A statistical analysis plan for the Adjunctive Corticosteroids for Tuberculous meningitis in HIV-positive adults (ACT HIV) clinical trial.
Joseph DonovanTrinh Dong Huu KhanhGuy E ThwaitesRonald Bertus Geskusnull nullPublished in: Wellcome open research (2021)
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.
Keyphrases
- hiv positive
- clinical trial
- study protocol
- double blind
- antiretroviral therapy
- men who have sex with men
- south africa
- hiv testing
- phase ii
- placebo controlled
- phase iii
- open label
- hiv infected
- human immunodeficiency virus
- hiv aids
- randomized controlled trial
- clinical practice
- hepatitis c virus
- low dose
- high dose
- electronic health record
- machine learning
- combination therapy
- big data
- early onset
- drug induced
- artificial intelligence