Evidence map›Paper›PMID 25582793›Full record

Trial reportBMC infectious diseases2015

Predictors and outcomes of Mycobacterium tuberculosis bacteremia among patients with HIV and tuberculosis co-infection enrolled in the ACTG A5221 STRIDE study.

John A Crump, Xingye Wu, Michelle A Kendall, Prudence D Ive, Johnstone J Kumwenda, Beatriz Grinsztejn, Ute Jentsch, Susan Swindells

Registry-linked trialOpen access · goldAbstract readRandomized Controlled Trial
In one paragraph

Trial report in BMC infectious diseases, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00108862 (A Strategy Study of Immediate Versus Deferred Initiation of Antiretroviral Therapy for AIDS Disease-Free Survival in HIV-Infected Persons Treated for Tuberculosis With CD4 Less Than 250 Cells/mm^3), which is not on this map. Cited by 10 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
10citing papers in PubMed, 2 pooled it
2.7field-weighted citation impact, top 10% 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.

NCT00108862 phase4completednot on this map

A Strategy Study of Immediate Versus Deferred Initiation of Antiretroviral Therapy for AIDS Disease-Free Survival in HIV-Infected Persons Treated for Tuberculosis With CD4 Less Than 250 Cells/mm^3

TypeinterventionalSponsorAdvancing Clinical Therapeutics Globally for HIV/AIDS and Other InfectionsRan2006 to 2010Enrolled809ConditionsHIV Infection, TuberculosisArmsStrategy: Immediate ART, Strategy: Deferred ART
3 · Its place in the literature

Who cites it

10 citing papers in PubMed, 2 syntheses or guidelines pooled it, 16 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Review
  4. Review
  5. Article
  6. Article
  7. Mortality in Severe Human Immunodeficiency Virus-Tuberculosis Associates With Innate Immune Activation and Dysfunction of Monocytes.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2017
    Article
  8. Observational
  9. Mycobacterium tuberculosis Bacteremia Among Acutely Febrile Children in Western Kenya.The American journal of tropical medicine and hygiene · 2015
    Article
  10. 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

8 authors at 6 institutions in 5 countries.

John A CrumpDepartment of Medicine, Division of Infectious Diseases and International Health, Durham, NC, 27710, USA. john.crump@duke.edu.
Xingye WuCenter for Biostatistics in AIDS Research, Harvard School of Public Health, 651 Huntington Avenue, Boston, MA, 02115, USA. xwu@sdac.harvard.edu.
Michelle A KendallCenter for Biostatistics in AIDS Research, Harvard School of Public Health, 651 Huntington Avenue, Boston, MA, 02115, USA. kendall@sdac.harvard.edu.
Prudence D IveDepartment of Medicine, University of the Witwatersrand, Private Bag 3, Wits 2050, Johannesburg, South Africa. pive@witshealth.co.za.
Johnstone J KumwendaDepartment of Internal Medicine, College of Medicine, University of Malawi, Private Bag 360, Chichiri, Blantyre 3, Malawi. jonnykumwenda@hotmail.com.
Beatriz GrinsztejnEvandro Chagas Clinical Research Institute, Oswaldo Cruz Foundation, Avenue Brasil 4365, Manguinhos 21040-360, Rio de Janeiro, Brazil. beatriz.grinsztejn@gmail.com.
Ute JentschSchool of Pathology, University of the Witwatersrand, Private Bag 3, Wits 2050, Johannesburg, South Africa. ujentsch@cls.co.za.
Susan SwindellsDivision of Infectious Diseases, Department of Internal Medicine, University of Nebraska Medical Center, 42nd and Emile, Omaha, NE 68198, USA. sswindells@unmc.edu.
Cancer Research And Biostatistics · USUniversity of the Witwatersrand · ZADuke University · USFundação Oswaldo Cruz · BRUniversity of Malawi · MWUniversity of Nebraska 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
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
The Malawi Clinical Trials UnitUM1AI069518 · NIAID · JOHNS HOPKINS UNIVERSITY · PI JACKY M JENNINGS, TAHA E TAHA · 2012 to 2026
$43.8M
Wits HIV Research Group CLINICAL TRIAL UNIT (CTU) reapplicationUM1AI069463 · NIAID · WITS HEALTH CONSORTIUM (PTY), LTD · PI REES, HELEN, SANNE, IAN MATTHIAS · 2012 to 2025
$31.8M
Botswana-Harvard T.H. Chan School of Public Health AIDS Initiative Partnership CTU Y18 SupplementUM1AI069456 · NIAID · THE BOTSWANA HARVARD HEALTH PARTNERSHIP · PI SHAHIN LOCKMAN, Joseph Moeketsi Makhema · 2012 to 2026
$29.4M
The FIOCRUZ Therapeutic and Prevention HIV/AIDS Clinical Trials Unit (FioTrials)UM1AI069476 · NIAID · FUNDACAO OSWALDO CRUZ · PI BEATRIZ GRINSZTEJN · 2012 to 2026
$26.3M
HIV/AIDS Clinical Trials UnitU01AI069484 · NIAID · DUKE UNIVERSITY · PI BARTLETT, JOHN A · 2007 to 2011
$14.6M
Colorado AIDS Clinical Trials UnitU01AI069450 · NIAID · UNIVERSITY OF COLORADO DENVER · PI CAMPBELL, THOMAS B. · 2007 to 2011
$8.3M
NIAID NIH HHS U01 AI068636NIAID NIH HHS U01 AI069450NIAID NIH HHS U01 AI069484NIAID NIH HHS UM1 AI068634NIAID NIH HHS UM1 AI068636NIAID NIH HHS UM1 AI069424NIAID NIH HHS UM1 AI069432NIAID NIH HHS UM1 AI069456NIAID NIH HHS UM1 AI069463NIAID NIH HHS UM1 AI069476NIAID NIH HHS UM1 AI069518NIAID NIH HHS UM1 AI106701
6 · The paper itself

