EARNEST: Europe-Africa Research Network for Evaluation of Second-line Therapy
Evaluating the options for second-line therapy in patients failing a first-line treatment regimen in Africa
What is this study about?
A randomised controlled trial to evaluate options for second-line therapy in 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.
Who is included?
HIV infected adults who have taken a first-line NNRTI-based regimen for at least 2 years and have developed treatment failure.
When is it taking place?
The EARNEST trial recruited 1277 HIV positive individuals between April 2010 to April 2011. The trial participants will be followed for 144 weeks (3 years) and the trial is hence expected to finish in the first quarter of 2014.
Where is it taking 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 is funding the study?
European and Developing Countries Clinical Trials Partnership (EDCTP).
|Type of study:||Randomised trial|
|Status:||Closed to recruitment; in follow-up|
|Study start date:||12 April 2010|
|Study end date:||February 2014|
|Randomisation target:||1200 patients|
|Randomisations achieved:||1277 patients, as of 30 April 2011|
|Also included in this study:||Health Economics|
Quality of life outcomes
|Chief investigator:||Nick Paton|
|Inclusion criteria:||1. Previously documented HIV infection on at least one standard antibody-based test|
2. Age 12 years and above
3. Taking 2NRTI + NNRTI-based regimen continuously for at least 12 months
4. Naïve to protease inhibitor therapy
5. Good adherence to ART
6. HIV treatment failure
|Exclusion criteria:||1. Any major clinical contraindications to the use of bPI, the NRTIs that are available to be selected for a second-line regimen, or raltegravir|
2. Known Hepatitis B carrier
3. Requirement for concomitant medication with known major interactions with study drugs for which drug substitutions or dose alterations are not available or acceptable
4. Women who are currently pregnant or breastfeeding
5. Current participation in another clinical trial or research protocol
6. Life expectancy of less than one month in the opinion of the treating physician
|Intervention and control groups:||Arm A: bPI + 2 NRTIs |
Arm B: bPI + raltegravir
Arm C: bPI alone
|Method of randomisation:||Patients will be randomised using a computer-generated algorithm based on random permuted blocks and randomisation will be stratified by site and screening CD4 cell count.|
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