Europe-Africa Research Network for Evaluation of Second-line Therapy
Evaluating the options for second-line therapy in HIV positive patients failing a first-line treatment regimen in Africa
What was this study about?
A randomised controlled trial to evaluate options for second-line therapy in HIV patients failing a first-line 2NRTI + NNRTI regimen in Africa.
Following the massive rollout of ART in Africa, large numbers of people are receiving first-line ART and over the coming few years an increasing number will be developing treatment failure and requiring second-line therapy.
What difference did this study make?
The trial results provided the first randomised evidence to strongly support current WHO recommendations, which had been based on expert opinion extrapolating from trials in high-income countries. Ongoing analyses demonstrate that the excellent responses with NRTIs were achieved despite extensive cross-resistance, suggesting that our understanding of resistance mechanisms remains incomplete.
EARNEST findings have contributed to the design of the ODYSSEY trial in children and adolescents, and a planned future trial in adults utilising the long acting depot-injectable prodrug, cabotegravir, of the second generation strand-transfer integrase inhibitor, dolutegravir.
Type of study
Who funded the study?
European and Developing Countries Clinical Trials Partnership (EDCTP).
When did it take place?
The EARNEST trial recruited 1277 HIV positive individuals between April 2010 to April 2011. The trial participants were followed for 144 weeks (3 years) and the trial finished in the first quarter of 2014.
Where did it take place?
Joint Clinical Research Centre (JCRC), Kampala, Uganda | JCRC Fort Portal, Uganda | JCRC Mbarara, Uganda | JCRC Mbale, Uganda | The Infectious Diseases Institute, Kampala, Uganda | Nsambya Hospital, Kampala, Uganda | University of Zimbabwe Medical School Clinical Research Centre (UZCRC), Harare, Zimbabwe | Queen Elizabeth Central Hospital, Blantyre, Malawi | JCRC Gulu, Uganda | JCRC Kakira, Uganda | JCRC Kabale, Uganda | Mzuzu Central Hospital, Mzuzu, Malawi | Moi Teaching Referral Hospital (MTRH), Eldoret, Kenya | University Teaching Hospital (UTH), Lusaka, Zambia
Who was included?
HIV infected adults who have taken a first-line NNRTI-based regimen for at least 2 years and have developed treatment failure.