Adjunctive Corticosteroids For Tuberculous Meningitis In HIV-Infected Adults (The ACT HIV Trial)


Clinical Trial Registration
Registration number: NCT03092817

April 2016 – March 2024

Principal Investigators
Professor Guy Thwaites
Associate Professor Raph Hamers

ACT HIV is a parallel-group, randomised (1:1), double-blind, placebo-controlled multi-centre Phase III trial comparing dexamethasone versus placebo for 6–8 weeks in addition to standard anti-tuberculosis and antiretroviral treatment.


Tuberculous meningitis (TBM) is the most severe form of tuberculosis. Co-infection with HIV increases the risk of developing TBM, complicates treatment, and substantially worsens outcomes. Whether corticosteroids confer a survival benefit in HIV-infected patients with TBM remains uncertain.


Our primary aim is to determine whether dexamethasone is a safe and effective addition to the first 6–8 weeks of anti-tuberculosis treatment of TBM in patients with HIV in terms of:

  • Improving survival;
  • Lengthening the time to new neurological events, IRIS, drug-related adverse events, opportunistic infections, and disability;
  • Longer-term neurological outcomes;
  • Reducing HIV-associated malignancy.

Our secondary aim is to investigate alternative management strategies in a subset of patients who develop drug-induced liver injury (DILI), which will enable the safe continuation of rifampicin and isoniazid therapy whenever possible.


Joseph Donovan, Trinh Dong Huu Khanh, Guy E Thwaites, Ronald B Geskus, ACT HIV investigators
Wellcome Open Res
July 7, 2022
DOI: 10.12688/wellcomeopenres.17154.2
Fiona V Cresswell, Angharad G Davis, Kusum Sharma, Robindra Basu Roy, Ahmad Rizal Ganiem, Enock Kagimu, Regan Solomons, Robert J Wilkinson, Nathan C Bahr, Nguyen Thuy Thuong Thuong, Tuberculous Meningitis International Research Consortium
Wellcome Open Res
January 28, 2021
DOI: 10.12688/wellcomeopenres.15506.3


Joseph Donovan

Dr Joseph Donovan

Erlina Burhan

Erlina Burhan

HTD-updated logo

Hospital For Tropical Diseases


Pham Ngoc Thach Hospital

RSCM Hospital Universitas Indonesia

RSCM Hospital Universitas Indonesia

RSUP Persahabatan Hospital

RSUP Persahabatan Hospital

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