Evidence map›Paper›PMID 24836963›Full record

Trial reportPloS one2014

Clinical and virological efficacy of etravirine plus two active Nucleos(t)ide analogs in an heterogeneous HIV-infected population.

Luis F López-Cortés, Pompeyo Viciana, José A Girón-González, Alberto Romero-Palacios, Manuel Márquez-Solero, Maria A Martinez-Perez, Miguel A López-Ruz, Javier de la Torre-Lima, Francisco Téllez-Pérez, Marcial Delgado-Fernández and 4 more

Registry-linked trialOpen access · goldAbstract readClinical TrialMulticenter Study
In one paragraph

Trial report in PloS one, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01437241 (Virological Efficacy and Safety of Etravirine Plus 2 Active Nucleos), which is not on this map. Cited by 2 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed, 1 pooled it
0.7field-weighted citation impact, top 30% 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.

NCT01437241 completednot on this map

Virological Efficacy and Safety of Etravirine Plus 2 Active Nucleos(t)Ide Reverse-transcriptase Inhibitors (NRTIs) in HIV-1-infected Patients

TypeobservationalSponsorHospitales Universitarios Virgen del RocíoRan2009 to 2011Enrolled175ConditionsHIV-1-infection
3 · Its place in the literature

Who cites it

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

  1. Pooled it
  2. Article
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

14 authors at 11 institutions in 1 country.

Luis F López-CortésInstituto de Biomedicina de Sevilla (IBiS), Hospital Universitario Virgen del Rocío/CSIC/Universidad de Sevilla, Sevilla, Spain; Enfermedades Infecciosas, Microbiología y Medicina Preventiva, Hospital Universitario Virgen del Rocío, Sevilla, Spain.
Pompeyo VicianaInstituto de Biomedicina de Sevilla (IBiS), Hospital Universitario Virgen del Rocío/CSIC/Universidad de Sevilla, Sevilla, Spain.
José A Girón-GonzálezHospital Universitario Puerta del Mar, Cádiz, Spain.
Alberto Romero-PalaciosHospital Universitario de Puerto Real, Cádiz, Spain.
Manuel Márquez-SoleroHospital Universitario Virgen de la Victoria, Málaga, Spain.
Maria A Martinez-PerezHospital Universitario San Cecilio, Granada, Spain.
Miguel A López-RuzHospital Universitario Virgen de las Nieves, Granada, Spain.
Javier de la Torre-LimaHospital Costa del Sol, Málaga, Spain.
Francisco Téllez-PérezHospital La Línea, Cádiz, Spain.
Marcial Delgado-FernándezHospital Universitario Carlos Haya, Málaga, Spain.
Milagros Garcia-LázaroHospital Universitario Reina Sofía, Córdoba, Spain.
Fernando LozanoHospital Universitario de Valme, Sevilla, Spain.
Mohamed O Mohamed-BalghataComplejo Hospitalario de Jaén, Jaén, Spain.
Sociedad Andaluza de Enfermedades Infecciosas
Hospital Universitario Puerta del Mar · ESComplejo Hospitalario de Jaén · ESHospital Clínico Universitario Virgen de la Victoria · ESHospital Costa del Sol · ESHospital Universitario de Valme · ESHospital Universitario Puerto Real · ESHospital Universitario Reina Sofía · ESHospital Universitario Virgen de las Nieves · ESHospital Universitario Virgen del Rocío · ESInstituto de Investigación Biosanitaria de Granada · ESUniversidad de Sevilla · ES

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

unlabelledEtravirine (ETV) is recommended in combination with a boosted protease inhibitor plus an optimized background regimen for salvage therapy, but there is limited experience with its use in combination with two nucleos(t)ide reverse-transcriptase inhibitors (NRTIs). This multicenter study aimed to assess the efficacy of this combination in two scenarios: group A) subjects without virologic failure on or no experience with non-nucleoside reverse-transcriptase inhibitors (NNRTIs) switched due to adverse events and group B) subjects switched after a virologic failure on an efavirenz- or nevirapine-based regimen. The primary endpoint was efficacy at 52 weeks analysed by intention-to-treat. Virologic failure was defined as the inability to suppress plasma HIV-RNA to <50 copies/mL after 24 weeks on treatment, or a confirmed viral load >200 copies/mL in patients who had previously achieved a viral suppression or had an undetectable viral load at inclusion. Two hundred eighty seven patients were included. Treatment efficacy rates in group A and B were 88.0% (CI95, 83.9-92.1%) and 77.4% (CI95, 65.0-89.7%), respectively; the rates reached 97.2% (CI95, 95.1-99.3%) and 90.5% (CI95, 81.7-99.3), by on-treatment analysis. The once-a-day ETV treatment was as effective as the twice daily dosing regimen. Grade 1-2 adverse events were observed motivating a treatment switch in 4.2% of the subjects. In conclusion, ETV (once- or twice daily) plus two analogs is a suitable, well-tolerated combination both as a switching strategy and after failure with first generation NNRTIs, ensuring full drug activity.

trial registrationClinicalTrials.gov NCT01437241.

Indexed as

Drug Therapy, CombinationEndpoint DeterminationGene Expression Regulation, ViralHIV InfectionsHumansKaplan-Meier EstimateNitrilesPyridazinesPyrimidinesReverse Transcriptase InhibitorsRNA, ViralSalvage TherapySpainTreatment OutcomeetravirineNitrilesPyridazinesPyrimidinesReverse Transcriptase InhibitorsRNA, Viral

Identifiers

PMID24836963
PMCPMC4023987
OpenAlexW2001009580

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.