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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

In recent years, Uganda has significantly strengthened its regulatory and ethics review capacity for clinical research. Regulation of clinical research is the responsibility of the Uganda National Council for Science and Technology (UNCST), which accredits the country’s institutional research ethics committees.

However, Uganda also has other important regulatory and ethical review structures, such as the National Drug Authority. Developing submissions for different bodies can be time-consuming and costly, and may deter sponsors of multicentre clinical studies; researchers may also be unsure which regulatory agencies they need to approach. In addition, it has been challenging for different agencies to share information about complex trials, leading to fragmentation and sometimes duplication of efforts. 

In the EDCTP-funded CREDU project, an international consortium developed and piloted a new clinical research information management system, known as CRIMS. In the follow-up SCRECU project, CRIMS is being rolled out across a wider range of stakeholders, including the 23 institutional research ethics committees in Uganda.

The CRIMS system provides a common platform supporting the submission, review and approval of clinical research protocols. The project is working with Uganda’s institutional research ethics committees to ensure they have the technical infrastructure and skills to implement CRIMS. This will help to ensure a consistency of approach across different agencies and ethics committees, as well as the sharing of information.

The project also includes a nested evaluation of CRIMS in different settings, to support further enhancements to the system in light of user experience.

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 SCRECU project will support the scaling up of an online ethics review system across additional stakeholders in Uganda, helping to raise and harmonise standards across institutional research ethics committees and providing a more efficient mechanism for researchers preparing submissions. It will be better prepare the country to manage increased numbers of clinical trial applications of increasing complexity, thereby consolidating Uganda’s position as an attractive location for clinical studies and trials.

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