Adjunctive Corticosteroids for Tuberculous Meningitis in HIV-infected Adults (The ACT HIV Trial)
Status:
Active, not recruiting
Trial end date:
2022-05-01
Target enrollment:
Participant gender:
Summary
The investigators will conduct a randomized, double blind, placebo controlled trial of
adjunctive dexamethasone in the initial (6-8 weeks) treatment of tuberculous meningitis in
Vietnamese adults. The trial will address a primary hypothesis in all enrolled patients, and
a secondary hypothesis in a sub-group of enrolled patients who develop anti-tuberculosis
drug-induced liver injury (DILI). The primary hypothesis is adjunctive dexamethasone
increases survival from TBM in HIV co-infected adults. The secondary hypothesis is current
guidelines for the management of anti-tuberculosis drug-induced liver injury in those with
TBM result in the premature interruption of rifampicin and isoniazid (the critical active
drugs in early therapy) and are thereby placing participants at risk of poor outcomes.
Phase:
Phase 3
Details
Lead Sponsor:
Oxford University Clinical Research Unit, Vietnam
Collaborators:
Cipto Mangunkusumo Hospital, Jakarta, Indonesia Eijkman Oxford Clinical Research Unit, Indonesia Hospital for Tropical Diseases, Ho Chi Minh City, Vietnam Pham Ngoc Thach Hospital, Ho Chi Minh City, Vietnam RSUP Persahabatan Hospital, Jakarta, Indonesia