Evidence map›Paper›PMID 24367599›Full record

Trial reportPloS one2013

Dynamics of immune reconstitution and activation markers in HIV+ treatment-naïve patients treated with raltegravir, tenofovir disoproxil fumarate and emtricitabine.

Nicholas T Funderburg, Adriana Andrade, Ellen S Chan, Susan L Rosenkranz, Darlene Lu, Brian Clagett, Heather A Pilch-Cooper, Benigno Rodriguez, Judith Feinberg, Eric Daar and 4 more

Registry-linked trialOpen access · goldAbstract readClinical Trial
In one paragraph

Trial report in PloS one, 2013. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00660972 (First-Phase Viral Decay Rates in Treatment-Naive Subjects Initiating Treatment With Raltegravir), which is not on this map. Cited by 42 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
42citing papers in PubMed, 2 pooled it
2.0field-weighted citation impact, top 14% 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.

NCT00660972 phase1completednot on this map

First-Phase Viral Decay Rates in Treatment-Naive Subjects Initiating Treatment With Raltegravir (RAL) and Emtricitabine (FTC)/Tenofovir Disoproxil Fumarate (TDF): A Pilot Study

TypeinterventionalSponsorNational Institute of Allergy and Infectious Diseases (NIAID)Ran2008 to 2010Enrolled40ConditionsHIV InfectionsArmsRaltegravir, Emtricitabine/tenofovir disoproxil fumarate
3 · Its place in the literature

Who cites it

42 citing papers in PubMed, 2 syntheses or guidelines pooled it, 55 citations in OpenAlex.

  1. The Hitchhiker Guide to CD4Frontiers in immunology · 2021
    Pooled it
  2. Pooled it
  3. Trial
  4. Trial
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  7. Trial
  8. Trial
  9. Article
  10. Review
  11. Article
  12. Article
  13. Article
  14. The role of CD38 in HIV infection.AIDS research and therapy · 2021
    Review
  15. Article
  16. Article
  17. COVID-19 crossing paths with AIDS in the homeless.Journal of medical virology · 2021
    Article
  18. Plasma Inflammatory Biomarkers Associated with Advanced Liver Fibrosis in HIV-HCV-Coinfected Individuals.International journal of environmental research and public health · 2020
    Article
  19. Antimicrobial agents and chemotherapy · 2020
    Article
  20. Review
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

14 authors at 8 institutions in 1 country.

Nicholas T FunderburgCase Western Reserve University, Division of Infectious Diseases and HIV Medicine, Cleveland, Ohio, United States of America.
Adriana AndradeThe Johns Hopkins University, Baltimore, Maryland, United States of America.
Ellen S ChanCenter for Biostatistics in AIDS Research, Harvard School of Public Health, Boston, Massachusetts, United States of America.
Susan L RosenkranzCenter for Biostatistics in AIDS Research, Harvard School of Public Health, Boston, Massachusetts, United States of America.
Darlene LuCenter for Biostatistics in AIDS Research, Harvard School of Public Health, Boston, Massachusetts, United States of America.
Brian ClagettCase Western Reserve University, Division of Infectious Diseases and HIV Medicine, Cleveland, Ohio, United States of America.
Heather A Pilch-CooperCase Western Reserve University, Division of Infectious Diseases and HIV Medicine, Cleveland, Ohio, United States of America.
Benigno RodriguezCase Western Reserve University, Division of Infectious Diseases and HIV Medicine, Cleveland, Ohio, United States of America.
Judith FeinbergUniversity of Cincinnati Medical Center, Cincinnati, Ohio, United States of America.
Eric DaarLos Angeles Biomedical Research Institute at Harbor UCLA Medical Center, Torrance, California, United States of America.
John MellorsUniversity of Pittsburg Medical Center, Pittsburg, Pennsylvania, United States of America.
Daniel KuritzkesBrigham and Women's Hospital and Harvard Medical School, Boston, Massachusetts, United States of America.
Jeffrey M JacobsonDrexel University College of Medicine, Philadelphia, Pennsylvania, United States of America.
Michael M LedermanCase Western Reserve University, Division of Infectious Diseases and HIV Medicine, Cleveland, Ohio, United States of America.
Case Western Reserve University · USCancer Research And Biostatistics · USBrigham and Women's Hospital · USDrexel University · USHarbor–UCLA Medical Center · USJohns Hopkins University · USPittsburg State University · USUniversity of Cincinnati Medical Center · US

