Evidence map›Paper›PMID 24699474›Full record

Trial reportPloS one2014

HIV-1 RNA levels and antiretroviral drug resistance in blood and non-blood compartments from HIV-1-infected men and women enrolled in AIDS clinical trials group study A5077.

Rami Kantor, Daniel Bettendorf, Ronald J Bosch, Marita Mann, David Katzenstein, Susan Cu-Uvin, Richard D'Aquila, Lisa Frenkel, Susan Fiscus, Robert Coombs and 1 more

Registry-linked trialOpen access · goldAbstract readClinical TrialMulticenter Study
In one paragraph

Trial report in PloS one, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00007488 (Virologic Studies in Compartmental Samples From HIV-Infected Subjects Changing or Initiating Potent Antiretroviral Therapy), which is not on this map. Cited by 10 papers.

0numbers the graph read from it
0cells of the map it votes in
10citing papers in PubMed
1.1field-weighted citation impact, top 23% 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.

NCT00007488 completednot on this map

Virologic Studies in Compartmental Samples From HIV-Infected Subjects Changing or Initiating Potent Antiretroviral Therapy

TypeobservationalSponsorNational Institute of Allergy and Infectious Diseases (NIAID)Ran2000 to 2004Enrolled164ConditionsHIV Infections
3 · Its place in the literature

Who cites it

10 citing papers in PubMed, 13 citations in OpenAlex.

  1. Article
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  5. Article
  6. Article
  7. Article
  8. Article
  9. Does cerumen have a risk for transmission of HIV?European journal of clinical microbiology & infectious diseases : official publication of the European Society of Clinical Microbiology · 2015
    Article
  10. Article
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

11 authors at 7 institutions in 1 country.

Rami KantorDivision of Infectious Diseases, Department of Medicine, Brown University Alpert Medical School, Providence, Rhode Island, United States of America.
Daniel BettendorfHarvard School of Public Health, Harvard University, Boston, Massachusetts, United States of America.
Ronald J BoschHarvard School of Public Health, Harvard University, Boston, Massachusetts, United States of America.
Marita MannDivision of Infectious Diseases, Department of Medicine, Brown University Alpert Medical School, Providence, Rhode Island, United States of America.
David KatzensteinDivision of Infectious Diseases, Department of Medicine, Stanford University, Stanford, California, United States of America.
Susan Cu-UvinDivision of Infectious Diseases, Department of Medicine, Brown University Alpert Medical School, Providence, Rhode Island, United States of America.
Richard D'AquilaDivision of Infectious Diseases, Department of Medicine, Northwestern University, Chicago, Illinois, United States of America.
Lisa FrenkelDepartment of Pediatrics and Laboratory Medicine, University of Washington School of Medicine, Seattle, Washington, United States of America.
Susan FiscusCenter for Infectious Diseases, University of North Carolina, Chapel Hill, North Carolina, United States of America.
Robert CoombsDepartment of Laboratory Medicine and Division of Infectious Diseases, Department of Medicine, University of Washington School of Medicine, Seattle, Washington, United States of America.
ACTG A5077 Study Team
Harvard University Press · USJohn Brown University · USUniversity of Washington · USBrown University · USNorthwestern University · USStanford University · USUniversity of North Carolina at Chapel Hill · 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
LOC-IMPAACT Leadership GroupPharmacokinetics and Safety of Remdesivir for Treatment of COVID-19 in Pregnant Women in the USUM1AI068632 · NIAID · SOCIAL AND SCIENTIFIC SYSTEMS, INC. · PI Jennifer Jao, Sharon A Nachman · 2011 to 2026
$278.1M
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
WOMEN'S HEALTH AGENDAU01AI038858 · NIAID · SOCIAL AND SCIENTIFIC SYSTEMS, INC. · PI BENSON, CONSTANCE ANN · 1996 to 2008
$157.5M
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
University of Washington/Fred Hutch Center for AIDS ResearchP30AI027757 · NIAID · UNIVERSITY OF WASHINGTON · PI Judith Tsui · 1988 to 2026
$104.9M
STATISTICAL AND DATA MANAGEMENT CENTERU01AI038855 · NIAID · HARVARD UNIVERSITY (SCH OF PUBLIC HLTH) · PI HUGHES, MICHAEL DAVID · 1996 to 2006
$78.1M
Virology, Immunology, and Microbiology CoreP30AI050410 · NIAID · UNIV OF NORTH CAROLINA CHAPEL HILL · PI DAVID M. MARGOLIS · 2001 to 2026
$76.9M
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
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
WOMEN'S HEALTH AGENDAU01AI027664 · NIAID · UNIVERSITY OF WASHINGTON · PI COLLIER, ANN CORNWALL · 1988 to 2006
$11.4M
NIAID NIH HHS AI- 27664NIAID NIH HHS AI-27757NIAID NIH HHS AI-38855NIAID NIH HHS AI-38858NIAID NIH HHS AI-50410NIAID NIH HHS AI-68634NIAID NIH HHS AI-68636NIAID NIH HHS P30 AI027757NIAID NIH HHS P30 AI050410NIAID NIH HHS U01 AI038855NIAID NIH HHS U01 AI038858NIAID NIH HHS U01 AI068634NIAID NIH HHS U01 AI068636NIAID NIH HHS UM1 AI068632NIAID NIH HHS UM1 AI068634NIAID NIH HHS UM1 AI068636NIAID NIH HHS UM1 AI069412NIAID NIH HHS UM1 AI106701NICHD NIH HHS HD-40540NICHD NIH HHS P01 HD040540
6 · The paper itself

