Publications

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

Dr Stephen Ian Walimbwa

Uganda

EDCTP portfolio: Clinical Research & Development Fellowships

Dr Stephen Ian Walimbwa was hosted for one year at the Novartis Institutes for Biomedical Research in Basel, Switzerland. focusing on early phase clinical research.

Broadening the scope of an institutional clinical trials unit

The EDCTP clinical R&D Fellowships support researchers and key members of clinical trial research teams from low- and middle-income countries for them to acquire specific skills in clinical research and development through placements in pharmaceutical companies, product development partnerships (PDPs) and research institutions. Dr Walimba aimed to acquire experience and expertise in early-phase clinical trials especially.

The challenge

Dr Walimbwa was hosted for one year at the Novartis Institutes for Biomedical Research (NIBR) in Basel, Switzerland. Under the mentorship of NIBR scientists within translational medicine, he participated in clinical trials that provided early proof of efficacy in humans, and in clinical trials that profiled the safety, tolerability, pharmacokinetics and pharmacodynamics of novel compounds. Some of these novel compounds will be key in the management of autoimmune diseases, neglected tropical diseases, malaria and rare diseases.

The fellowship allowed Dr Walimbwa to receive training and acquire skills and expertise in the design, set-up, operationalisation and follow-up of phase I-IIa clinical trials. Furthermore, he was able to establish a network of contacts within Swiss academia and pharmaceutical industry which will provide opportunities for collaboration, career progression and development of strategies for addressing poverty-related diseases.

The project

Dr Walimba’s experience and expertise in early-phase clinical trials will be a vital contribution to the capacity of the Clinical Trials Unit at the Infectious Diseases Institute (IDI) of the Makerere University College of Health Sciences.

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

The EDCTP clinical R&D Fellowships support researchers and key members of clinical trial research teams from low- and middle-income countries for them to acquire specific skills in clinical research and development through placements in pharmaceutical companies, product development partnerships (PDPs) and research institutions. Dr Walimba aimed to acquire experience and expertise in early-phase clinical trials especially.

Dr Walimbwa was hosted for one year at the Novartis Institutes for Biomedical Research (NIBR) in Basel, Switzerland. Under the mentorship of NIBR scientists within translational medicine, he participated in clinical trials that provided early proof of efficacy in humans, and in clinical trials that profiled the safety, tolerability, pharmacokinetics and pharmacodynamics of novel compounds. Some of these novel compounds will be key in the management of autoimmune diseases, neglected tropical diseases, malaria and rare diseases.

The fellowship allowed Dr Walimbwa to receive training and acquire skills and expertise in the design, set-up, operationalisation and follow-up of phase I-IIa clinical trials. Furthermore, he was able to establish a network of contacts within Swiss academia and pharmaceutical industry which will provide opportunities for collaboration, career progression and development of strategies for addressing poverty-related diseases.

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.

Dr Walimba’s experience and expertise in early-phase clinical trials will be a vital contribution to the capacity of the Clinical Trials Unit at the Infectious Diseases Institute (IDI) of the Makerere University College of Health Sciences.

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