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Welcome to the internet pages of the German Competence Network for HIV/AIDS
The German Competence Network for HIV/AIDS (KompNet HIV/AIDS) is one of currently 25 medical competence networks that receive funding from the German Federal Ministry of Education and Research (BMBF). The main German working groups that are active in clinical research and basic research with a close orientation towards clinical practice in the specialty of HIV and AIDS medicine have formed an umbrella collaboration as a national research alliance. Combining and coordinating pertinent research activities are vital to create the ideal conditions for:
- Improving the treatability of HIV disease
- Improving the quality of life of people living with HIV
- Increasing the life expectancy of patients infected with HIV
- Patient cohort
- Infrastructure projects
- Cooperations
- Studies
- Submission of projects
- Our events
- Publications
Press releases and Mediaclipping
Competence Network for HIV/AIDS
The Competence Network for HIV/AIDS and its objectives
The primary aim of the Competence Network for HIV/AIDS is to bundle all competences that exist in Germany in the specialty HIV/AIDS in a joint research and communications alliance. Creating the network helped institute an authoritative, new, supraregional structure that can take on and implement medical and research questions and developments much faster and more efficiently than would be possible by involving all individual studies and expert groups.
Additionally, the Competence Network for HIV/AIDS is a national research alliance and as such provides opportunities for far more effective cooperation with European (NEAT, COHERE, MITOC) and other international (BBMRI) research alliances.
Optimised knowledge transfer
A telematic platform was set up as a means of communication and data exchange. Within the network, different methodological and quality assurance services have become established whose work is coordinated by the network office.
All this has resulted in a structure that
1. Organises and promotes the horizontal exchange of information and knowledge of particular and occasionally focused and specialised competences between the centres; and
2. Promotes and supports the vertical transfer of knowledge between basic research, patient care provision, patients’ self-help organisations, and the wider public.
Our research projects
Several concrete scientific projects are affiliated to the cohort, with the result that the focus is on the following research objectives:
- Research into the course of HIV infection and its treatability in particular groups of patients that are mostly underrepresented in clinical studies without access to a large supraregional cohort, especially in women;
- Research into biological predictive variables for therapy failures: development of new HIV strains, viral persistence in different parts of the body; and
- Research into HIV associated, specific complications affecting certain organs, including the central nervous system, the gastrointestinal tract, and the skin;
- Research into the pathogenesis of metabolic disorders associated with HIV therapy, such as lipodystrophy
- Research into new immunological and genetic markers that determine disease progression, treatability, and undesirable side effects of medication;
- Research into new therapeutic strategies to restore immunological and neurological functions;
- Research into the psychological, social, and economic consequences of HIV infection and the social dynamics of gender specific and sexual identity and their effect on risk behaviour, protection, and healthcare provision.
The Competence Network for HIV/AIDS (KompNet HIV/AIDS) is an general national research alliance and as such includes the most important German working groups active in clinical research and basic research with a close orientation towards clinical practice. The intended result is, by combining research activities, to create better conditions for improvements in the treatability of HIV disease, improved quality of life, and extended life expectancy of patients with HIV infection.
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Speaker and Chairman KompNet HIV/AIDS Prof. Dr. N.H. Brockmeyer
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Scientific Coordinator/ | |
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Cohort Manager KompNet HIV/AIDS
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Ordinary (voting) members
Ordinary members of the competence network, as set out by its statutes, are:
- The speaker of the network and the members of the steering committee;
- The heads of the centres participating in data collection (1 member per centre)
- Scientists who are running their own projects within the competence network or seek to do so (1 member per project);
- All members of the patient advisory board;
- A representative of the DAH
- A representative from the Robert Koch-Institute;
- Scientists can gain membership of the Competence Network for HIV/AIDS with external projects that receive funding outside the Competence Network for HIV/AIDS, on application to the head office for presentation to the steering committee.
Associate members (not eligible to vote)
In addition to ordinary members, persons and institutions that have registered interest in collaboration, or which are not actively participating in any project or data collection in the network but have registered their interest and/or want to use the network’s services, can apply for associate membership.
The heads of the centres that have discontinued their documentation after the end of the second funding period on 30 June 2007 are associate members.
Associate members have the same status as ordinary members but are not entitled to vote.
Supporting members (not eligible to vote)
Supporting members are natural or legal persons under public and private law who/that are prepared to support the objectives of the Competence Network for HIV/AIDS spiritually or materially and whose application for membership has been granted by the steering committee.
How to become a member
Membership applications should be sent to the spokesman of the competence network. Applications are accepted at all times, but for a decision to be made they need to be lodged with the head office of the competence network a minimum of four weeks before a steering committee meeting. Applications can be informal; required documentation includes:
- Career path of the applicant;
- Summary of past and current research projects;
- Description of the planned collaboration projects
The Speaker's Reports on applications received in the steering committee sessions and presents them individually for voting. The steering committee decides each application individually, with a two-thirds majority of steering committee members present. The members’ assembly confirms the steering committee’s decision; in individual cases, the members’ assembly can reject an application that was granted by the steering committee, again with a two-thirds majority.
Membership period
Membership ceases:
- For ordinary members, when their project that is integrated into the competence network or their contract at a collaborating centre comes to an end. On application, the membership can then be modified into associate membership. The application can me made informally and requires the speaker's consent;
- If a member resigns, which has to be submitted to the head office in writing;
- By exclusion, which the steering committee can decree if obligations have not been met or the statutes or interests of the competence network have been disregarded.
Applying for membership
How do I become a member of the Competence Network for HIV/AIDS?
Application form for membership in the Competence Network for HIV/AIDS (PDF, 56 kB)
Please submit your completed application form with your original signature, accompanied by further documents as required (see membership) in the KompNet office (see below).
The steering committee makes its decision about applications on an individual basis according to the statues of the Competence Network for HIV/AIDS; the steering committee’s decision has to be confirmed by the membership’s general meeting.
Contact address:
Competence Network for HIV/AIDS
Prof. Dr. N. H. Brockmeyer
Clinic for Dermatology, Venerology and Allergy
at the Ruhr-Universität Bochum
Gudrunstr. 56
D-44791 Bochum
Germany
Other competence networks
To improve the quality and result orientation of research, undergraduate and postgraduate medical training, and healthcare provision, the Federal Ministry of Education and Research (BMBF) initiated the competition “Competence networks in medicine” in 1998.
Currently, the BMBF is funding several large-scale projects that focus on particular diseases. The best research and healthcare institutions contribute their competence and infrastructure to the competence network (see also internet portal of competence networks in medicine).
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Our projects
Research conducted by the Competence Network for HIV/AIDS
In medicine, the answers to many questions in clinical, epidemiological, and laboratory science can be found only by studying large numbers of patients. The patient cohort of the Competence Network for HIV/AIDS is making such a large group available for research in Germany for the first time. The study list of the Competence Network for HIV/AIDS includes projects that investigate very diverse scientific questions and tasks.
Stucture
Background and objectives
Study design
- The cohort as study design
- Study protocol
- Technical infrastructure and quality management
- Data protection
Biomaterial banks
Study projects about the cohort
Background and objectives
Background
HIV infection is characterised by a chronic course of individually widely divergent duration from the time of infection to a diagnosis of AIDS or death. To understand the natural disease course, assess the future development of the HIV/AIDS epidemic, determine possible effects of antiretroviral therapy (AR), and evaluate new therapeutic strategies it is of great importance to recognise the factors influencing these variables and the extent of changes resulting from these factors.
