Evidence map›Paper›PMID 25948863›Full record

Trial reportThe Journal of infectious diseases2015

Changes in Bone Mineral Density After Initiation of Antiretroviral Treatment With Tenofovir Disoproxil Fumarate/Emtricitabine Plus Atazanavir/Ritonavir, Darunavir/Ritonavir, or Raltegravir.

Todd T Brown, Carlee Moser, Judith S Currier, Heather J Ribaudo, Jennifer Rothenberg, Theodoros Kelesidis, Otto Yang, Michael P Dubé, Robert L Murphy, James H Stein and 1 more

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

Trial report in The Journal of infectious diseases, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. It is linked to trial NCT00851799 (Cardiovascular, Anthropometric, and Skeletal Effects of Antiretroviral Therapy), which is not on this map. Cited by 67 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
67citing papers in PubMed, 1 pooled it
15.0field-weighted citation impact, top 1% 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.

NCT00851799 completednot on this map

Cardiovascular, Anthropometric, and Skeletal Effects of Antiretroviral Therapy (ART) Initiation With Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF) Plus Atazanavir/Ritonavir (ATV/r), Darunavir/Ritonavir (DRV/r), or Raltegravir (RAL): Metabolic Substudy of A5257

TypeobservationalSponsorAdvancing Clinical Therapeutics Globally for HIV/AIDS and Other InfectionsRan2009 to 2013Enrolled334ConditionsHIV InfectionArmsEmtricitabine/tenofovir disoproxil fumarate, Ritonavir, Atazanavir, Raltegravir, Darunavir
3 · Its place in the literature

Who cites it

67 citing papers in PubMed, 1 synthesis or guideline pooled it, 119 citations in OpenAlex.

  1. Diagnosis, prevention, and treatment of bone fragility in people living with HIV: a position statement from the Swiss Association against Osteoporosis.Osteoporosis international : a journal established as result of cooperation between the European Foundation for Osteoporosis and the National Osteoporosis Foundation of the USA · 2019
    Guideline
  2. Trial
  3. Trial
  4. Trial
  5. Trial
  6. Trial
  7. Trial
  8. Trial
  9. A Single-dose Zoledronic Acid Infusion Prevents Antiretroviral Therapy-induced Bone Loss in Treatment-naive HIV-infected Patients: A Phase IIb Trial.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2016
    Trial
  10. Trial
  11. Article
  12. Article
  13. Article
  14. Article
  15. Review
  16. Cardiometabolic health in people with HIV: expert consensus review.The Journal of antimicrobial chemotherapy · 2024
    Review
  17. Article
  18. Article
  19. Article
  20. Review

7 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

11 authors at 8 institutions in 1 country.

