“
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.

The challenge

Sudan, the third largest country in Africa by area, has been affected by persistent insecurity in multiple areas, leading to extensive displacement of people and creating highly vulnerable populations. Despite some progress, infectious diseases still account for 30% of deaths in Sudan. In addition, levels of antimicrobial resistance are alarmingly high.

Despite these security challenges and political instability, some health research is conducted in Sudan. The Enhancing Ethics in Sudan project aims to contribute to stronger health research infrastructure by developing national and institutional capacities for ethical review of research. The project focuses on the two main regulatory and ethics authorities in the country, the National Health Research Ethics Committee and the National Medicine Board, as well as Sudan’s research ethics committees.

The first part of the project involved the review of the national guidelines that govern research on human participants, which were published by the Federal Ministry of Health in 2007. Through the work of 13 experts in research ethics, updated guidelines were developed, approved by the Federal Ministry of Health, and distributed to all research ethics committees in Sudan.

The project also worked with National Health Research Ethics Committee and the National Medicine Board to clarify their respective roles and responsibilities, including standard operating procedures (SOPs) for each. A template has also been developed to enable state and institutional research ethics committee to establish their own SOPs. A two-day workshop and discussion event was organised for members of the two bodies.

The project has also mapped institutional research ethics committees in Sudan, which identified nine functional committees. The project supported the training of 116 research ethics committee members from 16 institutes across five states, through a four-day workshop and three-week online course. Members of the project team have also assisted the Federal Ministry of Health in its review and strengthening of the National Health Research Ethics Committee, in the dissemination of updated guidelines, and strengthening of the accreditation system for research ethics committees.

The project has also helped to establish a national network – the Sudanese Network of Research Ethics Committees  – linking national regulatory authorities and research ethics committees. This network will help to harmonise and standardise processes and provide a forum for discussion of ethical issues and challenges.

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 project has strengthened national and institutional capacities for ethical review of research, ensuring stronger protection of the interests of human participants in clinical studies. Indirectly, the project also stimulated the Federal Ministry of Health to remind state Ministries of Health of their responsibility to establish state-level research ethics committees. Creation of such committees will further protect the interests of highly vulnerable populations.

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