|
Tuberculosis, malaria and infection with the Human Immunodeficiency Virus (HIV) are major causes of sickness and death in
many countries of the world. These diseases affect largely people living in conditions of extreme poverty. The current incidence and
prevalence of tuberculosis is severely straining the capacity of some National Tuberculosis Control Programmes to successfully administer
the WHO recommended standard 6-month regimen. The estimated development of a new anti-tuberculosis drugs, from discovery to marketing, is
approximately 20 years and the cost estimated by the Stop TB Partnership for effective treatments is almost 5 billion US dollars. By testing
a different combinations of drugs that are currently in use, we believe that we can cut that development time by 10 years and at a far lower cost.
World Without TB (WWTB), a registered charity in the U.K. on a not-for-profit basis in order to
maximise the resources available to assist other similar organisations, devoted to the rapid eradication of TB, by carrying out small scale clinical
trials using drugs currently given for the treatment of the disease. These trials of new drug combinations
could cut the length of time patients have to take their medicine by a third, and possibly even by half. The
trials will aim to define treatment schemes which will have:
- High cure rates
- Reduced treatment duration
- Improved compliance
- Reduced toxicity
- Reduced chances of unfavourable interactions with antiretroviral treatment for concomitant HIV/Aids
- Reduced burden of administration on the National Tuberculosis Control Programmes of high burden countries.
Overall, these long-term trials have, as their objective, to provide a sound evidence base on which national policies for the treatment
and eradication of, in the first place, tuberculosis and later, malaria and HIV infection, will be made. The following paragraphs give an account
of the problem to be addressed and its extent, and propose some of the solutions designed to reduce the problem and lead to its eventual
eradication. The plan will propose the envisaged solution, its costs and its impact on the target population. The role of the stakeholders and the
benefactors will be crucial to the success of WWTB. The establishment of the project will be implemented in stages, the timelines of which are
described below. It is envisioned that the timelines from conception of the project to its establishment as a viable and credible organisation
will be achieved within the next ten years. |
|
WHAT IS OUR MISSION?
Our mission is the global eradication of tuberculosis through the identification of
safe and effective treatment regimens of very short durations.
This will be achieved through :
Clinical trials
- We plan to conduct a
series of clinical trials, with the drugs currently used in the
treatment of tuberculosis, the objectives of which will be to
significantly reduce the treatment duration from the current six
months. Each trial will conform to the Guidelines on Good
Clinical Practice defined by the International Conference on
Harmonisation of Technical Requirements for Registration of
Pharmaceuticals for Human Use (ICH GCP Guidelines).
Capacity strengthening
- Organisations involved
in tuberculosis control, such as treatment centres of the
National Tuberculosis Control Programmes and Hospitals and
University Research Groups will be assessed for their capacity
to participate in the trials and any weaknesses identified will
be strengthened in order to be able improve their capacity to
participate in the trials.
Equipment supply
- Where necessary,
laboratory and office equipment will be supplied to improve
capacity
Training
- Staff at participating
centres will have the opportunity to be trained in the use of
new equipment as well as software for data entry and data
management.
Workshops
- Group training on issues
such as ICH GCP Guidelines, trial design, protocol preparation
and all aspects of trial conduct will be carried out through
regular workshops and the provision of written materials.
Networking
- Regional, continental
and international networks will be encouraged through multisite
participation in trials and international meetings.
|
