Evidence map›Paper›PMID 22479327›Full record

Trial reportPloS one2012

Comparison of bone and renal effects in HIV-infected adults switching to abacavir or tenofovir based therapy in a randomized trial.

Thomas A Rasmussen, Danny Jensen, Martin Tolstrup, Ulla S Nielsen, Erland J Erlandsen, Henrik Birn, Lars Østergaard, Bente L Langdahl, Alex L Laursen

Registry-linked trialOpen access · goldAbstract readComparative StudyRandomized Controlled Trial
In one paragraph

Trial report in PloS one, 2012. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00647244 (Efficacy and Safety of Switching From AZT to Tenofovir), which is not on this map. Cited by 30 papers.

0numbers the graph read from it
0cells of the map it votes in
30citing papers in PubMed
8.1field-weighted citation impact, top 2% 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.

NCT00647244 phase4completednot on this map

Efficacy and Safety of Switching From AZT to Tenofovir

TypeinterventionalSponsorAarhus University HospitalRan2008 to 2010Enrolled40ConditionsHIV InfectionsArmsTenofovir disoproxil fumarate, Abacavir
3 · Its place in the literature

Who cites it

30 citing papers in PubMed, 55 citations in OpenAlex.

  1. Trial
  2. Trial
  3. Effects of Emtricitabine/Tenofovir on Bone Mineral Density in HIV-Negative Persons in a Randomized, Double-Blind, Placebo-Controlled Trial.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2015
    Trial
  4. Increased bone resorption during tenofovir plus lopinavir/ritonavir therapy in Chinese individuals with HIV.Osteoporosis international : a journal established as result of cooperation between the European Foundation for Osteoporosis and the National Osteoporosis Foundation of the USA · 2015
    Trial
  5. Trial
  6. Trial
  7. Article
  8. Article
  9. Alternative switching strategies based on regimens with a low genetic barrier: do clinicians have a choice nowadays?European journal of clinical microbiology & infectious diseases : official publication of the European Society of Clinical Microbiology · 2019
    Review
  10. Article
  11. Article
  12. Article
  13. Article
  14. Review
  15. Review
  16. Article
  17. Bone health in HIV and hepatitis B or C infections.Therapeutic advances in musculoskeletal disease · 2017
    Review
  18. Article
  19. Article
  20. Review
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

9 authors at 2 institutions in 1 country.

Thomas A RasmussenDepartment of Infectious Diseases, Aarhus University Hospital, Aarhus, Denmark. thomrasm@rm.dk
Danny Jensen
Martin Tolstrup
Ulla S Nielsen
Erland J Erlandsen
Henrik Birn
Lars Østergaard
Bente L Langdahl
Alex L Laursen
Aarhus University Hospital · DKRegionshospitalet Viborg · DK

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionOur objective was to compare the bone and renal effects among HIV-infected patients randomized to abacavir or tenofovir-based combination anti-retroviral therapy.

methodsIn an open-label randomized trial, HIV-infected patients were randomized to switch from zidovudine/lamivudine (AZT/3TC) to abacavir/lamivudine (ABC/3TC) or tenofovir/emtricitabine (TDF/FTC). We measured bone mass density (BMD) and bone turnover biomarkers (osteocalcin, osteocalcin, procollagen type 1 N-terminal propeptide (P1NP), alkaline phosphatase, type I collagen cross-linked C-telopeptide (CTx), and osteoprotegerin). We assessed renal function by estimated creatinine clearance, plasma cystatin C, and urinary levels of creatinine, albumin, cystatin C, and neutrophil gelatinase-associated lipocalin (NGAL). The changes from baseline in BMD and renal and bone biomarkers were compared across study arms.

resultsOf 40 included patients, 35 completed 48 weeks of randomized therapy and follow up. BMD was measured in 33, 26, and 27 patients at baseline, week 24, and week 48, respectively. In TDF/FTC-treated patients we observed significant reductions from baseline in hip and lumbar spine BMD at week 24 (-1.8% and -2.5%) and week 48 (-2.1% and -2.1%), whereas BMD was stable in patients in the ABC/3TC arm. The changes from baseline in BMD were significantly different between study arms. All bone turnover biomarkers except osteoprotegerin increased in the TDF/FTC arm compared with the ABC/3TC arm, but early changes did not predict subsequent loss of BMD. Renal function parameters were similar between study arms although a small increase in NGAL was detected among TDF-treated patients.

conclusionSwitching to TDF/FTC-based therapy led to decreases in BMD and increases in bone turnover markers compared with ABC/3TC-based treatment. No major difference in renal function was observed.

trial registrationClinicaltrials.gov NCT00647244.

Indexed as

AbacavirAdenineAdultAlkaline PhosphataseAnti-HIV AgentsAntiretroviral Therapy, Highly ActiveBiomarkersBone and BonesBone DensityCreatinineCystatin CDeoxycytidineDideoxynucleosidesDrug CombinationsEmtricitabineFemaleAbacavirabacavir, lamivudine drug combinationAdenineAlkaline PhosphataseAnti-HIV AgentsBiomarkersCreatinineCystatin CDeoxycytidineDideoxynucleosidesDrug CombinationsEmtricitabineLamivudineOrganophosphonatesOsteocalcinTenofovir

Identifiers

PMID22479327
PMCPMC3315554
OpenAlexW1999892617

What OpenQuestion holds

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LicenceCC BY
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.