Questions of this nature can often be answered only by means of long-term observation of a large group of patients. To this end, the German Competence Network for HIV/AIDS (KompNet) maintains a national patient cohort that includes 8000 patients as its central research instrument. The technical realisation of the cohort started in 2002; the first patient was included in the summer of 2004. The cohort comprises 21 treatment centres that are distributed all over Germany and that continually document clinical and sociodemographic data (see Study design). Further, blood specimens (serum and DNA) are collected at regular intervals from all included patients; further biomaterials may be collected in the context of clinical investigations, with the respective patient’s consent.
The composition of the clinical centres reflects Germany’s particular healthcare situation for HIV positive patients by means of hospital outpatient departments on the one hand and private practices specialising in HIV medicine/care on the other hand.
The patient cohort contains several modules that provide a detailed representation of particular groups of patients and important partial aspects of HIV infection and its treatment. Individual cohorts exist for children who are HIV positive or who are exposed to HIV and pregnant women with HIV infection, as well as for research into resistance in the context of antiretroviral therapy, coinfection with hepatitis, and neurological aspects.
The patient cohort provides an important basis for medical and health political decisions regarding people with HIV or AIDS in Germany. The clinical and sociodemographic data of the cohort and the biomaterials are available for use to all interested scientists and other institutions on application.
The patient cohort forms the foundation for patient oriented research into HIV/AIDS in Germany for all basic scientists, clinical scientists, epidemiologists, and social scientists who are networked within the Competence Network for HIV/AIDS.
Objectives
The central objective is to conduct a cohort study into HIV/AIDS that is largely representative for Germany. The tasks required to implement such a study include:
- Setting up and maintaining a suitable organisational and technical infrastructure for the collection and distribution of clinical and sociodemographic data as well as biomaterials,
- Quality assurance of the ongoing data documentation to a high standard,
- Continuing recruitment of suitable patients in order to ensure that the typical German healthcare structure for HIV positive patients is adequately represented,
- Provision of statistical-methodological competences for research into the cohort,
- Generating research projects on the basis of cohort data,
- Cooperation with scientists and scientific networks at the national and international level,
- Publications of the research results in national and international scientific media.
The patient cohort forms the basis of research projects into the course of HIV infection and the effects of antiretroviral treatment in the disciplines epidemiology, clinical sciences, basic sciences, social sciences, and public health (see Scientific Boards). The most important aim is to safeguard and improve the quality standard of medical care for HIV positive patients in Germany. Epidemiological questions in order to quantify HIV related morbidity/mortality and characterise the healthcare situation for HIV positive patients in Germany. are also of central interest. Additionally, the cohort data serves to generate basic scientific and clinical hypotheses that are investigated in further specific research projects, again potentially including cohort data and biomaterials.
The scientific plan of the Competence Network for HIV/AIDS set out five main areas of research:
- Biomedical research and prevention,
- Ageing with HIV/AIDS,
- Oncological disorders in the course of HIV infection,
- Influence of HIV/AIDS on psychosocial and neurological aspects, and
- Research in pregnant women and children.
The interdisciplinary cooperation of the scientists within the Competence Network for HIV/AIDS is an important requirement in order to research these topics as comprehensively as possible. Translational research is of particular importance for the effective transfer of scientific results into therapeutic practice.
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Study design
The cohort as the study design
In the context of a cohort study, a large number of patients is observed for a lengthy time period. These patients are selected according to stringently defined inclusion criteria as a representative sample from a total population of patients. The total population of the KompNet-cohort is based on,consists of all HIV positive patients in Germany who are under medical supervision.
Cohort studies mostly observe a large set of variables from the very beginning in order to identify previously potentially unknown factors (exposures), whose importance can be shown only by means of a long observational period. These factors may be the development of long-term side effects or certain diseases that occur only at a late stage of illness and under certain conditions. Cohort studies are of particular importance for researching rare events that may remain unnoticed in a shorter observation of a smaller patient group.
As new scientific insights always identify new important factors, the composition of variables in a cohort is mostly flexible and new variables may be included. This is certainly the case for the cohort of the Competence Network for HIV/AIDS.
The design of a cohort study differs clearly, for example, from another study type that is commonly used in medicine: the clinical trial. The aim of a clinical trial is to determine the influence of previously defined factors on a certain event. Such an event may be therapeutic response or the development of side effects that were defined at the outset. In a clinical study, all events of interest and factors of influence that are to be measured have been defined at study onset and won’t be changed. Interesting events that were not intended to be analysed from the outset cannot be considered further in a clinical study. The observation period is also notably shorter - commonly 12, 24, or 26 months. The observation period of a cohort study is ideally infinite.
An important variable in the context of cohort studies is the person time that is being collected (mostly measured in person years). This describes the sum of all individual observation periods of the study participants under observation (FIGURE). The aim is to document as many person years as possible and thus mirror the reality in increasing detail. The larger the number of person years the easier it is to determine any factors that may influence the development of rare events such as comorbidities or side effects. The observation of patients can be done retrospectively (looking back into the past) as well as prospectively (looking ahead into the future).
Person time:
Sum of all individual observation periods
In the context of a cohort, only those patients are observed in whom a certain influence or feature was present (exposed) or not (non-exposed). This exposure has to be defined exactly, but it can surface as very disparate features. An exposure may, for example, be the administration of a particular drug, a poor immune status of a certain duration, or belonging to a particular sex or age group. It is then analysed whether there are differences between exposed participants and non-exposed participants with regard to the development of a particular feature. This may be the development of a particular side effect or comorbidity.
Design of a cohort study
A great advantage of a cohort study lies in the fact that patients are observed in “real time”. This means that exposures and events are captured in a timely, continuous fashion and by taking into account the real time interval between exposure and occurrence of an event. By selecting patients appropriately, it is thus possible to measure directly the proportion of patients in whom a particular event occurs in a particular time period (mostly a year) - the incidence. The incidence is crucial for assessing the importance of influencing factors (exposures) and their risk because it can take into account the time period that is required for a particular event to develop. This is not possible with other study types and is a real advantage of a cohort study compared with other study types. Other important epidemiological measures can also be deduced from the incidence, such as the incidence rate or the relative risk for a particular event.
A second important advantage lies in the fact that - in contrast to cross sectional studies, for example - the patients are observed in a clear temporal sequence. It is thus always possible to determine precisely whether a potential factor immediately preceded a particular event. The causality of an event can thus potentially be proved is the variables are selected appropriately.
The third advantage is the fact that patients are observed under real life conditions. This helps avoid mistakes that may arise from an experimental study design under artificial conditions. This is highly important in researching the development of side effects in everyday real treatment practice. However, it requires capturing a very large number of influencing factors in order to represent these real conditions as comprehensively as possible and not overlook any important factors.
The disadvantage of a cohort study lies in the immense effort and cost that is incurred in conducting such studies. Because of the long observation period and the large number of variables it is often necessary to ensure complete documentation throughout. In order for the study to show high effectiveness it is necessary to define up-front the exposures and possible confounders (other variables of influence), which is not always completely possible in view of the current knowledge at any given time. A very important cause of the limited validity of such analyses is loss to follow-up, the unplanned departure of participants from the study. Ensuring follow-up documentation is therefore one of the central challenges in conducting a cohort study.
The cohort is a study type of great scientific validity and evidence. It has an extremely flexible design that enables the study of many different effects of an exposure. If enough patient years are represented, even rare events can be studied in great detail. A cohort study can generate hypotheses for further studies. It permits great variability in the composition of patients, which enables observation under natural conditions. A cohort study thus possesses great representativeness and external validity. Cohort studies help answer important epidemiological, clinical, and basic scientific questions that cannot be represented in other clinical studies or study types. An important subject in this context is, for example, research into the long-term sequelae of HIV infection and their treatment.
