Evidence map›Paper›PMID 29161288›Full record

Trial reportPloS one2017

Switch to maraviroc with darunavir/r, both QD, in patients with suppressed HIV-1 was well tolerated but virologically inferior to standard antiretroviral therapy: 48-week results of a randomized trial.

Barbara Rossetti, Roberta Gagliardini, Genny Meini, Gaetana Sterrantino, Vincenzo Colangeli, Maria Carla Re, Alessandra Latini, Manuela Colafigli, Francesca Vignale, Stefano Rusconi and 21 more

Abstract readRandomized Controlled Trial
In one paragraph

Trial report in PloS one, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 4 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed, 1 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.

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

4 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
  2. Trial
  3. Article
  4. 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

31 authors.

Barbara RossettiInfectious Diseases Unit, Azienda Ospedaliera Universitaria Senese, Siena, Italy.ORCID http://orcid.org/0000-0003-1659-9241
Roberta GagliardiniClinic of Infectious Diseases, Catholic University of Sacred Heart, Rome, Italy.
Genny MeiniDepartment of Medical Biotechnology, University of Siena, Siena, Italy.
Gaetana SterrantinoClinic of Infectious Diseases, Azienda Ospedaliera Universitaria Careggi, Firenze, Italy.
Vincenzo ColangeliClinic of Infectious Diseases, Azienda Ospedaliera Universitaria S.Orsola Malpighi, Bologna, Italy.
Maria Carla ReMicrobiology, Azienda Ospedaliera Universitaria S.Orsola Malpighi, Bologna, Italy.
Alessandra LatiniInfectious Dermatology and Allergology IRCCS IFO, Roma, Italy.
Manuela ColafigliInfectious Dermatology and Allergology IRCCS IFO, Roma, Italy.
Francesca VignaleClinic of Infectious Diseases, G. D'Annunzio University, Chieti, Italy.
Stefano RusconiInfectious and Tropical Diseases Unit, DIBIC L. Sacco Hospital, University of Milano, Milano, Italy.
Valeria MicheliMicrobiology and Virology Laboratory, L. Sacco Hospital, Milano, Italy.
Antonio Di BiagioInfectious Diseases Unit, IRCCS S. Martino-IST, Genova, Italy.
Giancarlo OrofinoInfectious Diseases Unit A, Amedeo di Savoia Hospital, Torino, Italy.
Valeria GhisettiMicrobiology and Virology Laboratory, Amedeo di Savoia Hospital, Torino, Italy.
Alessandra FantauzziDepartment of Clinical Medicine, Sapienza University of Rome, Roma, Italy.
Vincenzo VulloDepartment of Public Health and Infectious Diseases, Sapienza University of Rome, Roma, Italy.
Pierfrancesco GrimaDivision of Infectious Diseases, S. Caterina Novella Hospital, Galatina, Lecce, Italy.
Daniela FrancisciClinic of Infectious Diseases, University of Perugia, Perugia, Italy.
Claudio MastroianniInfectious Disease Unit, SM Goretti Hospital, Department of Public Health and Infectious Diseases, Sapienza University, Latina, Italy.
Andrea AntinoriInfectious Diseases Unit, IRCCS L. Spallanzani, Roma, Italy.
Michele TrezziInfectious Diseases Unit, Pistoia Hospital, Pistoia, Italy.
Lucia LisiPharmacology Department, Catholic University of Sacred Heart, Rome, Italy.
Pierluigi NavarraPharmacology Department, Catholic University of Sacred Heart, Rome, Italy.
Benedetta CanovariInfectious Diseases Unit, Pesaro Hospital, Pesaro, Italy.
Antonella D'Arminio MonforteInfectious and Tropical Diseases Institute, Department of Health Sciences, University of Milan San Paolo Hospital, Milan, Italy.
Silvia LamonicaClinic of Infectious Diseases, Catholic University of Sacred Heart, Rome, Italy.
Alessandro D'AvinoClinic of Infectious Diseases, Catholic University of Sacred Heart, Rome, Italy.
Maurizio ZazziDepartment of Medical Biotechnology, University of Siena, Siena, Italy.
Simona Di GiambenedettoClinic of Infectious Diseases, Catholic University of Sacred Heart, Rome, Italy.
Andrea De LucaInfectious Diseases Unit, Azienda Ospedaliera Universitaria Senese, Siena, Italy.
for GUSTA trial study group

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectivesPrimary study outcome was absence of treatment failure (virological failure, VF, or treatment interruption) per protocol at week 48.

methodsPatients on 3-drug ART with stable HIV-1 RNA <50 copies/mL and CCR5-tropic virus were randomized 1:1 to maraviroc with darunavir/ritonavir qd (study arm) or continue current ART (continuation arm).

resultsIn June 2015, 115 patients were evaluable for the primary outcome (56 study, 59 continuation arm). The study was discontinued due to excess of VF in the study arm (7 cases, 12.5%, vs 0 in the continuation arm, p = 0.005). The proportion free of treatment failure was 73.2% in the study and 59.3% in the continuation arm. Two participants in the study and 10 in the continuation arm discontinued therapy due to adverse events (p = 0.030). At VF, no emergent drug resistance was detected. Co-receptor tropism switched to non-R5 in one patient. Patients with VF reported lower adherence and had lower plasma drug levels. Femoral bone mineral density was significantly improved in the study arm.

conclusionSwitching to maraviroc with darunavir/ritonavir qd in virologically suppressed patients was associated with improved tolerability but was virologically inferior to 3-drug therapy.

Indexed as

AdultAnti-HIV AgentsAntiretroviral Therapy, Highly ActiveCyclohexanesDarunavirDrug Therapy, CombinationFemaleHIV-1HIV InfectionsHumansMaleMaravirocMiddle AgedRitonavirTreatment OutcomeTriazolesAnti-HIV AgentsCyclohexanesDarunavirMaravirocRitonavirTriazoles

Identifiers

PMID29161288
PMCPMC5697828

What OpenQuestion holds

Textmetadata
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.