Evidence map›Paper›PMID 26208341›Full record

Trial reportPloS one2015

Maraviroc Intensification of cART in Patients with Suboptimal Immunological Recovery: A 48-Week, Placebo-Controlled Randomized Trial.

Steven F L van Lelyveld, Julia Drylewicz, Maaike Krikke, Ellen M Veel, Sigrid A Otto, Clemens Richter, Robin Soetekouw, Jan M Prins, Kees Brinkman, Jan Willem Mulder and 9 more

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

Trial report in PloS one, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00875368 (Maraviroc Immune Recovery Study, A Multicenter, Randomized, Placebo-controlled, Exploratory Mechanistic Study Into the Role of Maraviroc on Immune Recovery), which is not on this map. Cited by 21 papers.

0numbers the graph read from it
0cells of the map it votes in
21citing papers in PubMed
3.0field-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.

NCT00875368 phase4completednot on this map

Maraviroc Immune Recovery Study, A Multicenter, Randomized, Placebo-controlled, Exploratory Mechanistic Study Into the Role of Maraviroc on Immune Recovery

TypeinterventionalSponsorS.F.L. van LelyveldRan2009 to 2012Enrolled85ConditionsHIV InfectionsArmsmaraviroc, Placebo
3 · Its place in the literature

Who cites it

21 citing papers in PubMed, 32 citations in OpenAlex.

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  19. Inflammation, immune activation, and cardiovascular disease in HIV.AIDS (London, England) · 2016 · on this map
    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

19 authors at 7 institutions in 1 country.

Steven F L van LelyveldDepartment of Internal Medicine & Infectious Diseases, University Medical Center Utrecht, Utrecht, The Netherlands; Department of Internal Medicine & Gastroenterology, Spaarne Gasthuis, Haarlem, The Netherlands.
Julia DrylewiczDepartment of Immunology, University Medical Center Utrecht, Utrecht, The Netherlands.
Maaike KrikkeDepartment of Internal Medicine & Infectious Diseases, University Medical Center Utrecht, Utrecht, The Netherlands.
Ellen M VeelDepartment of Immunology, University Medical Center Utrecht, Utrecht, The Netherlands.
Sigrid A OttoDepartment of Immunology, University Medical Center Utrecht, Utrecht, The Netherlands.
Clemens RichterDepartment of Internal Medicine, Rijnstate Hospital, Arnhem, The Netherlands.
Robin SoetekouwDepartment of Internal Medicine & Gastroenterology, Spaarne Gasthuis, Haarlem, The Netherlands.
Jan M PrinsDepartment of Internal Medicine, Division of Infectious Diseases, Center for Infection and Immunity, Academic Medical Center, University of Amsterdam, Amsterdam, The Netherlands.
Kees BrinkmanDepartment of Internal Medicine, Onze Lieve Vrouwe Gasthuis, Amsterdam, The Netherlands.
Jan Willem MulderDepartment of Internal Medicine, Slotervaart Hospital, Amsterdam, The Netherlands.
Frank KroonDepartment of Infectious Diseases, Leiden University Medical Center, Leiden, The Netherlands.
Ananja MiddelDepartment of Internal Medicine & Infectious Diseases, University Medical Center Utrecht, Utrecht, The Netherlands.
Jori SymonsDepartment of Medical Microbiology, University Medical Center Utrecht, Utrecht, The Netherlands.
Annemarie M J WensingDepartment of Medical Microbiology, University Medical Center Utrecht, Utrecht, The Netherlands.
Monique NijhuisDepartment of Medical Microbiology, University Medical Center Utrecht, Utrecht, The Netherlands.
José A M BorghansDepartment of Immunology, University Medical Center Utrecht, Utrecht, The Netherlands.
Kiki TesselaarDepartment of Immunology, University Medical Center Utrecht, Utrecht, The Netherlands.
Andy I M HoepelmanDepartment of Internal Medicine & Infectious Diseases, University Medical Center Utrecht, Utrecht, The Netherlands.
MIRS study group
University Medical Center Utrecht · NLLeiden University Medical Center · NLOLVG · NLRijnstate Hospital · NLSlotervaartziekenhuis · NLSpaarne Gasthuis · NLUniversity of Amsterdam · NL

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectiveThe immunomodulatory effects of the CCR5-antagonist maraviroc might be beneficial in patients with a suboptimal immunological response, but results of different cART (combination antiretroviral therapy) intensification studies are conflicting. Therefore, we performed a 48-week placebo-controlled trial to determine the effect of maraviroc intensification on CD4+ T-cell counts and immune activation in these patients.

designDouble-blind, placebo-controlled, randomized trial.

methodsMajor inclusion criteria were 1. CD4+ T-cell count <350 cells/μL while at least two years on cART or CD4+ T-cell count <200 cells/μL while at least one year on cART, and 2. viral suppression for at least the previous 6 months. HIV-infected patients were randomized to add maraviroc (41 patients) or placebo (44 patients) to their cART regimen for 48 weeks. Changes in CD4+ T-cell counts (primary endpoint) and other immunological parameters were modeled using linear mixed effects models.

resultsNo significant differences for the modelled increase in CD4+ T-cell count (placebo 15.3 CD4+ T cells/μL (95% confidence interval (CI) [1.0, 29.5] versus maraviroc arm 22.9 CD4+ T cells/μL (95% CI [7.4, 38.5] p = 0.51) or alterations in the expression of markers for T-cell activation, proliferation and microbial translocation were found between the arms. However, maraviroc intensification did increase the percentage of CCR5 expressing CD4+ and CD8+ T-cells, and the plasma levels of the CCR5 ligand MIP-1β. In contrast, the percentage of ex-vivo apoptotic CD8+ and CD4+ T-cells decreased in the maraviroc arm.

conclusionsMaraviroc intensification of cART did not increase CD4+ T-cell restoration or decrease immune activation as compared to placebo. However, ex-vivo T-cell apoptosis was decreased in the maraviroc arm.

trial registrationClinicalTrials.gov NCT00875368.

Indexed as

Antiretroviral Therapy, Highly ActiveAdultAnti-HIV AgentsCCR5 Receptor AntagonistsCD4-CD8 RatioCD4-Positive T-LymphocytesCD8-Positive T-LymphocytesCyclohexanesDouble-Blind MethodFemaleHIV-1HIV Fusion InhibitorsHIV InfectionsHumansLymphocyte CountMaleAnti-HIV AgentsCCR5 protein, humanCCR5 Receptor AntagonistsCyclohexanesHIV Fusion InhibitorsMaravirocReceptors, CCR5Triazoles

Identifiers

PMID26208341
PMCPMC4514679
OpenAlexW2216960478

What OpenQuestion holds

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LicenceCC BY
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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.