Study protocol
The patient cohort of the Competence Network for HIV/AIDS is a cohort study with a retrospective as well as prospective design. It currently includes 25 documenting centres that are distributed all over Germany. Their composition reflects Germany’s particular situation - namely, that about two thirds of patients are treated by private practices specialising in HIV medicine/care and about one-third in hospital outpatient departments
Compesition of the CompNet cohort
Patient cohort
Basis module: 25 HIV centres
10 Hospitals
15 practices specialising in HIV medicine/care
Resistance module: 9 laboratories
Children’s cohort: 8 centres
Pregnant women’s cohort: 10 centres
Neurology module: 1 centre
Center for Clinical Studies in Cologne
Office
In addition to the documentation of adult patients who are positive for HIV in the basis module, the patient cohort comprises a children’s cohort, a pregnant women’s cohort, a resistance module, a hepatitis module, and a neurology module. The children’s cohort and pregnant women’s cohort are quasi-independent cohorts. The resistance, hepatitis, and neurology module provide complementary data for the patients captured in the basis module. The data are administered in central databases; additionally, biological specimens from the patients are systematically collected n biomaterial banks and also documented in the databases.
Modules of the CompNet cohort
In 2007, shortages in financial funding resulted in a reduction of the number of patients from some 15.000 to 8000, the number of documenting centres fell from 44 to the current 25. The data of the patients no longer under observation are still available and can be used for specific analyses.
The responsible ethics committees of all documenting centres approved the study protocol as well as the relevant patient information. For the children’s cohort and the pregnant women’s cohort, specific conditions apply (see there). For studies that - in addition to standard documentation -require the collection of further clinical or sociodemographic information or for further studies to be conducted (for example, intervention studies), repeated approval by an ethics committee may be necessary in some circumstances. Ethics approval votes are collected by the office of the Competence Network for HIV/AIDS.
The inclusion criteria for the basis module of the patient cohort are:
- Age of 18 years or older
- Medical care delivered in one of the participating centres, and
- Patient’s written consent.
After the initial documentation of a patient has been set up, up to 283 sociodemographic and clinical variables are collected prospectively at half-yearly intervals (a complete list of variables is available here). These are subcategorised into topic areas:
- Sociodemographic data,
- Medical history (family history, individual HIV related history, only for initial documentation),
- Clinical and laboratory findings (HIV/AIDS, further findings include the hepatitis module),
- Substance misuse
- Death.
Data that arose between two follow-up dates are documented by means of circular templates in the chronologically next follow-up. As many circular templatesas needed can be devised so that all relevant data are completely captured.
If available in the centre, retrospective data for the patients are captured that pre-date their agreement to participate in the Competence Network for HIV/AIDS. These comprise a limited dataset of HIV specific laboratory markers (CD4 cells, CD8 cells, viral load, CDC stage, prescribed antiretroviral treatment).
A particular feature of the patient cohort of the Competence Network for HIV/AIDS is its comprehensive sociodemographic dataset, which provides a good basis for social scientific research into HIV/AIDS.
At the time of entry into the study and three years after inclusion, an EDTA sample of 9 ml is obtained - with the patient’s consent - for DNA extraction. Also at the time of entry and subsequently at six-monthly intervals, a serum sample of 10 ml is taken. Further biomaterials, such as cerebrospinal fluid, lymph nodes, or skin specimens are obtained and stored in the context of separate investigations and after the patient has given special consent. The biomaterials are taken and stored in accordance with binding standards (standard operating procedures, SOPs).
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Technical infrastructure and quality management
The responsibility for the technical infrastructure of the patient cohort lies by the Clinical Trial Center Cologne (CTC Cologne). In close cooperation with the cohort manager, who is based in the office of the Competence Network for HIV/AIDS, the CTC provides the required IT service, data management, and comprehensive quality assurance processes for the data. The CTC trains the staff responsible for documentation at the clinical centres and maintains a telephone hotline for these.
To realise the patient cohort, a telematics platform was created that serves as the supporting instrument of communication and data exchange. In deciding on the required information technology structures of the network, solutions were preferred that were already used successfully at large scientific institutions and conform to EU directives, the regulation of good clinical practice 8-2004 (bgbl 104s2081mpdf), and FDA standards. The study software in use is MACRO.
The data are entered into the database at the participating centres by trained personnel. Standard operating procedures are in place that are collated in a documentation manual. The data are entered by using a specially configured and secured laptop computer and transmitted online via a secure gateway to the CTC.
IT-Data-FLOW
From about the summer of 2009, documentation will not be done on laptops by via an internet link and a secure CITRIX access. This will make the documentation for the centres as well as servicing the IT system and implementing new IT developments notably more flexible. In the pregnant women’s cohort and the children’s cohort, documentation is done by a centrally based member of staff who travels to the centres.
In the CTC, the data are stored on certified and secure servers that are constantly backed up and kept in closed rooms.
To ensure that the data are of high quality, comprehensive quality management measures exist at several levels:
Data entry: The data are documented by using a highly standardised user interface. The variables are collected - with few exceptions - in a standardised manner on the basis of regularly updated itemised lists, by using drop-down menus so as to minimise documentation errors during data entry. The documentation staff are trained individually by the CTC in how to use this interface. The documentation is done on the basis of compulsory SOPs that are compiled in a manual.
Central monitoring: central quality monitoring consists of five different complementary processes. These processes result in lists of queries that are returned to the documenting centres. These correct the data on the laptop; the corrected data are then transmitted back into the CTC database.
Central monitoring
1. In generating the current status of the data, a comprehensive report regarding the completeness of the entered data is produced. All obligatory variables are checked one by one. Missing data are reported to the participating centres for completion.
2. The monitoring routines built into the user interface report formal implausibilities back to the documenting staff at the moment of data entry (for example, if the date of the first HIV test pre-dates the date of birth). Further data entry is possible only once the error has been corrected.
3. Further implausibilities are reported back to the documenting centres, for checking and correction if required, after a current data status has been generated, by means of programming routines in the context of default plausibility checks.
4. If the set of variables is changed - for example, by introducing new variables or changes of variable types - the variables concerned are checked in samples for completeness and quality. Errors are reported back, in case of systematic errors a comprehensive error testing is undertaken and measures initiated to eliminate the error sources.
5. For analyses in the context of scientific projects, the data are checked in cooperation with the participating scientists for plausibility of content, and the results of the test is immediately implemented in the dataset produced for the project to enable rapid analysis. Simultaneously, the documenting centres receive query lists for corrections to the database.
Onsite monitoring on demand: If during one of the checking processes explained above it becomes obvious that systematic errors have occurred in one of the documenting centres then it is possible for a CTC monitor to perform a monitoring procedure in this particular institution The monitor will compare real patient files with the data documented in the database and if required provide further training for the documenting staff.
Changes to the database structure: If changes are made to the structure of the database or the variables, these are always tested in a virtual environment first, corrected if required, and implemented in the original database only once they are fully functioning.