Todd T BrownJohns Hopkins University, Baltimore, Maryland.
Carlee MoserCenter for Biostatistics in AIDS Research, Harvard School of Public Health, Boston, Massachusetts.
Judith S CurrierDavid Geffen School of Medicine, University of California-Los Angeles.
Heather J RibaudoCenter for Biostatistics in AIDS Research, Harvard School of Public Health, Boston, Massachusetts.
Jennifer RothenbergSocial and Scientific Systems, Washington D.C.
Theodoros KelesidisDavid Geffen School of Medicine, University of California-Los Angeles.
Otto YangDavid Geffen School of Medicine, University of California-Los Angeles.
Michael P DubéKeck School of Medicine, University of Southern California, Los Angeles, California.
Robert L MurphyFeinberg School of Medicine, Northwestern University, Chicago, Illinois.
James H SteinUniversity of Wisconsin School of Medicine and Public Health, Madison.
Grace A McComseyCase Western Reserve University School of Medicine, Cleveland, Ohio.
University of California, Los Angeles · USCancer Research And Biostatistics · USCase Western Reserve University · USJohns Hopkins University · USNorthwestern University · USSocial and Scientific Systems (United States) · USUniversity of Southern California · USUniversity of Wisconsin–Madison · 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
The impact of HIV viral diversity and cellular immunity on HIV pathogenesisP30AI060354 · NIAID · HARVARD UNIVERSITY (MEDICAL SCHOOL) · PI RAJESH T GANDHI · 2004 to 2026
$94.4M
Engaging University of California Stakeholders for Biorespository ResearchUL1TR000004 · NCATS · UNIVERSITY OF CALIFORNIA, SAN FRANCISCO · PI GRANDIS, JENNIFER RUBIN · 2012 to 2015
$78.0M
Virology, Immunology, and Microbiology CoreP30AI050410 · NIAID · UNIV OF NORTH CAROLINA CHAPEL HILL · PI DAVID M. MARGOLIS · 2001 to 2026
$76.9M
Virology and Molecular Biomarkers CoreP30AI050409 · NIAID · EMORY UNIVERSITY · PI Ann M Chahroudi, Colleen F Kelley · 2002 to 2026
$74.0M
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
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
Institute for Clinical and Translational ResearchUL1TR001079 · NCATS · JOHNS HOPKINS UNIVERSITY · PI FORD, DANIEL ERNEST · 2013 to 2017
$60.1M
UCLA Clinical and Translational Science InstituteUL1TR000124 · NCATS · UNIVERSITY OF CALIFORNIA LOS ANGELES · PI DUBINETT, STEVEN M. · 2012 to 2015
$57.0M
NCATS NIH HHS 1UL1TR001111NCATS NIH HHS UL1 TR000004NCATS NIH HHS UL1 TR000124NCATS NIH HHS UL1TR000124NCATS NIH HHS UL1 TR000170NCATS NIH HHS UL1TR000170NCATS NIH HHS UL1 TR000439NCATS NIH HHS UL1TR000439NCATS NIH HHS UL1 TR000445NCATS NIH HHS UL1 TR000454NCATS NIH HHS UL1 TR001079NCATS NIH HHS UL1TR001079NCATS NIH HHS UL1 TR001082NCATS NIH HHS UL1 TR001111NCATS NIH HHS UL1 TR002489NCATS NIH HHS UL1TR024160NCRR NIH HHS UL1 RR024160NHLBI NIH HHS HL095126NHLBI NIH HHS HL095132NHLBI NIH HHS R01 HL095126NHLBI NIH HHS R01 HL095132NIAID NIH HHS 2 UM1 AI068636-08NIAID NIH HHS 2UM1 AI069418-08NIAID NIH HHS 2UM1AI069432NIAID NIH HHS 2UM1AI069439-08NIAID NIH HHS 2UM1 AI069465NIAID NIH HHS 2 UM1 AI069503-08NIAID NIH HHS 5U01AI069471NIAID NIH HHS 5UM1AI069484-07NIAID NIH HHS AI068634NIAID NIH HHS AI 068636NIAID NIH HHS AI069424NIAID NIH HHS AI069432NIAID NIH HHS AI069439NIAID NIH HHS AI-069471NIAID NIH HHS AI069501NIAID NIH HHS AI56933NIAID NIH HHS AI69471NIAID NIH HHS AI 69501NIAID NIH HHS K24 AI056933NIAID NIH HHS P30 AI028697NIAID NIH HHS P30 AI050409NIAID NIH HHS P30AI050409NIAID NIH HHS P30 AI050410NIAID NIH HHS P30 AI060354NIAID NIH HHS P30AI50410NIAID NIH HHS U01 AI068634NIAID NIH HHS U01 AI068636NIAID NIH HHS U01AI068636NIAID NIH HHS U01 AI069424NIAID NIH HHS U01 AI069432NIAID NIH HHS U01 AI069439NIAID NIH HHS U01 AI069471NIAID NIH HHS U01 AI069481NIAID NIH HHS U01 AI069501NIAID NIH HHS UM1 AI068634NIAID NIH HHS UM1 AI068636NIAID NIH HHS UM1 AI069418NIAID NIH HHS UM1 AI069423NIAID NIH HHS UM1 AI069423-08NIAID NIH HHS UM1 AI069424NIAID NIH HHS UM1 AI069432NIAID NIH HHS UM1 AI069439NIAID NIH HHS UM1AI069439NIAID NIH HHS UM1 AI069465NIAID NIH HHS UM1 AI069471NIAID NIH HHS UM1 AI069472NIAID NIH HHS UM1AI069472NIAID NIH HHS UM1 AI069481NIAID NIH HHS UM1 AI069484NIAID NIH HHS UM1 AI069494NIAID NIH HHS UM1AI069494NIAID NIH HHS UM1 AI069496NIAID NIH HHS UM1 AI069501NIAID NIH HHS UM1 AI069503NIAID NIH HHS UM1 AI069511NIAID NIH HHS UM1 AI069532NIAID NIH HHS UM1 AI106701NIAID NIH HHS UM1AI68634PHS HHS A1069424PHS HHS UMAI069481
6 · The paper itself

Abstract

backgroundSpecific antiretroviral therapy (ART) medications and the severity of human immunodeficiency virus (HIV) disease before treatment contribute to bone mineral density (BMD) loss after ART initiation.

methodsWe compared the percentage change in BMD over 96 weeks in 328 HIV-infected, treatment-naive individuals randomized equally to tenofovir disoproxil fumarate/emtricitabine (TDF/FTC) plus atazanavir/ritonavir (ATV/r), darunavir/ritonavir (DRV/r), or raltegravir (RAL). We also determined whether baseline levels of inflammation markers and immune activation were independently associated with BMD loss.

resultsAt week 96, the mean percentage changes from baseline in spine and hip BMDs were similar in the protease inhibitor (PI) arms (spine: -4.0% in the ATV/r group vs -3.6% in the DRV/r [P = .42]; hip: -3.9% in the ATV/r group vs -3.4% in the DRV/r group [P = .36]) but were greater in the combined PI arms than in the RAL arm (spine: -3.8% vs -1.8% [P < .001]; hip: -3.7% vs -2.4% [P = .005]). In multivariable analyses, higher baseline concentrations of high-sensitivity C-reactive protein, interleukin 6, and soluble CD14 were associated with greater total hip BMD loss, whereas markers of CD4(+) T-cell senescence and exhaustion (CD4(+)CD28(-)CD57(+)PD1(+)) and CD4(+) T-cell activation (CD4(+)CD38(+)HLA-DR(+)) were associated with lumbar spine BMD loss.

conclusionsBMD losses 96 weeks after ART initiation were similar in magnitude among patients receiving PIs, ATV/r, or DRV/r but lowest among those receiving RAL. Inflammation and immune activation/senescence before ART initiation independently predicted subsequent BMD loss.

Indexed as

AdultAnti-HIV AgentsAtazanavir SulfateBone DensityDarunavirDrug Therapy, CombinationEmtricitabineFemaleHIVHIV InfectionsHIV Integrase InhibitorsHIV Protease InhibitorsHumansMaleMiddle AgedRaltegravir PotassiumAnti-HIV AgentsAtazanavir SulfateDarunavirEmtricitabineHIV Integrase InhibitorsHIV Protease InhibitorsRaltegravir PotassiumReverse Transcriptase InhibitorsRitonavirTenofovirbone mineral densityhuman immunodeficiency virusinflammationintegrase inhibitorprotease inhibitor

Identifiers

PMID25948863
PMCPMC4577040
OpenAlexW1940034849

What OpenQuestion holds

Textmetadata
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.