Abstract

backgroundWe evaluated predictors and outcomes of Mycobacterium tuberculosis bacteremia among participants undergoing baseline mycobacterial blood culture in the ACTG A5221 STRIDE study, a randomized clinical trial comparing earlier with later ART among HIV-infected patients suspected of having tuberculosis with CD4-positive T-lymphocyte counts (CD4 counts) <250 cells/mm(3). We conducted a secondary analysis comparing participants with respect to presence or absence of M. tuberculosis bacteremia.

methodsParticipants with a baseline mycobacterial blood culture were compared with respect to the presence or absence of M. tuberculosis bacteremia. Baseline predictors of M. tuberculosis bacteremia were identified and participant outcomes were compared by mycobacteremia status.

resultsOf 90 participants with baseline mycobacterial blood cultures, 29 (32.2%) were female, the median (IQR) age was 37 (31-45) years, CD4 count was 81 (33-131) cells/mm(3), HIV-1 RNA level was 5.39 (4.96-5.83) log10 copies/mL, and 18 (20.0%) had blood cultures positive for M. tuberculosis. In multivariable analysis, lower CD4 count (OR 0.85 per 10-cell increase, p = 0.012), hemoglobin ≤8.5 g/dL (OR 5.8, p = 0.049), and confirmed tuberculosis (OR 17.4, p = 0.001) were associated with M. tuberculosis bacteremia. There were no significant differences in survival and AIDS-free survival, occurrence of tuberculosis immune reconstitution inflammatory syndrome (IRIS), or treatment interruption or discontinuation by M. tuberculosis bacteremia status. IRIS did not differ significantly between groups despite trends toward more virologic suppression and greater CD4 count increases at week 48 in the bacteremic group.

conclusionsAmong HIV-infected tuberculosis suspects, lower CD4 count, hemoglobin ≤8.5 g/dL, and the presence of microbiologically confirmed pulmonary tuberculosis were associated with increased adjusted odds of mycobacteremia. No evidence of an association between M. tuberculosis bacteremia and the increased risk of IRIS was detected.

trial registrationClinicalTrials.gov: NCT00108862 .

Indexed as

HIV-1AdultAge FactorsAntiretroviral Therapy, Highly ActiveBacteremiaCD4 Lymphocyte CountCoinfectionFemaleHIV InfectionsHumansMaleMiddle AgedMycobacterium tuberculosisSex FactorsSouth AfricaSurvival Analysis

Identifiers

PMID25582793
PMCPMC4297427
OpenAlexW2126632078

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.