Publications

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

Dr Dan Kajungu

Uganda

EDCTP portfolio: Career Development Fellowships

Dr Dan Kajungu conducts the VXMedSSurv project which utilises demographic and health care data and monitoring to understand the risk of adverse reactions and treatment outcomes in health facilities.

Monitoring use and safety of vaccines and medicines

Developing countries receive immense volumes of drugs and vaccines because of the huge disease burden. However, the burden of adverse reactions/effect of these efficacious drugs and vaccines at the population level has not been fully explored in the African context. This is in addition to medication errors, irrational drug use, poor drug quality and counterfeits which undermine patient safety as well as put the health system’s credibility in jeopardy.

The VXMedSSurv project will utilise the health and demographic surveillance system (HDSS) to monitor the safety and use of vaccines and medicines (pharmacovigilance) in both public and private health facilities.

The challenge

Dr Kajungu and his team use will utilise the health and demographic surveillance system (HDSS) in Uganda to monitor the safety and use of vaccines and medicines (pharmacovigilance) in both public and private health facilities.

The VXMedSSurv project will actively and passively track adverse drug and vaccine reactions and/or events, within the Iganga Mayuge health and demographic surveillance site in Uganda. Using the system, the study link demographic HDSS data with health facility data like immunisation, diagnosis, prescriptions and antenatal-care outcomes. In this way, the project will study drug utilisation and diagnostics to understand their contribution to the risk of adverse reactions and treatment outcomes. Beyond the project lifespan, the team will establish a reproductive and pregnancy registry to capture treatment seeking patterns, maternal immunisation and lifestyle during pregnancy as well as pregnancy outcomes in women of reproductive age. Data mining of spontaneous reporting systems data and electronic health records for pharmacovigilance purposes using various machine learning methods will be used to identify potential adverse drug reactions and detection of drug safety signals.

The project

The outputs and findings of the project and its follow-up will be used directly by regulators, pharmaceutical companies, academia, and researchers to improve pharmacovigilance policies in Africa. The study will also hone the expertise of the fellow in pharmacoepidemiology and pharmacovigilance in African settings. Moreover, it will add to his experience in research leadership and project management. Capacity building and mentorship activities in the project will empower junior African researchers in Africa with an interest in pharmacovigilance.

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

Developing countries receive immense volumes of drugs and vaccines because of the huge disease burden. However, the burden of adverse reactions/effect of these efficacious drugs and vaccines at the population level has not been fully explored in the African context. This is in addition to medication errors, irrational drug use, poor drug quality and counterfeits which undermine patient safety as well as put the health system’s credibility in jeopardy.

The VXMedSSurv project will utilise the health and demographic surveillance system (HDSS) to monitor the safety and use of vaccines and medicines (pharmacovigilance) in both public and private health facilities.

Dr Kajungu and his team use will utilise the health and demographic surveillance system (HDSS) in Uganda to monitor the safety and use of vaccines and medicines (pharmacovigilance) in both public and private health facilities.

The VXMedSSurv project will actively and passively track adverse drug and vaccine reactions and/or events, within the Iganga Mayuge health and demographic surveillance site in Uganda. Using the system, the study link demographic HDSS data with health facility data like immunisation, diagnosis, prescriptions and antenatal-care outcomes. In this way, the project will study drug utilisation and diagnostics to understand their contribution to the risk of adverse reactions and treatment outcomes. Beyond the project lifespan, the team will establish a reproductive and pregnancy registry to capture treatment seeking patterns, maternal immunisation and lifestyle during pregnancy as well as pregnancy outcomes in women of reproductive age. Data mining of spontaneous reporting systems data and electronic health records for pharmacovigilance purposes using various machine learning methods will be used to identify potential adverse drug reactions and detection of drug safety signals.

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 outputs and findings of the project and its follow-up will be used directly by regulators, pharmaceutical companies, academia, and researchers to improve pharmacovigilance policies in Africa. The study will also hone the expertise of the fellow in pharmacoepidemiology and pharmacovigilance in African settings. Moreover, it will add to his experience in research leadership and project management. Capacity building and mentorship activities in the project will empower junior African researchers in Africa with an interest in pharmacovigilance.

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