Evidence map›Paper›PMID 25117929›Full record

Trial reportJournal of acquired immune deficiency syndromes (1999)2014

Changes in proteinuria and albuminuria with initiation of antiretroviral therapy: data from a randomized trial comparing tenofovir disoproxil fumarate/emtricitabine versus abacavir/lamivudine.

Christina M Wyatt, Douglas Kitch, Samir K Gupta, Camlin Tierney, Eric S Daar, Paul E Sax, Belinda Ha, Kathleen Melbourne, Grace A McComsey, AIDS Clinical Trials Group Study A5224s Team

Open access · greenAbstract readComparative StudyRandomized Controlled Trial
In one paragraph

Trial report in Journal of acquired immune deficiency syndromes (1999), 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 16 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
16citing papers in PubMed, 1 pooled it
3.5field-weighted citation impact, top 8% 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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

16 citing papers in PubMed, 1 synthesis or guideline pooled it, 20 citations in OpenAlex.

  1. Pooled it
  2. Trial
  3. Trial
  4. Trial
  5. Trial
  6. Article
  7. Article
  8. Observational
  9. Observational
  10. Bearing the Burden of Non-AIDS Comorbidities: This Is What Women Aging With Human Immunodefiency Virus Look Like.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2021
    Article
  11. The Prevalence and Burden of Non-AIDS Comorbidities Among Women Living With or at Risk for Human Immunodeficiency Virus Infection in the United States.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2021
    Article
  12. Article
  13. Review
  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

10 authors at 7 institutions in 2 countries.

Christina M Wyatt*Division of Nephrology, Department of Medicine, Icahn School of Medicine at Mount Sinai, New York, NY; †Center for Biostatistics in AIDS Research, Harvard School of Public Health, Boston, MA; ‡Department of Medicine, Indiana University School of Medicine, Indianapolis, IN; §Department of Medicine, Los Angeles Biomedical Research Institute at Harbor-UCLA Medical Center, Torrance, CA; ‖Department of Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, MA; ¶ViiV Healthcare, Research Triangle Park, NC; #Gilead Sciences, Foster City, CA; and **Department of Pediatrics, Case Western Reserve University, Cleveland, OH.
Douglas Kitch
Samir K Gupta
Camlin Tierney
Eric S Daar
Paul E Sax
Belinda Ha
Kathleen Melbourne
Grace A McComsey
AIDS Clinical Trials Group Study A5224s Team
Harvard University Press · USCase Western Reserve University · USGilead Sciences (United States) · USIcahn School of Medicine at Mount Sinai · USIndiana University · USUniversity of California, Los Angeles · USViiV Healthcare (Spain) · ES

