Dr Armel Martin Zemsi Kala

Cameroon

EDCTP portfolio: Clinical Research & Development Fellowships

Dr Armel Martin Zemsi Kala pursued a training at Janssen Pharmaceutical NV, Beerse, Belgium, with a view to trainng and mentoring students and junior researchers in Cameroon.

Transferring knowledge to junior researchers

As pertains to this type of fellowship, Dr Zemsi Kala aims to acquire knowledge and practical expertise in many aspects of the setup and conduct of clinical trials in sub-Saharan Africa, e.g. with a view to identifying gaps in regulatory and clinical capacities.

The challenge

In addition to his routine clinical activities as a general practitioner, Dr Kala has been contributing as a sub-investigator in various research programs and health promotion activities in the fields of HIV and tuberculosis at his institution in Cameroon. He has also been involved at site level in the planning, set-up and conduct of a GSK-funded Ebola vaccine trial.

The aim of the project is to complement his experience in implementing health and research projects in resource-constrained settings, with better knowledge of study design, regulatory requirements and trial reporting.

He seeks to learn how to proactively identify gaps and corresponding investments to be made in terms of the regulatory framework, capacity building (infrastructure/resources) and evaluate the operational readiness of investigational sites in different countries. He wants to gain expertise in the management of complex multi-country trials and learn various aspects of a clinical trial from protocol design to clinical study reporting.

The project

After the placement period, for six months Dr Kala focused on the so-called reintegration activities of the clinical R&D fellowships at his home institution. He organised a 4 days training workshop on research methodology for 60 medical students. Furthermore, he designed and implemented two research projects in collaboration with two medical students as mentees. Finally, he set up an online forum on which junior researchers can discuss issues they face in their projects with more experienced researchers.

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

As pertains to this type of fellowship, Dr Zemsi Kala aims to acquire knowledge and practical expertise in many aspects of the setup and conduct of clinical trials in sub-Saharan Africa, e.g. with a view to identifying gaps in regulatory and clinical capacities.

In addition to his routine clinical activities as a general practitioner, Dr Kala has been contributing as a sub-investigator in various research programs and health promotion activities in the fields of HIV and tuberculosis at his institution in Cameroon. He has also been involved at site level in the planning, set-up and conduct of a GSK-funded Ebola vaccine trial.

The aim of the project is to complement his experience in implementing health and research projects in resource-constrained settings, with better knowledge of study design, regulatory requirements and trial reporting.

He seeks to learn how to proactively identify gaps and corresponding investments to be made in terms of the regulatory framework, capacity building (infrastructure/resources) and evaluate the operational readiness of investigational sites in different countries. He wants to gain expertise in the management of complex multi-country trials and learn various aspects of a clinical trial from protocol design to clinical study reporting.

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.

After the placement period, for six months Dr Kala focused on the so-called reintegration activities of the clinical R&D fellowships at his home institution. He organised a 4 days training workshop on research methodology for 60 medical students. Furthermore, he designed and implemented two research projects in collaboration with two medical students as mentees. Finally, he set up an online forum on which junior researchers can discuss issues they face in their projects with more experienced researchers.

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

About us

The European & Developing Countries Clinical Trials Partnership (EDCTP) is a public–public partnership between 14 European and 16 African countries, supported by the European Union. EDCTP’s vision is to reduce the individual, social and economic burden of poverty-related infectious diseases by affecting sub-Saharan Africa. EDCTP’s mission is to accelerate the development of new or improved medicinal products for the identification, treatment and prevention of infectious diseases, including emerging and re-emerging diseases, through pre- and postregistration clinical studies, with emphasis on phase II and III clinical trials. Our approach integrates conduct of research with development of African clinical research capacity and networking. The second EDCTP programme is implemented by the EDCTP Association supported under Horizon 2020, the European Union’s Framework Programme for Research and Innovation.

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