaele del Monte Tabor –FCSR-CSL Università degli Studi di Roma Tor Vergata Dept.of Public Health -UTV Università degli studi di Milano -Department of Clinical Sciences “L.Sacco”-UNIMI St.Stephens  AIDS Trust - Dep. Of HIV-SSAT Royal Free and University College Medical School of UCL - Dep. Of Primary Care and Population Sciences-UCL Sozialmedizinischess Zentrum Baumgartner H-HE-Otto Wagner Spital Mit Pflegezentrum -OWS Center Hospitalier Universitaire (CHUV) - SWISS HIV Cohort Study -SCHS PENTA for the treatment and care of children with HIV and related diseases – Onlus -PENTA University of Copenhagen –UCPH/CHIP

  23. ResearchPriorities • Large randomized clinical trial • HIV-HCV co-infection • Integration Grants • NEAT Research Grants • Focused education and training programs

  24. ACTORS OF EDUCATION AND TRAINING PROGRAMSIncluding PhD and Master Programs2007-2011 David Haerry – SCHS / Norbert H. Brockmeyer – CN-AIDS-D / Vicente Soriano – HCIII / Andrzej Horban – WSZ Jens Lundgren – CHIP / Mauro Moroni/Massimo Galli – UNIMI Mike Youle – UCL / Remko Van Leeuwen – IATEC Brigitte Schmied – OWS / Patrick Francioli/Manuel Battegay –SCHS Marisa De Rosa – CINECA / Genevieve Chene – UB2 Anton Pozniak – SSAT /

  25. Web Portalwww. neat-noe.orgPublic and Member sitesDocumentation Videos Interviews re hot topicsReportsMeetingsPublications

  26. Feedback….. And Future

  27. FP6 NEAT PROJECT SCIENTIFIC REVIEWDate of review: June 30, 2010 • The decision of restructuring and reassigning the work groups to not more than 4 WPs appears very wise and obviously translated into a more effective overall structure. ……… • Impressive is principally the successful setup of a clinical trial on timely and very relevant clinical issues, • i.e. the setup of a novel database targeting issues such as HCV/HIV co- infection and sexual transmission of HCV. • NEAT is about to establish a competent network to address key questions in the context of long term HIV management. The NEAT/ANRS trial 001 may be one of those key studies.

  28. The collaborative efforts seem to have now reached the initially set aims. • An impressive record of publications in peer reviewed journals as well as presentations at international conferences speak for themselves - congratulations. • Also the principal idea of internally reviewed IGs that stem from within the consortium is judged asexcellent. • The consortium has in the meantime produced an appealing public web portal….

  29. ……a request to the Commission for a 18 months extension (July 2013)at no cost

  30. 41 Partner Institutions • 16 European Countries • Over 450 researchers • 357 affiliated Centers • May be the largest NoE ever funded by the European Commission.....

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