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 .....

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

CompNet-cohort

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

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

Current number of samples

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

Physician Virologist Webserver SmartGene Database SmartGene Merged Database

MACRO Webserver

ZKS -Köln

Data for external cooperation

SmartGene

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 

• nly slight overlaps expected

Thank you for your attention!