“
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

The challenge for many early-career researchers is to hone their skills and experience in clinical product R&D. The EDCTP clinical R&D fellowships allow fellows to do just that through a placement in a clinical research organisation. Dr Staples aimed especially to familiarise herself with all the requirements for phase III/IV clinical trials and other study designs such as pragmatic trials and real-world observational studies.

Dr Staples has a background in medicine and started to work as a research clinician in 2012; she completed a Master’s in Transdisciplinary Health and Development Studies from Stellenbosch University. Since 2012, she participated in several TB and HIV clinical trials. Working at THINK (TB and HIV Investigative Network, Durban, KwaZulu-Natal, South Africa) she was promoted to Principal investigator in 2013 and conducted multiple phase II and III trials, which were conducted in collaboration with sponsors such as TB Alliance, MRC UK, and pharmaceutical industry.

Her placement at Julius Clinical, the Netherlands immersed her in the operation of this scientific clinical research organisation. She was able to train on all aspects of phase III/IV clinical trials, from proposal writing to reporting and manuscript preparation, from design and protocol development, site selection and initiation, trial management (including GCP and data-management) to monitoring and pharmacovigilance. 

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.

Besides preparing her for the next step in her career as a researcher (developing her own research project and successfully apply for funding), the immediate impact at THINK, her home institution, will be an extensive training and role development programme for all staff in combination with revisiting and developing guidelines and standard operating procedures and reviewing the conditions and key requirements of quality service. She also envisages developing an African research network.

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