Evidence map›Paper›PMID 37183889›Full record

Trial reportClinical infectious diseases : an official publication of the Infectious Diseases Society of America2023

Antiretroviral Therapy Intensification for Neurocognitive Impairment in Human Immunodeficiency Virus.

Scott L Letendre, Huichao Chen, Ashley McKhann, Jhoanna Roa, Alyssa Vecchio, Eric S Daar, Baiba Berzins, Peter W Hunt, Christina M Marra, Thomas B Campbell and 14 more

Open access · bronzeAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Clinical infectious diseases : an official publication of the Infectious Diseases Society of America, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 20 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
20citing papers in PubMed, 1 pooled it
3.5field-weighted citation impact, top 7% 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

20 citing papers in PubMed, 1 synthesis or guideline pooled it, 25 citations in OpenAlex.

  1. Pooled it
  2. Trial
  3. Review
  4. Article
  5. Review
  6. Review
  7. Article
  8. Article
  9. The miRNomics of antiretroviral therapy-induced obesity.Functional & integrative genomics · 2025
    Review
  10. Article
  11. Article
  12. Risk factors for cognitive decline in persons with HIV.Current opinion in infectious diseases · 2025
    Review
  13. Review
  14. Review
  15. Review
  16. Review
  17. Article
  18. Article
  19. Review
  20. 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

24 authors at 14 institutions in 1 country.

Scott L LetendreUniversity of California-San Diego, San Diego, California, USA.ORCID 0000-0003-3490-4975
Huichao ChenHarvard T. H. Chan School of Public Health, Boston, Massachusetts, USA.
Ashley McKhannHarvard T. H. Chan School of Public Health, Boston, Massachusetts, USA.
Jhoanna RoaDLH Corporation, Silver Spring, Maryland, USA.
Alyssa VecchioUniversity of North Carolina, Chapel Hill, North Carolina, USA.
Eric S DaarLundquist Institute at Harbor-University of California-Los Angeles Medical Center, Torrance, California, USA.
Baiba BerzinsNorthwestern University, Chicago, Illinois, USA.
Peter W HuntUniversity of California-San Francisco, San Francisco, California, USA.
Christina M MarraUniversity of Washington School of Medicine, Seattle, Washington, USA.
Thomas B CampbellUniversity of Colorado School of Medicine, Denver, Colorado, USA.
Robert W CoombsUniversity of Washington School of Medicine, Seattle, Washington, USA.
Qing MaUniversity at Buffalo, Buffalo, New York, USA.ORCID 0000-0003-0123-9913
Shobha SwaminathanRutgers New Jersey Medical School, Newark, New Jersey, USA.
Bernard J C MacatangayUniversity of Pittsburgh, Pittsburgh, Pennsylvania, USA.
Gene D MorseUniversity at Buffalo, Buffalo, New York, USA.
Thomas MillerDLH Corporation, Silver Spring, Maryland, USA.
David RusinDLH Corporation, Silver Spring, Maryland, USA.
Alexander L GreningerUniversity of Washington School of Medicine, Seattle, Washington, USA.
Belinda HaViiV Healthcare Ltd, Research Triangle Park, North Carolina, USA.
Beverly Alston-SmithDivision of AIDS, National Institutes of Health, Rockville, Maryland, USA.
Kevin RobertsonUniversity of North Carolina, Chapel Hill, North Carolina, USA.
Robert PaulUniversity of Missouri, St. Louis, Missouri, USA.
Serena SpudichYale School of Medicine, New Haven, Connecticut, USA.
A5324 Study Team
University of Washington · USHarvard University · USUniversity at Buffalo, State University of New York · USUniversity of North Carolina at Chapel Hill · USNational Institutes of Health · USNorthwestern University · USRutgers, The State University of New Jersey · USUCLA Medical Center · USUniversity of California San Diego · USUniversity of California, San Francisco · USUniversity of Colorado Denver · USUniversity of Missouri–St. Louis · USUniversity of Pittsburgh · USYale University · 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
LC: HIV Vaccine Trials NetworkUM1AI068618 · NIAID · FRED HUTCHINSON CANCER RESEARCH CENTER · PI Margaret Juliana McElrath · 2011 to 2026
$483.6M
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
University of Washington/Fred Hutch Center for AIDS ResearchP30AI027757 · NIAID · UNIVERSITY OF WASHINGTON · PI CONNIE L CELUM · 1988 to 2026
$104.9M
Yale Clinical and Translational Science Award (U Component)UL1TR001863 · NCATS · YALE UNIVERSITY · PI John H. Krystal, LUCILA OHNO-MACHADO · 2016 to 2026
$102.9M
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
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
STRUCTURAL NEUROIMAGING COREP30MH062512 · NIMH · UNIVERSITY OF CALIFORNIA, SAN DIEGO · PI DAVID J MOORE · 2001 to 2026
$50.4M
Weill Cornell Medicine - Rutgers New Jersey Medical School Clinical Trials UnitUM1AI069419 · NIAID · WEILL MEDICAL COLL OF CORNELL UNIV · PI ROY M. GULICK · 2012 to 2026
$44.6M
NCATS NIH HHS UL1 TR001863NCATS NIH HHS UL1 TR002384NIAID NIH HHS P30 AI027757NIAID NIH HHS U01 AI068636NIAID NIH HHS U01 AI069424NIAID NIH HHS UM1 AI068618NIAID NIH HHS UM1 AI068634NIAID NIH HHS UM1 AI068636NIAID NIH HHS UM1 AI069419NIAID NIH HHS UM1 AI069424NIAID NIH HHS UM1 AI069432NIAID NIH HHS UM1 AI069463NIAID NIH HHS UM1 AI069471NIAID NIH HHS UM1 AI069481NIAID NIH HHS UM1 AI069494NIAID NIH HHS UM1 AI069511NIAID NIH HHS UM1 AI106701NIA NIH HHS R01 AG063659NIMH NIH HHS P30 MH062512
6 · The paper itself

