Publications

Funding for clinical research |drugs, vaccines, microbicides, diagnostics | HIV/AIDS, tuberculosis, malaria, other infectious diseases |sub-Saharan Africa

EDCTP portfolio: Clinical Research & Development Fellowships

Dr Isidore Traore acquired advanced skills in clinical trial management at Merck KGaA, Germany, and back at the Centre Muraz contributed to improving the quality of clinical research of its new Department of Clinical Research.

Advancing international standards in clinical research in Burkina Faso

Centre Muraz is a biomedical research centre located at Bobo-Dioulasso (Burkina Faso) with experience in conducting clinical trials in HIV, malaria, tuberculosis, Ebola, etc. Its new Department of Clinical Research needs to continue to strengthen its capacities and retain young scientists in Burkina Faso. Therefore, the fellowship offered an opportunity to acquire advanced knowledge and skills in clinical trial design and operations at Merck in Germany.

The challenge

The first six months at Merck allowed Dr Traore to rotate through different departments, in order to update his competencies and have a good understanding of Merck’s activities and organisation. These activities included a tour of the Merck headquarters, immersion in the Department of Global Clinical Operations, attendance of the clinical trial management and governance meetings, and the completion of 194 training modules in Security, ICH-GCP, GPVP as well as Merck’s Policies, SOPs and Work Instructions.

To become proficient in clinical trials operations and study implementation, he was involved in the management of phase I/II trials. In order to build a future strategic partnership with Merck for conducting clinical trials at Centre MURAZ, he adapted a site assessment checklist which was shared with Centre MURAZ. He also familiarised himself with the Merck development pipeline. At Merck, he was mentored by the Director of Early Stage Clinical Operations, Global Clinical Operations and the Head of Financial & Performance Planning & Analysis.

The project

The impact of his placement at Merck Global Clinical Operations will be both individual and institutional. The advanced knowledge and skills he acquired will further his career development. These will help him to increase the quality of his research protocols and his publications in peer-reviewed journals.

His capabilities and activities will also sustain Centre MURAZ’s research platform. Dr Traore has shared with his home institution, Centre MURAZ, best practices identified at Merck which could be implemented to strengthen the ongoing capacity development, such as the administrative management of the Department of Clinical Research. He has conducted training workshops at Centre MURAZ using the training module developed at Merck. During the reintegration phase after his return to Burkina Faso, he and others planned statistical analysis and publication of the data collected during previous studies at Centre MURAZ. Moreover, a specific epidemiological study protocol is to be developed to identify potential participants who could be enrolled in future HIV and malaria clinical trials in Burkina Faso. A long-term partnership with Merck may be established.

Impact


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

Bringing antiretroviral drugs to children

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

Centre Muraz is a biomedical research centre located at Bobo-Dioulasso (Burkina Faso) with experience in conducting clinical trials in HIV, malaria, tuberculosis, Ebola, etc. Its new Department of Clinical Research needs to continue to strengthen its capacities and retain young scientists in Burkina Faso. Therefore, the fellowship offered an opportunity to acquire advanced knowledge and skills in clinical trial design and operations at Merck in Germany.

The first six months at Merck allowed Dr Traore to rotate through different departments, in order to update his competencies and have a good understanding of Merck’s activities and organisation. These activities included a tour of the Merck headquarters, immersion in the Department of Global Clinical Operations, attendance of the clinical trial management and governance meetings, and the completion of 194 training modules in Security, ICH-GCP, GPVP as well as Merck’s Policies, SOPs and Work Instructions.

To become proficient in clinical trials operations and study implementation, he was involved in the management of phase I/II trials. In order to build a future strategic partnership with Merck for conducting clinical trials at Centre MURAZ, he adapted a site assessment checklist which was shared with Centre MURAZ. He also familiarised himself with the Merck development pipeline. At Merck, he was mentored by the Director of Early Stage Clinical Operations, Global Clinical Operations and the Head of Financial & Performance Planning & Analysis.

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.

The impact of his placement at Merck Global Clinical Operations will be both individual and institutional. The advanced knowledge and skills he acquired will further his career development. These will help him to increase the quality of his research protocols and his publications in peer-reviewed journals.

His capabilities and activities will also sustain Centre MURAZ’s research platform. Dr Traore has shared with his home institution, Centre MURAZ, best practices identified at Merck which could be implemented to strengthen the ongoing capacity development, such as the administrative management of the Department of Clinical Research. He has conducted training workshops at Centre MURAZ using the training module developed at Merck. During the reintegration phase after his return to Burkina Faso, he and others planned statistical analysis and publication of the data collected during previous studies at Centre MURAZ. Moreover, a specific epidemiological study protocol is to be developed to identify potential participants who could be enrolled in future HIV and malaria clinical trials in Burkina Faso. A long-term partnership with Merck may be established.

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