Funding

Leadership and Operations Center (LOC), AIDS Clinical Trials Group (ACTG); LOC 1/UM1AI068636 · NIAID · UNIV OF NORTH CAROLINA CHAPEL HILL · PI Joseph J Eron, RAJESH T GANDHI · 2011 to 2026
$1073.1M
Statistical and Data Management Center (SDMC), AIDS Clinical Trials Group (ACTG)UM1AI068634 · NIAID · HARVARD UNIVERSITY D/B/A HARVARD SCHOOL OF PUBLIC HEALTH · PI Marlene Ann Cooper, Michael David Hughes · 2011 to 2026
$246.6M
AIDS Clinical Trials Group NetworkU01AI068636 · NIAID · SOCIAL AND SCIENTIFIC SYSTEMS, INC. · PI KURITZKES, DANIEL R. · 2006 to 2010
$147.1M
Validation, CLIA and Qualification (VQC): Enhancing the RS ratio as a tool for AIDS Clinical Trial Group (ACTG) tuberculosis trialsUM1AI106701 · NIAID · UNIVERSITY OF CALIFORNIA LOS ANGELES · PI Grace M Aldrovandi · 2014 to 2026
$116.8M
The impact of HIV viral diversity and cellular immunity on HIV pathogenesisP30AI060354 · NIAID · HARVARD UNIVERSITY (MEDICAL SCHOOL) · PI ROBERT A. PARKER · 2004 to 2026
$94.4M
Harvard Medical School Vaccine Clinical Trials UnitUM1AI069412 · NIAID · BRIGHAM AND WOMEN'S HOSPITAL · PI Lindsey Robert Baden, Daniel R. Kuritzkes · 2012 to 2026
$57.2M
UCLA Clinical and Translational Science InstituteUL1TR000124 · NCATS · UNIVERSITY OF CALIFORNIA LOS ANGELES · PI DUBINETT, STEVEN M. · 2012 to 2015
$57.0M
UCLA AIDS Prevention and Treatment Clinical Trials UnitUM1AI069424 · NIAID · UNIVERSITY OF CALIFORNIA LOS ANGELES · PI Judith S. Currier, RAPHAEL J LANDOVITZ · 2012 to 2026
$51.8M
WG3: HIV, Co-infections and Co-morbiditiesP30AI036219 · NIAID · CASE WESTERN RESERVE UNIVERSITY · PI Sharon L. Hillier, JONATHAN KARN · 1994 to 2026
$50.0M
Case Clinical Trials Unit: Administrative Supplement NOSI AI-20-031.UM1AI069501 · NIAID · CASE WESTERN RESERVE UNIVERSITY · PI George Yendewa · 2012 to 2026
$40.4M
University of Pittsburgh Clinical Trials UnitUM1AI069494 · NIAID · UNIVERSITY OF PITTSBURGH AT PITTSBURGH · PI SUSAN L KOLETAR, John W Mellors · 2012 to 2026
$38.0M
University of Pennsylvania HIV Clinical Trials UnitUM1AI069534 · NIAID · UNIVERSITY OF PENNSYLVANIA · PI Ian Frank, PABLO TEBAS · 2012 to 2026
$33.0M
NCATS NIH HHS UL1 TR000124NCATS NIH HHS UL1TR000124NCATS NIH HHS UL1 TR000170NHLBI NIH HHS K99 HL108743NIAID NIH HHS AI060354NIAID NIH HHS AI-068636NIAID NIH HHS AI069424NIAID NIH HHS AI069472NIAID NIH HHS AI 36219NIAID NIH HHS AI-69501NIAID NIH HHS P30 AI036219NIAID NIH HHS P30 AI060354NIAID NIH HHS U01 AI068636NIAID NIH HHS U01 AI069424NIAID NIH HHS U01 AI069472NIAID NIH HHS U01 AI069501NIAID NIH HHS UM1 AI068634NIAID NIH HHS UM1 AI068636NIAID NIH HHS UM1 AI069412NIAID NIH HHS UM1 AI069424NIAID NIH HHS UM1 AI069472NIAID NIH HHS UM1 AI069494NIAID NIH HHS UM1 AI069501NIAID NIH HHS UM1 AI069534NIAID NIH HHS UM1 AI106701
6 · The paper itself

Abstract

backgroundThe dynamics of CD4+ T cell reconstitution and changes in immune activation and inflammation in HIV-1 disease following initiation of antiretroviral therapy (ART) are incompletely defined and their underlying mechanisms poorly understood.

methodsThirty-nine treatment-naïve patients were treated with raltegravir, tenofovir DF and emtricitabine. Immunologic and inflammatory indices were examined in persons with sustained virologic control during 48 weeks of therapy.

resultsInitiation of ART increased CD4+ T cell numbers and decreased activation and cell cycle entry among CD4+ and CD8+ T cell subsets, and attenuated markers of coagulation (D-dimer levels) and inflammation (IL-6 and TNFr1). These indices decayed at different rates and almost all remained elevated above levels measured in HIV-seronegatives through 48 weeks of viral control. Greater first and second phase CD4+ T cell restoration was related to lower T cell activation and cell cycling at baseline, to their decay with treatment, and to baseline levels of selected inflammatory indices, but less so to their changes on therapy.

conclusionsART initiation results in dynamic changes in viral replication, T cell restoration, and indices of immune activation, inflammation, and coagulation. These findings suggest that determinants of T cell activation/cycling and inflammation/coagulation may have distinguishable impact on immune homeostasis.

trial registrationClinicaltrials.gov NCT00660972.

Indexed as

AdenineAdultAnti-HIV AgentsBiomarkersCD4 Lymphocyte CountCD4-Positive T-LymphocytesDeoxycytidineEmtricitabineFemaleHIV-1HIV InfectionsHumansLymphocyte ActivationMaleMiddle AgedOrganophosphonatesAdenineAnti-HIV AgentsBiomarkersDeoxycytidineEmtricitabineOrganophosphonatesPyrrolidinonesRaltegravir PotassiumTenofovir

Identifiers

PMID24367599
PMCPMC3867440
OpenAlexW2053951267

What OpenQuestion holds

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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.