The objective of the proposal is to strengthen and extend the existing successful European collaboration in clinical trials in HIV infection which (in collaboration with Australia) has recruited over 7000 individuals in the last 6 years. A formal structure would be established for the exchange of information and ideas in order to
develop a co-ordinated programme of clinical research. No single European country has either sufficient resources or HIV-infected individuals to answer all the relevant therapeutic questions rapidly. Collaboration will ensure unnecessary duplication of effort and efficient use of resources. Involving new countries will increase the number of clinicians and HIV infected individuals able to participate in trials.
Clinical trials of anti-retroviral therapies:
The main priority of the group would be to develop a co-ordinated programme of trials to assess new therapies.
It would include:
1) exploratory studies:
- based on virological and immunological assessments to evaluate the activity of new drug combinations and alternative ways of using drugs together
2) intermediate studies:
- based on clinical outcomes to assess clinical benefits and risks of new therapies
3) strategic studies:
- to determine optimal approaches for disease control, addressing questions such as the timing of initiation of therapy, changes in therapy and its discontinuation.
Improved methods to ensure the long term follow up of individuals in trials to assess long-term risks and benefits would be developed. The evaluation of virological and immunological assessments within trials and their quality control would also be a priority.
Close liaison with the pharmaceutical industry would be important with advantages for both the group and the industry. However, the group needs to be able to meet and to develop clinical trials independent of financial support from the industry and to continue to design, undertake and analyse trials independently, as appropriate.
Many drugs are given in the treatment of HIV disease. The group will monitor and investigate serious adverse events, especially those which are unusual and unpredictable, both within the trials and in other patients treated in the participating clinical centres. No one centre in Europe has access to sufficient patients to discern a clear pattern of reactions, and also because of ethnic and environmental differences, the patterns may vary in different populations.
The management of HIV infected individuals is costly, making heavy demands on health care resources. Economic analyses would be carried out on ongoing trials and introduced prospectively in future trials to compare the cost effectiveness of different therapeutic strategies.
The Steering Group responsible for overseeing the project would decide the priorities and timescale of the research programme and subgroups would be set up to co-ordinate the virological, pharmacovigilance and data management aspects. Collaboration with several other Concerted Actions, particularly related to virological and immunological assessments and to pharmacovigilance is planned.