Evidence map›Paper›PMID 26323809›Full record

Trial reportJournal of neurovirology2016

Peripheral neuropathy in HIV patients in sub-Saharan Africa failing first-line therapy and the response to second-line ART in the EARNEST trial.

Alejandro Arenas-Pinto, Jennifer Thompson, Godfrey Musoro, Hellen Musana, Abbas Lugemwa, Andrew Kambugu, Aggrey Mweemba, Dickens Atwongyeire, Margaret J Thomason, A Sarah Walker and 2 more

Abstract readMulticenter StudyRandomized Controlled Trial
PubMed Publisher
In one paragraph

Trial report in Journal of neurovirology, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 21 papers.

0numbers the graph read from it
0cells of the map it votes in
21citing papers in PubMed
2.1field-weighted citation impact, top 13% 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

21 citing papers in PubMed, 30 citations in OpenAlex.

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  8. HIV-related Neuropathy: Pathophysiology, Treatment and Challenges.Journal of neurology and experimental neuroscience · 2021
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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

12 authors at 6 institutions in 5 countries.

Alejandro Arenas-PintoMRC Clinical Trials Unit at UCL, Institute of Clinical Trials & Methodology, Aviation House, 125 Kingsway, London, WC2B 6NH, UK. A.Arenas-Pinto@ucl.ac.uk.ORCID http://orcid.org/0000-0002-3368-5005
Jennifer ThompsonMRC Clinical Trials Unit at UCL, Institute of Clinical Trials & Methodology, Aviation House, 125 Kingsway, London, WC2B 6NH, UK.
Godfrey MusoroUniversity of Zimbabwe Clinical Research Centre, Harare, Zimbabwe.
Hellen MusanaJoint Clinical Research Centre (JCRC), Kampala, Uganda.
Abbas LugemwaJoint Clinical Research Centre (JCRC), Mbarara, Uganda.
Andrew KambuguInfectious Diseases Institute, Makerere University, Kampala, Uganda.
Aggrey MweembaUniversity Teaching Hospital, Lusaka, Zambia.
Dickens AtwongyeireJoint Clinical Research Centre (JCRC), Kakira, Uganda.
Margaret J ThomasonMRC Clinical Trials Unit at UCL, Institute of Clinical Trials & Methodology, Aviation House, 125 Kingsway, London, WC2B 6NH, UK.
A Sarah WalkerMRC Clinical Trials Unit at UCL, Institute of Clinical Trials & Methodology, Aviation House, 125 Kingsway, London, WC2B 6NH, UK.
Nicholas I PatonMRC Clinical Trials Unit at UCL, Institute of Clinical Trials & Methodology, Aviation House, 125 Kingsway, London, WC2B 6NH, UK.
EARNEST Trial Team
MRC Clinical Trials Unit at UCL · GBNational University of Singapore · SGUniversity of Zimbabwe · ZWUniversity Teaching Hospital · ZMInfectious Diseases Institute · UGJoint Clinical Research Centre · UG

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Sensory peripheral neuropathy (PN) remains a common complication in HIV-positive patients despite effective combination anti-retroviral therapy (ART). Data on PN on second-line ART is scarce. We assessed PN using a standard tool in patients failing first-line ART and for 96 weeks following a switch to PI-based second-line ART in a large Randomised Clinical Trial in Sub-Saharan Africa. Factors associated with PN were investigated using logistic regression. Symptomatic PN (SPN) prevalence was 22% at entry (N = 1,251) and was associated (p < 0.05) with older age (OR = 1.04 per year), female gender (OR = 1.64), Tuberculosis (TB; OR = 1.86), smoking (OR = 1.60), higher plasma creatinine (OR = 1.09 per 0.1 mg/dl increase), CD4 count (OR = 0.83 per doubling) and not consuming alcohol (OR = 0.55). SPN prevalence decreased to 17% by week 96 (p = 0.0002) following similar trends in all study groups (p = 0.30). Asymptomatic PN (APN) increased over the same period from 21 to 29% (p = 0.0002). Signs suggestive of PN (regardless of symptoms) returned to baseline levels by week 96. At weeks 48 and 96, after adjusting for time-updated associations above and baseline CD4 count and viral load, SPN was strongly associated with TB (p < 0.0001). In summary, SPN prevalence was significantly reduced with PI-based second-line therapy across all treatment groups, but we did not find any advantage to the NRTI-free regimens. The increase of APN and stability of PN-signs regardless of symptoms suggest an underlying trend of neuropathy progression that may be masked by reduction of symptoms accompanying general health improvement induced by second-line ART. SPN was strongly associated with isoniazid given for TB treatment.

Indexed as

AdultAfrica South of the SaharaAlcohol AbstinenceAnti-HIV AgentsAntiretroviral Therapy, Highly ActiveAntitubercular AgentsCD4 Lymphocyte CountCD4-Positive T-LymphocytesDrug CombinationsFemaleHIV-1HIV InfectionsHumansIsoniazidLogistic ModelsLopinavirAnti-HIV AgentsAntitubercular AgentsDrug CombinationsIsoniazidLopinavirlopinavir-ritonavir drug combinationRaltegravir PotassiumRitonavirRNA, ViralAfricaHIVPeripheral neuropathySecond-line ARTTuberculosis

Identifiers

PMID26323809
OpenAlexW1231801184

What OpenQuestion holds

Textmetadata
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.