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Risk Factor Analyses for Immune Reconstitution Inflammatory Syndrome in a Randomized Study of Early vs. Deferred ART during an Opportunistic Infection

BACKGROUND: Immune reconstitution inflammatory syndrome (IRIS) is reported widely in patients initiating antiretroviral therapy (ART). However, few studies are prospective, and no study has evaluated the impact of the timing of ART when allocated randomly during an acute opportunistic infection (OI)...

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Autores principales: Grant, Philip M., Komarow, Lauren, Andersen, Janet, Sereti, Irini, Pahwa, Savita, Lederman, Michael M., Eron, Joseph, Sanne, Ian, Powderly, William, Hogg, Evelyn, Suckow, Carol, Zolopa, Andrew
Formato: Texto
Lenguaje:English
Publicado: Public Library of Science 2010
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2895658/
https://www.ncbi.nlm.nih.gov/pubmed/20617176
http://dx.doi.org/10.1371/journal.pone.0011416
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author Grant, Philip M.
Komarow, Lauren
Andersen, Janet
Sereti, Irini
Pahwa, Savita
Lederman, Michael M.
Eron, Joseph
Sanne, Ian
Powderly, William
Hogg, Evelyn
Suckow, Carol
Zolopa, Andrew
author_facet Grant, Philip M.
Komarow, Lauren
Andersen, Janet
Sereti, Irini
Pahwa, Savita
Lederman, Michael M.
Eron, Joseph
Sanne, Ian
Powderly, William
Hogg, Evelyn
Suckow, Carol
Zolopa, Andrew
author_sort Grant, Philip M.
collection PubMed
description BACKGROUND: Immune reconstitution inflammatory syndrome (IRIS) is reported widely in patients initiating antiretroviral therapy (ART). However, few studies are prospective, and no study has evaluated the impact of the timing of ART when allocated randomly during an acute opportunistic infection (OI). METHODOLOGY/PRINCIPAL FINDINGS: A5164 randomized 282 subjects with AIDS-related OIs (tuberculosis excluded), to early or deferred ART. IRIS was identified prospectively using pre-defined criteria. We evaluated associations between IRIS and baseline variables in subjects with follow-up on ART using Wilcoxon and Fisher's exact tests, logistic regression, and Cox models with time-varying covariates. Twenty of 262 (7.6%) subjects developed IRIS after a median of 33 days on ART. Subjects with fungal infections (other than pneumocystis) developed IRIS somewhat more frequently (OR = 2.7; 95% CI: 1.02, 7.2; p-value = 0.06 (using Fisher's exact test)). In Cox models, lower baseline and higher on-treatment CD4+ T-cell counts and percentage were associated with IRIS. Additionally, higher baseline and lower on-treatment HIV RNA levels were associated with IRIS. Corticosteroids during OI management and the timing of ART were not associated with the development of IRIS. IMPLICATIONS: In patients with advanced immunosuppression and non-tuberculous OIs, the presence of a fungal infection, lower CD4+ T-cell counts and higher HIV RNA levels at baseline, and higher CD4+ T-cell counts and lower HIV RNA levels on treatment are associated with IRIS. Early initiation of ART does not increase the incidence of IRIS, and concern about IRIS should not prompt deferral of ART. TRIAL REGISTRATION: ClinicalTrials.gov NCT00055120
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spelling pubmed-28956582010-07-08 Risk Factor Analyses for Immune Reconstitution Inflammatory Syndrome in a Randomized Study of Early vs. Deferred ART during an Opportunistic Infection Grant, Philip M. Komarow, Lauren Andersen, Janet Sereti, Irini Pahwa, Savita Lederman, Michael M. Eron, Joseph Sanne, Ian Powderly, William Hogg, Evelyn Suckow, Carol Zolopa, Andrew PLoS One Research Article BACKGROUND: Immune reconstitution inflammatory syndrome (IRIS) is reported widely in patients initiating antiretroviral therapy (ART). However, few studies are prospective, and no study has evaluated the impact of the timing of ART when allocated randomly during an acute opportunistic infection (OI). METHODOLOGY/PRINCIPAL FINDINGS: A5164 randomized 282 subjects with AIDS-related OIs (tuberculosis excluded), to early or deferred ART. IRIS was identified prospectively using pre-defined criteria. We evaluated associations between IRIS and baseline variables in subjects with follow-up on ART using Wilcoxon and Fisher's exact tests, logistic regression, and Cox models with time-varying covariates. Twenty of 262 (7.6%) subjects developed IRIS after a median of 33 days on ART. Subjects with fungal infections (other than pneumocystis) developed IRIS somewhat more frequently (OR = 2.7; 95% CI: 1.02, 7.2; p-value = 0.06 (using Fisher's exact test)). In Cox models, lower baseline and higher on-treatment CD4+ T-cell counts and percentage were associated with IRIS. Additionally, higher baseline and lower on-treatment HIV RNA levels were associated with IRIS. Corticosteroids during OI management and the timing of ART were not associated with the development of IRIS. IMPLICATIONS: In patients with advanced immunosuppression and non-tuberculous OIs, the presence of a fungal infection, lower CD4+ T-cell counts and higher HIV RNA levels at baseline, and higher CD4+ T-cell counts and lower HIV RNA levels on treatment are associated with IRIS. Early initiation of ART does not increase the incidence of IRIS, and concern about IRIS should not prompt deferral of ART. TRIAL REGISTRATION: ClinicalTrials.gov NCT00055120 Public Library of Science 2010-07-01 /pmc/articles/PMC2895658/ /pubmed/20617176 http://dx.doi.org/10.1371/journal.pone.0011416 Text en Grant et al. http://creativecommons.org/licenses/by/4.0/ This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are properly credited.
spellingShingle Research Article
Grant, Philip M.
Komarow, Lauren
Andersen, Janet
Sereti, Irini
Pahwa, Savita
Lederman, Michael M.
Eron, Joseph
Sanne, Ian
Powderly, William
Hogg, Evelyn
Suckow, Carol
Zolopa, Andrew
Risk Factor Analyses for Immune Reconstitution Inflammatory Syndrome in a Randomized Study of Early vs. Deferred ART during an Opportunistic Infection
title Risk Factor Analyses for Immune Reconstitution Inflammatory Syndrome in a Randomized Study of Early vs. Deferred ART during an Opportunistic Infection
title_full Risk Factor Analyses for Immune Reconstitution Inflammatory Syndrome in a Randomized Study of Early vs. Deferred ART during an Opportunistic Infection
title_fullStr Risk Factor Analyses for Immune Reconstitution Inflammatory Syndrome in a Randomized Study of Early vs. Deferred ART during an Opportunistic Infection
title_full_unstemmed Risk Factor Analyses for Immune Reconstitution Inflammatory Syndrome in a Randomized Study of Early vs. Deferred ART during an Opportunistic Infection
title_short Risk Factor Analyses for Immune Reconstitution Inflammatory Syndrome in a Randomized Study of Early vs. Deferred ART during an Opportunistic Infection
title_sort risk factor analyses for immune reconstitution inflammatory syndrome in a randomized study of early vs. deferred art during an opportunistic infection
topic Research Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2895658/
https://www.ncbi.nlm.nih.gov/pubmed/20617176
http://dx.doi.org/10.1371/journal.pone.0011416
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