Evidence map›Paper›PMID 21596680›Full record

Trial reportClinical infectious diseases : an official publication of the Infectious Diseases Society of America2011

Timing of initiation of antiretroviral therapy in human immunodeficiency virus (HIV)--associated tuberculous meningitis.

M Estee Török, Nguyen Thi Bich Yen, Tran Thi Hong Chau, Nguyen Thi Hoang Mai, Nguyen Hoan Phu, Pham Phuong Mai, Nguyen Thi Dung, Nguyen Van Vinh Chau, Nguyen Duc Bang, Nguyen Anh Tien and 17 more

2 registry-linked trialsOpen access · bronzeAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Clinical infectious diseases : an official publication of the Infectious Diseases Society of America, 2011. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 142 papers, 10 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
142citing papers in PubMed, 10 pooled it
31.5field-weighted citation impact, top 1% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT03092817 phase3completednot on this mapstarted 2017, after this paper: background citation

A Randomized Double Blind Placebo Controlled Trial of Adjunctive Dexamethasone for the Treatment of HIV-infected Adults With Tuberculous Meningitis

TypeinterventionalSponsorOxford University Clinical Research Unit, VietnamRan2017 to 2023Enrolled520ConditionsTuberculosis, Tuberculous Meningitis, Drug-Induced Liver Injury, HIVArmsDexamethasone, Placebo
NCT03100786 phase3completednot on this mapstarted 2018, after this paper: background citation

A Randomized Double Blind Placebo Controlled Non-inferiority Trial of Adjunctive Dexamethasone for the Treatment of HIV-uninfected Adults With Tuberculous Meningitis Stratified by Leukotriene A4 Hydrolase Genotype

TypeinterventionalSponsorOxford University Clinical Research Unit, VietnamRan2018 to 2024Enrolled702ConditionsTuberculosis, Tuberculous Meningitis, Drug-Induced Liver InjuryArmsDexamethasone, Placebo
3 · Its place in the literature

Who cites it

142 citing papers in PubMed, 10 syntheses or guidelines pooled it, 312 citations in OpenAlex.

  1. A clinical practice guideline for tuberculous meningitis.The Lancet. Infectious diseases · 2026
    Guideline
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  4. Treatment of Drug-Resistant Tuberculosis. An Official ATS/CDC/ERS/IDSA Clinical Practice Guideline.American journal of respiratory and critical care medicine · 2019
    Guideline
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  14. Challenges in conducting trials for pediatric tuberculous meningitis: lessons from the field.The international journal of tuberculosis and lung disease : the official journal of the International Union against Tuberculosis and Lung Disease · 2019
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  18. Clinical Outcomes of Patients With Drug-Resistant Tuberculous Meningitis Treated With an Intensified Antituberculosis Regimen.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2017
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82 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

27 authors at 4 institutions in 3 countries.

M Estee TörökDepartment of Infectious Diseases, Cambridge University Hospitals National Health Service Foundation Trust, Cambridge, United Kingdom. estee.torok@addenbrookes.nhs.uk
Nguyen Thi Bich Yen
Tran Thi Hong Chau
Nguyen Thi Hoang Mai
Nguyen Hoan Phu
Pham Phuong Mai
Nguyen Thi Dung
Nguyen Van Vinh Chau
Nguyen Duc Bang
Nguyen Anh Tien
N H Minh
Nguyen Quang Hien
Phan Vuong Khac Thai
Doan The Dong
Do Thi Tuong Anh
Nguyen Thi Cam Thoa
Nguyen Ngoc Hai
Nguyen Ngoc Lan
Nguyen Thi Ngoc Lan
Hoang Thi Quy
Nguyen Huy Dung
Tran Tinh Hien
Nguyen Tran Chinh
Cameron Paul Simmons
Menno de Jong
Marcel Wolbers
Jeremy James Farrar
Hospital for Tropical Diseases · VNUniversity of Oxford · GBNational Health Service · GBOxford University Clinical Research Unit · VN

Funding

Wellcome Trust 084368
6 · The paper itself

Abstract

backgroundThe optimal time to initiate antiretroviral therapy (ART) in human immunodeficiency virus (HIV)-associated tuberculous meningitis is unknown.

methodsWe conducted a randomized, double-blind, placebo-controlled trial of immediate versus deferred ART in patients with HIV-associated tuberculous meningitis to determine whether immediate ART reduced the risk of death. Antiretroviral drugs (zidovudine, lamivudine, and efavirenz) were started either at study entry or 2 months after randomization. All patients were treated with standard antituberculosis treatment, adjunctive dexamethasone, and prophylactic co-trimoxazole and were followed up for 12 months. We conducted intention-to-treat, per-protocol, and prespecified subgroup analyses.

resultsA total of 253 patients were randomized, 127 in the immediate ART group and 126 in the deferred ART group; 76 and 70 patients died within 9 months in the immediate and deferred ART groups, respectively. Immediate ART was not significantly associated with 9-month mortality (hazard ratio [HR], 1.12; 95% confidence interval [CI], .81-1.55; P = .50) or the time to new AIDS events or death (HR, 1.16; 95% CI, .87-1.55; P = .31). The percentage of patients with severe (grade 3 or 4) adverse events was high in both arms (90% in the immediate ART group and 89% in the deferred ART group; P = .84), but there were significantly more grade 4 adverse events in the immediate ART arm (102 in the immediate ART group vs 87 in the deferred ART group; P = .04).

conclusionsImmediate ART initiation does not improve outcome in patients presenting with HIV-associated tuberculous meningitis. There were significantly more grade 4 adverse events in the immediate ART arm, supporting delayed initiation of ART in HIV-associated tuberculous meningitis. Clinical Trials Registration. ISRCTN63659091.

Indexed as

AdultAlkynesAnti-HIV AgentsAnti-Inflammatory AgentsAntiretroviral Therapy, Highly ActiveAntitubercular AgentsBenzoxazinesCyclopropanesDexamethasoneDouble-Blind MethodFemaleHIV InfectionsHumansLamivudineMalePlacebosAlkynesAnti-HIV AgentsAnti-Inflammatory AgentsAntitubercular AgentsBenzoxazinesCyclopropanesDexamethasoneefavirenzLamivudinePlacebosTrimethoprim, Sulfamethoxazole Drug CombinationZidovudine

Identifiers

PMID21596680
PMCPMC4340579
OpenAlexW2163117709

What OpenQuestion holds

Textmetadata
LicenceTDM
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.