Abstract

backgroundDetectable HIV-1 in body compartments can lead to transmission and antiretroviral resistance. Although sex differences in viral shedding have been demonstrated, mechanisms and magnitude are unclear. We compared RNA levels in blood, genital-secretions and saliva; and drug resistance in plasma and genital-secretions of men and women starting/changing antiretroviral therapy (ART) in the AIDS Clinical Trials Group (ACTG) 5077 study.

methodsBlood, saliva and genital-secretions (compartment fluids) were collected from HIV-infected adults (≥ 13 years) at 14 United-States sites, who were initiating or changing ART with plasma viral load (VL) ≥ 2,000 copies/mL. VL testing was performed on all compartment fluids and HIV resistance genotyping on plasma and genital-secretions. Spearman rank correlations were used to evaluate concordance and Fisher's and McNemar's exact tests to compare VL between sexes and among compartments.

resultsSamples were available for 143 subjects; 36% treated (23 men, 29 women) and 64% 'untreated' (40 men, 51 women). RNA detection was significantly more frequent in plasma (100%) than genital-secretions (57%) and saliva (64%) (P<0.001). A higher proportion of men had genital shedding versus women (78% versus 41%), and RNA detection was more frequent in saliva versus genital-secretions in women when adjusted for censoring at the limit of assay detection. Inter-compartment fluid VL concordance was low in both sexes. In 22 (13 men, 9 women) paired plasma-genital-secretion genotypes from treated subjects, most had detectable resistance in both plasma (77%) and genital-secretions (68%). Resistance discordance was observed between compartments in 14% of subjects.

conclusionsHIV shedding and drug resistance detection prior to initiation/change of ART in ACTG 5077 subjects differed among tissues and between sexes, making the gold standard blood-plasma compartment assessment not fully representative of HIV at other tissue sites. Mechanisms of potential sex-dependent tissue compartmentalization should be further characterized to aid in optimizing treatment and prevention of HIV transmission.

trial registrationClinicalTrials.gov NCT00007488.

Indexed as

Acquired Immunodeficiency SyndromeAdultAnti-HIV AgentsBloodBody Fluid CompartmentsDrug Resistance, ViralFemaleGenotypeHIV-1HIV InfectionsHumansLongitudinal StudiesMaleMiddle AgedRNA, ViralSalivaAnti-HIV AgentsRNA, Viral

Identifiers

PMID24699474
PMCPMC3974754
OpenAlexW2101501710

What OpenQuestion holds

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LicenceCC BY
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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.