Evidence map›Paper›PMID 34398958›Full record

ArticleClinical infectious diseases : an official publication of the Infectious Diseases Society of America2021

Urine Lipoarabinomannan Testing in Adults With Advanced Human Immunodeficiency Virus in a Trial of Empiric Tuberculosis Therapy.

Mitch M Matoga, Gregory P Bisson, Amita Gupta, Sachiko Miyahara, Xin Sun, Carrie Fry, Yukari C Manabe, Johnstone Kumwenda, Kanyama Cecilia, Mulinda Nyirenda and 6 more

Open access · hybridAbstract read
In one paragraph

Article in Clinical infectious diseases : an official publication of the Infectious Diseases Society of America, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed
0.3field-weighted citation impact, top 40% 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

3 citing papers in PubMed, 6 citations in OpenAlex.

  1. Article
  2. Review
  3. Article
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

16 authors at 8 institutions in 5 countries.

Mitch M MatogaUniversity of North Carolina Project, Lilongwe, Malawi.ORCID 0000-0002-6542-8193
Gregory P BissonDivision of Infectious Diseases, Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania, USA.
Amita GuptaCenter for Clinical Global Health Education, Division of Infectious Diseases, Department of Medicine, Johns Hopkins University, Baltimore, Maryland, USA.ORCID 0000-0001-7036-2718
Sachiko MiyaharaCenter for Biostatistics in AIDS Research, Department of Biostatistics, Harvard T. H. Chan School of Public Health, Boston, Massachusetts, USA.
Xin SunCenter for Biostatistics in AIDS Research, Department of Biostatistics, Harvard T. H. Chan School of Public Health, Boston, Massachusetts, USA.
Carrie FryFrontier Science Foundation, Amherst, New York, USA.
Yukari C ManabeDivision of Infectious Diseases, Department of Medicine, Johns Hopkins University School of Medicine, Baltimore, Maryland, USA.
Johnstone KumwendaMalawi College of Medicine-Johns Hopkins University Research Project, Blantyre, Malawi.
Kanyama CeciliaUniversity of North Carolina Project, Lilongwe, Malawi.
Mulinda NyirendaMalawi College of Medicine-Johns Hopkins University Research Project, Blantyre, Malawi.
McNeil NgongondoUniversity of North Carolina Project, Lilongwe, Malawi.
Abineli MbeweUniversity of North Carolina Project, Lilongwe, Malawi.
David LagatMoi University School of Medicine, Eldoret, Kenya.
Carole WallisBioanalytical Research Corporation and Lancet Laboratories, Johannesburg, South Africa.
Henry MugerwaJoint Clinical Research Centre, Kampala, Uganda.
Mina C HosseinipourDivision of Infectious Diseases, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina,USA.
Johns Hopkins University · USCancer Research And Biostatistics · USFrontier Science & Technology Research Foundation · USJoint Clinical Research Centre · UGLancet Laboratories · ZAMoi University · KEUniversity of North Carolina at Chapel Hill · USUniversity of Pennsylvania · 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
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
LC: HIV Prevention Trials Network - Laboratory Support for the SARS-CoV-2 Seroprevalence Study (CoVPN 5002)UM1AI068613 · NIAID · JOHNS HOPKINS UNIVERSITY · PI SUSAN H ESHLEMAN, Mark A Marzinke · 2011 to 2026
$100.2M
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
The Malawi Clinical Trials UnitUM1AI069518 · NIAID · JOHNS HOPKINS UNIVERSITY · PI JACKY M JENNINGS, TAHA E TAHA · 2012 to 2026
$43.8M
TrainingU54EB007958 · NIBIB · JOHNS HOPKINS UNIVERSITY · PI Yukari C Manabe, Susan Anne Tuddenham · 2007 to 2026
$34.6M
The Johns Hopkins Baltimore-Washington-India Clinical Trials Unit (BWI CTU)UM1AI069465 · NIAID · JOHNS HOPKINS UNIVERSITY · PI Charles W. Flexner, Amita Gupta · 2012 to 2026
$34.1M
United States Military HIV Research Program (MHRP) Clinical Trials UnitUM1AI108568 · NIAID · WALTER REED ARMY INSTITUTE OF RESEARCH · PI Julie A. Ake, Merlin L Robb · 2014 to 2026
$24.3M
UJMT – ORWH – Gazzetta, Issa-BoubeD43TW009340 · FIC · UNIV OF NORTH CAROLINA CHAPEL HILL · PI William Checkley, Benjamin H. Chi · 2017 to 2026
$14.8M
NURTURE:Research Training and Mentoring Program for Career Development of Faculty at Makerere University College of Health SciencesD43TW010132 · FIC · MAKERERE UNIVERSITY COLLEGE OF HEALTH SCIENCES · PI SEWANKAMBO, NELSON K · 2015 to 2019
$4.3M
HIV Co-infections in Uganda: TB, Cryptococcus, and Viral Hepatitis.D43TW009771 · FIC · JOHNS HOPKINS UNIVERSITY · PI CASTELNUOVO, BARBARA, KAMBUGU, ANDREW DDUNGU · 2014 to 2023
$3.3M
FIC NIH HHS D43 TW009340FIC NIH HHS D43 TW009771FIC NIH HHS D43 TW010132NIAID NIH HHS R01 AI080417NIAID NIH HHS UM1 AI068613NIAID NIH HHS UM1 AI068634NIAID NIH HHS UM1 AI068636NIAID NIH HHS UM1 AI069423NIAID NIH HHS UM1 AI069465NIAID NIH HHS UM1 AI069518NIAID NIH HHS UM1 AI106701NIAID NIH HHS UM1 AI108568NIBIB NIH HHS U54 EB007958
6 · The paper itself

