Evidence map›Paper›PMID 20930640›Full record

Trial reportJournal of acquired immune deficiency syndromes (1999)2011

Changes in inflammatory and coagulation biomarkers: a randomized comparison of immediate versus deferred antiretroviral therapy in patients with HIV infection.

Jason V Baker, Jacqueline Neuhaus, Daniel Duprez, Lewis H Kuller, Russell Tracy, Waldo H Belloso, Stephane De Wit, Fraser Drummond, H Clifford Lane, Bruno Ledergerber and 5 more

Registry-linked trialAbstract readComparative StudyRandomized Controlled Trial
In one paragraph

Trial report in Journal of acquired immune deficiency syndromes (1999), 2011. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02380391 (EValuation of REsidual Platelet REactivity After Acute Coronary Syndrome in HIV-infected Patients. The EVERE2ST-HIV Study.), which is not on this map. Cited by 100 papers.

0numbers the graph read from it
0cells of the map it votes in
100citing papers in PubMed
13.8field-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.

NCT02380391 completednot on this mapstarted 2013, after this paper: background citation

EValuation of REsidual Platelet REactivity After Acute Coronary Syndrome in HIV-infected Patients. The EVERE2ST-HIV Study.

TypeobservationalSponsorSaint Antoine University HospitalRan2013 to 2014Enrolled260ConditionsAcute Coronary Syndrome, HIV
3 · Its place in the literature

Who cites it

100 citing papers in PubMed, 157 citations in OpenAlex.

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  5. Immediate Antiretroviral Therapy Reduces Risk of Infection-Related Cancer During Early HIV Infection.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2016
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  8. 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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40 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

15 authors at 9 institutions in 6 countries.

Jason V BakerUniversity of Minnesota, Minneapolis, MN, USA. baker459@umn.edu
Jacqueline Neuhaus
Daniel Duprez
Lewis H Kuller
Russell Tracy
Waldo H Belloso
Stephane De Wit
Fraser Drummond
H Clifford Lane
Bruno Ledergerber
Jens Lundgren
Daniel E Nixon
Nicholas I Paton
James D Neaton
INSIGHT SMART Study Group
University of Copenhagen · DKUniversity of Minnesota · USUNSW Sydney · AUCentre Hospitalier Universitaire de Saint-Pierre · BEMedical Research Council · GBNational Centre for Clinical Research on Emerging Drugs · AUNational Institute of Allergy and Infectious Diseases · USUniversity Hospital of Zurich · CHUniversity of Zurich · CH

Funding

COMMUNITY PROGRAMS FOR CLINICAL RESEARCH ON AIDSU01AI046362 · NIAID · SOCIAL AND SCIENTIFIC SYSTEMS, INC. · PI GORDIN, FRED M · 2000 to 2006
$75.9M
Pathogenesis and Treatment of HIV InfectionZIAAI000585 · NIAID · NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES · PI LANE, CLIFFORD · 2009 to 2025
$26.8M
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
Lipoproteins, HIV, and Antiretroviral Therapy in SMARTR01HL090934 · NHLBI · UNIVERSITY OF MINNESOTA · PI DUPREZ, DANIEL A · 2007 to 2008
$748k
Medical Research Council MC_U122886352NCRR NIH HHS K12 RR023247NHLBI NIH HHS HL 090934-01NHLBI NIH HHS R01 HL090934NIAID NIH HHS U01 AI042170NIAID NIH HHS U01AI042170NIAID NIH HHS U01 AI046362NIAID NIH HHS U01AI46362
6 · The paper itself

Abstract

objectivesAmong a subgroup of participants in the Strategies for Management of Antiretroviral Therapy (SMART) Trial that were naïve to antiretroviral therapy (ART) or off ART (6 months or longer) at study entry, risk of AIDS and serious non-AIDS events were increased for participants who deferred ART compared with those randomized to (re)initiate ART immediately. Our objective was to determine whether ART initiation in this group reduced markers of inflammation and coagulation that have been associated with increased mortality risk in SMART. Changes in these biomarkers have been described after stopping ART, but not after starting ART in SMART.

methodsStored specimens for 254 participants (126 drug conservation [DC] and 128 viral suppression [VS]) who were naïve to ART or off ART (6 months or longer) were analyzed for interleukin-6, high sensitivity C-reactive protein, and D-dimer at baseline and Months 2 and 6.

resultsAt Month 6, 62% of the VS group had HIV RNA less than 400 copies/mL and median CD4 count was 190 cells/mm3 higher than for the DC group (590 versus 400 cells/mm3). Compared with DC, the VS group had 32% (95% confidence interval, 19%-43%) lower D-dimer levels at Month 6 (P < 0.001); differences were not significant for high sensitivity C-reactive protein or interleukin-6 levels.

conclusionsIn this randomized comparison of immediate versus delayed ART initiation, D-dimer, but not interleukin-6 and high sensitivity C-reactive protein, declined significantly after starting ART. Further studies are needed to determine whether improvements in D-dimer are associated with reduced risk of clinical disease and whether adjunct treatments used in combination with ART can reduce inflammation among individuals with HIV infection.

Indexed as

AdultAnti-HIV AgentsBiomarkersBlood CoagulationCD4 Lymphocyte CountC-Reactive ProteinFemaleFibrin Fibrinogen Degradation ProductsHIV InfectionsHumansInflammationInterleukin-6MaleMiddle AgedTime FactorsViral LoadAnti-HIV AgentsBiomarkersC-Reactive ProteinFibrin Fibrinogen Degradation Productsfibrin fragment DInterleukin-6

Identifiers

PMID20930640
PMCPMC3005856
OpenAlexW2167709851

What OpenQuestion holds

Textmetadata
LicenceTDM
Read underepoch 390

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.