PMID- 20617176
OWN - NLM
STAT- MEDLINE
DCOM- 20101019
LR  - 20211020
IS  - 1932-6203 (Electronic)
IS  - 1932-6203 (Linking)
VI  - 5
IP  - 7
DP  - 2010 Jul 1
TI  - Risk factor analyses for immune reconstitution inflammatory syndrome in a 
      randomized study of early vs. deferred ART during an opportunistic infection.
PG  - e11416
LID - 10.1371/journal.pone.0011416 [doi]
LID - e11416
AB  - 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.
FAU - Grant, Philip M
AU  - Grant PM
AD  - Stanford University, Palo Alto, California, United States of America. 
      pmgrant@stanford.edu
FAU - Komarow, Lauren
AU  - Komarow L
FAU - Andersen, Janet
AU  - Andersen J
FAU - Sereti, Irini
AU  - Sereti I
FAU - Pahwa, Savita
AU  - Pahwa S
FAU - Lederman, Michael M
AU  - Lederman MM
FAU - Eron, Joseph
AU  - Eron J
FAU - Sanne, Ian
AU  - Sanne I
FAU - Powderly, William
AU  - Powderly W
FAU - Hogg, Evelyn
AU  - Hogg E
FAU - Suckow, Carol
AU  - Suckow C
FAU - Zolopa, Andrew
AU  - Zolopa A
LA  - eng
SI  - ClinicalTrials.gov/NCT00055120
GR  - UM1 AI068634/AI/NIAID NIH HHS/United States
GR  - ImNIH/Intramural NIH HHS/United States
GR  - UM1 AI069556/AI/NIAID NIH HHS/United States
GR  - AI68634/AI/NIAID NIH HHS/United States
GR  - AI68636/AI/NIAID NIH HHS/United States
GR  - AI069556/AI/NIAID NIH HHS/United States
GR  - U01 AI069423/AI/NIAID NIH HHS/United States
GR  - AI38858/AI/NIAID NIH HHS/United States
GR  - U01 AI069556/AI/NIAID NIH HHS/United States
GR  - U01 AI038858/AI/NIAID NIH HHS/United States
GR  - U01 AI068636/AI/NIAID NIH HHS/United States
GR  - P30 AI050410/AI/NIAID NIH HHS/United States
GR  - U01 AI068634/AI/NIAID NIH HHS/United States
GR  - UM1 AI068636/AI/NIAID NIH HHS/United States
PT  - Journal Article
PT  - Randomized Controlled Trial
PT  - Research Support, N.I.H., Extramural
PT  - Research Support, N.I.H., Intramural
DEP - 20100701
PL  - United States
TA  - PLoS One
JT  - PloS one
JID - 101285081
RN  - 0 (Anti-Retroviral Agents)
RN  - 0 (RNA, Viral)
SB  - IM
MH  - Adult
MH  - Analysis of Variance
MH  - Anti-Retroviral Agents/*adverse effects/pharmacology/*therapeutic use
MH  - Female
MH  - HIV/drug effects
MH  - Humans
MH  - Immune Reconstitution Inflammatory Syndrome/*etiology
MH  - Male
MH  - Middle Aged
MH  - Opportunistic Infections/*drug therapy
MH  - Proportional Hazards Models
MH  - RNA, Viral/metabolism
MH  - Risk Factors
MH  - T-Lymphocyte Subsets/drug effects
MH  - Time Factors
MH  - Young Adult
PMC - PMC2895658
COIS- Competing Interests: The authors have declared that no competing interests exist.
EDAT- 2010/07/10 06:00
MHDA- 2010/10/20 06:00
PMCR- 2010/07/01
CRDT- 2010/07/10 06:00
PHST- 2010/01/14 00:00 [received]
PHST- 2010/06/11 00:00 [accepted]
PHST- 2010/07/10 06:00 [entrez]
PHST- 2010/07/10 06:00 [pubmed]
PHST- 2010/10/20 06:00 [medline]
PHST- 2010/07/01 00:00 [pmc-release]
AID - 10-PONE-RA-15543R1 [pii]
AID - 10.1371/journal.pone.0011416 [doi]
PST - epublish
SO  - PLoS One. 2010 Jul 1;5(7):e11416. doi: 10.1371/journal.pone.0011416.