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EDCTP portfolio: Clinical Research & Development Fellowships

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Mr Aboubakar Soma is trained in comprehensive clinical trial competencies and skills at IDDO/WWARN (United Kingdom) to train young researchers at the Centre Muraz.

Supporting the next generation of researchers in Burkina Faso 

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Sub-Saharan African countries urgently need to further develop their clinical research capabilities on poverty-related diseases such as malaria, HIV, tuberculosis and neglected tropical diseases. To lead research projects on diagnostics, drugs and vaccines for these diseases, African researchers need to develop their skills even more.

The challenge

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Mr Aboubakar Soma will train at the Infectious Diseases Data Observatory/the Worldwide Antimalarial Resistance Network (IDDO/WWARN); afterwards, he will return to the Centre Muraz in Burkina Faso to share and implement his new knowledge.

After English language training, he will start with his placement activities to gain skills in clinical trial competencies, covering: clinical trial design (protocol development); statistics (sample size calculation and data analysis); protocol development and systematic reviews) ethical considerations and patient safety (GCP and GCLP), study and site management, and data management and informatics (CRF and source data, quality control and data correction and clinical trial databases). He will also enhance his skills in using clinical trial toolkits for antimalarial drugs. Moreover, he will acquire skills in geospatial analysis using ArcGIS.

Centre MURAZ is a biomedical centre dedicated to research and control of tropical diseases and malaria. It is experienced in evaluating strategies for the prevention of malaria, HIV, and meningococcal disease through clinical trials. Centre MURAZ is also conducting a phase II trial on an Ebola vaccine. In July 2018, Centre MURAZ merged with two other research centres to form the National Institute of Public Health (INSP) of Burkina Faso. The INSP’s mission comprises research, disease prevention & control and training.

After this placement at WARRN, Mr Soma will conduct several projects at Centre MURAZ. He will organise three comprehensive dissemination workshops. The training modules for the workshops will be developed during his placement under the supervision of mentors from both organisations.

He will also develop a specific efficacy study protocol on malaria listing several research questions on malaria that could be addressed by the specific protocol.

The project

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An IDDO/WARRN team will visit the Centre MURAZ to build a strategic partnership. Moreover, Mr Soma will aim to strengthen partnerships with other research centres in Burkina Faso and West Africa. To that end, the training workshops and his methodological support will be open to applicants from other research centres in Burkina Faso whenever possible.

His future role will be to give continuous methodological support to the young researchers involved in MSc or PhD programmes. This methodological support to young researchers and the strengthening of the strategic relationships will have a long-term impact on research capacity in Burkina Faso and centres in West Africa.

Impact

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test the safety and efficacy of this new formulation in young children

Bringing antiretroviral drugs to children

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The CHAPAS trials have ensured that many more children with HIV have benefited
from life-saving antiretrovirals.

EDCTP portfolio: HIV & HIV-associated infections

The challenge

Sub-Saharan African countries urgently need to further develop their clinical research capabilities on poverty-related diseases such as malaria, HIV, tuberculosis and neglected tropical diseases. To lead research projects on diagnostics, drugs and vaccines for these diseases, African researchers need to develop their skills even more.

watermark

Mr Aboubakar Soma will train at the Infectious Diseases Data Observatory/the Worldwide Antimalarial Resistance Network (IDDO/WWARN); afterwards, he will return to the Centre Muraz in Burkina Faso to share and implement his new knowledge.

After English language training, he will start with his placement activities to gain skills in clinical trial competencies, covering: clinical trial design (protocol development); statistics (sample size calculation and data analysis); protocol development and systematic reviews) ethical considerations and patient safety (GCP and GCLP), study and site management, and data management and informatics (CRF and source data, quality control and data correction and clinical trial databases). He will also enhance his skills in using clinical trial toolkits for antimalarial drugs. Moreover, he will acquire skills in geospatial analysis using ArcGIS.

Centre MURAZ is a biomedical centre dedicated to research and control of tropical diseases and malaria. It is experienced in evaluating strategies for the prevention of malaria, HIV, and meningococcal disease through clinical trials. Centre MURAZ is also conducting a phase II trial on an Ebola vaccine. In July 2018, Centre MURAZ merged with two other research centres to form the National Institute of Public Health (INSP) of Burkina Faso. The INSP’s mission comprises research, disease prevention & control and training.

After this placement at WARRN, Mr Soma will conduct several projects at Centre MURAZ. He will organise three comprehensive dissemination workshops. The training modules for the workshops will be developed during his placement under the supervision of mentors from both organisations.

He will also develop a specific efficacy study protocol on malaria listing several research questions on malaria that could be addressed by the specific protocol.

The project

The later CHAPAS-3 trial compared the efficacy and safety of three fixed-dose combinations including two without stavudine (found to have some long-term side effects in adults, leading to a recommendation that its use be discontinued in children). The trial the first of its kind in Africa studied nearly 500 children at four sites in two African countries.

An IDDO/WARRN team will visit the Centre MURAZ to build a strategic partnership. Moreover, Mr Soma will aim to strengthen partnerships with other research centres in Burkina Faso and West Africa. To that end, the training workshops and his methodological support will be open to applicants from other research centres in Burkina Faso whenever possible.

His future role will be to give continuous methodological support to the young researchers involved in MSc or PhD programmes. This methodological support to young researchers and the strengthening of the strategic relationships will have a long-term impact on research capacity in Burkina Faso and centres in West Africa.

ratios forfixed-dose combinations and on appropriatedosage according to weight. 

The CHAPAS-3 trial confirmed the effectiveness of fixed-dose combinations, providing further impetus to the rollout of antiretrovirals to children. Its evidence on abacavir informed the WHO recommendation of abacavir-containing combinations for first-line therapy in children. Trial data have also been used to support applications for regulatory approval for new scored efavirenz tablets.

Impact

L’homme RF et al. Nevirapine, stavudine and lamivudine pharmacokinetics in African children on paediatric fixed-dose combination tablets. AIDS. 2008;22(5):557–65.

Mulenga V et al. Abacavir, zidovudine, or stavudine as paediatric tablets for African HIVinfected children (CHAPAS-3): an open-label, parallel-group, randomised controlled trial. Lancet Infect Dis. 2016;16(2):169–79.

WHO. Guidelines on the use of antiretroviral drugs for treating and preventing HIV infection: recommendations for a public health approach. 2010.

WHO. Consolidated guidelines on the use of antiretroviral drugs
for treating and preventing

HIV infection: Recommendations for a public health approach
(second edition). 2016

Projects: Children with HIV in Africa Pharmacokinetics and Adherence of Simple Antiretroviral Regimens (CHAPAS): CHAPAS-1 and -3

Project lead: Professor Chifumbe Chintu, University Teaching Hospital, Zambia (CHAPAS-1); Dr Veronica Mulenga, University Teaching Hospital, Zambia (CHAPAS-3)

Target population(s): Children with HIV

Sample size: 71 (CHAPAS-1); 480 (CHAPAS-3)

Countries involved: Ireland, the Netherlands, the UK, the USA, Zambia (CHAPAS-1); Uganda, Zambia (CHAPAS-3)

Project duration: 2005–2009 (CHAPAS-1); 2010 –2011 (CHAPAS-3)

EDCTP funding: €1.2M (CHAPAS-1); €4.6M (CHAPAS-3)

Total project funding: €1.2M (CHAPAS-1); €5.0M