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.


Julie Huynh, Nhat Hoang Thanh Le, Bao Hoai Le Nguyen, Hai Thanh Hoang, Thu Anh Dang Do, Tram Thi Bich Trinh, Dung Thi Mong Vu, Vinh Dinh Do, Ngoc My Nghiem, Joseph Donovan, Phu Hoan Nguyen, Thanh Van Dang, Thu Thi Anh Nguyen, Bang Duc Nguyen, Ha Minh Thi Dang, Nghia Trung Dang Ho, Tan Van Le, Van Hong Le, Guy Thwaites, Nguyen Thuy Thuong Thuong
J Infect Dis
January 3, 2024
DOI: 10.1093/infdis/jiad606
Joseph Donovan, Nguyen D Bang, Darma Imran, Ho D T Nghia, Erlina Burhan, Dau T T Huong, Nguyen T T Hiep, Lam H B Ngoc, Dang V Thanh, Nguyen T Thanh, Anna L S Wardhani, Kartika Maharani, Cakra P Gasmara, Nguyen H H Hanh, Pham K N Oanh, Riwanti Estiasari, Do D A Thu, Ardiana Kusumaningrum, Le T Dung, Do C Giang, Dang T M Ha, Nguyen H Lan, Nguyen V V Chau, Nguyen T M Nguyet, Ronald B Geskus, Nguyen T T Thuong, Evelyne Kestelyn, Raph L Hamers, Nguyen H Phu, Guy E Thwaites; ACT HIV Investigators
N Engl J Med
October 12, 2023
DOI: 10.1056/NEJMoa2216218
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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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