EDCTP portfolio: Clinical Research & Development Fellowships
index
The CANTAM network is drawing on South–South and North–South collaborations to strengthen clinical trial capacity in less-developed centres in Central Africa.
CANTAM2: Central African Network on Tuberculosis, HIV/AIDS and Malaria
Countries in Central Africa are badly affected by poverty-related infectious diseases. Furthermore, many of these countries have limited capacity to carry out international standard clinical trials and other clinical studies on these infections.
Nevertheless, centres of research excellence do exist in Central Africa and have the potential to disseminate knowledge and good practice through networking, taking advantage of their links to academic institutions in Europe.
The challenge
CANTAM was established in 2009 with EDCTP funding. It initially encompassed seven institutions in three countries – Cameroon, Republic of Congo and Gabon – and had the specific aim of developing the capacity of institutions in Cameroon and the Republic of Congo, drawing on an established research centre in Gabon.
Initial funding enabled the institutions to establish the CANTAM network and to connect to other regional and international networks. It provided a platform for training of multiple master’s and PhD students in collaboration with European partners, as well as extensive short-term training. The network also carried out epidemiological studies characterising the prevalence, genotypes, and drug resistance profiles of HIV, malaria and TB pathogens in Cameroon and the Republic of Congo to provide a baseline for future intervention studies.
In follow-up CANTAM2 funding, the network is expanding to include additional African and European partners, including the Democratic Republic of the Congo, France, Switzerland and the UK, with Zambia as a collaborator. The scope of research has been expanded to include co-infections, including neglected infectious diseases, and co-morbidities.
CANTAM2 continues to have a focus on capacity-building, helping to build skills in conduct of clinical trials as well as the capacity of ethics review boards and regulatory authorities. A mentorship plan has been established to support the development of early-career researchers and to promote women in science. It is also strengthening laboratory capacity in participating institutions, including a new molecular biology and parasitology laboratory in the Republic of Congo and upgraded biobanks in the Republic of Congo and Cameroon, and establishing community liaison at each site to provide baseline data in advance of intervention studies.
Studies will have a particular focus on monitoring for adverse reactions to treatments, genetic characterisation of drug resistance, and analysis of drug–drug interactions. One specific project is a multicentre pharmacovigilance study of the Pyramax antimalarial treatment. Other studies will characterise the prevalence of co-morbidities and co-infections with soil-transmitted helminths and other neglected infectious diseases in local populations.
The project
CANTAM is extending the number of institutions and number of health research staff able to take part in multicentre clinical trials in Central Africa. Baseline data on key pathogens will provide an important resource ahead of intervention studies. CANTAM is also reaching out to new partners, for example to offer assistance to ministries of health and regulatory agencies, and formed part of the PANDORA-ID-NET Consortium funded by the EDCTP to develop preparedness for outbreaks of emerging and re-emerging infectious diseases.
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
Countries in Central Africa are badly affected by poverty-related infectious diseases. Furthermore, many of these countries have limited capacity to carry out international standard clinical trials and other clinical studies on these infections.
Nevertheless, centres of research excellence do exist in Central Africa and have the potential to disseminate knowledge and good practice through networking, taking advantage of their links to academic institutions in Europe.
CANTAM was established in 2009 with EDCTP funding. It initially encompassed seven institutions in three countries – Cameroon, Republic of Congo and Gabon – and had the specific aim of developing the capacity of institutions in Cameroon and the Republic of Congo, drawing on an established research centre in Gabon.
Initial funding enabled the institutions to establish the CANTAM network and to connect to other regional and international networks. It provided a platform for training of multiple master’s and PhD students in collaboration with European partners, as well as extensive short-term training. The network also carried out epidemiological studies characterising the prevalence, genotypes, and drug resistance profiles of HIV, malaria and TB pathogens in Cameroon and the Republic of Congo to provide a baseline for future intervention studies.
In follow-up CANTAM2 funding, the network is expanding to include additional African and European partners, including the Democratic Republic of the Congo, France, Switzerland and the UK, with Zambia as a collaborator. The scope of research has been expanded to include co-infections, including neglected infectious diseases, and co-morbidities.
CANTAM2 continues to have a focus on capacity-building, helping to build skills in conduct of clinical trials as well as the capacity of ethics review boards and regulatory authorities. A mentorship plan has been established to support the development of early-career researchers and to promote women in science. It is also strengthening laboratory capacity in participating institutions, including a new molecular biology and parasitology laboratory in the Republic of Congo and upgraded biobanks in the Republic of Congo and Cameroon, and establishing community liaison at each site to provide baseline data in advance of intervention studies.
Studies will have a particular focus on monitoring for adverse reactions to treatments, genetic characterisation of drug resistance, and analysis of drug–drug interactions. One specific project is a multicentre pharmacovigilance study of the Pyramax antimalarial treatment. Other studies will characterise the prevalence of co-morbidities and co-infections with soil-transmitted helminths and other neglected infectious diseases in local populations.
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.
CANTAM is extending the number of institutions and number of health research staff able to take part in multicentre clinical trials in Central Africa. Baseline data on key pathogens will provide an important resource ahead of intervention studies. CANTAM is also reaching out to new partners, for example to offer assistance to ministries of health and regulatory agencies, and formed part of the PANDORA-ID-NET Consortium funded by the EDCTP to develop preparedness for outbreaks of emerging and re-emerging infectious diseases.
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