A statistical analysis plan for the Adjunctive Corticosteroids for Tuberculous meningitis in HIV-positive adults (ACT HIV) clinical trial.

Joseph Donovan,Trinh Dong Huu Khanh,Ronald B Geskus,Guy E Thwaites

doi:10.12688/wellcomeopenres.17154.1

Abstract

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.

Highlights

Background and rationale for study TheACT HIV clinical trial is a randomised double-blind placebo-controlled trial of adjunctive dexamethasone for the treatment of tuberculous meningitis (TBM) in HIV-positive adults
TBM is the most severe form of tuberculosis, with mortality approaching 50% in people living with HIV2–5 despite the best available appropriate anti-TB chemotherapy
Study participants were randomised to dexamethasone or placebo, with this intervention termed ‘study drug’

Summary

19 Oct 2021 report report

Keywords Tuberculous meningitis, human immunodeficiency virus, corticosteroids, clinical trial, analysis plan. Scope of document 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)’. Background and rationale for study The ACT HIV clinical trial is a randomised double-blind placebo-controlled trial of adjunctive dexamethasone for the treatment of tuberculous meningitis (TBM) in HIV-positive adults. TBM develops when Mycobacterium tuberculosis, initially acquired via the respiratory route, disseminates via the blood to form a secondary focus in the brain Rupture of this secondary focus into the subarachnoid space results in TBM, with the consequent host inflammatory response being important for bacterial killing, and responsible for the pathological complications and often-fatal consequences of the infection.

Any serious adverse events reported by 12 months from randomisation

Summary Summary statistic statistic n

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Findings

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