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An European Network for the Virological evaluation of international trials for new Anti-HIV therapies

Objective

i) To create a network consisting from institutes of most of the member states of the European Community
ii) To establish a structural, lasting core network which will enable efficient and effective international clinical trials for new anti-HIV therapies.
iii) To decrease the costs of future clinical trials for anti-HIV therapies up to 30%. iv) To enable the participants to set up also a national network for the virological evaluation of clinical trials for new anti-HIV therapies in their own country.
v) To prepare and to distribute reagents and other resources for the quality control and standardisation of virological methods used in European trials.
vi) To provide young researchers and technicians with targeted training and mobility facilities which enables them to participate in other research teams.
vii) To disseminate, exploit and publish the results of the project in a common way.

The main problem in the search for a cure for AIDS is emergence of drug resistant viruses. It is critical to analyse the appearance of these drug resistant viruses and it's effect on viral load in clinical trials evaluating new drugs or a combination of drugs. Currently there are no consensus methods for the evaluation of drug resistant viruses and viral load used in Europe. Also no intra-laboratory quality control between European institutes has been installed. The lack of an uniform virological evaluation and the lack of continuous quality control programmes in Europe interferes with the efficiency and effectiveness of international clinical trials for new anti-HIV therapies.
Therefore, a network consisting of leading institutes from most member states of the European Community will be created. This network will facilitate an efficient and effective virological evaluation of international clinical trials for new anti-HIV therapies. Within this network consensus methods will be further developed and evaluated on a continuous bases. This will be done for quantification of HIV RNA as well as for molecular and biological characterisation of drug resistant viruses. Well defined reagents in the from of molecularly designed drug resistant viruses will be manufactured and distributed by a centralised facility to all participating laboratories. In close collaboration with the main clinical investigators in Europe and a representation of most pharmaceutical industries active in the development of drug therapies new methodologies will be designed and evaluated by the network. In order to achieve these objectives the CA is reinforced by the provision of network resources (reagents and other quality control products).
In conclusion qualified virological laboratories will join their forces, supported by their clinical investigators and the pharmaceutical companies, to create a network for a standardised, quality controlled virological evaluation of clinical trials to find more effective therapies for HIV infection. Furthermore the costs of future clinical trials will be decreased up to a 30%.

Coordinator

Academisch Ziekenhuis Utrecht
Address
100,Heidelberglaan
3508 GA Utrecht
Netherlands