Evidence map›Paper›PMID 21592994›Full record

Trial reportThe Journal of infectious diseases2011

Higher levels of CRP, D-dimer, IL-6, and hyaluronic acid before initiation of antiretroviral therapy (ART) are associated with increased risk of AIDS or death.

David R Boulware, Katherine Huppler Hullsiek, Camille E Puronen, Adam Rupert, Jason V Baker, Martyn A French, Paul R Bohjanen, Richard M Novak, James D Neaton, Irini Sereti and 1 more

Open access · bronzeAbstract readRandomized Controlled Trial
In one paragraph

Trial report in The Journal of infectious diseases, 2011. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 213 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
213citing papers in PubMed, 1 pooled it
24.8field-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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

213 citing papers in PubMed, 1 synthesis or guideline pooled it, 314 citations in OpenAlex.

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  12. Changes in Inflammation and Immune Activation With Atazanavir-, Raltegravir-, Darunavir-Based Initial Antiviral Therapy: ACTG 5260s.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2015
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153 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

11 authors at 6 institutions in 2 countries.

David R BoulwareUniversity of Minnesota, Minneapolis, Minnesota, USA.
Katherine Huppler Hullsiek
Camille E Puronen
Adam Rupert
Jason V Baker
Martyn A French
Paul R Bohjanen
Richard M Novak
James D Neaton
Irini Sereti
INSIGHT Study Group
University of Minnesota System · USNational Institute of Allergy and Infectious Diseases · USNational Institutes of Health · USScience Applications International Corporation (United States) · USUniversity of Illinois Chicago · USUniversity of Western Australia · AU

Funding

International Network for Strategic Initiatives in Global HIV Trials (INSIGHT)U01AI068641 · NIAID · UNIVERSITY OF MINNESOTA · PI NEATON, JAMES DENNIS · 2006 to 2010
$120.1M
COMMUNITY PROGRAMS FOR CLINICAL RESEARCH ON AIDSU01AI046362 · NIAID · SOCIAL AND SCIENTIFIC SYSTEMS, INC. · PI GORDIN, FRED M · 2000 to 2006
$75.9M
Immunopathogenic Mechanisms of Human Immunodeficiency Virus (HIV) DiseaseZIAAI001121 · NIAID · NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES · PI SERETI, IRINI · 2010 to 2025
$27.2M
TERRY BEIRN COMMUNITY PROGRAMS FOR CLINICAL RESEARCH ONU01AI042170 · NIAID · UNIVERSITY OF MINNESOTA TWIN CITIES · PI NEATON, JAMES DENNIS · 1997 to 2006
$23.2M
Scholar Development Clinical Research (RMI)K12RR023247 · NCRR · UNIVERSITY OF MINNESOTA TWIN CITIES · PI LUEPKER, RUSSELL V · 2005 to 2009
$13.5M
University of Minnesota Clinical and Translational Science Institute (UMN CTSI)KL2RR033182 · NCRR · UNIVERSITY OF MINNESOTA · PI BLAZAR, BRUCE R · 2011 to 2011
$1.4M
Outcomes of Cryptococcal Meningitis in UgandaK24AI096925 · NIAID · UNIVERSITY OF MINNESOTA · PI BOHJANEN, PAUL R · 2011 to 2015
$1.0M
Immune Reconstitution Syndrome in HIV infected Persons in Resource-Limited AreasK23AI073192 · NIAID · UNIVERSITY OF MINNESOTA · PI BOULWARE, DAVID R · 2009 to 2012
$530k
Medical Research Council MC_U122886352NCRR NIH HHS K12 RR023247NCRR NIH HHS K12RR023247-05NCRR NIH HHS KL2 RR033182NIAID NIH HHS K23 AI073192NIAID NIH HHS K23AI073192-02NIAID NIH HHS K24 AI096925NIAID NIH HHS L30 AI066779NIAID NIH HHS U01AI042170NIAID NIH HHS U01AI046362NIAID NIH HHS U01AI068641
6 · The paper itself

Abstract

backgroundSubstantial morbidity occurs during the first year of antiretroviral therapy (ART) in persons with advanced human immunodeficiency virus (HIV) disease despite HIV suppression. Biomarkers may identify high-risk groups.

methodsPre-ART and 1-month samples from an initial ART trial were evaluated for biomarkers associated with AIDS events or death within 1-12 months. Case patients (n = 63) and control patients (n = 126) were 1:2 matched on baseline CD4 cell count, hepatitis status, and randomization date. All had ≥ 1 log(10) HIV RNA level decrease at 1 month.

resultsCase patients had more frequent prior AIDS events, compared with control patients (P = .004), but similar HIV RNA levels at baseline. Pre-ART and 1-month C-reactive protein (CRP), D-dimer, and interleukin 6 (IL-6) levels and pre-ART hyaluronic acid (HA) levels were associated with new AIDS events or death (P ≤ .01). Patients who experienced immune reconstitution inflammatory syndrome (IRIS) events had higher pre-ART tumor necrosis factor α (TNF-α) and HIV RNA levels and significant 1-month increases in CRP, D-dimer, IL-6, interleukin 8, CXCL10, TNF-α, and interferon-γ levels, compared with patients who experienced non-IRIS events (P ≤ .03). Individuals with baseline CRP and HA levels above the cohort median (>2.1 mg/L and >50.0 ng/mL, respectively) had increased risk of AIDS or death (OR, 4.6 [95% CI, 2.0-10.3]; P < .001) and IRIS (OR, 8.7 [95% CI, 2.2-34.8] P = .002).

conclusionsBiomarkers of Inflammation (CRP, IL-6), coagulation (D-dimer), and tissue fibrosis (HA) measured pre-ART and at 1 month are associated with higher risk of AIDS events, IRIS, or death, warranting additional study as risk stratification strategies.

Indexed as

Acquired Immunodeficiency SyndromeAdultAnti-Retroviral AgentsBiomarkersCase-Control StudiesC-Reactive ProteinDisease ProgressionFemaleFibrin Fibrinogen Degradation ProductsHIV InfectionsHumansHyaluronic AcidImmune Reconstitution Inflammatory SyndromeInterleukin-6MaleMiddle AgedAnti-Retroviral AgentsBiomarkersC-Reactive ProteinFibrin Fibrinogen Degradation Productsfibrin fragment DHyaluronic AcidIL6 protein, humanInterleukin-6RNA, Viral

Identifiers

PMID21592994
PMCPMC3096784
OpenAlexW2122544370

What OpenQuestion holds

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Registered trials

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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.