Abstract

backgroundThe urine lipoarabinomannan (LAM) antigen test is a tuberculosis (TB) diagnostic test with highest sensitivity in individuals with advanced human immunodeficiency virus (HIV). Its role in TB diagnostic algorithms for HIV-positive outpatients remains unclear.

methodsThe AIDS Clinical Trials Group (ACTG) A5274 trial demonstrated that empiric TB therapy did not improve 24-week survival compared to isoniazid preventive therapy (IPT) in TB screen-negative HIV-positive adults initiating antiretroviral therapy with CD4 counts <50 cells/µL. Retrospective LAM testing was performed on stored urine obtained at baseline. We determined the proportion of LAM-positive participants and conducted modified intent-to-treat analysis excluding LAM-positive participants to determine the effect on 24-week survival, TB incidence, and time to TB using Kaplan-Meier method.

resultsA5274 enrolled 850 participants; 53% were male and the median CD4 count was 18 (interquartile range, 9-32) cells/µL. Of the 850, 566 (67%) had LAM testing (283 per arm); 28 (5%) were positive (21 [7%] and 7 [2%] in the empiric and IPT arms, respectively). Of those LAM-positive, 1 participant in each arm died and 5 of 21 and 0 of 7 in empiric and IPT arms, respectively, developed TB. After excluding these 28 cases, there were 19 and 21 deaths in the empiric and IPT arms, respectively (P = .88). TB incidence remained higher (4.6% vs 2%, P = .04) and time to TB remained faster in the empiric arm (P = .04).

conclusionsAmong outpatients with advanced HIV who screened negative for TB by clinical symptoms, microscopy, and Xpert testing, LAM testing identified an additional 5% of individuals with TB. Positive LAM results did not change mortality or TB incidence.

Indexed as

HIV InfectionsTuberculosisAdultDiagnostic Tests, RoutineHIVHumansLipopolysaccharidesMalePoint-of-Care SystemsRetrospective StudiesSensitivity and SpecificitylipoarabinomannanLipopolysaccharidesadvanced HIV diseaseempiric TB therapyisoniazid preventive therapytuberculosisurine LAM

Identifiers

PMID34398958
PMCPMC8366821
OpenAlexW3135239998

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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.