dc.contributor.author | Post, FA | |
dc.contributor.author | Szubert, AJ | |
dc.contributor.author | Prendergast, AJ | |
dc.contributor.author | Johnston, V | |
dc.contributor.author | Lyall, H | |
dc.contributor.author | Fitzgerald, F | |
dc.contributor.author | Musiime, V | |
dc.contributor.author | Musoro, G | |
dc.contributor.author | Chepkorir, P | |
dc.contributor.author | Agutu, C | |
dc.contributor.author | Mallewa, J | |
dc.contributor.author | Rajapakse, C | |
dc.contributor.author | Wilkes, H | |
dc.contributor.author | Hakim, J | |
dc.contributor.author | Mugyenyi, P | |
dc.contributor.author | Walker, AS | |
dc.contributor.author | Gibb, DM | |
dc.contributor.author | Pett, SL | |
dc.contributor.author | Reduction of EArly mortaLITY in HIV-infected adults and children starting antiretroviral therapy (REALITY) Trial Team | |
dc.date.accessioned | 2019-03-19T14:58:43Z | |
dc.date.available | 2019-03-19T14:58:43Z | |
dc.date.issued | 2018-03-04 | |
dc.identifier.citation | Frank A Post, Alexander J Szubert, Andrew J Prendergast, Victoria Johnston, Hermione Lyall, Felicity Fitzgerald, Victor Musiime, Godfrey Musoro, Priscilla Chepkorir, Clara Agutu, Jane Mallewa, Chathurika Rajapakse, Helen Wilkes, James Hakim, Peter Mugyenyi, A Sarah Walker, Diana M Gibb, Sarah L Pett, Reduction of EArly mortaLITY in HIV-infected adults and children starting antiretroviral therapy (REALITY) Trial Team; Causes and Timing of Mortality and Morbidity Among Late Presenters Starting Antiretroviral Therapy in the REALITY Trial, Clinical Infectious Diseases, Volume 66, Issue suppl_2, 4 March 2018, Pages S132–S139, https://doi.org/10.1093/cid/cix1141 | en_US |
dc.identifier.uri | https://qmro.qmul.ac.uk/xmlui/handle/123456789/56348 | |
dc.description.abstract | Background: In sub-Saharan Africa, 20%-25% of people starting antiretroviral therapy (ART) have severe immunosuppression; approximately 10% die within 3 months. In the Reduction of EArly mortaLITY (REALITY) randomized trial, a broad enhanced anti-infection prophylaxis bundle reduced mortality vs cotrimoxazole. We investigate the contribution and timing of different causes of mortality/morbidity. Methods: Participants started ART with a CD4 count <100 cells/µL; enhanced prophylaxis comprised cotrimoxazole plus 12 weeks of isoniazid + fluconazole, single-dose albendazole, and 5 days of azithromycin. A blinded committee adjudicated events and causes of death as (non-mutually exclusively) tuberculosis, cryptococcosis, severe bacterial infection (SBI), other potentially azithromycin-responsive infections, other events, and unknown. Results: Median pre-ART CD4 count was 37 cells/µL. Among 1805 participants, 225 (12.7%) died by week 48. Fatal/nonfatal events occurred early (median 4 weeks); rates then declined exponentially. One hundred fifty-four deaths had single and 71 had multiple causes, including tuberculosis in 4.5% participants, cryptococcosis in 1.1%, SBI in 1.9%, other potentially azithromycin-responsive infections in 1.3%, other events in 3.6%, and unknown in 5.0%. Enhanced prophylaxis reduced deaths from cryptococcosis and unknown causes (P < .05) but not tuberculosis, SBI, potentially azithromycin-responsive infections, or other causes (P > .3); and reduced nonfatal/fatal tuberculosis and cryptococcosis (P < .05), but not SBI, other potentially azithromycin-responsive infections, or other events (P > .2). Conclusions: Enhanced prophylaxis reduced mortality from cryptococcosis and unknown causes and nonfatal tuberculosis and cryptococcosis. High early incidence of fatal/nonfatal events highlights the need for starting enhanced-prophylaxis with ART in advanced disease. Clinical Trials Registration: ISRCTN43622374. | en_US |
dc.description.sponsorship | Joint Global Health Trials Scheme of the UK Department for International Development, the Wellcome Trust and Medical Research Council (MRC) (grant number G1100693) | en_US |
dc.description.sponsorship | PENTA Foundation | en_US |
dc.description.sponsorship | port was provided by the PENTA Foundation and core support to the MRC Clinical Trials Unit at University College London (UCL) (grant numbers MC_ UU_12023/23 and MC_UU_12023/26). | en_US |
dc.description.sponsorship | World Health Organization | en_US |
dc.format.extent | S132 - S139 | |
dc.language | eng | |
dc.language.iso | en | en_US |
dc.publisher | Oxford University Press (OUP) | en_US |
dc.relation.ispartof | Clinical Infectious Diseases | |
dc.rights | This is an open access article distributed under the terms of the Creative Commons Attribution IGO License (http://creativecommons. org/licenses/by/3.0/igo/legalcode), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. In any reproduction of this article there should not be any suggestion that WHO or this article endorse any specific organisation or products. The use of the WHO logo is not permitted. This notice should be preserved along with the article’s original URL. | |
dc.title | Causes and Timing of Mortality and Morbidity Among Late Presenters Starting Antiretroviral Therapy in the REALITY Trial. | en_US |
dc.type | Article | en_US |
dc.rights.holder | © 2018 World Health Organization; licensee Oxford University Press USA | |
dc.identifier.doi | 10.1093/cid/cix1141 | |
pubs.author-url | https://www.ncbi.nlm.nih.gov/pubmed/29514234 | en_US |
pubs.issue | suppl_2 | en_US |
pubs.notes | No embargo | en_US |
pubs.publication-status | Published | en_US |
pubs.volume | 66 | en_US |
rioxxterms.funder | Default funder | en_US |
rioxxterms.identifier.project | Default project | en_US |
qmul.funder | The impact of cotrimoxazole on healthly birth and growth in rural Zimbabwe::Wellcome Trust | en_US |