Latest Publications:
• Jansen K., N. H. Brockmeyer, M. Hahn, I. Kaul, S. Fenske, M. Rausch, B. Kuhlmann, A. Ulmer, E. Lauenroth-Mai, T. Harrer, M. Hower, A. Skaletz-Rorowski, C. Michalik, and the Competence Network for HIV/AIDS. Epidemiological composition, clinical and Treatment Characteristics for the patient cohort of the German Competence Network for HIV/AIDS. Eur J Med Res (2009) 14: 415-25. (PDF Download)
• Jansen K, Michalik C, Hahn M, Dupke S, Esser S, Jaeger H, Köppe S, Moll A, Plettenberg A, Schmidt RE, Skaletz-Rorowski A, Brockmeyer NH, and the Competence Network for HIV/AIDS. The Patient Cohort of the German Competence Network for HIV/AIDS (KompNet): a Profile. European Journal of Medical Research (2009) 14: 323-331. (PDF Download)
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Data protection
Questions concerning data protection and patients’ rights are of utmost importance in the cohort of the Competence Network for HIV/AIDS. It is a priority for all those working in the Competence Network for HIV/AIDS to provide the greatest possible protection for the data of the patients who have agreed to participate in the cohort. The data protection concept of the patient cohort and its different parts has therefore been developed in an involved process among scientists, patients’ representatives, data protection officers, and the relevant specialist societies, especially the German AIDS Help (DAH) reg. assoc. and the telematic platform for medical research networks (TMF).
The model applied to the patient cohort is based on the generic data protection concept (Model B) of the TMF, which has been agreed with all state data protection officers in Germany and the German AIDS Help (DAH). It was adapted to the concrete conditions of a patient cohort in order to protect the data as well as possible.
The study protocol and all changes that are made to it have to be approved by the ethics committees of all documenting centres.
The patients’ data are stored in the central database under a pseudonym; only the patients themselves and their treating physicians know the link between pseudonym and real name. The physician thus acts as the trustee for the data. The data are thus subject to the same strict data protection regulations as all other patient files in a doctor’s possession.
Before they participate in the cohort, patients receive extensive verbal and written information about the study and sign a declaration of consent. Only once consent has been obtained are patient data allowed to be documented. The details on information and consent are available in several languages.
The data collected over time can be linked to each other by means of the allocated individual pseudonym. The pseudonym also links the biomaterials to the patient data. Further, an opportunity exists to contact the patient via their doctor if they might be included in any additional study.
Scientists who want to work with the cohort data need to submit a formal application to the Competence Network for HIV/AIDS. In case the application is granted they receive a dataset that is encoded one additional time. It is therefore impossible for the scientist in question to identify any patients.
A detailed explanation of the data protection concept is available here.
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Modules
In addition to the documentation of adult patients who are HIV positive in the basis module, the patient cohort include a children’s cohort, a pregnant women’s cohort, a resistance module, a hepatitis module, and a neurology module. The children’s cohort and pregnant women’s cohorts can be regarded as independent cohorts. The resistance, hepatitis, and neurology modules provide additional data on the patients who are included in the basis module. The data are administered in central databases; biological specimens from the patients are systematically collected in biomaterial banks and also decomented in the databases.
Modules of the KompNet cohort
Children’s cohort
In the children’s cohort of the Competence Network for HIV/AIDS, pseudonymised clinical data about HIV positive children or those with exposures are collected retrospectively and prospectively, in collaboration with the Paediatric Working Group AIDS (PAAD). In Germany, eight currently documenting centres are participating in the children’s cohort.
Children who are exposed to HIV are observed until their 24th month of life. If no seroconversion has occurred in this time period, the children are regarded as HIV negative. HIV positive children are documented in the children’s cohort as long as they are being treated by their paediatrician. In some cases this lasts until their 21st year of life. If they change to another treating physician, the patients can continue to be documented in the basis module of the Competence Network’s cohort. Links enabling such transfers exist between the children’s cohort, basis module, and pregnant women’s cohort.
Blood specimens are kept in the context of the children’s cohort too. This is of particular importance because notably less clinical and basic research has been conducted in the paediatric setting than in adults. The children’s particular situation is respected in that only 4 ml blood is taken at the first occasion, and only 1 ml at the follow-ups. For DNA extraction, a lower amount of 5 ml EDTA blood is taken once.
The inclusion criteria are:
- Age <18 years,
- Medical care is given in a participating centre, and
- Written consent has been obtained.
The study protocol for the children’s cohort has been approved by the ethics committees of all documenting centres. For the children’s cohort, specific patient information and declarations of consent exist for children who are exposed to HIV or HIV positive, and for their parents.
The data for HIV exposed children without seroconversion are documented for 24 months. For HIV positive children, the documentation is undertaken as in the basis module on the basis of six-monthly follow-ups (see Cohort study design).
Data from the following areas are documented:
- Sociodemographics,
- Mother’s medical history,
- Birth history,
- HIV history, and
- Clinical findings and therapy (HIV/AIDS and other findings/treatments).
An overview of the variables that are documented is available here.
With regard to implementing data protection, assuring data quality, and technical realisation of the documentation, the same conditions apply as for the basis module.
In contrast to the basis module, the data for the children’s cohort are documented by a centrally based member of staff in a standardised fashion; the staff member travels to the participating centres. Because of the smaller case numbers this process ensures the highest degree of flexibility.
The documentation of the children’s cohort has been made possible thanks to the generous support of Abbott Laboratories.
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Pregnant women’s cohort
In the pregnant women’s cohort of the Competence Network for HIV/AIDS, pseudonymised clinical data from HIV positive pregnant women are collected nationwide. In all of Germany, 10 documenting centres are participating in the pregnant women’s module.
By documenting the data under a pseudonym, a longitudinal observation of the patients is possible, in contrast to other anonymised pregnant women’s registries. If the patient is also documented in the basis module, the technical plan is to link these two datasets. The same is true for the continued observation of HIV exposed or HIV positive children in the children’s cohort of the Competence Network for HIV/AIDS, for which a linking mechanism has been created accordingly. All pregnant women who are not documented in the basis module can be included in it as long as the documentation is done in a participating centre.
A further important feature of the pregnant women’s cohort is the option to store blood specimens from the patients and make these available for research purposes. On inclusion into the study, the patient gives a 10 ml sample and a 9 ml EDTA specimen for DNA extraction; these specimens are stored.
The inclusion criteria are:
- An existing pregnancy,
- Medical care is received in a participating centre, and
- Written consent has been obtained.
The study protocol for the pregnant women’s cohort has been approved by the ethics committees of all participating centres. Specific patient information and a specific declaration of consent exist for the pregnant women’s module.
Owing to the circumscribed time period of a pregnancy, the data are documented once, without any follow-up (if patients subsequently enter the basis module, all further follow-ups after the pregnancy are documented there). Potential changes to the antiretroviral regimen, intermittent comorbidities, etc are fully documented in the pregnant women’s cohort.
Data are documented from the following areas:
- Sociodemographics,
- Gynaecological history,
- Gynaecology: development of current pregnancy,
- Childbirth/delivery,
- HIV history, and
- Clinical findings and therapy (HIV/AIDS and other findings/therapies).
An overview of the variables that are documented is available here.
In contrast to the basis module, the data for the pregnant women’s cohort are documented in a standardised fashion of a centrally based staff member who travels to the participating centres. Because of the smaller number of cases this process ensures the highest degree of flexibility.
With regard to implementing data protection, assuring the quality of the data, and the technical realisation of the documentation, the same conditions apply as for the basis module.
Background and objectives
In recent years, resistance tests have become an important instrument in the context of therapeutic monitoring. As a rule, the laboratories conduct so called genotypic examinations, whereby the patient’s viral genetic material, the HIV genome, is sequenced and examined for mutations.
Since September 2008, patients’ sequencing data have been retrospectively and prospectively collected in a standardised fashion in the resistance module of the Competence Network for HIV/AIDS and have been made available for research purposes. In combination with the extensive clinical and sociodemographic set of variables that is documented for cohort patients, a comprehensive collection of data is created that is a valuable foundation for research. Research results gained on this basis serve to improve the current knowledge about the development of therapeutic resistance and can therefore improve the therapeutic prospects of people with HIV/AIDS.
