Evidence map›Paper›PMID 27347650›Full record

Trial reportHIV clinical trials2016

Characteristics associated with virologic failure in high-risk HIV-positive participants with prior failure: a post hoc analysis of ACTG 5251.

Gregory K Robbins, Susan E Cohn, Linda J Harrison, Laura Smeaton, Laura Moran, David Rusin, Marjorie Dehlinger, Theresa Flynn, Sara Lammert, Albert W Wu and 2 more

Registry-linked trialAbstract readMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in HIV clinical trials, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00988442 (A Randomized Trial of Enhanced Nursing Telephone Support to Improve Medication Self-Management and Viral Outcomes of Antiretroviral Therapy-Experienced Patients), which is not on this map. Cited by 5 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed, 1 pooled it
–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.

NCT00988442 phase2terminatednot on this map

A Randomized Trial of Enhanced Nursing Telephone Support to Improve Medication Self-Management and Viral Outcomes of Antiretroviral Therapy-Experienced Patients

TypeinterventionalSponsorAdvancing Clinical Therapeutics Globally for HIV/AIDS and Other InfectionsRan2010 to 2013Enrolled59ConditionsHIV InfectionsArmsEnhanced nursing telephone support, Standard care
3 · Its place in the literature

Who cites it

5 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
  2. Trial
  3. Article
  4. Article
  5. 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.

Gregory K Robbinsa Massachusetts General Hospital/Harvard Medical School , Boston, MA , USA.
Susan E Cohnb Department of Medicine , Northwestern University Feinberg School of Medicine , Chicago, IL , USA.
Linda J Harrisonc Center for Biostatistics in AIDS Research, Harvard TH Chan School of Public Health , Boston, MA , USA.
Laura Smeatonc Center for Biostatistics in AIDS Research, Harvard TH Chan School of Public Health , Boston, MA , USA.
Laura Morand Social and Scientific Systems, Inc , Silver Spring, MD , USA.
David Rusine Frontier Science & Technology Research Foundation , Amherst, NY , USA.
Marjorie Dehlingerf National Institute of Allergy and Infectious Diseases, National Institutes of Health , Bethesda, MD , USA.
Theresa Flynna Massachusetts General Hospital/Harvard Medical School , Boston, MA , USA.
Sara Lammerta Massachusetts General Hospital/Harvard Medical School , Boston, MA , USA.
Albert W Wug Johns Hopkins Bloomberg School of Public Health , Baltimore, MD , USA.
Steven A Safrenh Department of Psychology , University of Miami , Coral Gables, FL , USA.
Nancy R Reynoldsi School of Nursing , Yale University , New Haven, CT , USA.

