Evidence map›Paper›PMID 29112070›Full record

Trial reportAIDS (London, England)2017

Switching from a ritonavir-boosted protease inhibitor to a dolutegravir-based regimen for maintenance of HIV viral suppression in patients with high cardiovascular risk.

José M Gatell, Lambert Assoumou, Graeme Moyle, Laura Waters, Margaret Johnson, Pere Domingo, Julie Fox, Esteban Martinez, Hans-Jürgen Stellbrink, Giovanni Guaraldi and 8 more

Open access · hybridAbstract readEquivalence TrialRandomized Controlled Trial
In one paragraph

Trial report in AIDS (London, England), 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 41 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
41citing papers in PubMed, 2 pooled it
6.5field-weighted citation impact, top 2% 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

41 citing papers in PubMed, 2 syntheses or guidelines pooled it, 91 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Trial
  4. Trial
  5. Trial
  6. Switching to Bictegravir, Emtricitabine, and Tenofovir Alafenamide in Virologically Suppressed Adults With Human Immunodeficiency Virus.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2021
    Trial
  7. Cabotegravir Is Not Associated With Weight Gain in Human Immunodeficiency Virus-uninfected Individuals in HPTN 077.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2020
    Trial
  8. Trial
  9. Article
  10. Review
  11. Article
  12. Article
  13. Review
  14. Review
  15. Glycemic Control in Patients Living With HIV Initiated on Integrase Inhibitor-Based Three-Drug Antiretroviral Therapy.The Journal of pharmacy technology : jPT : official publication of the Association of Pharmacy Technicians · 2024
    Article
  16. Article
  17. Review
  18. Article
  19. Review
  20. Article
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

18 authors at 16 institutions in 7 countries.

José M GatellaHospital Clinic/IDIBAPS, University of Barcelona, Barcelona, Spain bINSERM, Institut Pierre Louis d'épidémiologie et de Santé Publique (IPLESP UMRS 1136), Sorbonne Universités, UPMC Univ Paris 06, Paris, France cSt Stephens AIDS Trust, Chelsea and Westminster Hospital dMortimer Market Center eRoyal Free Hospital, London, UK fHospital de Sant Pau, Barcelona, Spain gGuys and St. Thomas Hospital, London, UK hICH Study Centrum, Hamburg, Germany iUniversity of Modena and Reggio Emilia, Modena, Italy jHospital de Elche, Elche, Spain kSouthmead Hospital, Bristol, UK lSaint Pierre Hospital, Université Libre de Bruxelles, Brussels mInstitute of Tropical Medicine, Antwerp, Belgium nUniversitatsklinikum, Essen, Germany oUniversity Hospital of Nantes, Nantes, France.
Lambert Assoumou
Graeme Moyle
Laura Waters
Margaret Johnson
Pere Domingo
Julie Fox
Esteban Martinez
Hans-Jürgen Stellbrink
Giovanni Guaraldi
Mar Masia
Mark Gompels
Stephane De Wit
Eric Florence
Stefan Esser
François Raffi
Anton L Pozniak
NEAT022 Study Group*
Inserm · FRApple (Israel) · ILCentre Hospitalier Universitaire de Nantes · FRChelsea and Westminster Hospital · GBEssen University Hospital · DEHospital Clínic de Barcelona · ESHospital de Sant Pau · ESHospital General Universitario de Elche · ESInfektionsmedizinisches Centrum Hamburg · DEInstituut voor Tropische Geneeskunde · BEMortimer Surgery · GBSouthmead Hospital · GBSt Thomas' Hospital · GBThe Royal Free Hospital · GBUniversité Libre de Bruxelles · BEUniversity of Modena and Reggio Emilia · IT

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectiveTo compare the efficacy, safety, and impact on lipid fractions of switching from a ritonavir-boosted protease inhibitor (PI/r) to a dolutegravir (DTG) regimen.

methodsHIV type 1-infected adults more than 50 years or with a Framingham score more than 10% were eligible if plasma HIV RNA less than 50 copies per ml for at least 24 weeks while on a PI/r regimen. Patients were randomized to switch to DTG or to remain on PI/r. Primary endpoints were: proportion maintaining HIV RNA less than 50 copies per ml and percentage change from baseline of total cholesterol at week 48.

resultsIn total, 415 patients (32 sites in six European countries) were randomized: 205 to DTG and 210 to continue PI/r. About 89% were men, 87% more than 50 years, 74% had a Framingham score more than 10%, with a median CD4 cell count of 617 cells per μl and suppressed viremia for a median of 5 years. At week 48, in the intent-to-treat analysis, treatment success rate was 93.1% in DTG group and 95.2% in PI/r group (difference -2.1%, 95% confidence interval -6.6 to 2.4, noninferiority demonstrated). There were four virological failures with DTG and one with PI/r with no emergent resistance mutations. There was no significant difference in severe adverse events or grade 3 or 4 adverse events or treatment modifying adverse events. Total cholesterol and other lipid fractions (except high-density lipoprotein cholesterol) improved significantly (P < 0.001) in the DTG group regardless of PI/r at baseline.

conclusionSwitching to a DTG regimen in virologically suppressed HIV type 1 patients with high cardiovascular disease risk was noninferior, and significantly improved lipid profiles.

Indexed as

Cardiovascular DiseasesDolutegravirDrug SubstitutionFemaleHeterocyclic Compounds, 3-RingHIV InfectionsHIV Integrase InhibitorsHIV Protease InhibitorsHumansMaintenance ChemotherapyMaleMiddle AgedOxazinesPiperazinesPyridonesRitonavirDolutegravirHeterocyclic Compounds, 3-RingHIV Integrase InhibitorsHIV Protease InhibitorsOxazinesPiperazinesPyridonesRitonavir

Identifiers

PMID29112070
PMCPMC5690310
OpenAlexW2768049835

What OpenQuestion holds

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LicenceCC BY-NC-ND
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.