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Trial profile and progress overview (by March 30 th , 2011)

Trial profile and progress overview (by March 30 th , 2011). Trial profile and progress overview. INCLUSIONS. 1 st patient enrolled in France : July 30 th , 2009 1 st patient enrolled in Brazil : February 22 th , 2010 End of inclusions is postponed to July 2011

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Trial profile and progress overview (by March 30 th , 2011)

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  1. Trial profile and progress overview (by March 30th , 2011)

  2. Trial profile and progress overview INCLUSIONS • 1st patient enrolled in France : July 30th, 2009 • 1st patient enrolled in Brazil : February 22th, 2010 • End of inclusions is postponed to July 2011 10 patients to be included per month 150 patients

  3. Brazilian Sites (1) Rio de Janeiro –Beatriz Grinsztejn Laboratório de Pesquisa Clínica em DST e Aids - IPEC / FIOCRUZ - Inclusion (prevision)  30 patients - Pharmacokinetic, Immunological and GeneticSub-studies  yes - Site Initiation (prevision)  december, 2009

  4. Brazilian Sites (2) Nova Iguaçu –José Henrique Pilotto Departamento de DST – Hospital Geral de Nova Iguaçu - Inclusion (prevision)  30 patients - Pharmacokinetic, Immunological and GeneticSub-studies  yes - Site Initiation (prevision)  january, 2010

  5. Brazilian Sites (3) São Paulo –Jose Valdez Madruga Centro de Referência e Treinamento em DST/Aids – SES/SP - Inclusion (prevision)  25 patients - Pharmacokinetic and Immunological Sub-studies no - Genetic Sub-study yes - Site Initiation (prevision)  january, 2010

  6. Brazilian Sites (4) Porto Alegre –Nêmora Barcelos Serviço de Atenção Terapêutica – Hospital Sanatório Partenon - Inclusion (prevision)  25 patients - Pharmacokinetic and Immunological Sub-studies no - Genetic Sub-study yes - Site Initiation (prevision)  january, 2010

  7. Brazilian Sites (5) Salvador –Carlos Brites Laboratório de Pesquisa Clínica em Infectologia – Hospital Universitário Prof. Edgar Santos - Inclusion (prevision)  25 patients - Pharmacokinetic and Immunological Sub-studies no - Genetic Sub-study yes - Site Initiation (prevision)  january, 2010

  8. Brazilian Sites (6) • Hospital Conceição • Dr Breno Riegel Santos • Inclusion (prevision)  20 patients

  9. Brasil Coordinating site activities • Clinical Sites identification and contact • Financial agreements with the sites • Conduction of local regulatory process • Conduction of Drug importation and distribution to the clinical sites • Laboratory contracts development • Protocol training(lab,eCRFs,pharmacy) • Site initiation • Randomization • Site monitoring • Assistance with any protocol related issues • Repository

  10. ANVISA Submissions and Approvals (Protocol and Import License) Submission Date  30/07/2009 Registration Error at ANVISA  09/09/2009 New registration  09/09/2009 First questions received from ANVISA  10/11/2009 Answers protocolled at ANVISA  18/11/2009 Protocol and import license approval (prevision)  dezembro/2009

  11. First Training Performed (1) Date: 24 and 25/09/2009, in Rio de Janeiro Participants: - Brazilian PI - Brazilian Coordination - Subinvestigators, study coordinators and pharmacists of all sites - Loboratory cooordinators - Central Pharmacy Team

  12. First Training Performed (2) Activities: Presentation : protocol study operational precedures estimates of the patients inclusions laboratory procedures randomization procedures

  13. First Training Performed (3) Presentation: management medication procedures central pharmacy procedures SAEs report procedures capture System CRF monitoring procedures

  14. Initiation Visit at Sites (1) Visit performed by Project Manager, Monitor, Data Manager, Pharmacyst and Laboratory Coordinator Visits took place in the clinical department, all laboratories and the hospital pharmacy ANRS opening of clinical sites procedures were formalized

  15. Initiation Visit at Sites (2) The following issues were reviewed: study operational precedures laboratory procedures randomization procedures management medication procedures central pharmacy procedures SAEs report procedures monitoring procedures

  16. Initiation Visit at Sites (3) eCRF training was performed Site Initiation prevision: Rio de Janeiro december, 2009 Nova Iguaçu, São Paulo, Porto Alegre and Salvador  january/february, 2010

  17. Pre-inclusions and inclusions curves • In France:

  18. Pre-inclusions and inclusions curves • In Brazil:

  19. Pre-inclusions and inclusions curves • In Brazil and in France (until July 2011): 1st enrollment in France 1st enrollment in Brazil

  20. Number of randomized patients per month

  21. Distribution per site

  22. Flow diagram of ANRS 12 180 REFLATE TB trial data by 30 March 2011 Pre-included N = 149 France N = 8 Brazil N = 141 Non included N = 17 France N = 0 Brazil N = 17 Randomized N = 124 France N = 8 Brazil N = 116 Treated N = 124 Non treated N = 0 Lost to follow up N = 2 withdrawal N = 3 Strategy discontinuation N = 6 To be included into the analysis N = 124 Excluded from the analysis N = 0

  23. Withdrawal(s) – Lost to follow up - Strategy discontinuation • Withdrawals : N=3 • Lost-to-follow up : N=2 • Strategy discontinuations : N=6 • anti-TB : N=2 • ARV : N=3 • ARV and anti-TB : N=1

  24. Trial profile and progress overview Sub-studies enrolment

  25. Pharmacokinetic sub-study • Objectives • To study the pharmacokinetic interactions between rifampin and raltegravir (at the doses of either 400 mg bid and 800 mg bid Endpoint • Evolution of pharmacokinetic parameters of raltegravir between week 4 (with rifampin) and at least 1 month after rifampin discontinuation (before dose decrease for patients in the raltegravir 800 mg arm)

  26. Immunological sub-study • Objective • To assess the incidence of immune reconstitution inflammatory syndrome (IRIS) and to identify potential predictors of IRIS • Endpoint • Rate and predictors of immune reconstitution inflammatory syndrome (IRIS) • 40 patients planned by the protocol • 43 patients have been included • Inclusions were stopped in October 2010

  27. Genetic sub-study • Objective : • To assess relationship between genetic polymorphism of genes involved in the metabolization and transport of ARV or anti-TB drugs (UGT1A1, CYP2B6, acetylase, MDR1) and plasma concentrations, efficacy and tolerance • By March 30th , 2011 : • 120patientsagreed (and 4 disagreed) to participate so far

  28. PRESENTING REFLATE TB RESULTS Different possibilities (depending on patient recruitment and conference deadlines) • 19th Conference on Retroviruses and Opportunistic Infections (CROI) : • - on February-March 2012 • - Late breaker abstract on January 2012 (= last patient inclusion should be in June 2011) • XIX International AIDS Conference: • - on 22-27 July 2012 (Washington DC, USA) • - Abstract submission will open towards the end of 2011 • 52th Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC) : • - on September 2012 • - Abstract soumission deadline : May 2012

  29. INSERM-Bordeaux • Implementation of eCRF • Excellent day by day protocol management • Excellent level of communication and trouble shooting

  30. ANRS • All steps implemented so far came along very smoothly • Nice scientific environment and partnership

  31. Challenges • Finalize enrollment within the planned timeframe • Keep very low levels of LFU • Funding for substudies • Next projects?

  32. Obrigada!

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