Evidence map›Paper›PMID 27281061›Full record

Trial reportAIDS (London, England)2016

Differential CD4+ cell count increase and CD4+ :  CD8+ ratio normalization with maraviroc compared with tenofovir.

Ellen S Chan, Alan L Landay, Todd T Brown, Heather J Ribaudo, Paria Mirmonsef, Igho Ofotokun, M Neale Weitzmann, Jeffrey Martinson, Karin L Klingman, Joseph J Eron and 3 more

Abstract readClinical Trial, Phase IIComparative StudyMulticenter Study
In one paragraph

Trial report in AIDS (London, England), 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 5 papers.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed
1.1field-weighted citation impact, top 22% 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

5 citing papers in PubMed, 9 citations in OpenAlex.

  1. Antiretroviral Therapy Intensification for Neurocognitive Impairment in Human Immunodeficiency Virus.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2023
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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

13 authors at 8 institutions in 2 countries.

Ellen S ChanaStatistical and Data Analysis Center, Harvard Chan School of Public Health, Boston, Massachusetts bDepartment of Immunology and Microbiology, Rush University Medical Center, Chicago, Illinois cDivision of Endocrinology, Diabetes, and Metabolism, Johns Hopkins University, Baltimore, Maryland dDivision of Infectious Diseases eDivision of Endocrinology and Metabolism and Lipids, Emory University, Atlanta; Atlanta VA Medical Center, Decatur, Georgia fHIV Research Branch, Division of AIDS, National Institute of Allergy and Infectious Diseases, Bethesda, Maryland gDivision of Infectious Diseases, University of North Carolina, Chapel Hill, North Carolina hDivision of Infectious Diseases, University of Cincinnati, Cincinnati, Ohio iDivision of Infectious Diseases, Northwestern University, Chicago, Illinois, USA.
Alan L Landay
Todd T Brown
Heather J Ribaudo
Paria Mirmonsef
Igho Ofotokun
M Neale Weitzmann
Jeffrey Martinson
Karin L Klingman
Joseph J Eron
Carl J Fichtenbaum
Jill Plants
Babafemi O Taiwo
Atlanta VA Medical Center · USUniversity of North Carolina at Chapel Hill · USFundación Juan March · ESEmory University · USHarvard University · USMay Institute · USOffice of Infectious Diseases · USUniversity of Cincinnati · 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
Virus & Reservoirs CoreP30AI045008 · NIAID · UNIVERSITY OF PENNSYLVANIA · PI DAVID S METZGER · 1999 to 2026
$78.6M
Virology, Immunology, and Microbiology CoreP30AI050410 · NIAID · UNIV OF NORTH CAROLINA CHAPEL HILL · PI DAVID M. MARGOLIS · 2001 to 2026
$76.9M
Virology and Molecular Biomarkers CoreP30AI050409 · NIAID · EMORY UNIVERSITY · PI Ann M Chahroudi, Colleen F Kelley · 2002 to 2026
$74.0M
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
University of North Carolina Global HIV Prevention and Treatment Clinical Trials Unit 2024 SupplementUM1AI069423 · NIAID · UNIV OF NORTH CAROLINA CHAPEL HILL · PI Joseph J Eron, MINA CHRISTINE HOSSEINIPOUR · 2012 to 2026
$71.8M
CTSA INFRASTRUCTURE FOR PEDIATRIC RESEARCHUL1RR025780 · NCRR · UNIVERSITY OF COLORADO DENVER · PI SOKOL, RONALD J. · 2008 to 2011
$61.3M
Institute for Clinical and Translational ResearchUL1TR001079 · NCATS · JOHNS HOPKINS UNIVERSITY · PI FORD, DANIEL ERNEST · 2013 to 2017
$60.1M
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
NCATS NIH HHS UL1 TR000042NCATS NIH HHS UL1 TR000445NCATS NIH HHS UL1 TR000454NCATS NIH HHS UL1 TR001079NCATS NIH HHS UL1 TR001082NCATS NIH HHS UL1 TR001111NCRR NIH HHS UL1 RR024160NCRR NIH HHS UL1 RR025780NIAID NIH HHS P30 AI045008NIAID NIH HHS P30 AI050409NIAID NIH HHS P30 AI050410NIAID NIH HHS P30 AI073961NIAID NIH HHS U01 AI068634NIAID NIH HHS U01 AI068636NIAID NIH HHS U01 AI069424NIAID NIH HHS U01 AI069439NIAID NIH HHS U01 AI069447NIAID NIH HHS U01 AI069477NIAID NIH HHS U01 AI069501NIAID NIH HHS U01 AI069511NIAID NIH HHS UM1 AI068634NIAID NIH HHS UM1 AI068636NIAID NIH HHS UM1 AI069412NIAID NIH HHS UM1 AI069415NIAID NIH HHS UM1 AI069418NIAID NIH HHS UM1 AI069423NIAID NIH HHS UM1 AI069424NIAID NIH HHS UM1 AI069432NIAID NIH HHS UM1 AI069439NIAID NIH HHS UM1 AI069452NIAID NIH HHS UM1 AI069465NIAID NIH HHS UM1 AI069470NIAID NIH HHS UM1 AI069471NIAID NIH HHS UM1 AI069472NIAID NIH HHS UM1 AI069496NIAID NIH HHS UM1 AI069501NIAID NIH HHS UM1 AI069503NIAID NIH HHS UM1 AI069511NIAID NIH HHS UM1 AI106701
6 · The paper itself

Abstract

objectiveStudies exploring the immunologic effects of maraviroc (MVC) have produced mixed results; hence, it remains unclear whether MVC has unique immunologic effects in comparison with other antiretroviral drugs. We sought to determine whether MVC has differential effects compared with tenofovir disoproxil fumarate (TDF) during initial antiretroviral therapy.

designProspective study in AIDS Clinical Trials Group A5303, a double-blind, placebo-controlled trial (N = 262) of MVC vs. TDF, each combined with boosted darunavir and emtricitabine.

methodsA total of 31 cellular and soluble biomarkers were assayed at weeks 0 and 48. Polychromatic flow cytometry was performed on cryopreserved peripheral blood mononuclear cells. Soluble markers were assayed in plasma using ELISA kits. Analyses were as treated.

resultsAnalyses included 230 participants (119 in MVC arm and 111 in TDF arm). Over 48 weeks of treatment, no significant differences were detected in declines in markers of inflammation and activation with MVC vs. TDF. A greater CD4 T-cell count increase (median +234 vs. +188 cells/μl, P = 0.036), a smaller CD8 T-cell count decrease (-6 vs. -109 cells/μl, P = 0.008), and a smaller CD4 : CD8 ratio increase (0.26 vs. 0.39, P = 0.003) occurred with MVC. Among participants with a baseline CD4 : CD8 ratio less than 1, a smaller proportion of MVC group normalized to a ratio greater than 1 at week 48 (15 and 36%, P < 0.001).

conclusionMVC resulted in less improvement in the CD4 : CD8 ratio driven by greater increase in CD4 cell count but smaller decline in CD8 cell count. Changes in soluble or cellular biomarkers of inflammation and immune activation were not different between MVC and TDF.

Indexed as

CD4-CD8 RatioCD4 Lymphocyte CountAdultAnti-HIV AgentsCyclohexanesDarunavirDouble-Blind MethodEmtricitabineFemaleFlow CytometryHIV InfectionsHumansMaleMaravirocPlacebosProspective StudiesAnti-HIV AgentsCyclohexanesDarunavirEmtricitabineMaravirocPlacebosTenofovirTriazoles

Identifiers

PMID27281061
PMCPMC4966543
OpenAlexW2464627058

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.