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

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Bringing antiretroviral drugs to children

The CHAPAS trials have ensured that many more children with HIV have benefited
from life-saving antiretrovirals.

The challenge

Southern Africa has some of the world’s highest burdens of poverty-related infectious diseases, particularly HIV/AIDS and TB. Co-infections are common and drug resistance is a growing threat.

On the other hand, the sub-region has a number of internationally recognised research centres, and generates a significant proportion of sub-Saharan Africa’s research outputs. These centres of excellence provide opportunities to act as foci to build capacity in less well-developed institutions.

TESA was established in 2009 with EDCTP funding, initially with nine institutions from six countries. Its key aim was to develop and promote collaborations to support capacity building and training in participating institutions. During phase I funding, more than 80 students and clinical research staff received short-term training, 30 courses were organised, and 11 master’s, eight PhD and one postdoctoral fellowship were awarded. 

In addition, multiple laboratory sites were upgraded, baseline epidemiological studies carried out and consistent standard operating procedures were introduced.

In follow-up TESA II funding, the network has expanded to include 15 institutions from eight Southern African countries, one East African country and four European countries. Four institutions have been selected to act as reference centres, one for each specific disease area (HIV/AIDS, TB and malaria) while one institution acts as the reference data management centre. Reference laboratories have been established for each of the disease areas. The reference centres provide support to other sites in the network, as well as conducting training and capacity development in their respective areas.

Short-term training and exchange visits are being organised for researchers and research support staff. Events are also being organised to strengthen relationships with policymakers and support greater evidence-informed decision-making.

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.

TESA II is drawing on existing centres of excellence in Southern Africa, links to European institutions, and ongoing clinical studies to build clinical research capacities in less well-developed research centres. It is also strengthening collaborations with other networks with similar aims and with policymakers to coordinate activities and achieve greater impact.

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