Reduction of Early mortALITY in HIV-infected African adults and children starting antiretroviral therapy: a randomised controlled trial

Medical Research Council (UK)0 个研究点目标入组 1,805 人开始时间: 2011年10月18日最近更新: 2024年7月15日

适应症

试验速览

2017 Results article in https://www.ncbi.nlm.nih.gov/pubmed/28723333 2018 Results article in https://www.ncbi.nlm.nih.gov/pubmed/29653915 2018 Results article in https://www.ncbi.nlm.nih.gov/pubmed/30513108 2018 Results article in https://www.ncbi.nlm.nih.gov/pubmed/29514234 (added 01/10/2019) 2018 Results article in https://www.ncbi.nlm.nih.gov/pubmed/29514235 (added 01/10/2019) 2020 Other publications in https://pubmed.ncbi.nlm.nih.gov/33336080/ Calprotectin as a biomarker (added 21/12/2020) 2024 Other publications in https://pubmed.ncbi.nlm.nih.gov/38944653/ Biomarkers of mortality (added 01/07/2024)

•1. Aged 5 years or older (the lower age limit is because CD4 counts are less reliable predictors of immunodeficiency under 5 years: CD4 counts are recommended by WHO guidelines in older children)
•2. Documented HIV infection by HIV ELISA
•3. Naive to ART except for drugs given or received to prevent mother-to-child transmission
•4. CD4 T-cell count <100 cells/mm3 on blood test taken at screening for REALITY
•5. Results of screening haematology and biochemistry tests available
•6. Patient/carer provide informed consent (and children <18 years assent, as appropriate according to their age and knowledge of HIV status)

•1. Contraindications to any proposed antiretroviral drugs (including integrase inhibitors), isoniazid, fluconazole, albendazole or azithromycin
•2. Pregnant or breastfeeding or intending to become pregnant during the first 12 weeks of the study

发起方

Medical Research Council (UK)