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II IMB Meeting - Addis Ababa, October 13 2011 Integrated training activities and IT infrastructures to improve capacities in eastern African area JP.2009.10800.002 WP2 status with respect to planned objectives Maurizio Zazzi (Area Vasta)
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2 II IMB Meeting - Addis Ababa, October 13 2011 Integrated training activities and IT infrastructures to improve capacities in eastern African area Started: March 2010 Will end: February 2013 WP 1 Project management WP 2 Clinical Trials WP 3 Capacity Building WP 4 Networking
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Excerpts from proposal actions To provide easy to use, resident data management systems for HIV and for HIV/TB-coinfection (InfCare HIV and open source local EuResist DB) together with on-site training courses. To provide training courses on management of drug resistance. To provide training courses on the use of the freely available EuResist treatment response Prediction tool (www.euresist.org). To provide HIV genotyping and viral load measurement for patients at the involved sites where not available. To retrain and evaluate retrospectively the EuResist Prediction tool with African data. To upload to the EuResist database the data derived from the HIV/TB and from the prevention of mother-to-child transmission trials in order to expand the training dataset for these specific issues. 3 II IMB Meeting - Addis Ababa, October 13 2011
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WP2 – Clinical trials 600 patients mentioned in the proposal Equally distributed among Tanzania, Kenya, Ethiopia? What is the current status of enrolment in each country? Are data coming from clinical trials or from clinical practice? Is it confirmed that these will be data from HIV/TB coinfected patients or from pregnant women? What is missing? 4 II IMB Meeting - Addis Ababa, October 13 2011
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WP2 – Clinical trials 5 II IMB Meeting - Addis Ababa, October 13 2011 Treatment 8-12 week viral load -12 to 0 week genotype 20-28 week viral load Patient demographics Baseline CD4 and VL Past drug exposure Past genotypes Patient demographics Baseline CD4 and VL Past drug exposure Past genotypes Mandatory Optional Structure of data required for EuResist testing Most informative when drug resistant
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WP2 – Publication plan Apart from clinical trial data… Epidemiology data Prevalence of drug resistance in pregnant women at Neema Training activities Is the split genotyping procedure a good option, better than DBS testing? We need a sensitivity analysis on at least 50 samples EuResist prediction system Can the system reliably predict response to treatment in the African setting? Can it perform better after re-training with the African dataset? 6 II IMB Meeting - Addis Ababa, October 13 2011
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