Evidence map›Paper›PMID 16984654›Full record

Trial reportRetrovirology2006

Zidovudine plus lamivudine in Human T-Lymphotropic Virus type-I-associated myelopathy: a randomised trial.

Graham P Taylor, Peter Goon, Yoshitaka Furukawa, Hannah Green, Anna Barfield, Angelina Mosley, Hirohisa Nose, Abdel Babiker, Peter Rudge, Koichiro Usuku and 3 more

Registry-linked trialAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Retrovirology, 2006. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00272480 (Zidovudine Plus Lamivudine in HTLV-I-associated Myelopathy), which is not on this map. Cited by 49 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
49citing papers in PubMed, 2 pooled it
–field-weighted citation impact
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.

NCT00272480 phase2 / phase3completednot on this map

Zidovudine Plus Lamivudine in HTLV-I-associated Myelopathy: a Randomised Trial

TypeinterventionalSponsorImperial College LondonRan1999 to 2002Enrolled16ConditionsHTLV-I-associated MyelopathyArmsZidovudine/lamivudine, Placebos
3 · Its place in the literature

Who cites it

49 citing papers in PubMed, 2 syntheses or guidelines pooled it.

  1. Pooled it
  2. Pain prevalence, characteristics and associated factors in human T-cell lymphotropic virus type 1 infected patients: a systematic review of the literature.The Brazilian journal of infectious diseases : an official publication of the Brazilian Society of Infectious Diseases
    Pooled it
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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

13 authors.

Graham P TaylorDepartment of GU Medicine and Communicable Diseases, Faculty of Medicine, Imperial College, London, UK. g.p.taylor@imperial.ac.uk.
Peter Goon
Yoshitaka Furukawa
Hannah Green
Anna Barfield
Angelina Mosley
Hirohisa Nose
Abdel Babiker
Peter Rudge
Koichiro Usuku
Mitsuhiro Osame
Charles R M Bangham
Jonathan N Weber

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundNo therapies have been proven to persistently improve the outcome of HTLV-I-associated myelopathy. Clinical benefit has been reported with zidovudine and with lamivudine in observational studies. We therefore conducted a randomised, double blind, placebo controlled study of six months combination therapy with these nucleoside analogues in sixteen patients.

resultsPrimary outcomes were change in HTLV-I proviral load in PBMCs and clinical measures. Secondary endpoints were changes in T-cell subsets and markers of activation and proliferation. Six patients discontinued zidovudine. No significant changes in pain, bladder function, disability score, gait, proviral load or markers of T-cell activation or proliferation were seen between the two arms. Active therapy was associated with an unexplained decrease in CD8 and non-T lymphocyte counts.

conclusionFailure to detect clinical improvement may have been due irreversible nerve damage in these patients with a long clinical history and future studies should target patients presenting earlier. The lack of virological effect but may reflect a lack of activity of these nucleoside analogues against HTLV-I RT in vivo, inadequate intracellular concentrations of the active moiety or the contribution of new cell infection to maintaining proviral load at this stage of infection may be relatively small masking the effects of RT inhibition.

Indexed as

AgedAnti-HIV AgentsCell ProliferationDouble-Blind MethodDrug Therapy, CombinationFemaleHumansLamivudineMaleMiddle AgedParaparesis, Tropical SpasticPlacebosViral LoadZidovudineAnti-HIV AgentsLamivudinePlacebosZidovudine

Identifiers

PMID16984654
PMCPMC1590049

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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.