Evidence map›Paper›PMID 23042974›Full record

ArticleClinical infectious diseases : an official publication of the Infectious Diseases Society of America2013

Epstein-Barr and other herpesvirus infections in patients with early onset type 1 diabetes treated with daclizumab and mycophenolate mofetil.

Brett J Loechelt, David Boulware, Michael Green, Lindsey R Baden, Peter Gottlieb, Heidi Krause-Steinrauf, Adriana Weinberg, Type 1 Diabetes TrialNet Daclizumab/Mycophenolic Acid Study Group

Registry-linked trialOpen access · bronzeAbstract read
In one paragraph

Article in Clinical infectious diseases : an official publication of the Infectious Diseases Society of America, 2013. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00100178 (New Onset of Type 1 Diabetes Mycophenolate Mofetil-Daclizumab Clinical Trial), which is not on this map. Cited by 11 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
11citing papers in PubMed, 1 pooled it
1.9field-weighted citation impact, top 13% 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.

NCT00100178 phase2completednot on this map

New Onset of Type 1 Diabetes Mycophenolate Mofetil-Daclizumab Clinical Trial (Preservation of Pancreatic Production of Insulin Through Immunosuppression-POPPII #1)

TypeinterventionalSponsorNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)Ran2004 to 2008Enrolled126ConditionsDiabetes Mellitus, Type 1ArmsMycophenolate mofeteil (MMF), Daclizumab (DZB), Placebo control for Mycophenolate mofeteil (MMF), Placebo control for Daclizumab (DZB)
3 · Its place in the literature

Who cites it

11 citing papers in PubMed, 1 synthesis or guideline pooled it, 20 citations in OpenAlex.

  1. Guideline
  2. Trial
  3. Reactivation of latent viruses in individuals receiving rituximab for new onset type 1 diabetes.Journal of clinical virology : the official publication of the Pan American Society for Clinical Virology · 2013
    Trial
  4. Review
  5. Article
  6. Review
  7. Article
  8. Article
  9. Article
  10. Review
  11. Review
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

8 authors at 6 institutions in 1 country.

Brett J LoecheltChildren's National Medical Center, Washington, DC, USA.
David Boulware
Michael Green
Lindsey R Baden
Peter Gottlieb
Heidi Krause-Steinrauf
Adriana Weinberg
Type 1 Diabetes TrialNet Daclizumab/Mycophenolic Acid Study Group
University of Colorado Denver · USBrigham and Women's Hospital · USChildren's Hospital of Pittsburgh · USChildren's National · USGeorge Washington University · USUniversity of South Florida · US

Funding

UCSF CLINICAL AND TRANSLATIONAL SCIENCE INSTITUTEUL1RR024131 · NCRR · UNIVERSITY OF CALIFORNIA, SAN FRANCISCO · PI JOHNSTON, S. CLAIBORNE · 2006 to 2011
$111.2M
Type 1 Diabetes Trialnet: Operations Coord. CenterU01DK061055 · NIDDK · GEORGE WASHINGTON UNIVERSITY · PI LACHIN, JOHN M · 2001 to 2008
$93.2M
UNIVERSITY OF PITTSBURGH CLINICAL AND TRANSLATIONAL SCIENCE INSTITUTE: BPCAUL1RR024153 · NCRR · UNIVERSITY OF PITTSBURGH AT PITTSBURGH · PI REIS, STEVEN E · 2006 to 2011
$73.9M
CTSA INFRASTRUCTURE FOR PEDIATRIC RESEARCHUL1RR025780 · NCRR · UNIVERSITY OF COLORADO DENVER · PI SOKOL, RONALD J. · 2008 to 2011
$61.3M
YALE UNIVERSITY CLINICAL AND TRANSLATIONAL SCIENCE AWARD PROGRAMUL1RR024139 · NCRR · YALE UNIVERSITY · PI SHERWIN, ROBERT S · 2006 to 2011
$56.8M
VANDERBILT UNIVERSITY CTSA FOR PEDIATRIC RESEARCHUL1RR024975 · NCRR · VANDERBILT UNIVERSITY · PI BERNARD, GORDON RAPHAEL · 2007 to 2011
$45.7M
Vector and Transgenic Mouse CoreP30DK017047 · NIDDK · UNIVERSITY OF WASHINGTON · PI Sakeneh Zraika · 1986 to 2026
$41.4M
Spectrum Stanford Center for clinical and Translational Research and EducationUL1TR001085 · NCATS · STANFORD UNIVERSITY · PI CULLEN, MARK RICHARD, GREENBERG, HARRY BERNARD · 2013 to 2017
$37.1M
YOUTH DRUG ABUSE, ADHD, AND RELATED DISRUPTIVE DISORDERSM01RR000400 · NCRR · UNIVERSITY OF MINNESOTA TWIN CITIES · PI BACHANOVA, VERONIKA S · 1985 to 2009
$33.7M
NORTH AND CENTRAL TEXAS CTSA FOR PEDIATRIC RESEARCHUL1RR024982 · NCRR · UT SOUTHWESTERN MEDICAL CENTER · PI TOTO, ROBERT DANIEL · 2007 to 2011
$27.9M
Stanford Center for Clinical and Translational Education and Research (SCCTER)UL1UL1RR025744 · NCRR · STANFORD UNIVERSITY · PI GREENBERG, HARRY BERNARD · 2008 to 2011
$22.4M
LOS ANGELES BASIN CLINICAL AND TRANSLATIONAL SCIENCE INSTITUTEUL1RR031986 · NCRR · UNIVERSITY OF SOUTHERN CALIFORNIA · PI BUCHANAN, THOMAS A · 2010 to 2011
$21.1M
NCATS NIH HHS UL1 TR001085NCRR NIH HHS M01 RR000400NCRR NIH HHS M01 RR00400NCRR NIH HHS UL1 RR024131NCRR NIH HHS UL1 RR024139NCRR NIH HHS UL1 RR024153NCRR NIH HHS UL1 RR024975NCRR NIH HHS UL1 RR024982NCRR NIH HHS UL1 RR025744NCRR NIH HHS UL1 RR025761NCRR NIH HHS UL1 RR025780NCRR NIH HHS UL1 RR029890NCRR NIH HHS UL1 RR031986NIDDK NIH HHS P30 DK017047NIDDK NIH HHS U01 DK061010NIDDK NIH HHS U01 DK061016NIDDK NIH HHS U01 DK061034NIDDK NIH HHS U01 DK061036NIDDK NIH HHS U01 DK061040NIDDK NIH HHS U01 DK061041NIDDK NIH HHS U01 DK061042NIDDK NIH HHS U01 DK061055NIDDK NIH HHS U01 DK061058NIDDK NIH HHS U01 DK084565NIDDK NIH HHS U01 DK085453NIDDK NIH HHS U01 DK085461NIDDK NIH HHS U01 DK085463NIDDK NIH HHS U01 DK085466NIDDK NIH HHS U01 DK085499NIDDK NIH HHS U01 DK085505NIDDK NIH HHS U01 DK085509NLM NIH HHS HHSN267200800019CPHS HHS U01 K061055
6 · The paper itself