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
Yale Clinical and Translational Science Award (U Component)UL1TR001863 · NCATS · YALE UNIVERSITY · PI John H. Krystal, LUCILA OHNO-MACHADO · 2016 to 2026
$102.9M
Virology, Immunology, and Microbiology CoreP30AI050410 · NIAID · UNIV OF NORTH CAROLINA CHAPEL HILL · PI DAVID M. MARGOLIS · 2001 to 2026
$76.9M
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
Harvard Medical School Vaccine Clinical Trials UnitUM1AI069412 · NIAID · BRIGHAM AND WOMEN'S HOSPITAL · PI Lindsey Robert Baden, Daniel R. Kuritzkes · 2012 to 2026
$57.2M
UCSD Department of Medicine HIV/AIDS Clinical Trials UnitUM1AI069432 · NIAID · UNIVERSITY OF CALIFORNIA, SAN DIEGO · PI TIMOTHY J. WILKIN · 2012 to 2026
$50.4M
Re-Entry Supplement: Investigation of Oral Microbial Enzymes for the Detection and Treatment of Periodontal DiseaseUL1TR002489 · NCATS · UNIV OF NORTH CAROLINA CHAPEL HILL · PI BUSE, JOHN BERNARD, SHAHEEN, NICHOLAS J · 2018 to 2022
$48.6M
Clinical and Translational Science CenterUL1TR000457 · NCATS · WEILL MEDICAL COLL OF CORNELL UNIV · PI IMPERATO-MCGINLEY, JULIANNE L · 2012 to 2016
$46.0M
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
North Carolina Translational & Clinical Sciences Institute (NC TraCS)UL1TR001111 · NCATS · UNIV OF NORTH CAROLINA CHAPEL HILL · PI BUSE, JOHN BERNARD, CAREY, TIMOTHY S · 2013 to 2017
$43.9M
NCATS NIH HHS UL1 TR000445NCATS NIH HHS UL1 TR000457NCATS NIH HHS UL1 TR001111NCATS NIH HHS UL1 TR001863NCATS NIH HHS UL1 TR002489NIAID NIH HHS K01 AI062435NIAID NIH HHS P30 AI050410NIAID NIH HHS P30 AI073961NIAID NIH HHS U01 AI068636NIAID NIH HHS U01 AI069419NIAID NIH HHS U01 AI069432NIAID NIH HHS U01 AI069465NIAID NIH HHS U01 AI069471NIAID NIH HHS U01 AI069501NIAID NIH HHS UM1 AI068634NIAID NIH HHS UM1 AI068636NIAID NIH HHS UM1 AI069412NIAID NIH HHS UM1 AI069419NIAID NIH HHS UM1 AI069423NIAID NIH HHS UM1 AI069432NIAID NIH HHS UM1 AI069439NIAID NIH HHS UM1 AI069452NIAID NIH HHS UM1 AI069465NIAID NIH HHS UM1 AI069471NIAID NIH HHS UM1 AI069501NIAID NIH HHS UM1 AI069503
6 · The paper itself

Abstract

unlabelledPatients with prior virologic failure (VF) are at an increased risk of subsequent failure, emergence of resistance, and death. This analysis identifies outcomes and correlates of VF in a high-risk population.

methodsA5251 was designed to evaluate an enhanced adherence counseling intervention delivered by nurses from a central call site on virologic suppression. Due to slow enrollment, the study was closed prematurely and revised study endpoints were evaluated (week 24 VF (HIV-1 RNA ≥200 copies/ml) and non-perfect adherence (<100% self-reported using both the ACTG adherence questionnaire and visual analog scale (VAS)).

resultsFifty-nine participants were enrolled, 43 (73%) black non-Hispanic and 23 (39%) women. Median prior antiretroviral regimen changes were three and the co-morbidity in this population was higher than typical for HIV clinical trials. At week 24 (n = 41), 24 (59%) failed to reach virologic suppression (HIV-1 RNA <200 copies/ml) and 25 (63%) reported non-perfect adherence. Higher depression (CES-D10) and adverse illness perceptions (IPQ-B) were associated with week 24 non-adherence. Early clinical assessments (week 12 HIV-RNA ≥200 copies/mL and non-perfect adherence) as well as higher depression and adverse illness perceptions were associated with week 24 VF. DISCUSSION: In this high-risk population, the proportion of participants with suboptimal adherence and VF was unacceptably high. Interventions to address this treatment gap are clearly needed. Depression and a higher illness perception score, failure to achieve virologic suppression by week 12, and less than perfect adherence could be used to target individuals for early interventions in treatment-experienced, high-risk individuals at high risk for VF.

Indexed as

Antiretroviral Therapy, Highly ActiveHIV-1AdultAgedAnti-HIV AgentsCD4 Lymphocyte CountDrug Resistance, ViralFemaleHIV InfectionsHumansMaleMedication AdherenceMiddle AgedRisk FactorsStandard of CareTime FactorsAnti-HIV AgentsAdherenceAntiretroviral therapyCenter for Epidemiological Studies Depression Scale (CES-D10)Combination antiretroviral therapy (ART)High risk populationsHuman immunodeficiency virus (HIV)IPQ-B Brief Illness Perception Questionnaire (IPQ-B)Virologic failureVisual Analog Scale (VAS)

Identifiers

PMID27347650
PMCPMC5035042

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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.