Evidence map›Paper›PMID 31157663›Full record

Trial reportAIDS (London, England)2019

The benefit of immediate compared with deferred antiretroviral therapy on CD4+ cell count recovery in early HIV infection.

Shweta Sharma, Katherine E Schlusser, Pola de la Torre, Giuseppe Tambussi, Rika Draenert, Angie N Pinto, Julia A Metcalf, James D Neaton, Oliver Laeyendecker, INSIGHT START Study Group

Abstract readComparative StudyRandomized Controlled Trial
In one paragraph

Trial report in AIDS (London, England), 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 15 papers.

0numbers the graph read from it
0cells of the map it votes in
15citing papers in PubMed
–field-weighted citation impact
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

15 citing papers in PubMed.

  1. Article
  2. Article
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  5. Article
  6. Article
  7. Review
  8. Article
  9. Article
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  11. Article
  12. Unique Needs for the Implementation of Emergency Department Human Immunodeficiency Virus Screening in Adolescents.Academic emergency medicine : official journal of the Society for Academic Emergency Medicine · 2020
    Article
  13. Determinants of suboptimal CD4Journal of the International AIDS Society · 2020
    Article
  14. Article
  15. 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

10 authors.

Shweta SharmaDivision of Biostatistics, School of Public Health, University of Minnesota, Minneapolis, Minnesota.
Katherine E SchlusserDepartment of Medicine, Johns Hopkins University School of Medicine, Baltimore, Maryland.
Pola de la TorreCooper University Hospital, Camden, New Jersey, USA.
Giuseppe TambussiIRCCS Ospedale San Raffaele, Milan, Italy.
Rika DraenertSection Clinical Infectious Diseases, Klinikum der Universität Munich, Medizinische Klinik IV, Munich, Germany.
Angie N PintoThe Kirby Institute, The University of New South Wales, Sydney, New South Wales, Australia.
Julia A MetcalfDivision of Clinical Research, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, Maryland, USA.
James D NeatonDivision of Biostatistics, School of Public Health, University of Minnesota, Minneapolis, Minnesota.
Oliver LaeyendeckerDepartment of Medicine, Johns Hopkins University School of Medicine, Baltimore, Maryland.
INSIGHT START Study Group

Funding

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
International Network for Strategic Initiatives in Global HIV Trials (INSIGHT)UM1AI068641 · NIAID · UNIVERSITY OF MINNESOTA · PI NEATON, JAMES DENNIS · 2011 to 2014
$83.5M
International Network for Strategic Initiatives in Global HIV Trials (INSIGHT): STARTUM1AI120197 · NIAID · UNIVERSITY OF MINNESOTA · PI NEATON, JAMES DENNIS · 2015 to 2017
$65.1M
Extended follow-up of randomized participants in the INSIGHT START trialU01AI136780 · NIAID · UNIVERSITY OF MINNESOTA · PI GRUND, BIRGIT, REILLY, CAVAN S. · 2019 to 2024
$18.0M
International Studies of the Acquired Immune Deficiency Syndrome (AIDS)ZIAAI000361 · NIAID · NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES · PI REDD, ANDREW · 2009 to 2025
$15.8M
Laboratory and Statistical Development of Cross-Sectional HIV Incidence AssaysR01AI095068 · NIAID · JOHNS HOPKINS UNIVERSITY · PI ESHLEMAN, SUSAN H · 2011 to 2021
$6.6M
Medical Research Council MC_UU_12023/23NIAID NIH HHS R01 AI095068NIAID NIH HHS U01 AI136780NIAID NIH HHS UM1 AI068613NIAID NIH HHS UM1 AI068641NIAID NIH HHS UM1 AI120197
6 · The paper itself

Abstract

objectiveTo assess the impact of immediate vs. deferred antiretroviral therapy (ART) on CD4 recovery among individuals early in HIV infection.

designUsing serologic markers of early infection together with self-reported dates of infection and HIV diagnosis, ART-naive participants who were randomized to immediate vs. deferred ART in the Strategic Timing of Antiretroviral Treatment trial were classified into subgroups of duration of HIV infection at baseline. CD4 cell count recovery over follow-up according to duration of HIV infection was investigated.

methodsThree subgroups were defined: first, infected 6 months or less (n = 373); second, infected 6-24 months (n = 2634); and third, infected 24 months or longer (n = 1605). Follow-up CD4, CD8, and CD4 : CD8 ratio for the immediate and deferred ART groups were compared by subgroup using linear models. For the deferred ART group, decline to CD4 less than 350 cells/μl or AIDS according to infection duration was compared using time-to-event methods.

resultsFollow-up CD4 cell count differences (immediate minus deferred) were greater for those recently infected (+231 cells/μl) compared with the two other subgroups (202 and 171 cells/μl; P < 0.001). CD4 : CD8 ratio treatment differences varied significantly (P < 0.001) according to duration of infection. In the deferred ART group, decline to CD4 less than 350 cells/μl or AIDS was greater among those recently infected (16.1 vs. 13.2 and 10.5 per 100 person years for those infected 6-24 and ≥24 months; P = 0.002).

conclusionIn this randomized comparison of immediate vs. deferred ART, the CD4 cell count difference was greatest for those recently infected with HIV, emphasizing the importance of immediate ART initiation.

Indexed as

AdultAgedAged, 80 and overAnti-Retroviral AgentsAntiretroviral Therapy, Highly ActiveCD4 Lymphocyte CountFemaleHIV InfectionsHumansMaleMiddle AgedSecondary PreventionTreatment OutcomeYoung AdultAnti-Retroviral Agents

Identifiers

PMID31157663
PMCPMC6561661

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Registered trials

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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.