A randomised controlled trial to evaluate options for second-line therapy in patients failing a first-line 2 nucleoside reverse transcriptase inhibitors (2NRTI) and non-nucleoside reverse transcriptase inhibitor (NNRTI) regimen in Africa

Medical Research Council (MRC) (UK)0 sites1,200 target enrollmentSeptember 22, 2009

Overview

2014 Results article in http://www.ncbi.nlm.nih.gov/pubmed/25014688 results 2017 Results article in http://www.ncbi.nlm.nih.gov/pubmed/28495562 observational analysis results 2018 Results article in http://www.ncbi.nlm.nih.gov/pubmed/29108797 follow-up results 2023 Other publications in https://pubmed.ncbi.nlm.nih.gov/36723505/ Substudy results (added 02/02/2023)

Registry

who.int

Start Date

September 22, 2009

End Date

September 15, 2013

Last Updated

3 years ago

Study Type

Interventional

Sex

All

Sponsor

Medical Research Council (MRC) (UK)

•1\. Previously documented HIV infection on at least one standard antibody\-based test
•2\. Aged 12 years and above, either sex
•3\. Taking 2NRTI \+ NNRTI\-based regimen continuously for at least 12 months
•4\. Naive to protease inhibitor therapy
•5\. Good adherence to anti\-retroviral therapy (ART) in the 12 weeks prior to screening defined as no more than 10% of doses missed (patients who do not have good adherence should be given adherence
•counselling and re\-assessed after an appropriate time interval of not less than 4 weeks)
•6\. Clinically stable and receiving treatment for any known opportunistic infections
•7\. HIV treatment failure defined by the one or more of the following clinical, immunological and virological criteria (modified from World Health Organization \[WHO] 2006 criteria):
•7\.1\. Clinical: A1 and A2 and A3 must be fulfilled:
•A1: New or recurrent WHO stage 4 condition occurring after at least 12 months on ART

•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 (Hepatitis B surface antigen positive)
•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\. Currently receiving chemotherapy for malignancy
•5\. Women who are currently pregnant or breastfeeding
•6\. Current participation in another clinical trial involving a treatment intervention (may be permitted in some circumstances, but must first be discussed with the EARNEST chief investigator)
•7\. Life expectancy of less than one month in the opinion of the treating physician