Evidence map›Paper›PMID 31490959›Full record

ArticlePloS one2019

Inflammatory biomarker levels over 48 weeks with dual vs triple lopinavir/ritonavir-based therapy: Substudy of a randomized trial.

Darrell H S Tan, Maria Jose Rolon, Maria Ines Figueroa, Omar Sued, Ana Gun, Rupert Kaul, Janet M Raboud, Leah Szadkowski, Mark W Hull, Sharon L Walmsley and 2 more

Open access · goldAbstract readComparative Study
In one paragraph

Article in PloS one, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 5 papers.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed
0.3field-weighted citation impact, top 41% 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

5 citing papers in PubMed, 5 citations in OpenAlex.

  1. Trial
  2. Article
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  4. Article
  5. 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

12 authors at 4 institutions in 2 countries.

Darrell H S TanSt. Michael's Hospital Division of Infectious Diseases, Toronto, ON, Canada.ORCID 0000-0002-3069-2875
Maria Jose RolonFundación Huésped, Pasaje Angel Peluffo 3932 (C1202ABB), Ciudad Autónoma de Buenos Aires, Argentina.
Maria Ines FigueroaFundación Huésped, Pasaje Angel Peluffo 3932 (C1202ABB), Ciudad Autónoma de Buenos Aires, Argentina.
Omar SuedFundación Huésped, Pasaje Angel Peluffo 3932 (C1202ABB), Ciudad Autónoma de Buenos Aires, Argentina.
Ana GunFundación Huésped, Pasaje Angel Peluffo 3932 (C1202ABB), Ciudad Autónoma de Buenos Aires, Argentina.
Rupert KaulUniversity Health Network Division of Infectious Diseases, Toronto, ON, Canada.
Janet M RaboudToronto General Hospital Research Institute, University Health Network, Toronto, ON, Canada.
Leah SzadkowskiToronto General Hospital Research Institute, University Health Network, Toronto, ON, Canada.
Mark W HullSt. Paul's Hospital, Vancouver, BC, Canada.
Sharon L WalmsleyUniversity Health Network Division of Infectious Diseases, Toronto, ON, Canada.
Pedro CahnFundación Huésped, Pasaje Angel Peluffo 3932 (C1202ABB), Ciudad Autónoma de Buenos Aires, Argentina.
Argentinean GARDEL research network
Fundación Huésped · ARUniversity Health Network · CASt. Michael's Hospital · CASt. Paul's Hospital · CA

Funding

CIHR
6 · The paper itself

Abstract

backgroundInflammation has been associated with increased morbidity and mortality in HIV-positive patients. We compared inflammatory biomarkers with dual therapy using lopinavir/ritonavir plus lamivudine (LPV/r+3TC) versus triple therapy using LPV/r plus two nucleoside reverse transcriptase inhibitors (LPV/r+2NRTIs) in treatment-naïve HIV-positive adults.

methodsThis was a substudy among Argentinian participants in the randomized trial GARDEL. We measured hsCRP, IL-6, MCP-1, TNF, D-dimer and sCD14 from plasma collected at baseline, week 24 and week 48. Generalized estimating equations with an identity/logit link were used to model the average impact of dual versus triple therapy on each biomarker over time, controlling for baseline levels. Additional models estimated the average effect of virologic suppression on biomarker levels over time, adjusting for age, sex, and baseline CD4 count.

resultsOf 191 trial participants enrolled in Argentina, 172 had baseline and follow-up measurements and were included. Median (IQR) age was 35.5 (28.5, 45) years and CD4 cell count was 310 (219, 414) cells/mm3. Dual therapy was not associated with significantly different biomarker levels over 48 weeks relative to triple therapy. Virologic suppression was associated with statistically significant decreases in MCP-1, TNF and D-dimer levels and an unexpected increase in sCD14 levels. No change was observed in hsCRP or the proportion of participants with undetectable IL-6 levels.

conclusionsIn addition to having virologic non-inferiority, LPV/r+3TC dual therapy is generally associated with similar inflammatory biomarker levels over 48 weeks compared to LPV/r+2NRTIs triple therapy in treatment-naïve adults. Further study of dual treatment regimens is warranted.

Indexed as

AdultBiomarkersFemaleHIV InfectionsHumansInflammationLopinavirMaleMiddle AgedRandomized Controlled Trials as TopicRitonavirTime FactorsTreatment OutcomeBiomarkersLopinavirRitonavir

Identifiers

PMID31490959
PMCPMC6730918
OpenAlexW2972006664

What OpenQuestion holds

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LicenceCC BY
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.