Trial reportAIDS (London, England)2010
Randomized placebo-controlled trial of prednisone for paradoxical tuberculosis-associated immune reconstitution inflammatory syndrome.
Trial report in AIDS (London, England), 2010. 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 167 papers, 6 of them syntheses that pooled 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.
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.
A Double-Blind Randomized Placebo Controlled Trial for Prevention of Tuberculosis-Immune Reconstitution Inflammatory Syndrome With Non-Steroid Anti-Inflammatory Drugs (NSAIDs) in HIV-Infected Adults
A Randomized Double Blind Placebo Controlled Trial of Adjunctive Dexamethasone for the Treatment of HIV-infected Adults With Tuberculous Meningitis
Who cites it
167 citing papers in PubMed, 6 syntheses or guidelines pooled it, 404 citations in OpenAlex.
- Official American Thoracic Society/Centers for Disease Control and Prevention/Infectious Diseases Society of America Clinical Practice Guidelines: Treatment of Drug-Susceptible Tuberculosis.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2016Guideline
- Executive Summary: Official American Thoracic Society/Centers for Disease Control and Prevention/Infectious Diseases Society of America Clinical Practice Guidelines: Treatment of Drug-Susceptible Tuberculosis.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2016Guideline
- Adjunctive steroid therapy for managing pulmonary tuberculosis.The Cochrane database of systematic reviews · 2014Pooled it
- Tuberculosis Immune Reconstitution Inflammatory Syndrome in children initiating Antiretroviral Therapy for HIV infection: A systematic literature review.The Pediatric infectious disease journal · 2014Pooled it
- Guidelines for the prevention and treatment of opportunistic infections in HIV-exposed and HIV-infected children: recommendations from the National Institutes of Health, Centers for Disease Control and Prevention, the HIV Medicine Association of the Infectious Diseases Society of America, the Pediatric Infectious Diseases Society, and the American Academy of Pediatrics.The Pediatric infectious disease journal · 2013Guideline
- Guideline
- Daily vs Intermittent Antituberculosis Therapy for Pulmonary Tuberculosis in Patients With HIV: A Randomized Clinical Trial.JAMA internal medicine · 2018Trial
- Timing of antiretroviral therapy after diagnosis of cryptococcal meningitis.The New England journal of medicine · 2014Trial
- Matrix metalloproteinases and tissue damage in HIV-tuberculosis immune reconstitution inflammatory syndrome.European journal of immunology · 2014Trial
- Effect of prednisone on the pharmacokinetics of the integrase inhibitor dolutegravir.Antimicrobial agents and chemotherapy · 2013Trial
- Incidence of paradoxical tuberculosis-associated immune reconstitution inflammatory syndrome and impact on patient outcome.PloS one · 2013Trial
- Trial
- The immune reconstitution inflammatory syndrome after antiretroviral therapy initiation in patients with tuberculosis: findings from the SAPiT trial.Annals of internal medicine · 2012Trial
- Corticosteroid-modulated immune activation in the tuberculosis immune reconstitution inflammatory syndrome.American journal of respiratory and critical care medicine · 2012Trial
- Earlier versus later start of antiretroviral therapy in HIV-infected adults with tuberculosis.The New England journal of medicine · 2011Trial
- Timing of antiretroviral therapy for HIV-1 infection and tuberculosis.The New England journal of medicine · 2011Trial
- Tuberculosis-associated IRIS in a young non-HIV patient undergoing TNF-α blockade for ankylosis spondylitis: a rare case report from Italy.Journal of clinical tuberculosis and other mycobacterial diseases · 2026Article
- Prolonged Paradoxical TB-IRIS: 2 Case Reports and a Review of the Literature.Open forum infectious diseases · 2026Article
- Miliary Tuberculosis: A Comprehensive Review of Epidemiology, Clinical Manifestations, Diagnosis, Treatment, and Complications.Infection and drug resistance · 2026Review
- Thalidomide as an Adjunctive Therapy for HIV-Tuberculosis-Associated Immune Reconstitution Inflammatory Syndrome: A Case Series.Open forum infectious diseases · 2025Article
107 more citing papers are in PubMed but not listed here.
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
8 authors at 5 institutions in 3 countries.
Funding
Abstract
objectiveParadoxical tuberculosis-associated immune reconstitution inflammatory syndrome (TB-IRIS) is a frequent complication of antiretroviral therapy in resource-limited countries. We aimed to assess whether a 4-week course of prednisone would reduce morbidity in patients with paradoxical TB-IRIS without excess adverse events.
designA randomized, double-blind, placebo-controlled trial of prednisone (1.5 mg/kg per day for 2 weeks then 0.75 mg/kg per day for 2 weeks). Patients with immediately life-threatening TB-IRIS manifestations were excluded.
methodsThe primary combined endpoint was days of hospitalization and outpatient therapeutic procedures, which were counted as one hospital day.
resultsOne hundred and ten participants were enrolled (55 to each arm). The primary combined endpoint was more frequent in the placebo than the prednisone arm {median hospital days 3 [interquartile range (IQR) 0-9] and 0 (IQR 0-3), respectively; P = 0.04}. There were significantly greater improvements in symptoms, Karnofsky score, and quality of life (MOS-HIV) in the prednisone vs. the placebo arm at 2 and 4 weeks, but not at later time points. Chest radiographs improved significantly more in the prednisone arm at weeks 2 (P = 0.002) and 4 (P = 0.02). Infections on study medication occurred in more participants in prednisone than in placebo arm (27 vs. 17, respectively; P = 0.05), but there was no difference in severe infections (2 vs. 4, respectively; P = 0.40). Isolates from 10 participants were found to be resistant to rifampicin after enrolment.
conclusionPrednisone reduced the need for hospitalization and therapeutic procedures and hastened improvements in symptoms, performance, and quality of life. It is important to investigate for drug-resistant tuberculosis and other causes for deterioration before administering glucocorticoids.
Indexed as
Identifiers
What OpenQuestion holds
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.