“
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

With an estimated population of more than 200 million, Nigeria is the most populous country in Africa. Infectious diseases account for a high proportion of deaths in Nigeria, and in recent years the country has been affected by multiple infectious disease outbreaks, including Lassa fever, yellow fever and meningitis.

To address these challenges, clinical research is essential, and bodies such as the Nigeria Centre for Disease Control are driving forward public health research in the country.

The DREIN project aims to strengthen the environment for clinical research in Nigeria, working in close collaboration with the Federal Ministry of Health of Nigeria and key bodies involved in regulation of clinical research and ethics review of research proposals.

The project incorporates the Nigerian National Health Research Ethics Committee (NHREC), the Nigerian National Food and Drugs Administration and Control (NAFDAC), which jointly regulates clinical trials and manages the Nigerian Clinical Trials Registry with NHREC, and the Center for Bioethics and Research, Ibadan. It is also drawing upon training tools developed by the Council on Health Research for Development (COHRED).

The DREIN project is focusing on short-, medium- and long-term training of administrative and technical staff of research ethics committees in Nigeria. This includes two-month diploma-level training in research ethics coordinated by the Center for Bioethics and Research, as well as master’s-level training for key NHREC and NAFDAC staff. Staff at seven high-volume research ethics committees are being trained to RHInnO Ethics, the electronic ethics review software developed by COHRED, and RHInnO Ethics software is being upgraded.

The project is also promoting networking through annual joint training and workshops for the national agencies, whose staff are also being provided with advanced training in research ethics. In addition, it is providing technical assistance to support updating of the Nigerian National Code for Health Research Ethics and for development of sub-codes for research in vulnerable populations.

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 DREIN project will make an important contribution to the strengthening of health research infrastructure in Nigeria as it seeks to address its key infectious disease challenges.

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