Evidence map›Paper›PMID 23148287›Full record

Trial reportThe Journal of infectious diseases2012

HIV-1 amino acid changes among participants with virologic failure: associations with first-line efavirenz or atazanavir plus ritonavir and disease status.

Katie Mollan, Eric S Daar, Paul E Sax, Maya Balamane, Ann C Collier, Margaret A Fischl, Christina M Lalama, Ronald J Bosch, Camlin Tierney, David Katzenstein and 1 more

Registry-linked trialOpen access · bronzeAbstract readRandomized Controlled Trial
In one paragraph

Trial report in The Journal of infectious diseases, 2012. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00118898 (A Phase IIIB, Randomized Trial of Open-Label Efavirenz or Atazanavir With Ritonavir in Combination With Double-Blind Comparison of Emtricitabine/Tenofovir or Abacavir/Lamivudine in Antiretroviral-Naive Subjects), which is not on this map. Cited by 16 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
16citing papers in PubMed, 2 pooled it
0.6field-weighted citation impact, top 31% 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.

NCT00118898 phase3completednot on this map

A Phase IIIB, Randomized Trial of Open-Label Efavirenz or Atazanavir With Ritonavir in Combination With Double-Blind Comparison of Emtricitabine/Tenofovir or Abacavir/Lamivudine in Antiretroviral-Naive Subjects

TypeinterventionalSponsorAdvancing Clinical Therapeutics Globally for HIV/AIDS and Other InfectionsRan2005 to 2009Enrolled1,864ConditionsHIV InfectionsArmsAbacavir/Lamivudine, Atazanavir, Efavirenz, Emtricitabine/Tenofovir disoproxil fumarate, Ritonavir
3 · Its place in the literature

Who cites it

16 citing papers in PubMed, 2 syntheses or guidelines pooled it, 18 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. HIV and Drug-Resistant Subtypes.Microorganisms · 2023
    Review
  4. Article
  5. Article
  6. Article
  7. Article
  8. Article
  9. Article
  10. Observational
  11. Article
  12. HIV-1 drug resistance and resistance testing.Infection, genetics and evolution : journal of molecular epidemiology and evolutionary genetics in infectious diseases · 2016
    Review
  13. Article
  14. Article
  15. Article
  16. 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

11 authors at 6 institutions in 1 country.

Katie MollanHarvard School of Public Health, Center for Biostatistics in AIDS Research, FXB Bldg, 651 Huntington Ave, Boston, MA 02115-6017, USA. kmollan@sdac.harvard.edu
Eric S Daar
Paul E Sax
Maya Balamane
Ann C Collier
Margaret A Fischl
Christina M Lalama
Ronald J Bosch
Camlin Tierney
David Katzenstein
AIDS Clinical Trials Group Study A5202 Team
Harvard University · USPalo Alto University · USBrigham and Women's Hospital · USHarborview Medical Center · USThe Lundquist Institute · USUniversity of Miami · US

Funding

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
WOMEN'S HEALTH AGENDAU01AI038858 · NIAID · SOCIAL AND SCIENTIFIC SYSTEMS, INC. · PI BENSON, CONSTANCE ANN · 1996 to 2008
$157.5M
AIDS Clinical Trials Group NetworkU01AI068636 · NIAID · SOCIAL AND SCIENTIFIC SYSTEMS, INC. · PI KURITZKES, DANIEL R. · 2006 to 2010
$147.1M
The impact of HIV viral diversity and cellular immunity on HIV pathogenesisP30AI060354 · NIAID · HARVARD UNIVERSITY (MEDICAL SCHOOL) · PI ROBERT A. PARKER · 2004 to 2026
$94.4M
Statistical and Data Management Center for the AIDS Clinical Trials GroupU01AI068634 · NIAID · HARVARD SCHOOL OF PUBLIC HEALTH · PI HUGHES, MICHAEL DAVID · 2006 to 2010
$71.9M
UCLA Clinical and Translational Science InstituteUL1TR000124 · NCATS · UNIVERSITY OF CALIFORNIA LOS ANGELES · PI DUBINETT, STEVEN M. · 2012 to 2015
$57.0M
CTSA INFRASTRUCTURE FOR PEDIATRIC RESEARCHUL1RR024989 · NCRR · CASE WESTERN RESERVE UNIVERSITY · PI DAVIS, PAMELA B · 2007 to 2011
$53.7M
UNIVERSITY OF ROCHESTER'S RESEARCH ASSOCIATE ORGANIZATIONUL1RR024160 · NCRR · UNIVERSITY OF ROCHESTER · PI PEARSON, THOMAS ARTHUR · 2006 to 2011
$38.7M
Miami Treatment and Prevention Clinical Trials Unit (CTU)UM1AI069477 · NIAID · UNIVERSITY OF MIAMI SCHOOL OF MEDICINE · PI JAYAWEERA, DUSHYANTHA, SCOTT, GWENDOLYN BARBARA · 2012 to 2020
$9.2M
NCATS NIH HHS UL1 TR000124NCRR NIH HHS UL1 RR024160NIAID NIH HHS AI38858NIAID NIH HHS AI68634NIAID NIH HHS P30 AI060354NIAID NIH HHS U01 AI038858NIAID NIH HHS U01 AI068634NIAID NIH HHS U01 AI068636NIAID NIH HHS U01AI068636NIAID NIH HHS UM1 AI068634NIAID NIH HHS UM1 AI069477
6 · The paper itself

Abstract

backgroundAlthough specific human immunodeficiency virus type 1 (HIV-1) drug resistance mutations are well studied, little is known about cumulative amino acid changes, or how regimen and participant characteristics influence these changes.

methodsIn the AIDS Clinical Trials Group randomized study A5202 of treatment-naive HIV-infected participants, cumulative HIV-1 amino acid changes from pretreatment to virologic failure were evaluated in protease and reverse transcriptase (RT) gene sequences.

resultsAmong 265 participants with virologic failure, those assigned atazanavir plus ritonavir (ATV/r) did not have significantly more protease changes compared with those assigned efavirenz (EFV) (P ≥ .13). In contrast, participants with virologic failure assigned EFV had more RT changes, including and excluding known resistance codons (P < .001). At pretreatment, lower CD4 cell count, major resistance, more amino acid mixtures (all P < .001), hepatitis C antibody negativity (P = .05), and black race/ethnicity (P = .02) were associated with more HIV-1 amino acid changes.

conclusionsVirologic failure following EFV-containing treatment was associated with more HIV-1 amino acid changes compared to failure of ATV/r-containing treatment. Furthermore, we show that non-drug resistance mutations occurred more frequently among those failing EFV, the clinical relevance of which warrants further investigation. Pretreatment immunologic status may play a role in viral evolution during treatment, as evidenced by increased amino acid changes among those with lower pretreatment CD4 count. CLINICAL TRIALS REGISTRATION: NCT00118898.

Indexed as

Drug Resistance, ViralMutation, MissenseAdultAlkynesAmino Acid SubstitutionAnti-HIV AgentsAtazanavir SulfateBenzoxazinesCyclopropanesFemaleHIV-1HIV InfectionsHumansMaleOligopeptidesPyridinesAlkynesAnti-HIV AgentsAtazanavir SulfateBenzoxazinesCyclopropanesefavirenzOligopeptidesPyridinesRitonavir

Identifiers

PMID23148287
PMCPMC3502379
OpenAlexW2149062343

What OpenQuestion holds

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Read underepoch 390

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.