Evidence map›Paper›PMID 23801609›Full record

Trial reportThe Journal of infectious diseases2013

Three distinct phases of HIV-1 RNA decay in treatment-naive patients receiving raltegravir-based antiretroviral therapy: ACTG A5248.

Adriana Andrade, Susan L Rosenkranz, Anthony R Cillo, Darlene Lu, Eric S Daar, Jeffrey M Jacobson, Michael Lederman, Edward P Acosta, Thomas Campbell, Judith Feinberg and 4 more

Open access · bronzeAbstract readClinical TrialMulticenter Study
In one paragraph

Trial report in The Journal of infectious diseases, 2013. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 46 papers.

0numbers the graph read from it
0cells of the map it votes in
46citing papers in PubMed
3.2field-weighted citation impact, top 7% 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

46 citing papers in PubMed, 61 citations in OpenAlex.

  1. Trial
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  9. Raltegravir pharmacokinetics during pregnancy.Journal of acquired immune deficiency syndromes (1999) · 2014
    Trial
  10. Trial
  11. Review
  12. Article
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  16. Dominant CD4Cell reports. Medicine · 2023
    Article
  17. Review
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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 10 institutions in 1 country.

Adriana AndradeThe Johns Hopkins University, Baltimore, Maryland 21205, USA. aandrade@jhmi.edu
Susan L Rosenkranz
Anthony R Cillo
Darlene Lu
Eric S Daar
Jeffrey M Jacobson
Michael Lederman
Edward P Acosta
Thomas Campbell
Judith Feinberg
Charles Flexner
John W Mellors
Daniel R Kuritzkes
AIDS Clinical Trials Group A5248 Team
Cancer Research And Biostatistics · USJohns Hopkins University · USPittsburg State University · USBrigham and Women's Hospital · USCase Western Reserve University · USDrexel University · USThe Lundquist Institute · USUniversity of Alabama at Birmingham · USUniversity of Cincinnati · USUniversity of Colorado Hospital · 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
Institute for Clinical and Translational Research (UL1)UL1RR025005 · NCRR · JOHNS HOPKINS UNIVERSITY · PI FORD, DANIEL ERNEST · 2007 to 2011
$75.8M
Statistical and Data Management Center for the AIDS Clinical Trials GroupU01AI068634 · NIAID · HARVARD SCHOOL OF PUBLIC HEALTH · PI HUGHES, MICHAEL DAVID · 2006 to 2010
$71.9M
CTSA INFRASTRUCTURE FOR PEDIATRIC RESEARCHUL1RR025780 · NCRR · UNIVERSITY OF COLORADO DENVER · PI SOKOL, RONALD J. · 2008 to 2011
$61.3M
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
UCSD Department of Medicine HIV/AIDS Clinical Trials UnitUM1AI069432 · NIAID · UNIVERSITY OF CALIFORNIA, SAN DIEGO · PI TIMOTHY J. WILKIN · 2012 to 2026
$50.4M
NCATS NIH HHS UL1 TR000124NCRR NIH HHS RR025780NCRR NIH HHS UL1 RR 025005NCRR NIH HHS UL1 RR025005NCRR NIH HHS UL1 RR025780NIAID NIH HHS AI069465NIAID NIH HHS AI069472NIAID NIH HHS AI069494NIAID NIH HHS AI68634NIAID NIH HHS AI69450NIAID NIH HHS P30 AI060354NIAID NIH HHS U01 AI068634NIAID NIH HHS U01 AI068636NIAID NIH HHS U01 AI069450NIAID NIH HHS U01 AI069465NIAID NIH HHS U01 AI069472NIAID NIH HHS U01 AI069494NIAID NIH HHS UM1 AI068634NIAID NIH HHS UM1 AI068636NIAID NIH HHS UM1 AI069412NIAID NIH HHS UM1 AI069424NIAID NIH HHS UM1 AI069432NIAID NIH HHS UM1 AI069450NIAID NIH HHS UM1 AI069465NIAID NIH HHS UM1 AI069472NIAID NIH HHS UM1 AI069494NIAID NIH HHS UM1 AI069534NIAID NIH HHS UM1 AI106701
6 · The paper itself

Abstract

objectiveThe goal of this study was to define viral kinetics after initiation of raltegravir (RAL)-based antiretroviral therapy (ART).

methodsART-naive patients received RAL, tenofovir disoproxil fumarate, and emtricitabine for 72 weeks. Human immunodeficiency virus type 1 (HIV-1) RNA were measured by ultrasensitive and single-copy assays, and first (d1)-, second (d2)-, and, third (d3)-phase decay rates were estimated by mixed-effects models. Decay data were compared to historical estimates for efavirenz (EFV)- and ritonavir/lopinavir (LPV/r)-based regimens.

resultsBi- and tri-exponential models for ultrasensitive assay (n = 38) and single-copy assay (n = 8) data, respectively, provided the best fits over 8 and 72 weeks. The median d1 with ultrasensitive data was 0.563/day (interquartile range [IQR], 0.501-0.610/day), significantly slower than d1 for EFV-based regimens [P < .001]). The median duration of d1 was 15.1 days, transitioning to d2 at an HIV-1 RNA of 91 copies/mL, indicating a longer duration of d1 and a d2 transition at lower viremia levels than with EFV. Median patient-specific decay estimates with the single-copy assay were 0.607/day (IQR, 0.582-0.653) for d1, 0.070/day (IQR, 0.042-0.079) for d2, and 0.0016/day (IQR, 0.0005-0.0022) for d3; the median d1 duration was 16.1 days, transitioning to d2 at 69 copies/mL. d3 transition occurred at 110 days, at 2.6 copies/mL, similar to values for LPV/r-based regimens.

conclusionsModels using single-copy assay data revealed 3 phases of decay with RAL-containing ART, with a longer duration of first-phase decay consistent with RAL-mediated blockade of productive infection from preintegration complexes.

Indexed as

AdenineAdultAlkynesAnti-HIV AgentsBenzoxazinesCyclopropanesFemaleHIV-1HIV InfectionsHumansLopinavirMaleMiddle AgedOrganophosphonatesPilot ProjectsProspective StudiesAdenineAlkynesAnti-HIV AgentsBenzoxazinesCyclopropanesefavirenzLopinavirOrganophosphonatesPyrrolidinonesRaltegravir PotassiumRitonavirRNA, ViralTenofovirACTG A5160sACTG A5166sACTG A5248raltegravirRoche ultrasensitive assaysingle copy assayviral decay

Identifiers

PMID23801609
PMCPMC3749011
OpenAlexW2050451921

What OpenQuestion holds

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Registered trials

None linked

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.