The CompNet resistance module: Current status Klaus Jansen Cohort - PowerPoint PPT Presentation

The CompNet resistance module: Current status Klaus Jansen Cohort Manager Competence Network for HIV/AIDS

Aims of the resistance database • Collection of data on resistance of patients of the CompNet HIV/AIDS cohort • Linkage of virologic data with clinical and sociodemographic data • Analyses of course of disease and specific resistance patterns etc. • Participation on national and international research projects

Topics of scientific interest  Prevalence of resistant HIV in population of CompNet-cohort  Differences in therapy outcomes in patients having resistant HIV or in patients having not  Differences in therapy outcomes in patients having a previous resistance testing and harmonised therapy and in patients having no testing  Analyses of impact of resistances on TCE  Identification of new resistance patterns of new therapeutic regimens  Impact of differing variants of HIV on clinical outcome of treated patients .....

CompNet-cohort Composition Basis-Module: 25 HIV-centres  10 clinics  15 special. private practitioners Resistence-Module: 9 Labs Children-Cohort: 8 centres Pregnancy-Cohort: 10 centres Neurology-Module: 1 centre Central Office CompNet CCT Cologne

Central cohort characteristics  Prospective und retrospective documentation of 283 sociodemographic and clinical items  Number of patients: - total: ~ 16.500 - currently under Follow-up: ~8.200 (1/4 of all treated patients in Germany)  Person years - total: 62.900 person years - under treatment: 55.900 person years - prospective: 24.100 person years (since start in 2004)  Sex: 85,4% men  Main risk: 62.4% MSM  main aspects representative for German epidemiological situation

ART-Status  Mean duration since HIV-diagnosis: 10.3 years  Mean duration between HIV-diagnosis and initial ART: - Men: 3.9 years - Women: 4.2 years  Therapy status: - 12.6% ART-naive - 87,4% ART-experienced:  14.2% Initial Therapie  85.8% Follow-Up-Regimen - ~ 4,800 patients ART-naivity assured documented

Biomaterial-Banks Current number of samples Number of samples Storage Serum-bank 51.899 de-central DNA-bank 14.787 central CSF-bank 1.468 central Skin-bank 1.660 central Mucosa-bank 3.500 central Lymph node tissue-bank 120 central

Aspects as to data protection  Data protection very important topic as to involving of patients  Big fear of getting tracked as source of infection by restistance analyses, therefore:  complex and secure data flow  early involvement of patient representatives in setting up restistance-DB  need of secure data handling in scope of all collaborations

Structure of Resistence-DB SmartGene Webserver Database Virologist Physician SmartGene SmartGene Gen sequences + Sample Sequence number Sequence number Resistance analyses Sequence number, PID + Analyses of mutations Sequence number ZKS -Köln Merged Data for MACRO Database external Webserver (clinical data and cooperation analyses of mutations)

Current status  IT-tool for entry, storage and analyses: SmartGene-software  Implemented targets: PR, RT, IN, gp41  Implementation of software and training in all labs  Collection of retrospective data ongoing Partly, greater efforts while identifying retrospective sequences due to changes in lab-documentation systems etc.  Collection of prospective data concurrently

Current status  Only inclusion of data of patients having international IC  Only existing sequences are recorded, no extra testing  Coverage of CompNet-patients by 9 labs: ~ 76%  Current # of eligible patients having int. IC: 5,175  Documentation: - Current # of tests in clinical database: ~2.000 - Current # of sequences in SmartGene: 948  ongoing documentation

Data and Networking  Sharing of data set with researchers from inside and outside of CompNet appreciated  Requests possible for virologic data as well as in combination with clinical and sociodemographic data  Short proposal needed for conducting scientific projects  Proposal evaluated by scientific boards and SC of CompNet  After evaluation of proposal, data could be provided in different formats  Important: analysing and avoiding overlaps with other German patient populations  only slight overlaps expected

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