Evidence map›Paper›PMID 24802242›Full record

ArticlePloS one2014

Baseline natural killer and T cell populations correlation with virologic outcome after regimen simplification to atazanavir/ritonavir alone (ACTG 5201).

John E McKinnon, Robbie B Mailliard, Susan Swindells, Timothy J Wilkin, Luann Borowski, Jillian M Roper, Barbara Bastow, Mary Kearney, Ann Wiegand, John W Mellors and 2 more

Registry-linked trialOpen access · goldAbstract readControlled Clinical Trial
In one paragraph

Article in PloS one, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00084019 (A Prospective, Open-Label, Pilot Trial of Regimen Simplification to Atazanavir/Ritonavir Alone as Maintenance Antiretroviral Therapy After Sustained Virologic Suppression), which is not on this map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
–field-weighted citation impact, top 84% 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.

NCT00084019 nacompletednot on this map

A Prospective, Open-Label, Pilot Trial of Regimen Simplification to Atazanavir/Ritonavir Alone as Maintenance Antiretroviral Therapy After Sustained Virologic Suppression

TypeinterventionalSponsorNational Institute of Allergy and Infectious Diseases (NIAID)Ran2004 to 2006Enrolled36ConditionsHIV InfectionsArmsAtazanavir, Ritonavir
3 · Its place in the literature

Who cites it

1 citing paper in PubMed, 2 citations in OpenAlex.

  1. HIV post-treatment controllers have distinct immunological and virological features.Proceedings of the National Academy of Sciences of the United States of America · 2023
    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

12 authors at 7 institutions in 1 country.

John E McKinnonHenry Ford Hospital System, Detroit, Michigan, United States of America.
Robbie B MailliardUniversity of Pittsburgh, Pittsburgh, Pennsylvania, United States of America.
Susan SwindellsUniversity of Nebraska Medical Center, Omaha, Nebraska, United States of America.
Timothy J WilkinWeill-Cornell Medical College, New York, New York, United States of America.
Luann BorowskiUniversity of Pittsburgh, Pittsburgh, Pennsylvania, United States of America.
Jillian M RoperGeorge Washington University, Washington, DC, United States of America.
Barbara BastowSocial & Scientific Systems, Inc., Silver Spring, Maryland, United States of America.
Mary KearneyHIV Drug Resistance Program, NCI, Frederick, Maryland, United States of America.
Ann WiegandHIV Drug Resistance Program, NCI, Frederick, Maryland, United States of America.
John W MellorsUniversity of Pittsburgh, Pittsburgh, Pennsylvania, United States of America.
Charles R RinaldoUniversity of Pittsburgh, Pittsburgh, Pennsylvania, United States of America.
A5201 study team
University of Pittsburgh · USFrederick National Laboratory for Cancer Research · USCornell University · USGeorge Washington University · USHenry Ford Hospital · USSocial and Scientific Systems (United States) · USUniversity 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
UNIVERSITY OF PITTSBURGH CLINICAL AND TRANSLATIONAL SCIENCE INSTITUTE: BPCAUL1RR024153 · NCRR · UNIVERSITY OF PITTSBURGH AT PITTSBURGH · PI REIS, STEVEN E · 2006 to 2011
$73.9M
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
University of Pittsburgh Multicenter AIDS Cohort Study (MACS)U01AI035041 · NIAID · UNIVERSITY OF PITTSBURGH AT PITTSBURGH · PI MARTINSON, JEREMY JAMES, RINALDO, CHARLES R · 1993 to 2018
$71.4M
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
University of Pittsburgh Clinical Trials UnitUM1AI069494 · NIAID · UNIVERSITY OF PITTSBURGH AT PITTSBURGH · PI SUSAN L KOLETAR, John W Mellors · 2012 to 2026
$38.0M
University of Pittsburgh Clinical and Translational Science InstitutionKL2RR024154 · NCRR · UNIVERSITY OF PITTSBURGH AT PITTSBURGH · PI REIS, STEVEN E · 2006 to 2011
$22.2M
University of North Carolina AIDS Clinical Trials Unit (UNC ACTU)U01AI069423 · NIAID · UNIV OF NORTH CAROLINA CHAPEL HILL · PI ERON, JOSEPH J · 2007 to 2011
$21.8M
University of Puerto Rico Clinical Trials UnitUM1AI069415 · NIAID · UNIVERSITY OF PUERTO RICO MED SCIENCES · PI FEBO, IRMA LUZ, SANTANA-BAGUR, JORGE L. · 2012 to 2021
$15.2M
NCRR NIH HHS 1KL2- RR024154-03NCRR NIH HHS K12 RR024154NCRR NIH HHS KL2 RR024154NCRR NIH HHS UL1 RR024153NIAID NIH HHS 1R21-AI084423-02NIAID NIH HHS AI069450NIAID NIH HHS R21 AI084423NIAID NIH HHS R37 AI041870NIAID NIH HHS R37-AI41870NIAID NIH HHS U01 AI035041NIAID NIH HHS U01 AI068636NIAID NIH HHS U01-AI068636NIAID NIH HHS U01 AI069423NIAID NIH HHS U01 AI069450NIAID NIH HHS U01-AI35041NIAID NIH HHS UM1 AI068634NIAID NIH HHS UM1 AI068636NIAID NIH HHS UM1 AI069415NIAID NIH HHS UM1 AI069419NIAID NIH HHS UM1 AI069423NIAID NIH HHS UM1 AI069450NIAID NIH HHS UM1 AI069494NIAID NIH HHS UM1 AI106701
6 · The paper itself

Abstract

objectivesSimplified maintenance therapy with ritonavir-boosted atazanavir (ATV/r) provides an alternative treatment option for HIV-1 infection that spares nucleoside analogs (NRTI) for future use and decreased toxicity. We hypothesized that the level of immune activation (IA) and recovery of lymphocyte populations could influence virologic outcomes after regimen simplification.

methodsThirty-four participants with virologic suppression ≥ 48 weeks on antiretroviral therapy (2 NRTI plus protease inhibitor) were switched to ATV/r alone in the context of the ACTG 5201 clinical trial. Flow cytometric analyses were performed on PBMC isolated from 25 patients with available samples, of which 24 had lymphocyte recovery sufficient for this study. Assessments included enumeration of T-cells (CD4/CD8), natural killer (NK) (CD3+CD56+CD16+) cells and cell-associated markers (HLA-DR, CD's 38/69/94/95/158/279).

resultsEight of the 24 patients had at least one plasma HIV-1 RNA level (VL) >50 copies/mL during the study. NK cell levels below the group median of 7.1% at study entry were associated with development of VL >50 copies/mL following simplification by regression and survival analyses (p = 0.043 and 0.023), with an odds ratio of 10.3 (95% CI: 1.92-55.3). Simplification was associated with transient increases in naïve and CD25+ CD4+ T-cells, and had no impact on IA levels.

conclusionsLower NK cell levels prior to regimen simplification were predictive of virologic rebound after discontinuation of nucleoside analogs. Regimen simplification did not have a sustained impact on markers of IA or T lymphocyte populations in 48 weeks of clinical monitoring.

trial registrationClinicalTrials.gov NCT00084019.

Indexed as

Atazanavir SulfateCD4-CD8 RatioHIV-1HIV InfectionsHIV Protease InhibitorsHumansKiller Cells, NaturalOligopeptidesPyridinesRitonavirRNA, ViralAtazanavir SulfateHIV Protease InhibitorsOligopeptidesPyridinesRitonavirRNA, Viral

Identifiers

PMID24802242
PMCPMC4011688
OpenAlexW2170423149

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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.