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BackgroundAdjunctive glucocorticoids are widely used to treat human immunodeficiency virus (HIV)-associated tuberculous meningitis despite limited data supporting their safety and efficacy.MethodsWe conducted a double-blind, randomized, placebo-controlled trial involving HIV-positive adults (≥18 years of age) with tuberculous meningitis in Vietnam and Indonesia. Participants were randomly assigned to receive a 6-to-8-week tapering course of either dexamethasone or placebo in addition to 12 months of antituberculosis chemotherapy. The primary end point was death from any cause during the 12 months after randomization.ResultsA total of 520 adults were randomly assigned to receive either dexamethasone (263 participants) or placebo (257 participants). The median age was 36 years; 255 of 520 participants (49.0%) had never received antiretroviral therapy, and 251 of 484 participants (51.9%) with available data had a baseline CD4 count of 50 cells per cubic millimeter or less. Six participants withdrew from the trial, and five were lost to follow-up. During the 12 months of follow-up, death occurred in 116 of 263 participants (44.1%) in the dexamethasone group and in 126 of 257 participants (49.0%) in the placebo group (hazard ratio, 0.85; 95% confidence interval, 0.66 to 1.10; P = 0.22). Prespecified analyses did not reveal a subgroup that clearly benefited from dexamethasone. The incidence of secondary end-point events, including cases of immune reconstitution inflammatory syndrome during the first 6 months, was similar in the two trial groups. The numbers of participants with at least one serious adverse event were similar in the dexamethasone group (192 of 263 participants [73.0%]) and the placebo group (194 of 257 participants [75.5%]) (P = 0.52).ConclusionsAmong HIV-positive adults with tuberculous meningitis, adjunctive dexamethasone, as compared with placebo, did not confer a benefit with respect to survival or any secondary end point. (Funded by the Wellcome Trust; ACT HIV number, NCT03092817.).

Original publication





The New England journal of medicine

Publication Date





1357 - 1367


From the Oxford University Clinical Research Unit (J.D., D.T.T.H., N.T.T.H., L.H.B.N., D.V.T., N.T.T., D.D.A.T., N.T.M.N., R.B.G., N.T.T.T., E.K., N.H.P., G.E.T.), Pham Ngoc Thach Hospital for Tuberculosis and Lung Disease (N.D.B., L.T.D., D.C.G., D.T.M.H., N.H.L.), the Hospital for Tropical Diseases (H.D.T.N., N.T.T., N.H.H.H., P.K.N.O., N.V.V.C.), Pham Ngoc Thach University of Medicine (H.D.T.N.), and the School of Medicine, Vietnam National University of Ho Chi Minh City (N.H.H.H., N.H.P.) - all in Ho Chi Minh City, Vietnam; the Centre for Tropical Medicine and Global Health, Nuffield Department of Medicine, University of Oxford, Oxford (J.D., R.B.G., N.T.T.T., E.K., R.L.H., N.H.P., G.E.T.), and London School of Hygiene and Tropical Medicine, London (J.D.) - both in the United Kingdom; and Dr. Cipto Mangunkusumo National Reference Hospital (D.I., K.M., C.P.G., R.E., A.K.), Persahabatan National Respiratory Referral Hospital (E.B.), and Oxford University Clinical Research Unit Indonesia (A.L.S.W., R.L.H.), Faculty of Medicine, Universitas Indonesia, Jakarta, Indonesia.


ACT HIV Investigators