Evidence map›Paper›PMID 23225901›Full record

Trial reportThe Journal of infectious diseases2013

Safety and efficacy of dolutegravir in treatment-experienced subjects with raltegravir-resistant HIV type 1 infection: 24-week results of the VIKING Study.

Joseph J Eron, Bonaventura Clotet, Jacques Durant, Christine Katlama, Princy Kumar, Adriano Lazzarin, Isabelle Poizot-Martin, Gary Richmond, Vincent Soriano, Mounir Ait-Khaled and 6 more

3 registry-linked trialsOpen access · hybridAbstract readClinical Trial, Phase II
In one paragraph

Trial report in The Journal of infectious diseases, 2013. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 3 registered trials, which are not on this map. Cited by 142 papers, 4 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
142citing papers in PubMed, 4 pooled it
18.3field-weighted citation impact, top 1% 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.

NCT00950859 phase2completednot on this map

A Pilot Study to Assess the Antiviral Activity of GSK1349572 Containing Regimen in Antiretroviral Therapy (ART)-Experienced, HIV-1-infected Adult Subjects With Raltegravir Resistance

TypeinterventionalSponsorViiV HealthcareRan2009 to 2015Enrolled51ConditionsInfection, Human Immunodeficiency VirusArmsGSK1349572 (Cohort I), GSK1349572 (Cohort II)
NCT01328041 phase3completednot on this map

A Phase III Study to Demonstrate the Antiviral Activity and Safety of Dolutegravir in HIV-1 Infected Adult Subjects With Treatment Failure on an Integrase Inhibitor Containing Regimen.

TypeinterventionalSponsorViiV HealthcareRan2011 to 2015Enrolled183ConditionsInfection, Human Immunodeficiency VirusArmsdolutegravir
NCT02542852 phase2completednot on this mapstarted 2015, after this paper: background citation

A Pilot Phase II Study of a Nucleoside Sparing Regimen of Dolutegravir + Atazanavir/r in HIV-1 Infected Patients With Detectable Viremia (DOLATAV Study)

TypeinterventionalSponsorCastagna AntonellaRan2015 to 2017Enrolled10ConditionsHIV-1 InfectionArmsatazanavir 300 mg + ritonavir 100 mg + dolutegravir 50 mg
3 · Its place in the literature

Who cites it

142 citing papers in PubMed, 4 syntheses or guidelines pooled it, 307 citations in OpenAlex.

  1. Pooled it
  2. A systematic review of the genetic mechanisms of dolutegravir resistance.The Journal of antimicrobial chemotherapy · 2019
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  6. Pharmacokinetic Data of Dolutegravir in Second-line Treatment of Children With Human Immunodeficiency Virus: Results From the CHAPAS4 Trial.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2023
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82 more citing papers are in PubMed but not listed here.

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

16 authors at 12 institutions in 7 countries.

Joseph J EronInfectious Diseases Division, School of Medicine, University of North Carolina, Chapel Hill, NC 27599-7215, USA. jeron@med.unc.edu
Bonaventura Clotet
Jacques Durant
Christine Katlama
Princy Kumar
Adriano Lazzarin
Isabelle Poizot-Martin
Gary Richmond
Vincent Soriano
Mounir Ait-Khaled
Tamio Fujiwara
Jenny Huang
Sherene Min
Cindy Vavro
Jane Yeo
VIKING Study Group
GlaxoSmithKline (United Kingdom) · GBHôpital l'Archet · FRResearch Triangle Park Foundation · USUniversity of North Carolina at Chapel Hill · USAix-Marseille Université · FRBroward Health · USGeorgetown University · USHospital Clínico San Carlos · ESHospital Universitari Germans Trias i Pujol · ESSan Raffaele University of Rome · ITShionogi (Japan) · JPSorbonne Université · FR

Funding

Virology, Immunology, and Microbiology CoreP30AI050410 · NIAID · UNIV OF NORTH CAROLINA CHAPEL HILL · PI DAVID M. MARGOLIS · 2001 to 2026
$76.9M
NIAID NIH HHS P30 AI050410
6 · The paper itself

Abstract

backgroundDolutegravir (DTG; S/GSK1349572), a human immunodeficiency virus type 1 (HIV-1) integrase inhibitor, has limited cross-resistance to raltegravir (RAL) and elvitegravir in vitro. This phase IIb study assessed the activity of DTG in HIV-1-infected subjects with genotypic evidence of RAL resistance.

methodsSubjects received DTG 50 mg once daily (cohort I) or 50 mg twice daily (cohort II) while continuing a failing regimen (without RAL) through day 10, after which the background regimen was optimized, when feasible, for cohort I, and at least 1 fully active drug was mandated for cohort II. The primary efficacy end point was the proportion of subjects on day 11 in whom the plasma HIV-1 RNA load decreased by ≥0.7 log(10) copies/mL from baseline or was <400 copies/mL.

resultsA rapid antiviral response was observed. More subjects achieved the primary end point in cohort II (23 of 24 [96%]), compared with cohort I (21 of 27 [78%]) at day 11. At week 24, 41% and 75% of subjects had an HIV-1 RNA load of <50 copies/mL in cohorts I and II, respectively. Further integrase genotypic evolution was uncommon. Dolutegravir had a good, similar safety profile with each dosing regimen.

conclusionDolutegravir 50 mg twice daily with an optimized background provided greater and more durable benefit than the once-daily regimen. These data are the first clinical demonstration of the activity of any integrase inhibitor in subjects with HIV-1 resistant to RAL.

Indexed as

Drug Resistance, ViralAdultAgedAnti-HIV AgentsAntiretroviral Therapy, Highly ActiveDolutegravirFemaleHeterocyclic Compounds, 3-RingHIV-1HIV InfectionsHumansMaleMiddle AgedOxazinesPilot ProjectsPiperazinesAnti-HIV AgentsDolutegravirHeterocyclic Compounds, 3-RingOxazinesPiperazinesPyridonesPyrrolidinonesRaltegravir PotassiumRNA, Viral

Identifiers

PMID23225901
PMCPMC3563307
OpenAlexW2122026430

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

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.