“South Africa is leading the world’s response to the HIV epidemic with major research projects in the prevention, treatment and care of people living with HIV/AIDS and TB leading to breakthroughs and new treatments,” said Head and Principal Investigator at the Clinical HIV Research Unit (CHRU), a division of the Wits Health Consortium at the University of Witwatersrand, Professor Ian Sanne.
While speaking on World Clinical Trials Day earlier this week, Prof Sanne said: “Over the last 25 years the research and treatment of HIV/AIDS has evolved rapidly, possibly more than in any other field of medicine, significantly reducing the mortality and morbidity of people living with AIDS. South Africa’s contribution to these advancements is significant. Successful clinical trials here have led to the registration of over 30 medicines for HIV, a 95% reduction in mortality and a major reduction in HIV transmission.”
“We have also seen research successes in SA to prevent TB and treat drug-resistant TB. Three TB medicines as well as a one-month drug regimen that prevents TB amongst household contacts and those at high-risk were recently registered in SA,” continued Prof Sanne.
Prof Sanne explained that research priorities to prevent HIV have seen clinical trials focus on the evaluation of pre-exposure prophylaxis, on voluntary male medical circumcision and on phase III HIV vaccine clinical trials.
“Research is conducted in phases, with the first steps ensuring safety and efficacy. The success of a phase III clinical trial leads to changes in the way that treatment or prevention is provided. SA has a leading reputation in completing phase III trials,” said Prof Sanne.
Prof Sanne added that South Africa has internationally-acclaimed academic and research institutions, an efficient national laboratory infrastructure and a strong regulatory environment. “This ensures that our clinical trials adhere to international best practice in terms of ethics and good clinical research practice. It also positions SA at the centre of research efforts into infectious diseases and finding solutions to the world’s public health priorities of HIV/AIDS, TB and malaria.”
“The measurement of successful research is the impact on the disease. SA’s track record here is internationally regarded with many trials resulting in cures and reductions in the disease burden,” said Prof Sanne.
For every trial conducted by CHRU, the research is reviewed by the South African Health Products Regulatory Authority (SAHPRA), while the National Department of Health (NDoH) also has independent review processes. Standards also ensure that only competent investigators and research teams conduct clinical trials, while participation is dependent on informed consent by participants.
All major clinical trials are also monitored by an independent data safety monitoring board to ensure the ethical conduct of the study and to measure positive and negative outcomes as early as possible.
CHRU’s current research prioritises the development of an HIV vaccine, the treatment of HIV in adults and children and to improve prevention, for example through microbicides, circumcision or injectable long-acting antiretroviral therapy (ART).
“Costs of clinical research are dependent on grant applications that we make to major funding institutions which include the Medical Research Council, the National Institute for Health (NIH), USAID, the Gates Foundation and the EDCTP. Partnerships with the biotech and medical industries are also vital to access the patented medicines used in research,” said Prof Sanne.
“The safety of participants and quality of research are paramount and SA has established an excellent reputation amongst international networks such as the NIH’s AIDS Clinical Trials Group (ACTG) Network, of which CHRU is highest performing and enrolling site,” continued Prof anne
CHRU has an active Community Advisory Board which promotes community engagement, participant recruitment and educates community members about health promotion and clinical trials.