Evidence map›Paper›PMID 24334181›Full record

Trial reportHIV clinical trials

Early virologic response to abacavir/lamivudine and tenofovir/emtricitabine during ACTG A5202.

Philip M Grant, Camlin Tierney, Chakra Budhathoki, Eric S Daar, Paul E Sax, Ann C Collier, Margaret A Fischl, Andrew R Zolopa, Maya Balamane, David Katzenstein

Open access · greenAbstract readRandomized Controlled Trial
In one paragraph

Trial report in HIV clinical trials. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed
–field-weighted citation impact, top 87% 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

4 citing papers in PubMed, 5 citations in OpenAlex.

  1. Review
  2. Article
  3. Review
  4. 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 6 institutions in 1 country.

Philip M GrantDivision of Infectious Diseases, Stanford University, Palo Alto, California.
Camlin TierneyCenter for Biostatistics in AIDS Research, Harvard School of Public Health, Boston, Massachusetts.
Chakra BudhathokiCenter for Biostatistics in AIDS Research, Harvard School of Public Health, Boston, Massachusetts.
Eric S DaarDivision of HIV Medicine, Los Angeles Biomedical Research Institute at Harbor-UCLA Medical Center, Torrance, California.
Paul E SaxDivision of Infectious Diseases, Brigham and Women's Hospital and Harvard Medical School, Boston, Massachusetts.
Ann C CollierDivision of Infectious Diseases, University of Washington, Seattle, Washington.
Margaret A FischlDivision of Infectious Diseases, University of Miami, Miami, Florida.
Andrew R ZolopaDivision of Infectious Diseases, Stanford University, Palo Alto, California.
Maya BalamaneDivision of Infectious Diseases, Stanford University, Palo Alto, California.
David KatzensteinDivision of Infectious Diseases, Stanford University, Palo Alto, California.
Stanford University · USCancer Research And Biostatistics · USHarbor–UCLA Medical Center · USHarvard University · USUniversity of Miami · USUniversity of Washington · 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
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
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
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 AIDS Prevention and Treatment Clinical Trials UnitUM1AI069424 · NIAID · UNIVERSITY OF CALIFORNIA LOS ANGELES · PI Judith S. Currier, RAPHAEL J LANDOVITZ · 2012 to 2026
$51.8M
CTSA INFRASTRUCTURE FOR PEDIATRIC RESEARCHUL1RR024996 · NCRR · WEILL MEDICAL COLL OF CORNELL UNIV · PI IMPERATO-MCGINLEY, JULIANNE L · 2007 to 2011
$49.6M
Clinical and Translational Science CenterUL1TR000457 · NCATS · WEILL MEDICAL COLL OF CORNELL UNIV · PI IMPERATO-MCGINLEY, JULIANNE L · 2012 to 2016
$46.0M
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 TR000457NCRR NIH HHS UL1 RR024996NIAID NIH HHS AI38855NIAID NIH HHS AI38858NIAID NIH HHS AI68634NIAID NIH HHS AI68636NIAID NIH HHS U01 AI038855NIAID NIH HHS U01 AI038858NIAID NIH HHS U01 AI068634NIAID NIH HHS U01 AI068636NIAID NIH HHS UM1 AI068634NIAID NIH HHS UM1 AI068636NIAID NIH HHS UM1 AI069412NIAID NIH HHS UM1 AI069424NIAID NIH HHS UM1 AI069477
6 · The paper itself

Abstract

backgroundACTG A5202 randomized treatment-naïve individuals to tenofovir-emtricitabine (TDF/FTC) or abacavir-lamivudine (ABC/3TC) combined with efavirenz (EFV) or atazanavir/ritonavir (ATV/r). Individuals in the high screening viral load (VL) stratum (≥100,000 copies/mL) had increased rates of virologic failure with ABC/3TC.

objectiveTo compare regimen-specific early virologic response.

methodsUsing Wilcoxon rank-sum tests, we compared regimen-specific VL changes from entry to week 4 in A5202 subjects (N = 1,813) and from entry to week 1, 2, and 4 in substudy subjects (n = 179). We evaluated associations between week 4 VL change and time to virologic failure with Cox proportional hazards models.

resultsTDF/FTC and ABC/3TC produced similar week 4 VL declines in the entire study population and in the high VL stratum. EFV produced greater VL declines from baseline at week 4 than ATV/r (median -2.1 vs -1.9 log10 copies/mL; P < .001). In the substudy of subjects with week 1, 2, and 4 VL data, there was no difference in VL decline in individuals randomized to TDF/FTC versus ABC/3TC, but EFV resulted in greater VL decline from entry at each of these timepoints than ATV/r. Smaller week 4 VL decline was associated with increased risk of virologic failure.

conclusionsWithin all treatment arms, a less robust week 4 virologic response was associated with higher risk for subsequent virologic failure. However, between-regimen differences in week 4 VL declines did not parallel the previously reported differences in longer term virologic efficacy in A5202, suggesting that between-regimen differences in responses were not due to intrinsic differences in antiviral activity.

Indexed as

AbacavirAdenineAdultAnti-HIV AgentsCD4 Lymphocyte CountDeoxycytidineDideoxynucleosidesDrug CombinationsDrug Therapy, CombinationEmtricitabineFemaleHIV InfectionsHumansLamivudineMaleMiddle AgedAbacavirabacavir, lamivudine drug combinationAdenineAnti-HIV AgentsDeoxycytidineDideoxynucleosidesDrug CombinationsEmtricitabineLamivudineOrganophosphonatesTenofoviranti-HIV agentsdrug therapyHIV infectionstreatment outcomevirology

Identifiers

PMID24334181
PMCPMC4060613
OpenAlexW2156574761

What OpenQuestion holds

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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.