An African clinical trial with a worldwide impact reached an important milestone today, Friday 29th April. After only one year of recruitment, the Europe-Africa Research Network for Evaluation of Second-line Therapy (EARNEST) Trial has reached its ambitious target of enrolling 1200 HIV-positive individuals.
The EARNEST trial is the world’s largest trial investigating the best treatment options for individuals whose first combination of anti-HIV medicines is no longer working. The main aim of the trial is to find out whether in African HIV treatment programmes a new anti-HIV medicine called raltegravir (licensed for HIV treatment in Western countries) can be combined with a standard anti-HIV medicine called Aluvia (lopinavir/ritonavir) to benefit people who need to change their HIV treatment (i.e. switch to second-line therapy).
The 1200 EARNEST participants were enrolled at 14 sites in 5 African countries, namely Uganda, Zimbabwe, Malawi, Kenya and Zambia. The trial is conducted in partnership with the Institute of Tropical Medicine in Belgium, the Istituto Superiore di Sanita and CINECA in Italy, the Hospital La Paz in Spain, the University College Dublin in Ireland and the UK Medical Research Council who is also the Sponsor of the EARNEST trial. Funding has been provided by the European Union and the medicines for the trial have been donated free of charge by pharmaceutical companies including Merck and Abbott.
Now that trial recruitment has been completed and all EARNEST participants have been started on their second combination of anti-HIV medicines, the focus of EARNEST will be on collecting important information about the health of the participants as well as important information about their quality of life, social functioning and financial status. The trial will provide final results in early 2014. The findings of this African trial will inform future international HIV treatment guidelines such as those of the World Health Organisation, and are eagerly awaited around the world.
Aside from answering important medical questions and potentially changing the way that HIV-positive people are treated around the world, the EARNEST trial also provides important opportunities for training and networking in Africa. The EARNEST investigators have regular meetings (the last one in Entebbe, Uganda in December 2010) to exchange their experiences and discuss any issues, particularly those concerning second-line therapy. Experienced staff from Africa and Europe travel regularly to EARNEST trial sites to provide training and guidance, and several staff have been enrolled on PhD programmes or international courses in clinical trials.
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