Evidence map›Paper›PMID 31241541›Full record

Trial reportJournal of acquired immune deficiency syndromes (1999)2019

ART in HIV-Positive Persons With Low Pretreatment Viremia: Results From the START Trial.

Irini Sereti, Roy M Gulick, Sonya Krishnan, Stephen A Migueles, Adrian Palfreeman, Veronique Touzeau-Römer, Waldo H Belloso, Sean Emery, Matthew G Law, INSIGHT START Study Group

Open access · greenAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Journal of acquired immune deficiency syndromes (1999), 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 8 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
8citing papers in PubMed, 2 pooled it
0.9field-weighted citation impact, top 28% 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

8 citing papers in PubMed, 2 syntheses or guidelines pooled it, 14 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Observational
  4. Article
  5. Risk of Non-AIDS-Defining Events Is Lower in Antiretroviral Therapy (ART)-Naive HIV Controllers Than in Normal Progressors on Suppressive ART.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2025
    Article
  6. Article
  7. Article
  8. 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 at 6 institutions in 5 countries.

Irini SeretiHIV Pathogenesis Section, NIAID/NIH, Bethesda, MD.
Roy M GulickInfectious Diseases, Weill Cornell Medicine, Weill Cornell Medical College, Cornell University, New York, NY.
Sonya KrishnanHIV Pathogenesis Section, NIAID/NIH, Bethesda, MD.
Stephen A MiguelesHIV-Specific Immunity Section, NIAID/NIH, Bethesda, MD.
Adrian PalfreemanDepartment of Genitourinary Medicine, Leicester Royal Infirmary, Leicester, United Kingdom.
Veronique Touzeau-RömerDepartment of Immunodermatology and Infectious Skin Diseases, University Vienna General Hospital, Vienna, Austria.
Waldo H BellosoCICAL and Infectious Diseases Section, Internal Medicine Service, Hospital Italiano de Buenos Aires Argentina, Buenos Aires, Argentina.
Sean EmeryFaculty of Medicine, University of New South Wales, Sydney, Australia.
Matthew G LawFaculty of Medicine, Kirby Institute, University of New South Wales, Sydney, Australia.
INSIGHT START Study Group
UNSW Sydney · AUCornell University · USHospital Italiano de Buenos Aires · ARLeicester Royal Infirmary · GBNational Institute of Allergy and Infectious Diseases · USVienna General Hospital · AT

Funding

Disparities in COVID Disease Severity and Outcomes in New York CityUL1TR002384 · NCATS · WEILL MEDICAL COLL OF CORNELL UNIV · PI JULIANNE L IMPERATO-MCGINLEY · 2017 to 2026
$86.2M
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
CTSA INFRASTRUCTURE FOR PEDIATRIC RESEARCHUL1RR024996 · NCRR · WEILL MEDICAL COLL OF CORNELL UNIV · PI IMPERATO-MCGINLEY, JULIANNE L · 2007 to 2011
$49.6M
Immunopathogenic Mechanisms of Human Immunodeficiency Virus (HIV) DiseaseZIAAI001121 · NIAID · NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES · PI SERETI, IRINI · 2010 to 2025
$27.2M
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
Department of HealthMedical Research Council MC_UU_12023/23NCATS NIH HHS UL1 TR002384NCRR NIH HHS UL1 RR024996NIAID NIH HHS U01 AI136780NIAID NIH HHS UM1 AI068641NIAID NIH HHS UM1 AI120197
6 · The paper itself

Abstract

backgroundThe benefit of immediate antiretroviral therapy (ART) at CD4 >500 cells/μL was established in the Strategic Timing of Antiretroviral Treatment (START) study. The benefits and risks of immediate ART in participants with low pretreatment viremia, including virologic suppressors, were further assessed.

settingRandomized prospective international study.

methodsSTART participants with enrollment viremia <3000 c/mL were included. We compared clinical outcomes (grade 4 adverse events, hospitalizations, or death), plasma viremia, CD4 counts, and changes in biomarkers in immediate versus deferred ART groups.

resultsParticipants (N = 1134 including 93 with viremia ≤50 c/mL) had a median age of 37 years, 40% were women, and median CD4 was 713 cells/µL. Ninety-seven percent in the immediate and 29% in the deferred arm initiated ART at a median of 6 and 699 days, respectively. Clinical outcomes were experienced in 64 versus 61 patients in immediate and deferred arms (hazard ratio 1.10, 95% confidence interval: 0.77 to 1.56). The CD4 count difference was 125 cells/µL at 12 and 235 cells/µL at 36 months higher in the immediate versus deferred groups. D-dimer and VCAM levels decreased, and C-reactive protein increased, in the immediate arm at month 8. No significant changes in CD4 counts or biomarkers were observed in persons who maintained spontaneous virologic suppression.

conclusionsSTART participants with low enrollment viremia experienced higher CD4 counts, greater proportion with suppressed viremia, and decreases in D-dimer levels on immediate ART despite the lack of difference in serious clinical outcomes. These data support immediate ART in people with low viremia, although equipoise remains for suppressors.

Indexed as

AdultAnti-Retroviral AgentsBiomarkersCD4 Lymphocyte CountFemaleHIV InfectionsHIV SeropositivityHumansMaleMiddle AgedProportional Hazards ModelsProspective StudiesRNA, ViralViremiaAnti-Retroviral AgentsBiomarkersRNA, Viral

Identifiers

PMID31241541
PMCPMC6607914
OpenAlexW2940030007

What OpenQuestion holds

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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.