Evidence map›Paper›PMID 24244635›Full record

Trial reportPloS one2013

Maraviroc as intensification strategy in HIV-1 positive patients with deficient immunological response: an Italian randomized clinical trial.

Stefano Rusconi, Paola Vitiello, Fulvio Adorni, Elisa Colella, Emanuele Focà, Amedeo Capetti, Paola Meraviglia, Clara Abeli, Stefano Bonora, Marco D'Annunzio and 19 more

Registry-linked trialOpen access · goldAbstract readClinical Trial, Phase IVMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in PloS one, 2013. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00884858 (Use of Maraviroc), which is not on this map. Cited by 22 papers.

0numbers the graph read from it
0cells of the map it votes in
22citing papers in PubMed
2.9field-weighted citation impact, top 8% 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.

NCT00884858 phase4completednot on this map

Use of Maraviroc (MVC) in Immunological Non-responder HIV-1-infected Patients.

TypeinterventionalSponsorASST Fatebenefratelli SaccoRan2009 to 2011Enrolled100ConditionsHIV InfectionsArmsMaraviroc
3 · Its place in the literature

Who cites it

22 citing papers in PubMed, 42 citations in OpenAlex.

  1. Trial
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  16. Inflammation, immune activation, and cardiovascular disease in HIV.AIDS (London, England) · 2016 · on this map
    Review
  17. Article
  18. Article
  19. Review
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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

29 authors at 15 institutions in 1 country.

Stefano RusconiDivisione Clinicizzata di Malattie Infettive, DIBIC "Luigi Sacco", Università degli Studi, Milano, Italy.
Paola Vitiello
Fulvio Adorni
Elisa Colella
Emanuele Focà
Amedeo Capetti
Paola Meraviglia
Clara Abeli
Stefano Bonora
Marco D'Annunzio
Antonio Di Biagio
Massimo Di Pietro
Luca Butini
Giancarlo Orofino
Manuela Colafigli
Gabriella d'Ettorre
Daniela Francisci
Giustino Parruti
Alessandro Soria
Anna Rita Buonomini
Chiara Tommasi
Silvia Mosti
Francesca Bai
Silvia Di Nardo Stuppino
Manuela Morosi
Marco Montano
Pamela Tau
Esther Merlini
Giulia Marchetti
Ospedale San Paolo · ITIstituto Nazionale per le Malattie Infettive Lazzaro Spallanzani · ITLuigi Sacco Hospital · ITOspedale Amedeo di Savoia · ITOspedale di Circolo di Busto Arsizio · ITPoliclinico Tor Vergata · ITAzienda Ospedaliera San Gerardo · ITInstitute of Biomedical Technologies · ITOspedale di Santo Spirito · ITOspedale Policlinico San Martino · ITOspedale Santa Maria Annunziata · ITOspedali Riuniti di Ancona · ITPoliclinico Umberto I · ITUniversità Cattolica del Sacro Cuore · ITUniversity of Brescia · IT

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundImmunological non-responders (INRs) lacked CD4 increase despite HIV-viremia suppression on HAART and had an increased risk of disease progression. We assessed immune reconstitution profile upon intensification with maraviroc in INRs.

methodsWe designed a multi-centric, randomized, parallel, open label, phase 4 superiority trial. We enrolled 97 patients on HAART with CD4+<200/µL and/or CD4+ recovery ≤ 25% and HIV-RNA<50 cp/mL. Patients were randomized 1:1 to HAART+maraviroc or continued HAART. CD4+ and CD8+ CD45+RA/RO, Ki67 expression and plasma IL-7 were quantified at W0, W12 and W48.

resultsBy W48 both groups displayed a CD4 increase without a significant inter-group difference. A statistically significant change in CD8 favored patients in arm HAART+maraviroc versus HAART at W12 (p=.009) and W48 (p=.025). The CD4>200/µL and CD4>200/µL + CD4 gain ≥ 25% end-points were not satisfied at W12 (p=.24 and p=.619) nor at W48 (p=.076 and p=.236). Patients continuing HAART displayed no major changes in parameters of T-cell homeostasis and activation. Maraviroc-receiving patients experienced a significant rise in circulating IL-7 by W48 (p=.01), and a trend in temporary reduction in activated HLA-DR+CD38+CD4+ by W12 (p=.06) that was not maintained at W48.

conclusionsMaraviroc intensification in INRs did not have a significant advantage in reconstituting CD4 T-cell pool, but did substantially expand CD8. It resulted in a low rate of treatment discontinuations.

trial registrationClinicalTrials.gov NCT00884858 http://clinicaltrials.gov/show/NCT00884858.

Indexed as

Antiretroviral Therapy, Highly ActiveImmunocompromised HostAdultAnti-HIV AgentsBiomarkersCD4 Lymphocyte CountCD4-Positive T-LymphocytesCD8-Positive T-LymphocytesCyclohexanesFemaleHIV-1HIV InfectionsHumansInterleukin-7Ki-67 AntigenMaleAnti-HIV AgentsBiomarkersCyclohexanesIL7 protein, humanInterleukin-7Ki-67 AntigenMaravirocRNA, ViralTriazoles

Identifiers

PMID24244635
PMCPMC3828227
OpenAlexW2140960367

What OpenQuestion holds

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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.