Anton Pozniak Deputy Chair NEAT
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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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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

  • 357 affiliated Centers


  • 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.


NEAT MISSION


ACTIVITIES


WORKPACKAGE STRUCTURE

  • Toovertical

  • Partnersfelt “stuck” totheirallocated WP

  • Needto focus more on “activities” ratherthan on workpackages

  • NeedforSteeringCommitteecontrol


NEW NEAT STRUCTURE:FUSING ACTIVITIES WITH WORKPACKAGES


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


ResearchPriorities

  • Large randomized clinical trial

  • HIV-HCV co-infection

  • Integration Grants

  • NEAT Research Grants

  • Focused education and training programs


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


Screening/ Randomisation curve*

*Last updated:May 2, 2011


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


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


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


ResearchPriorities

  • Large randomized clinical trial

  • HIV-HCV co-infection

  • Integration Grants

  • NEAT Research Grants

  • Focused education and training programs


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


ResearchPriorities

  • Large randomized clinical trial

  • HIV-HCV co-infection

  • Integration Grants

  • NEAT Research Grants

  • Focused education and training programs


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


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


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


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


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


ResearchPriorities

  • Large randomized clinical trial

  • HIV-HCV co-infection

  • Integration Grants

  • NEAT Research Grants

  • Focused education and training programs


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 /


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


Feedback…..

And Future


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.


  • 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….


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


  • 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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