Evidence map›Paper›PMID 25872972›Full record

Trial reportHIV clinical trials

Differential skeletal impact of tenofovir disoproxil fumarate in young versus old HIV-infected adults.

Philip M Grant, Douglas Kitch, Grace A McComsey, Camlin Tierney, Belinda Ha, Todd T Brown

Open access · bronzeAbstract 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 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
1.5field-weighted citation impact, top 16% 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

2 citing papers in PubMed, 9 citations in OpenAlex.

  1. Trial
  2. 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

6 authors at 4 institutions in 1 country.

Philip M Grant
Douglas Kitch
Grace A McComsey
Camlin Tierney
Belinda Ha
Todd T Brown
Case Western Reserve University · USGlaxoSmithKline (United States) · USJohns Hopkins University · USStanford University · 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
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 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
UNIVERSITY OF SOUTHERN CALIFORNIA CLINICAL TRIALS UNITUM1AI069428 · NIAID · UNIVERSITY OF SOUTHERN CALIFORNIA · PI SATTLER, FRED R · 2012 to 2013
$3.3M
Stanford AIDS Clinical Trials UnitUM1AI069556 · NIAID · STANFORD UNIVERSITY · PI ZOLOPA, ANDREW RICHARD · 2012 to 2014
$2.0M
Mentoring in Endocrine and Metabolic Abnormalities in HIV and AgingK24AI120834 · NIAID · JOHNS HOPKINS UNIVERSITY · PI BROWN, TODD T · 2015 to 2025
$1.8M
Mechanisms and Clinical Factors Associated with ART associated Bone Loss in HIVK23AI108358 · NIAID · STANFORD UNIVERSITY · PI GRANT, PHILIP MAGNUS · 2013 to 2016
$719k
NIAID NIH HHS K23 AI108358NIAID NIH HHS K24 AI120834NIAID NIH HHS U01 AI068634NIAID NIH HHS UM1 AI068634NIAID NIH HHS UM1 AI068636NIAID NIH HHS UM1 AI069424NIAID NIH HHS UM1 AI069428NIAID NIH HHS UM1 AI069556
6 · The paper itself

Abstract

backgroundLower peak bone mass in early adulthood predicts subsequent fragility fractures. Antiretroviral toxicity could contribute to young HIV-infected individuals not achieving adequate peak bone mass.

objectiveTo determine if tenofovir disoproxil fumarate's (TDF) effect on bone mineral density (BMD) differs by age.

methodsWe examined BMD data at the lumbar spine and hip from AIDS Clinical Trials Group (ACTG) A5224s and ASSERT and randomized treatment-naive studies comparing TDF/emtricitabine versus abacavir/lamivudine (with efavirenz or atazanavir/ritonavir). In this post hoc analysis, we defined the TDF effect as the difference between mean 48-week BMD per cent changes for lumbar spine and hip in individuals randomized to TDF versus abacavir. We used multivariable linear regression to compare the TDF effect in individuals younger and older than 30 years. If TDF effect by age did not differ significantly between studies, we pooled study populations. Otherwise, analyses were conducted separately within each study population.

resultsAmong 652 subjects, 21% were below age 30 years. The relationship between age and TDF effect significantly differed between A5224s and ASSERT (P = 0.008 for lumbar spine; P = 0.007 for hip). In A5224s, there was more bone loss with TDF at lumbar spine and hip in subjects under 30 years old versus in older subjects ( - 4.5% vs - 1.4%; P = 0.045; - 4.3% vs - 1.6%; P = 0.026, respectively). There was no significant evidence for this age-associated TDF effect in ASSERT.

conclusionsThere was heterogeneity in the observed effect of TDF on bone density in young adults compared to older adults, suggesting that further investigation is required to understand the impact of age on BMD decline with TDF.

Indexed as

AbacavirAdolescentAdultAge FactorsAlkynesAnti-HIV AgentsBenzoxazinesBone DensityCyclopropanesDideoxynucleosidesDrug CombinationsEmtricitabineFemaleHIV InfectionsHumansLamivudineAbacavirabacavir, lamivudine drug combinationAlkynesAnti-HIV AgentsBenzoxazinesCyclopropanesDideoxynucleosidesDrug CombinationsefavirenzEmtricitabineLamivudineTenofoviradministration and dosage,adverse effects,Anti-HIV agents,Bone densitydrug therapy/virology,HIV infections,

Identifiers

PMID25872972
PMCPMC4467768
OpenAlexW2157110533

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.