The research questions that the resistance module is hoping to contribute to include:
- Epidemiological resistance patterns in the patient cohort, by class of drug and individual substances,
- Epidemiological description of the patient group with resistant within the cohort (sociodemographics, therapeutic status and regimen),
- Analysis of differences in the therapeutic responsiveness of patients with or without resistance,
- Analysing differences in the therapeutic responsiveness of patients with or without prior resistance tests and adapted therapy,
- Analysing the influence of resistance in “treatment change episodes”,
- Identification of new resistance patterns on the basis of current therapeutic schemes,
- Analysing the influence of different viral variants on the clinical outcome of HIV patients receiving ART
- Influence of subtypes and polymorphisms on the development of resistance
- Influence of particular resistance mutations (such as M184V or other primary resistance mutations) on the immunological course
Such a dataset can be made available to interested scientists on submission of a formal application.
Structure and extent of coverage
In Germany, a large number of resistance tests are conducted by very few laboratories. In the context of the resistance module, nine labs are currently documenting sequencing data from cohort patients from 21 of the 25 clinical centres. This is equivalent to about 70-75% of the cohort patients. The resistance module linked to the patient cohort of the Competence Network for HIV/AIDS thus allows nationwide analyses of resistance patterns for HIV. Additionally, linkage of the resistance data with the comprehensive existing dataset of the cohort is possible.
For the resistance database, no new data are generated but the results of routine resistance tsts are used. Additional lab tests are therefore unnecessary.
Up to 2010 the resistance module is funded to almost the full cost thanks to a collaboration with Virco, in whose context the Competence Network for HIV/AIDS makes available to Virco pseudonymised data on “treatment change episodes”. Virco has no means of influencing the scientific or structural direction of the resistance module. Virco uses the data exclusively for the purposes of evaluating and improving its methods in HIV resistance diagnostics. This was a crucial condition for this collaboration.
Technical solution
The IT platform used for the resistance module is software developed by Swiss company SmartGene. This software offers comprehensive scope for the storage and analysis of resistance data. The following analytic methods are available to participating labs:
- Sequence input of POL (PR and RT), integrase, and gp41 sequences as text/FASTA files, or as chromatograms by using the inbuilt IDNS-ProofReaderTM.
- Automatic detection and storage of mutations, clades, AA sequences.
- Ordered searches for specific fields of the added information, such as CD4 cell counts, date of sample, etc in scientists’ own samples and the cohort data collector.
- Search for specific mutation patterns in RT, PR, integrase, gp41.
- Sequence comparisons by means of similarity searches, multi-alignments, dendrograms.
- Rule based interpretation algorithms can be programmed into SmartGene, currently these are ANRS, HIVDB (Stanford). Resistance profiles can be established with these algorithms and stored as PDF reports.
Data protection
In developing a resistance module, taking into consideration the patients’ interests in terms of data protection of of the utmost importance. The necessary preconditions were therefore clarified in a laborious process in terms of data protection law and technology. By including data protection officers and patients’ representatives, a dataflow model was developed that implements the data protection requirements to a high standard. 
Dataflow model resistance module
The concept of the treating physician as the data trustee, which has been used in the Competence Network for HIV/AIDS, was kept in its entirety. The pseudonym that encrypts the patient data (PID) is still being comunicated exclusively between the documenting centres and the database of the Competence Network for HIV/AIDS. It is not used for communication between documenting centre and laboratory. To identify the sequencing data between documenting centre and lab, as well as between the SmartGene and CTC databases, a sequence number was introduced additionally, which is documented by the documenting centre in addition to the PID.
The sequencing data are stored on the SmartGene server independently of the clinical data. Resistance data are entered for those patients who have consented to international collaborations of the Competence Network for HIV/AIDS. Although the sequencing data are stored in a Swis database, German data protection guidelines have been implemented for passing on and processing of the data. The sequencing data and the clinical data are combined by the CTC only in the context of a defined query, which has to be granted permission by the steering committee of the Competence Network for HIV/AIDS. A new combined dataset is generated for each scientific project. Only the required variables are combined in this process.
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Hepatitis module
Coinfection with hepatitis, especially hepatitis B and C, is an important comorbidity from an epidemiological and clinical perspective - especially with a view to antiretroviral therapy and its side effects - because of the similar transmission risks in HIV patients.
For this reason, comprehensive clinical and laboratory findings for HIV positive patients with hepatitis coinfection are documented in the hepatitis module of the Competence Network for HIV/AIDS. The hepatitis module is a part of the basis module of the patient cohort. No particular inclusion in the hepatitis module is required; in case of coinfection the existing clinical and laboratory findings are documented on the basis of the existing consent. The parameters are as follows:
- Laboratory findings for hepatitis: anti-HBc, anti-HBs, anti-HCV, HbsAG, anti-HAV, anti-Hbc, anti-Hbe, anti-Hbs (quantitative and qualitative), HBeAG, HBsAG, HBV-DNA (quantitative and qualitative), HBV genotypes, HBV resistance testing, HBV treatment, HCV-AK, HCV-RNA (quantitative and qualitative), HCV genotype, HCV treatment, HDV-AK, HDV-RNA, HGV-AK, HGV-RNA (quantitative and qualitative), a-fetoprotein, alk. phosphatase, liver histology,
- Clinical hepatitis findings: ascites, spontaneous bacterial peritonitis, hepatic encephalopathy accompanied by coma, oesophageal varices, oesophageal variceal haemorrhage, haptorenal syndrome, icterus, raised ALT measurement (GPT), raised AST measurement (GOT), raised AP measurement, raised bilirubin measurement, liver transplantation, hepatocellular carcinoma,
- Vaccination findings for hepatitis: active vaccination HAV and HBV with number of vaccinations and individual dose, vaccine titres after 6 months,
- Medication.
The simple record of a potentially present coinfection with hepatitis is captured in a standardised fashion for all patients in the context of the general documentation.
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Neurology module
In the course of their HIV infection, neurological symptoms assume great importance for many patients. Neurological symptoms can develop as a result of the HIV infection itself but also as a result of AR. The precise mechanisms that underlie these phenomena are the subject of intense research.
To study these associations in the context of the patient cohort of the Competence Network for HIV/AIDS, detailed neurological findings for the cohort patients are documented in the specifically developed neurology module. The neurological HIV outpatient clinic in Düsseldorf University Hospital specialises in Germany in the diagnosis and treatment of HIV positive patients with neurological symptoms. The data for the neurology module in the Competence Network for HIV/AIDS are documented here.
The inclusion criteria are:
- The presence of a neurological pathology in the context of HIV/AIDS,
- Medical care is provided in a documenting centre.
Data from the following areas are documented:
- Neurological-diagnostic measures,
- clinical and laboratory findings of a neurological nature,
- Drug misuse, and
- Neurological therapy.
An overview of the documented variables is available here. The data are collected in a standardised manner. With regard to implementing data protection measures, assuring data quality, and technical realisation of the documentation, the same conditions apply as to the basis module.
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Biomaterial banks
Biomaterial banks have become a central component of biomedical research. Tissue specimens (in the Competence Network for HIV/AIDS: skin, lymph node tissue), blood (p0lasma, serum), cerebrospinal fluid (CSF), cells or extracts (DNA/RNA) are made available for the long term for medical-scientific study. Stored samples are linked with existing data on the course of illness of a particular patient. Biobanks therefore offer great potential for finding answers to urgent questions within medical research. Because of the very comprehensive sociodemographic and clinical dataset of the patient cohort, this is particularly so for the biomaterial banks of the Competence Network for HIV/AIDS.
