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

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Presentation on theme: "2007 - 2011 Coordinated by: Stefano Vella MD ISS - The Italian National Institute of Health - Rome - Italy Anton Pozniak Deputy Chair NEAT."— Presentation transcript:

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

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

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4 - 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.

5 NEAT MISSION INTEGRATION & HARMONIZATION SPREADING OF EXCELLENCE CLINICAL RESEARCH

6 ACTIVITIES STEERING COMMITTEE MANAGEMENT TEAM Scientific Advisory Committee Governance Advisory Committee JPA Integrating Committee14 WORK PACKAGES 44 TASK FORCES 8 SPECIAL ACTIVITIES JPA Research Committee JPA Spreading Committee ASSEMBLY

7 NEAT WORKPACKAGES 1 Network management and coordination 2 Clinical Research and Trial Design 3 Trial Management 4 Trial Analysis / Statistics 5 Community / Ethics 6 Virology 7 Immunology 8 Education & Training 9 Regulatory 10 EU Networking 11 International Networking 12 Information Technology 13 Fundraising 14 Self-assessment, standards & quality

8 WORKPACKAGE STRUCTURE Too vertical Partners felt “stuck” to their allocated WP Need to focus more on “activities” rather than on workpackages Need for Steering Committee control

9 NEW NEAT STRUCTURE: FUSING ACTIVITIES WITH WORKPACKAGES INTEGRATION & HARMONIZATION 12, 14, 5, 6, 7 + all concerned partners NETWORK FUNCTIONING 1, 13, 14, 10, 11, 12 SPREADING OF EXCELLENCE 8 + all concerned partners CLINICAL RESEARCH 2, 3, 4, 5, 6, 7, 9 + all concerned partners

10 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 RESEARCH AGENDA

11 Research Priorities  Large randomized clinical trial  HIV-HCV co-infection  Integration Grants  NEAT Research Grants  Focused education and training programs

12  Design * Randomization will be stratified by: Country Participation at viro-immunological sub-studyv RAL 400 mg BID DRV/RTV § 800/100 mg QD (4pills +1 BID) TDF/FTC fdc QD DRV/RTV § 800/100 mg QD (4pills QD) > 18 years 800 ARV-naïve patients HIV RNA > 1,000 c/mL CD4 cell count ≤ 500/mm 3 No major IAS mutations (2009) on genotype Planned study duration : 96 weeks after enrolment of the last patient Randomisation* 1 : 1 Open-label W96 § 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 NEAT 001/ANRS 143: Study design

13 NEAT 001/ANRS 143 TrialMay 9, Screening/ Randomisation curve* *Last updated: May 2, 2011

14 NEAT 001/ANRS 143 TrialMay 9, Sub-study sites and inclusions Neurocog Bone Dynamics PGx Core trial (FR, ES, GB, IE, IT, DE, BE) (FR, ES, IT, IE, DK, BE, NL, GB) (FR, ES, GB, IT, DE, HU) (not participating: DK, GR) TargetRandomised* Planned PatientsCountries *Last updated: May 9, 2011 % of Target 58% 42% 49% 100% 51%

15 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 Acknowledgements

16 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 affiliated clinical centers

17 Research Priorities  Large randomized clinical trial  HIV-HCV co-infection  Integration Grants  NEAT Research Grants  Focused education and training programs

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19 ACTORS OF THE HIV-HCV COINFECTION COHORT Probe-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

20 Research Priorities  Large randomized clinical trial  HIV-HCV co-infection  Integration Grants  NEAT Research Grants  Focused education and training programs

21 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

22 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 IG 2009

23 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

24 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 IG 2010

25 ACTORS OF INTEGRATION GRANTS 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

26 Research Priorities  Large randomized clinical trial  HIV-HCV co-infection  Integration Grants  NEAT Research Grants  Focused education and training programs

27 ACTORS OF EDUCATION AND TRAINING PROGRAMS Including PhD and Master Programs 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 /

28 Web Portal www. neat-noe.org Public and Member sites Documentation Videos Interviews re hot topics Reports Meetings Publications

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42 Feedback….. And Future

43 FP6 NEAT PROJECT SCIENTIFIC REVIEW Date 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.

44 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 as excellent. The consortium has in the meantime produced an appealing public web portal….

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

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47 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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