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
STATISTICAL AND DATA MANAGEMENT CENTERU01AI038855 · NIAID · HARVARD UNIVERSITY (SCH OF PUBLIC HLTH) · PI HUGHES, MICHAEL DAVID · 1996 to 2006
$78.1M
Virology, Immunology, and Microbiology CoreP30AI050410 · NIAID · UNIV OF NORTH CAROLINA CHAPEL HILL · PI DAVID M. MARGOLIS · 2001 to 2026
$76.9M
Institute for Clinical and Translational Research (UL1)UL1RR025005 · NCRR · JOHNS HOPKINS UNIVERSITY · PI FORD, DANIEL ERNEST · 2007 to 2011
$75.8M
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
CTSA INFRASTRUCTURE FOR PEDIATRIC RESEARCHUL1RR025780 · NCRR · UNIVERSITY OF COLORADO DENVER · PI SOKOL, RONALD J. · 2008 to 2011
$61.3M
Institute for Clinical and Translational ResearchUL1TR001079 · NCATS · JOHNS HOPKINS UNIVERSITY · PI FORD, DANIEL ERNEST · 2013 to 2017
$60.1M
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
NCATS NIH HHS UL1 TR000042NCATS NIH HHS UL1 TR000124NCATS NIH HHS UL1TR000124NCATS NIH HHS UL1 TR000448NCATS NIH HHS UL1 TR000457NCATS NIH HHS UL1 TR001079NCATS NIH HHS UL1 TR001082NCRR NIH HHS M01 RR000095NCRR NIH HHS M01 RR000750NCRR NIH HHS M01 RR00750NCRR NIH HHS MO1 RR 00095NCRR NIH HHS RR025780NCRR NIH HHS UL1 RR 024160NCRR NIH HHS UL1 RR024160NCRR NIH HHS UL1RR 024160NCRR NIH HHS UL1 RR024979NCRR NIH HHS UL1RR024979NCRR NIH HHS UL1 RR024992NCRR NIH HHS UL1 RR024996NCRR NIH HHS UL1 RR 025005NCRR NIH HHS UL1 RR025005NCRR NIH HHS UL1 RR025014NCRR NIH HHS UL1 RR025747NCRR NIH HHS UL 1RR 025747NCRR NIH HHS UL1 RR025780NCRR NIH HHS UL1 RR033176NCRR NIH HHS UL1RR033176NIAID NIH HHS 1U01AI069424-01NIAID NIH HHS 1 U01 AI069494-01NIAID NIH HHS 3U01AI046376-05S4NIAID NIH HHS 5U01AI025859NIAID NIH HHS 5-U01 AI069423-03NIAID NIH HHS 5U01 AI069 484-02 2705NIAID NIH HHS 5U01AI069494NIAID NIH HHS 5 U0I AI069415-03NIAID NIH HHS AI068634NIAID NIH HHS AI0694241NIAID NIH HHS AI069434NIAID NIH HHS AI069474NIAID NIH HHS AI069513NIAID NIH HHS AI069532NIAID NIH HHS AI27658NIAID NIH HHS AI 27661NIAID NIH HHS AI27665NIAID NIH HHS AI27668NIAID NIH HHS AI32782NIAID NIH HHS AI34853NIAID NIH HHS AI38855NIAID NIH HHS AI46339-01NIAID NIH HHS AI69432NIAID NIH HHS AI69450NIAID NIH HHS AI69501NIAID NIH HHS N01 AI72626NIAID NIH HHS P30-AI0450008-11NIAID NIH HHS P30 AI050410NIAID NIH HHS P30 AI050411NIAID NIH HHS U01 AI025859NIAID NIH HHS U01 AI027658NIAID NIH HHS U01 AI027661NIAID NIH HHS U01 AI027665NIAID NIH HHS U01 AI027668NIAID NIH HHS U01 AI032782NIAID NIH HHS U01 AI034853NIAID NIH HHS U01 AI038855NIAID NIH HHS U01 AI046339NIAID NIH HHS U01 AI046376NIAID NIH HHS U01 AI068634NIAID NIH HHS U01 AI068636NIAID NIH HHS U01AI068636NIAID NIH HHS U01 AI069415NIAID NIH HHS U01 AI069419NIAID NIH HHS U01 AI069423NIAID NIH HHS U01 AI069424NIAID NIH HHS U01 AI069432NIAID NIH HHS U01 AI069434NIAID NIH HHS U01 AI069450NIAID NIH HHS U01 AI069452NIAID NIH HHS U01 AI069467NIAID NIH HHS U01 AI069471NIAID NIH HHS U01 AI069472NIAID NIH HHS U01 AI069472-04NIAID NIH HHS U01 AI069474NIAID NIH HHS U01 AI069494NIAID NIH HHS U01 AI069495NIAID NIH HHS U01AI069495NIAID NIH HHS U01 AI069501NIAID NIH HHS U01 AI069511NIAID NIH HHS U01AI069511-02NIAID NIH HHS U01 AI069513NIAID NIH HHS U01 AI069532NIAID NIH HHS UM1 AI068634NIAID NIH HHS UM1 AI068636NIAID NIH HHS UM1 AI069412NIAID NIH HHS UM1 AI069419NIAID NIH HHS UM1 AI069423NIAID NIH HHS UM1 AI069424NIAID NIH HHS UM1 AI069432NIAID NIH HHS UM1 AI069434NIAID NIH HHS UM1 AI069450NIAID NIH HHS UM1 AI069452NIAID NIH HHS UM1 AI069471NIAID NIH HHS UM1 AI069474NIAID NIH HHS UM1 AI069494NIAID NIH HHS UM1 AI069501NIAID NIH HHS UM1 AI069513NIAID NIH HHS UM1 AI069532NIAID NIH HHS UM1 AI106701NIAID NIH HHS UO1-AI069467-04NIAID NIH HHS UOI AI 069472PHS HHS P30AL050409PHS HHS UO1AL69418-01
6 · The paper itself

Abstract

backgroundAntiretroviral therapy (ART) is associated with improved kidney function; however, the nucleotide reverse transcriptase inhibitor (NRTI) tenofovir disoproxil fumarate (TDF) has been associated with decreased kidney function and proteinuria.

methodsWe examined changes in urine protein:creatinine (UPCR) and urine albumin:creatinine (UACR) ratios in 245 ART-naive participants in A5202 randomized in a substudy to blinded NRTI (abacavir/lamivudine, ABC/3TC, n = 124 or TDF/emtricitabine, TDF/FTC, n = 121) with open-label protease inhibitor (PI) atazanavir/ritonavir or nonnucleoside reverse transcriptase inhibitor (NNRTI) efavirenz.

resultsAt baseline, 18% of participants had clinically significant proteinuria (UPCR ≥200 mg/g), and 11% had clinically significant albuminuria (UACR ≥30 mg/g). The prevalence of clinically significant proteinuria and albuminuria decreased from baseline to week 96 in all treatment groups. In intention-to-treat analyses, there was a significant effect of NRTI component on fold change in UPCR (P = 0.011) and UACR (P = 0.018) from baseline to week 96, with greater improvements in participants randomized to ABC/3TC. There was no significant effect of NNRTI/PI component on fold change in UPCR (P = 0.23) or UACR (P = 0.88), and no significant interactions between NRTI and NNRTI/PI components.

conclusionsIn this prespecified secondary analysis, ART initiation was associated with improvements in proteinuria and albuminuria, with significantly greater improvements in participants randomized to ABC/3TC versus TDF/FTC. These are the first data from a randomized trial to suggest that initiation of TDF/FTC may not be associated with the same degree of improvement in proteinuria and albuminuria that have been reported with other regimens. Future studies should consider the long-term clinical significance of these findings.

Indexed as

AbacavirAdenineAdultAlbuminuriaAnti-HIV AgentsDeoxycytidineDideoxynucleosidesDrug CombinationsEmtricitabineFemaleHIV-1HIV InfectionsHumansLamivudineLinear ModelsMaleAbacavirabacavir, lamivudine drug combinationAdenineAnti-HIV AgentsDeoxycytidineDideoxynucleosidesDrug CombinationsEmtricitabineLamivudineOrganophosphonatesTenofovir

Identifiers

PMID25117929
PMCPMC4134097
OpenAlexW2029295635

What OpenQuestion holds

Textmetadata
LicenceTDM
Read underepoch 390

Registered trials

None linked

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.