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Publication Details
AFRICAN RESEARCH NEXUS
SHINING A SPOTLIGHT ON AFRICAN RESEARCH
Randomized placebo-controlled trial of prednisone for paradoxical tuberculosis-associated immune reconstitution inflammatory syndrome
AIDS, Volume 24, No. 15, Year 2010
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Description
Objective: Paradoxical 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. Design: A 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. Methods: The primary combined endpoint was days of hospitalization and outpatient therapeutic procedures, which were counted as one hospital day. Results: One 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. Conclusion: Prednisone 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. © 2010 Wolters Kluwer Health | Lippincott Williams & Wilkins.
Authors & Co-Authors
Meintjes, Graeme Ayton
South Africa, Cape Town
Faculty of Health Sciences
South Africa, Cape Town
University of Cape Town
South Africa, Cape Town
Gf Jooste Hospital
Wilkinson, Robert J.
South Africa, Cape Town
Faculty of Health Sciences
South Africa, Cape Town
University of Cape Town
South Africa, Cape Town
Gf Jooste Hospital
United Kingdom, London
Imperial College London
United Kingdom, London
Mrc National Institute for Medical Research
Morroni, Chelsea
South Africa, Cape Town
Faculty of Health Sciences
South Africa, Cape Town
School of Public Health and Family Medicine
Pepper, Dominique J.
South Africa, Cape Town
Faculty of Health Sciences
South Africa, Cape Town
University of Cape Town
South Africa, Cape Town
Gf Jooste Hospital
Rebe, Kevin Brian
South Africa, Cape Town
University of Cape Town
South Africa, Cape Town
Gf Jooste Hospital
Rangaka, Molebogeng Xheeda
South Africa, Cape Town
Faculty of Health Sciences
Oni, Tolu
South Africa, Cape Town
Faculty of Health Sciences
United Kingdom, London
Imperial College London
Maartens, Gary Tuberculosis
South Africa, Cape Town
Faculty of Health Sciences
South Africa, Cape Town
University of Cape Town
Statistics
Citations: 326
Authors: 8
Affiliations: 6
Identifiers
Doi:
10.1097/QAD.0b013e32833dfc68
e-ISSN:
14735571
Research Areas
Disability
Health System And Policy
Infectious Diseases