A statistical analysis plan for the Adjunctive Corticosteroids for Tuberculous meningitis in HIV-positive adults (ACT HIV) clinical trial [version 1; peer review: 2 approved]

TBM is the most severe form of tuberculosis. Clinical trial data are required to provide an evidence base for adjunctive dexamethasone in HIV-positive individuals with TBM, and to guide clinical practice. This document details the planned analyses at 12 months post randomisation for the ACT HIV clin...

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Autores principales:	Joseph Donovan, Trinh Dong Huu Khanh, Guy E. Thwaites, Ronald B. Geskus, ACT HIV investigators
Formato:	article
Lenguaje:	EN
Publicado:	Wellcome 2021
Materias:	Medicine R Science Q
Acceso en línea:	https://doaj.org/article/5e2ecc06a5a8473cba32bb3e6a9aa60a
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spelling	oai:doaj.org-article:5e2ecc06a5a8473cba32bb3e6a9aa60a2021-11-08T10:54:12ZA statistical analysis plan for the Adjunctive Corticosteroids for Tuberculous meningitis in HIV-positive adults (ACT HIV) clinical trial [version 1; peer review: 2 approved]2398-502X10.12688/wellcomeopenres.17154.1https://doaj.org/article/5e2ecc06a5a8473cba32bb3e6a9aa60a2021-10-01T00:00:00Zhttps://wellcomeopenresearch.org/articles/6-280/v1https://doaj.org/toc/2398-502XTBM is the most severe form of tuberculosis. Clinical trial data are required to provide an evidence base for adjunctive dexamethasone in HIV-positive individuals with TBM, and to guide clinical practice. This document details the planned analyses at 12 months post randomisation for the ACT HIV clinical trial (NCT03092817); ‘a randomised double-blind placebo-controlled trial of adjunctive dexamethasone for the treatment of HIV co-infected adults with tuberculous meningitis (TBM)’. The primary endpoint of the ACT HIV trial is death (from any cause) over the first 12 months after randomisation. This statistical analysis plan expands upon and updates the analysis plan outlined in the published study protocol.Joseph DonovanTrinh Dong Huu KhanhGuy E. ThwaitesRonald B. GeskusACT HIV investigatorsWellcomearticleMedicineRScienceQENWellcome Open Research, Vol 6 (2021)
institution	DOAJ
collection	DOAJ
language	EN
topic	Medicine R Science Q
spellingShingle	Medicine R Science Q Joseph Donovan Trinh Dong Huu Khanh Guy E. Thwaites Ronald B. Geskus ACT HIV investigators A statistical analysis plan for the Adjunctive Corticosteroids for Tuberculous meningitis in HIV-positive adults (ACT HIV) clinical trial [version 1; peer review: 2 approved]
description	TBM is the most severe form of tuberculosis. Clinical trial data are required to provide an evidence base for adjunctive dexamethasone in HIV-positive individuals with TBM, and to guide clinical practice. This document details the planned analyses at 12 months post randomisation for the ACT HIV clinical trial (NCT03092817); ‘a randomised double-blind placebo-controlled trial of adjunctive dexamethasone for the treatment of HIV co-infected adults with tuberculous meningitis (TBM)’. The primary endpoint of the ACT HIV trial is death (from any cause) over the first 12 months after randomisation. This statistical analysis plan expands upon and updates the analysis plan outlined in the published study protocol.
format	article
author	Joseph Donovan Trinh Dong Huu Khanh Guy E. Thwaites Ronald B. Geskus ACT HIV investigators
author_facet	Joseph Donovan Trinh Dong Huu Khanh Guy E. Thwaites Ronald B. Geskus ACT HIV investigators
author_sort	Joseph Donovan
title	A statistical analysis plan for the Adjunctive Corticosteroids for Tuberculous meningitis in HIV-positive adults (ACT HIV) clinical trial [version 1; peer review: 2 approved]
title_short	A statistical analysis plan for the Adjunctive Corticosteroids for Tuberculous meningitis in HIV-positive adults (ACT HIV) clinical trial [version 1; peer review: 2 approved]
title_full	A statistical analysis plan for the Adjunctive Corticosteroids for Tuberculous meningitis in HIV-positive adults (ACT HIV) clinical trial [version 1; peer review: 2 approved]
title_fullStr	A statistical analysis plan for the Adjunctive Corticosteroids for Tuberculous meningitis in HIV-positive adults (ACT HIV) clinical trial [version 1; peer review: 2 approved]
title_full_unstemmed	A statistical analysis plan for the Adjunctive Corticosteroids for Tuberculous meningitis in HIV-positive adults (ACT HIV) clinical trial [version 1; peer review: 2 approved]
title_sort	statistical analysis plan for the adjunctive corticosteroids for tuberculous meningitis in hiv-positive adults (act hiv) clinical trial [version 1; peer review: 2 approved]
publisher	Wellcome
publishDate	2021
url	https://doaj.org/article/5e2ecc06a5a8473cba32bb3e6a9aa60a
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A statistical analysis plan for the Adjunctive Corticosteroids for Tuberculous meningitis in HIV-positive adults (ACT HIV) clinical trial [version 1; peer review: 2 approved]

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