Cohort patients consent to give an EDTA blood sample of 9 ml at the time of inclusion in the study and routinely every three years subsequently. The specimens are sent to the central DNA bank of the Competence Network at the Institute for Pharmacology at the University Hospital in Essen, for the purpose of DNA extraction. There, the specimens are stored at -20°C and kept available.
Additionally, a serum specimen of 10 ml is taken from every patient at the time of inclusion into the cohort and at six-monthly follow-ups. These samples are stored in a decentralised manner in the documenting centres at a recommended temperature of -80°C.
Further biomaterials such as CSF, lymph nodes, or skin specimens are taken from the patient in the context of separate examinations and after consent has been obtained separately. This materials are stored according to the requirements of each individual material.
The removal and storage of all biomaterials follow standard operating procedures. Prior consent from the patient needs to be obtained to allow for the samples being taken and stored.
The biomaterial bank of the Competence Network for HIV/AIDS currently contains the following specimens (May 2010):
| Number of samples | Storage | |
| Serum bank | 56.327 | decentralised |
| DNA bank | 16.292 | centralised |
| CSF bank | 1.468 | centralised |
| Skin bank | 3.500 | centralised |
| Lymph node bank | 120 | centralised |
| Mucosa bank | 1.660 | centralised |
The steering committee of the Competence Network for HIV/AIDS can make these biomaterials available to interested scientists on receipt of a formal application and a positive assessment. To generate maximum scientific benefit, research questions are given priority that also seek access to the related sociodemographic or clinical data from the patient cohort. Further details of how to apply are available here.
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Study projects related to the cohort
On the basis of the patient cohort of the Competence Network for HIV/AIDS, different evaluations are continually being done by collaborating scientists in the context of research projects. The projects use sociodemographic and clinical data from the patient cohort as well as the biomaterial banks. The projects range from descriptive studies of specific populations to complex clinical or basic scientific studies.
Project outlines can be submitted to the CTC office as a brief application. The applications are assessed as soon as possible by the steering committee of the Competence Network for HIV/AIDS. The Competence Network for HIV/AIDS welcomes applications from all interested scientists.
The following projects have been completed or are currently being implemented:
Completed projects
- KompNet-Pharmacogenetics-Study (Wyen)
- Comorbidities and concomitant medications of HIV positive patients in Germany (Jansen, Michalik, Baudewig, Haastert)
Abstract (PDF, 11KB), Poster (PDF, 111KB) - Comparison of populations, treatment characteristics and clinical outcomes between outpatient clinics and specialised private practitioners in Germany
Abstract (PDF, 11KB), Poster (PDF, 202KB) - Charakteristics of „late presenters“ in the KompNet cohort (Marcus, Michalik, Jansen)
Abstract (PDF, 12KB), Poster (PDF, 117KB)
Ongoing projects
- RNA expression profiles of long term, non-progressive, and „normal“ courses of HIV infection (Wolf)
- Clinical course of HIV infection in early versus late start of antiretrioviral therapy (Plettenberg, Wagner)
- Host susceptibility to EVF-associated treatment limiting toxicity in the German Competence Network: “KompNet-GenTox-Study” (Wyen)
- Sustained systemic immune activation in immunological non-responders after start of antiretroviral therapy (Behrens, Mohammad-Khani)
- NKG2D Polymorphism and CMV infection (Behrens, Witte)
- Evaluation od diabetes mellitus, metabolic syndrome, and subsequent complications (Behrens)
- Epidemiological description of the cohort of the Competence Network (Jansen, Michalik, Stoll)
- Clinical outcomes of HIV-positive patients having different income status (Jansen, Stoll, Heide, Mertens, Brockmeyer).
Abstract (PDF, 80KB), Lecture (PDF, 167KB)
The Competence Network for HIV/AIDS is an alliance of the main Germany working groups active in clinical research and basic research into HIV/AIDS, with a close orientation to clinical practice, which also conduct joint research projects. Participants include university departments as well as physicians specialising in HIV medicine/care, The German AIDS Help reg. assoc, and national reference centres. The close interdisciplinary collaboration that is a characterising feature of Germany’s Competence Network for HIV/AIDS forms the basis for the translational research that is being undertaken within the network, which in recent years has resulted in the successful translation of research results into treatment practice.
The scientific concept for the scientific orientation of the Competence Network for HIV/AIDS is being set out in the scientific boards.
The main topics focus on:
- Biomedical research and prevention
- Ageing
- Oncological pathologies developing over the course of HIV infection
- Research into pregnant women and children
All relevant bodies within the Competence Network for HIV/AIDS are involved in making the decision about which projects should be undertaken.
The decision-making process
Infrastructure projects
Three infrastructure projects within the Competence Network for HIV/AIDS receive funding from the federal ministry (BMBF):
Title: Patient network: increasing patients’ competences in the setting of HIV/AIDS treatment by vertical networking between the Competence Network for HIV/AIDS and people living with HIV/AIDS
Study centre: German AIDS Help (DAH) reg. assoc, Berlin
Principal investigator: Steffen Taubert, Berlin
For more information, follow this link.
Title: Project management, quality assurance, monitoring, and data management in the national patient registry of the Competence Network for HIV/AIDS
Study centre: Clinical Trial Center at the Faculty of Medicine at Cologne University (methodological part), Cologne
Principal investigator: Dr. Ursula Paulus, Cologne
For more information, follow this link.
Title: Setting up and establishing a central blood and DNA bank in support of collaborations between the participating research groups in the Competence Network for HIV/AIDS
Study centre: Institute of Pharmacogenetics, University of Duisburg-Essen, Essen
Principal investigator: Professor Dr. Siffert, Essen
For more information, follow this link.
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Cooperations
National collaborations
The Competence Network for HIV/AIDS maintains numerous collaborations with various institutions, bodies, associations, and individual persons, such as:
- The German AIDS-Hilfe reg. assoc.
- The German AIDS Foundation
- The German AIDS Society reg. assoc.
- The Robert Koch-Institute
- The national reference centres for retroviruses
- VfL Bochum 1848 [Bochum Football Club]
- UNICEF
- The HIV Contact Model Project
- Clinical scientists
- Basic scientists
- Epidemiologists
International collaborations
The German Competence Network for HIV/AIDS has contributed valuable pieces to the puzzle within international HIV research since its foundation, on the basis of its cohort and its biobanks. These pieces have supported the development of future strategies for the fight against the immunodeficiency syndrome. The national researchers’ alliance is now a member of:
- The Network for European AIDS Treatment (NEAT, see below); and
- The Collaboration of Observational HIV Epidemiological Research Europe (COHERE, see below), the European alliance of cohorts (see below).
Additionally, the German Competence Network for HIV/AIDS is a participant in the following international projects:
- MITOC (Mitochondrial toxicity in children and NRTI Exposure),
- ELITE (HIV Elite Controller Study),
- BBMRI (Biobanking and Biomolecular Resources Research Infrastructure),
- CHAIN (Network on HIV and anti-HIV drug resistance).
Collaborations have been initiated with Japan and Ukraine and the Zhejiang University in Hangzhou / China.
NEAT
50 years after the Treaties of Rome, the “birth certificate” of the European Union, on 1 February 2007 Rome was again the centre of a groundbreaking European collaboration agreement. On this day, the excellence network NEAT (Network for European AIDS Treatment) was inaugurated, to which 41 partners from 16 countries with 350 have pledged their allegiance. NEAT is funded by the European Union to the tune of Euro 12.5m over five years in the context of the 6th Framework Programme for Research and Technological Development.
The NEAT network aims to create the necessary conditions for European-wide clinical studies into the further development of antiretroviral treatment in HIV patients and to conduct clinical studies.
