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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

Although clinical research is growing in sub-Saharan Africa, French-speaking countries lag behind in the hosting of clinical studies, including clinical trials, and typically have less well-developed systems for ethics review of research proposals.

The Council on Health Research for Development (COHRED) has developed an electronic platform, known as RHInnO Ethics (https://rhinno.net), which is specifically designed for management and ethics review of research proposals. RHInnO Ethics is used by several countries in the region, but countries require support to introduce the system and to gain benefits from it.   

The ERUDIT project aims to ensure that the key bodies in Togo responsible for ethics review of clinical research – the national bioethics committee (Comité de Bioethique pour la Recherche en Santé, CBRS) – and drug safety monitoring (Direction de la Pharmacie, du Medicament et des Laboratoires, DPML) are equipped with the technological tools and skills to operate a high-quality ethics review and regulatory system.

It is bringing together multiple national and international partners to introduce the RHInnO Ethics platform into Togo, and to train key CBRS and DPML staff in its use. To enhance associated working practices, the project is also helping to develop and implement standard operating procedures for operation of the CBRS.

COHRED is coordinating implementation plans for RHInnO Ethics, while project partner TCD eClinical Solutions is supporting its technical installation and support, PharmaEthics is overseeing development of standard operating procedures, and Pharmalys is providing French-language support across the full range of clinical research review, auditing and inspection functions. Implementation of RHInnO Ethics will also provide the CBRS and DPML with access to the many resources developed for the system.

The project will also support development of websites for the two organisations, introduction of electronic document management systems, and for drafting of a code covering the ethics of human participation in research, which is currently not part of the Code de Santé Publique in Togo.

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 ERUDIT project will provide Togo’s key ethics review and pharmacovigilance bodies with access to well-established technical infrastructure for managing clinical research applications, as well as support for its introduction and to enhance associated working practices. It will therefore help to develop sustainable and robust national capacity for efficient and high-quality ethical review.

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