Evidence map›Paper›PMID 23204164›Full record

Trial reportThe Journal of infectious diseases2013

Changes in fat mitochondrial DNA and function in subjects randomized to abacavir-lamivudine or tenofovir DF-emtricitabine with atazanavir-ritonavir or efavirenz: AIDS Clinical Trials Group study A5224s, substudy of A5202.

Grace A McComsey, Eric S Daar, MaryAnn O'Riordan, Ann C Collier, Lisa Kosmiski, Jorge L Santana, Carl J Fichtenbaum, Heidi Fink, Paul E Sax, Daniel E Libutti and 1 more

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

Trial report in The Journal of infectious diseases, 2013. 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 38 papers.

0numbers the graph read from it
0cells of the map it votes in
38citing papers in PubMed
1.9field-weighted citation impact, top 14% 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

38 citing papers in PubMed, 57 citations in OpenAlex.

  1. Trial
  2. Trial
  3. Body Composition Changes After Initiation of Raltegravir or Protease Inhibitors: ACTG A5260s.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2016
    Trial
  4. Article
  5. Review
  6. Article
  7. Article
  8. Article
  9. Switch to Integrase Strand Transfer Inhibitors During the Menopausal Transition Is Associated With Accelerated Body Composition Change in Women With HIV.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2025
    Article
  10. Review
  11. Review
  12. Weight Gain After HIV Therapy Initiation: Pathophysiology and Implications.The Journal of clinical endocrinology and metabolism · 2024 · on this map
    Review
  13. Review
  14. Article
  15. Plants (Basel, Switzerland) · 2023
    Article
  16. The Potential ofCells · 2022
    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

11 authors at 8 institutions in 2 countries.

Grace A McComseyCase Western Reserve University, Cleveland, Ohio 44106, USA. grace.mccomsey@case.edu
Eric S Daar
MaryAnn O'Riordan
Ann C Collier
Lisa Kosmiski
Jorge L Santana
Carl J Fichtenbaum
Heidi Fink
Paul E Sax
Daniel E Libutti
Mariana Gerschenson
University of Hawaiʻi at Mānoa · USCase Western Reserve University · USHarborview Medical Center · USHarvard University · USThe Lundquist Institute · USUniversity of Cincinnati Medical Center · USUniversity of Colorado Denver · USUniversity of Puerto Rico System · PR

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
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 CENTERU01AI038855 · NIAID · HARVARD UNIVERSITY (SCH OF PUBLIC HLTH) · PI HUGHES, MICHAEL DAVID · 1996 to 2006
$78.1M
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
The Role of gp120 on Cardiovascular Disease in People Living with HIVU54MD007601 · NIMHD · UNIVERSITY OF HAWAII AT MANOA · PI Jerris Robert Hedges · 2017 to 2026
$59.5M
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
UCLA Clinical and Translational Science InstituteUL1TR000124 · NCATS · UNIVERSITY OF CALIFORNIA LOS ANGELES · PI DUBINETT, STEVEN M. · 2012 to 2015
$57.0M
Clinical and Translational Science CenterUL1TR000457 · NCATS · WEILL MEDICAL COLL OF CORNELL UNIV · PI IMPERATO-MCGINLEY, JULIANNE L · 2012 to 2016
$46.0M
UNDERSTANDING AND REDUCING ETHNIC DISPARITIES IN PREVENTABLE HOSPITALIZATIONSP20MD000173 · NIMHD · UNIVERSITY OF HAWAII AT MANOA · PI MAU, MARJORIE K. LEIMOMI MALA · 2002 to 2017
$21.0M
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
NCATS NIH HHS UL1 TR000124NCATS NIH HHS UL1 TR000457NIAID NIH HHS AI065348NIAID NIH HHS AI068634NIAID NIH HHS AI068636NIAID NIH HHS AI069434NIAID NIH HHS AI38855NIAID NIH HHS P30 AI060354NIAID NIH HHS R01 AI065348NIAID NIH HHS U01 AI038855NIAID NIH HHS U01 AI068634NIAID NIH HHS U01 AI068636NIAID NIH HHS U01 AI069434NIAID NIH HHS UM1 AI068634NIAID NIH HHS UM1 AI068636NIAID NIH HHS UM1 AI069412NIAID NIH HHS UM1 AI069415NIAID NIH HHS UM1 AI069434NIGMS NIH HHS GM103341NIGMS NIH HHS P30 GM103341NIMHD NIH HHS G12 MD007601NIMHD NIH HHS MD000173NIMHD NIH HHS MD007601NIMHD NIH HHS P20 MD000173NIMHD NIH HHS U54 MD007601
6 · The paper itself

Abstract

backgroundThe effect of nonthymidine nucleoside reverse-transcriptase inhibitors (NRTIs) on fat mitochondrial DNA (mtDNA) content and function is unclear.

methodsA5202 randomized antiretroviral therapy-naive human immunodeficiency virus-infected subjects to abacavir-lamivudine (ABC/3TC) versus tenofovir DF-emtricitabine (TDF/FTC) with efavirenz (EFV) or atazanavir-ritonavir (ATV/r). A5224s, substudy of A5202, enrolled 269 subjects with fat measurements by dual-energy x-ray absorptiometry and computed tomography. A subset of subjects underwent fat biopsies at baseline and week 96 for mtDNA content (real-time polymerase chain reaction) and oxidative phosphorylation nicotinamide adenine dinucleotide (reduced) dehydrogenase (complex I) and cytochrome c oxidase (complex IV) activity levels (immunoassays). Intent-to-treat analyses were performed using analysis of variance and paired t tests.

resultsFifty-six subjects (87% male; median age, 39 years) were included; their median body mass index, CD4 cell count, and fat mtDNA level were 26 kg/m(2), 227 cells/μL, and 1197 copies/cell, respectively. Fat mtDNA content decreased within the ABC/3TC and TDF/FTC groups (combining EFV and ATV/r arms; median change, -341 [interquartile range, -848 to 190; P = .03] and -400 [-661 to -221; P < .001] copies/cell, respectively), but these changes did not differ significantly between the 2 groups (P = .57). Complex I and IV activity decreased significantly in the TDF/FTC group (median change, -12.45 [interquartile range, -24.70 to 2.90; P = .003] and -8.25 [-13.90 to -1.30; P < .001], optical density × 10(3)/µg, respectively) but not the ABC/3TC group. Differences between the ABC/3TC and TDF/FTC groups were significant for complex I (P = .03).

conclusionsABC/3TC and TDF/FTC significantly and similarly decreased fat mtDNA content, but only TDF/FTC decreased complex I and complex IV activity levels. CLINICAL TRIALS REGISTRATION: NCT00118898.

Indexed as

AbacavirAdenineAdipose TissueAdultAlkynesAnti-HIV AgentsAtazanavir SulfateBenzoxazinesCyclopropanesDeoxycytidineDideoxynucleosidesDNA, MitochondrialDrug CombinationsDrug Therapy, CombinationEmtricitabineFemaleAbacavirabacavir, lamivudine drug combinationAdenineAlkynesAnti-HIV AgentsAtazanavir SulfateBenzoxazinesCyclopropanesDeoxycytidineDideoxynucleosidesDNA, MitochondrialDrug CombinationsefavirenzEmtricitabineLamivudineOligopeptidesOrganophosphonatesPyridinesReverse Transcriptase InhibitorsRitonavirTenofovir

Identifiers

PMID23204164
PMCPMC3549598
OpenAlexW2168688673

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.