Further, network partners in all European countries - especially in eastern Europe and the newly accessed EU member states - will pass on knowledge about HIV and AIDS to medical professionals in the context of NEAT, so as to introduce the therapeutic standards and treatment schemes that are available in western Europe to those regions.
German patient cohort is example for Ukraine
Ukraine is widely regarded as the epicentre of the AIDS epidemic in eastern Europe. The expertise for forming a Ukrainian patient cohort following the German example was taught in the context of a three-day workshop in Kiev on 22nd-24th September 2008. This workshop was organised under the overall control of the German Competence Network for HIV/AIDS and received financial support from NEAT. Accordingly, Ukraine is the first east European country to introduce a documentation system that will meet international standards in the very near future. The German network structure can, however, not be transferred in its identical form because the healthcare system in Ukraine is clearly different to that in Germany. Ukraine does not have practices that specialise in HIV/AIDS medicine; patients with HIV are being treated in hospitals and regional centres for AIDS-prevention.
In the context of their scientific workshop, the German Competence Network for HIV/AIDS and the Ukrainian Centre for AIDS Prevention first of all analysed the specific requirements for epidemiological surveillance of HIV/AIDS in Ukraine. The collaboration partners include the World Bank, the Robert Koch-Institute (RKI), the United Nations Economic Commission for Europe (UNECE), the German Society for Technical Cooperation (GTZ), the World Health Organization (WHO).
In concrete terms, the project, financed by the BMBF (International Bureau), aims to establish a registry with the data and findings of initially 1600 HIV patients. This takes into account issues of data protection. Altogether, 30 variables per patient will be collected that will enable conclusions for more targeted prevention initiatives. Since the German Competence Network for HIV/AIDS will make available its infrastructure for this exercise, the technical requirements ideal conditions for a patient cohort in Ukraine can be created without any additional financial expense.
COHERE
The network has achieved international visibility thanks to its activities within the Collaboration of Observational HIV Epidemiological Research Europe (COHERE). Data from the patient cohort of the German Competence Network for HIV/AIDS have served as building blocks for scientific projects that can be undertaken only on the basis of very large numbers of clinical data - for example, the epidemiologically oriented project “Age/sex specific death rates in ART-naive patients with CD4-count above 350 cells/mm3 compared with the general population”. 
In the context of MITOC (Mitochondrial Toxicity in Children), datasets from the children’s module of the cohort of the German Competence Network fo rHIV/AIDS are collected European-wide in order to investigate whether antiretroviral prophylaxis that children of HIV infected mothers receive before and after the birth lead to neurological sequelae in the long term.
In the context of the comprehensive European alliance project Biobanking and Biomolecular Resources Research Infrastructure (BBMRI), the intention is to link many of Europe’s existing biobanks. The aim is to network biobanks with different biomaterials and of different sizes and to make these accessible to the interested public more easily. The intention is to stimulate research on the basis of biomaterials within Europe. In a first phase, the feasibility of such a project is being studied. In Germany, BBMRI collaborates with the TMF project in the biobank registry. To find detailed information about BBMRI, follow this link.
Studies
Studies within the German Competence Network for HIV/AIDS
In the context of the German Competence Network for HIV/AIDS, numerous scientific studies are being conducted: projects awarded by the competence network itself that are funded by the BMBF (low-budget projects), projects from public third party funding, and projects sponsored by the pharmaceutical industry.
The following includes descriptions of low-budget projects as well as of other ongoing and completed studies:
- Low-budget projects
- Ongoing projects
- Completed projects
Low-budget projects
In the context of the German Competence Network for HIV/AIDS, those low-budget projects will receive funding from the Federal Ministry of Education and Research (BMBF) that are decided on by the competence network’s scientific advisory board - an international panel. Applications for planned project grants of up to a maximum of Euro 30,000 per project application can be submitted, for a maximum duration of one year. Information about ongoing Low-budget projects here.
Interested parties have the opportunity to apply for funding within the German Competence Network for HIV/AIDS by means of a project grant application - preferably in the area of clinically oriented research, social scientific research, or health economic research.
It is particularly important in this context that the project builds on the use of data from the patient cohort and biobanks of the German Competence Network for HIV/AIDS and that your project adds value to the work of the Competence Network for HIV/AIDS.
Ongoing projects
This section includes descriptions of currently ongoing studies in the German Competence Network for HIV/AIDS.
Overview
- Study projects relating to the cohort
- Infrastructure projects
- International collaborations
- Industry-sponsored projects
- Further ongoing studies
Completed projects
For further informations please follow this link.
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Submission of projects
We look forward to receiving applications for projects that you would like to conduct within the German Competence Network for HIV/AIDS.
For projects on the basis of the patient cohort, please contact:
Cohort manager
Klaus Jansen
Clinic of Dermatology, Venerology and Allergy, Ruhr-Universität Bochum
Gudrunstr. 56, D-44791 Bochum, Germany
Phone: +49 (0) 234 509-3501
Fax: +49 (0) 234 509-3475
Email: Klaus.Jansen@klinikum-bochum.de
We look forward to receiving a brief abstract of your study with this form.
For projects that reach beyond the scope of this framework, please contact:
Scientific coordination/management
PD Dr Adriane Skaletz-Rorowski
Clinic of Dermatology, Venerology and Allergy, Ruhr-Universität Bochum
Gudrunstr. 56, D-44791 Bochum, Germany
Phone: +49 (0) 234 509 -3486
Fax: +49 (0) 234 509 -3483
Email: a.skaletz@klinikum-bochum.de
All relevant bodies within the German Competence Network for HIV/AIDS are involved in the decision on which projects to fund.
The decision-making process
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Our events
The most important tasks of the German Competence Network for HIV/AIDS include knowledge transfer and organisation of conferences with the objective of facilitating the scientific exchange about HIV/AIDS.
In recent months, the German Competence Network for HIV/AIDS has organised several events or participated in their organisation:
- 5th German-Japanese HIV-Symposium, 9.-11. May 2010 in Tokyo, Japan
- Second NEAT Workshop, autum 2009 in Kiev, Ukraine
- German STD-Congress, 17.-19. September 2009 in Bochum
- SÖDAK 2009, 24.-27. June 2009 in St. Gallen, Switzerland
- Congress of the TMF, 1./2. April 2009 in Bochum
- 4th German-Japanese HIV-Symposium, 23./24. March 2009 in Bochum
- First NEAT Workshop, 22.-23. September 2008 in Kiev, Ukraine
- Extert conference HIV-Kontrovers, 11. October 2008 in Bochum
For detailled informations follow this link.
Publications
Click here for all the KompNet publications and abstracts from 2002-2010 or
go directly to the latest publications from 2010, or to the latest abstract from 2010.
Here you find an overview of the number and Impact Factor of the latest KompNet publications:
If you wish to submit a publication and involve the German Competence Network for HIV/AIDS, please adhere to the network’s publication guidelines.
Patients
People with HIV in the German Competence Network for HIV/AIDS
More than 8000 people with HIV/AIDS are participating in the national HIV cohort -the central research project of the competence network. Each year, individual projects are added, for which additional study participants are recruited.
Participation in a study requires a session in which information is provided by the treating physician and the participant gives his or her written consent. In order to ensure that all study participants have an opportunity to find out how the research project evolves, all relevant information about ongoing projects are posted to this website.
Additionally, the quarterly newsletter (Kompl@t) from the German AIDS-Hilfe about the competence network provides information on projects and study results. The newsletter can be downloaded as a pdf or you can subscribe to an email alert.