Abstract

backgroundWe assessed the morbidity of herpesviruses in patients with type 1 diabetes mellitus (T1D) enrolled in immunosuppressive treatment studies.

methodsEpstein-Barr virus (EBV), cytomegalovirus (CMV), herpes simplex virus (HSV), and varicella zoster virus (VZV) infections were monitored in 126 participants of a randomized, double-blind, placebo-controlled study of daclizumab (DZB) and mycophenolate mofetil (MMF) including DZB(+)MMF(+), DZB(-)MMF(+), DZB(+)MMF(-), and DZB(-)MMF(-). During the 2-year follow-up, herpesviral infections were monitored clinically, by serology and blood DNA polymerase chain reaction.

resultsAmong 57 baseline EBV-seronegative participants, 9 developed EBV primary infections, including 2 with infectious mononucleosis syndrome. There were no appreciable differences in the course of the primary EBV infections across treatment groups. Among 69 baseline EBV-seropositive participants, 22 had virologic reactivations, including 1 symptomatic DZB(-)MMF(+) subject. Compared with 7 DZB(-)MMF(-) EBV reactivators, the 9 DZB(+)MMF(+) reactivators tended to have more prolonged viremia (11.4 vs 4.4 months; P = .06) and higher cumulative viral burden (14.2 vs 12.5 log EBV copies/mL; P = .06). Four of 85 baseline CMV-seronegative subjects developed asymptomatic primary CMV infections. There were no CMV reactivations. Of 30 baseline HSV-seropositive subjects, 8 developed ≥1 episode of herpes labialis; 1 subject had a primary HSV infection; and 1 subject without baseline serology information had a new diagnosis of genital HSV. There were no significant differences in the incidence of HSV recurrences across treatment groups. Of 100 baseline VZV-seropositive subjects, 1 DZB(-)MMF(-) subject developed herpes zoster and 1 DZB(-)MMF(+) subject had Bell's palsy possibly related to VZV.

conclusionsThe use of DZB alone or in combination with MMF was not associated with increased morbidity due to herpesviruses. CLINICAL TRIALS REGISTRATION: NCT00100178.

Indexed as

AdolescentAdultAge of OnsetAntibodies, Monoclonal, HumanizedChildCytomegalovirusDaclizumabDiabetes Mellitus, Type 1Epstein-Barr Virus InfectionsFemaleHerpesviridaeHerpesviridae InfectionsHerpesvirus 4, HumanHumansImmunoglobulin GImmunosuppressive AgentsAntibodies, Monoclonal, HumanizedDaclizumabImmunoglobulin GImmunosuppressive AgentsMycophenolic Acid

Identifiers

PMID23042974
PMCPMC3526252
OpenAlexW2147278067

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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.