Abstract

backgroundNeurocognitive impairment (NCI) in people with HIV (PWH) on antiretroviral therapy (ART) is common and may result from persistent HIV replication in the central nervous system.

methodsA5324 was a randomized, double-blind, placebo-controlled, 96-week trial of ART intensification with dolutegravir (DTG) + MVC, DTG + Placebo, or Dual - Placebo in PWH with plasma HIV RNA <50 copies/mL on ART and NCI. The primary outcome was the change on the normalized total z score (ie, the mean of individual NC test z scores) at week 48.

resultsOf 357 screened, 191 enrolled: 71% male, 51% Black race, 22% Hispanic ethnicity; mean age 52 years; mean CD4+ T-cells 681 cells/µL. Most (65%) had symptomatic HIV-associated NC disorder. Study drug was discontinued due to an adverse event in 15 (8%) and did not differ between arms (P = .17). Total z score, depressive symptoms, and daily functioning improved over time in all arms with no significant differences between them at week 48 or later. Adjusting for age, sex, race, study site, efavirenz use, or baseline z score did not alter the results. Body mass index modestly increased over 96 weeks (mean increase 0.32 kg/m2, P = .006) and did not differ between arms (P > .10).

conclusionsThis is the largest, randomized, placebo-controlled trial of ART intensification for NCI in PWH. The findings do not support empiric ART intensification as a treatment for NCI in PWH on suppressive ART. They also do not support that DTG adversely affects cognition, mood, or weight.

Indexed as

Anti-HIV AgentsHIV-1HIV InfectionsAntiretroviral Therapy, Highly ActiveCD4-Positive T-LymphocytesFemaleHumansMaleMiddle AgedViral LoadAnti-HIV Agentsantiretroviral therapybraincognitionHIV

Identifiers

PMID37183889
PMCPMC10506779
OpenAlexW4376616719

What Socratic holds

Textmetadata
Read underepoch 390

Registered trials

None linked

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 Socratic graph.