People with HIV participate in the competence network not only as study participants but are involved in the decisions of the network by means of a patient advisory board. In conjunction with the German AIDS-Hilfe, this patient advisory board ensures that patients’ needs are borne in mind to a sufficient degree in all projects. The patient advisory board sends members eligible to vote to the steering committee and the individual decision-making scientific boards.
Please find further information in the pages Patient advisory board and German AIDS-Hilfe.
Press releases and Mediaclipping
From 1/2009-8/2010 13 press releases were published, all press information are currently updated and available here.
All articles (online and print) concerning the KompNet HIV/AIDS are summarised at the webpage under Mediaclipping. You can find there more than 45 articles which were published between during the last two years.
The monthly Newsletter of the KompNet is published in the end of every month, earlier issues can be found and downloaded here.
Industry
These pages contain profiles of our partners from the pharmaceutical industry, as submitted by themselves.
Essex Pharma
Combating HIV in new ways
Essex Pharma GmbH (Ltd) is the German subsidiary of the worldwide Schering-Plough Corporation and, as such, has long years’ experience in the research topics of severe chronic diseases such as infections and cancer. In this area of competence it is our declared aim to find new medications against HIV, to develop these, and to make them available to patients.
Combination treatment with at least three antiretroviral drugs has become the standard treatment for effective control of HIV infection. Long term use has resulted in the need to develop new classes of drugs, in order to counteract increasingly complex dosage regimens, long term side effects, and the development of resistant HIV strains. Schering Plough is exploring new avenues in the fight against the AIDS pandemic with its research and clinical development in the CCR5 antagonist Vicriviroc.
Jayaram Tagat discovered Vicriviroc
We can make an important contribution even in cases of severe complications of HIV disease. Concomitant chronic hepatitis C, if not treated, often results in rapidly progressive disintegration of the liver, especially in a setting of dual infection, but the infection can often be cured by administering pegylated interferon and ribavirin. Liposomal doxorubicin can lead to impressive regression of AIDS associated Kaposi sarcoma even at advanced tumour stages, and posaconazole is a highly effective antimycotic substance to fight diverse invasive fungal infections—especially in patients with underlying immunodeficiency.
Essex Pharma is the sponsor of the German AIDS award, which is awarded every other year by the German AIDS Society for research that deals in an excellent manner with HIV/AIDS at the clinical or basic scientific level and thus makes a groundbreaking contribution towards containing HIV infection and its sequelae. We are currently inviting tenders for the DAIG award; the winner will be announced in St Gallen in the context of the Deutsch-Schweiz-Österreichischer AIDS Kongress (SÖDAK, the German-Swiss-Austrian AIDS congress) in July 2009.
The German-Japanese Panel against AIDS was inaugurated by the German Competence Network for HIV/AIDS in the context of its international collaborations, jointly with Japanese HIV experts. At the 4th German-Japanese HIV-Symposium in Bochum in March 2009, and also at the 5th Symposium in 2010 in Tokyo, Essex Pharma sponsored the poster award.
Photo 1: The Essex poster prize 2009 won Kaori Asamitsu (Nagoya); Photo 2: Poster award winner 2010 for basic sciences: Kei Myakawa (Yokohama) and photo 3: Poster award winner 2010 fpr social sciences: Klaus Jansen (Bochum).
We welcome the initiatives and objectives of the German Competence Network for HIV/AIDS because we believe that the quality of research is directly linked to the quality of health care and will yield progress in prevention, prophylaxis, and improved therapy for HIV disease. Since 2009, Essex Pharma has been a supporting member, because the company regards the German Competence Network HIV/AIDS as an important guarantor of the future of AIDS research in Germany. 
Virco BVBA
Virco was established in 1995 by a small, experienced group of scientists and clinicians passionate about and committed to making a difference for patients living with HIV. The primary focus was to discover and develop innovative ways to bring practical and reliable resistance testing tools to doctors, to help them make better informed treatment decisions and to enhance patient care.
As a research-based biotechnology company, we apply advanced technologies in molecular biology, virology, genomics, robotics and electronic data processing to improve the diagnosis and management of infectious diseases. Virco continues to provide value added diagnostic services that enable optimized patient management for infectious diseases, and in particular with reference to HIV antiviral resistance.
In addition to supporting patient management in routine clinical care, Virco's unique and extensive knowledge base also supports clinicians, virologists and researchers in pharmaceutical drug development to facilitate the availability of life-enhancing medicines to those in need.
A pioneer in the field of HIV-1 drug resistance testing, our leadership results from translating cutting edge technology into practical diagnostic tools. Virco invests significant resources in R&D and supports numerous external scientific projects and clinical trials, assuring that our assays incorporate the newest drugs and drug classes and that we remain at the forefront of new developments in HIV resistance and therapy management.
In order to bring our services as widely as possible to market, we work closely with various partner companies and maintain active collaborations with patients and advocates involved in the battle against infectious diseases, such as HIV and hepatitis C.
It is to this end that Virco is collaborating with the German Competence Network for HIV/AIDS. Under this collaboration the Competence Network for HIV/AIDS and Virco exchange de-identified clinical outcome and resistance data to further understand HIV drug resistance, enabling the development by Virco of tools to assist HIV physicians in their treatment decisions. In return, Virco supports Competence Network for HIV/AIDS to create and maintain a HIV sequence resistance database, and provides the virco®TYPE HIV-1 resistance interpretation to German physicians participating in the Competence Network for HIV/AIDS.
We believe that significant collaborations such as the one we have with the German Competence Network for HIV/AIDS, can provide the power to build more accurate prediction tools needed to improve patient care. It is a great example of a partnership that can add diversity to the understanding which leads to innovation in HIV therapy. We are convinced that the cross-fertilization of expertise resulting from this collaboration may help to benefit HIV patients in Germany and worldwide.
Supporting members
Further sponsors sign up as “supporting members” in the Competence Network for HIV/AIDS.
Increasing numbers of drug manufacturers seek an opportunity to support the work of the German Competence Network for HIV/AIDS as supporting members, by providing a minimum amount of 10,000 Euro. These funds, which constitute essential support for the work of the national research alliance, are administered by the German Competence Network for HIV/AIDS and used for projects.
All members and patients express their thanks for the support and cooperation.
The sponsors so far in 2010 are (in alphabetical order):
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Projects
Title: Longterm efficacy and safety of Atazanavir/RTV in a non-interventional, prospective cohort of pretreated women
Coordination: Prof. Dr. N. H. Brockmeyer, Bochum, Dr. A. Haberl, Frankfurt; Dr. A. Potthoff, Bochum
Cooperation mit Bristol-Myers Squibb GmbH & Co. KGaA (BMS)
Title: Screening for HPV-related genital and anal intraepithelial neoplasia in HIV-infected patients in Germany (ScreenING)
Sponsor: German Competence Network for HIV/AIDS
Principal investigator: Prof. Dr. N. H. Brockmeyer, Bochum
Cooperation with Sanofi-Pasteur MSD
Title:Assessing patients’ preferences in the therapy of HIV/AIDS
Prinicpal investigator: Dr. M. Nübling, Denzlingen
Cooperation with Janssen Cilag GmbH in Neuss
Title: Resistance module in the context of the patient cohort of the German Competence Network for HIV/AIDS
Principal investigator: Prof. Dr. N. H. Brockmeyer, Bochum
Collaborations with
VIRCO BVBA, Mechelen, Belgium
SmartGene GmbH, Zug, Switzerland
Title: Comorbidities and concomitant medications of HIV positive patients in Germany
Participating scientists: Dr. R. Walli, Ms. Baudewig, K Jansen, Mr. Haastert
Collaboration with GlaxoSmithKline
Download:
English-German brochure of the Competence Network for HIV/AIDS 2008 (PDF