Evidence map›Paper›PMID 24446523›Full record

Trial reportThe Journal of infectious diseases2014

Dolutegravir in antiretroviral-experienced patients with raltegravir- and/or elvitegravir-resistant HIV-1: 24-week results of the phase III VIKING-3 study.

Antonella Castagna, Franco Maggiolo, Giovanni Penco, David Wright, Anthony Mills, Robert Grossberg, Jean-Michel Molina, Julie Chas, Jacques Durant, Santiago Moreno and 9 more

3 registry-linked trialsOpen access · bronzeAbstract readClinical TrialMulticenter Study
In one paragraph

Trial report in The Journal of infectious diseases, 2014. 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 145 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
145citing papers in PubMed, 3 pooled it
22.8field-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.

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
NCT02384395 nacompletednot on this mapstarted 2015, after this paper: background citation

IGHID 11417 - The Safety and Efficacy of Fixed Dose Combination Dolutegravir/Abacavir/Lamivudine FDC Initiated During Acute HIV Infection: Impact on the Latent HIV Reservoir and Long-Term Immunologic Effect

TypeinterventionalSponsorUniversity of North Carolina, Chapel HillRan2015 to 2021Enrolled40ConditionsHIV, Acute HIV InfectionArmsDolutegravir 50 mg, Lamivudine 300 mg, Abacavir 600 mg
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

145 citing papers in PubMed, 3 syntheses or guidelines pooled it, 325 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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  18. Two cases of possible transmitted HIV drug resistance to all currently available integrase inhibitors, the Netherlands, 2025.Euro surveillance : bulletin Europeen sur les maladies transmissibles = European communicable disease bulletin · 2026
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85 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

19 authors at 12 institutions in 8 countries.

Antonella CastagnaSan Raffaele Scientific Institute, Milan.
Franco MaggioloOspedale Riuniti, Bergamo.
Giovanni PencoOspedale Galliera, Genova, Italy.
David WrightCentral Texas Clinical Research, Austin, Texas.
Anthony MillsAnthony Mills MD Inc, Los Angeles, California.
Robert GrossbergMontefiore Medical Center, New York, New York.
Jean-Michel MolinaHôpital Saint-Louis, Paris.
Julie ChasHôpital Tenon, Paris.
Jacques DurantHôpital de L'Archet, Nice, France.
Santiago MorenoHospital Universitario Ramón y Cajal, Madrid, Spain.
Manuela DoroanaHospital de Santa Maria, Lisbon, Portugal.
Mounir Ait-KhaledGlaxoSmithKline, London, United Kingdom.
Jenny HuangGlaxoSmithKline, Mississauga, Ontario, Canada.
Sherene MinGlaxoSmithKline, Research Triangle Park, North Carolina.
Ivy SongGlaxoSmithKline, Research Triangle Park, North Carolina.
Cindy VavroGlaxoSmithKline, Research Triangle Park, North Carolina.
Garrett NicholsGlaxoSmithKline, Research Triangle Park, North Carolina.
Jane M YeoGlaxoSmithKline, London, United Kingdom.
VIKING-3 Study Group
Research Triangle Park Foundation · USGlaxoSmithKline (United Kingdom) · GBEnte Ospedaliero Ospedali Galliera · ITMontefiore Medical Center · USAzienda Ospedaliero Universitaria Ospedali Riuniti · ITGlaxoSmithKline (Canada) · CAHôpital l'Archet · FRHôpital Saint-Louis · FRHospital de Santa Maria · PTHospital Universitario Ramón y Cajal · ESSan Raffaele University of Rome · ITSorbonne Université · FR

Funding

Virus & Reservoirs CoreP30AI045008 · NIAID · UNIVERSITY OF PENNSYLVANIA · PI ROBERT GROSS · 1999 to 2026
$78.6M
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 AI045008NIAID NIH HHS P30 AI050410
6 · The paper itself

Abstract

backgroundThe pilot phase IIb VIKING study suggested that dolutegravir (DTG), a human immunodeficiency virus (HIV) integrase inhibitor (INI), would be efficacious in INI-resistant patients at the 50 mg twice daily (BID) dose.

methodsVIKING-3 is a single-arm, open-label phase III study in which therapy-experienced adults with INI-resistant virus received DTG 50 mg BID while continuing their failing regimen (without raltegravir or elvitegravir) through day 7, after which the regimen was optimized with ≥1 fully active drug and DTG continued. The primary efficacy endpoints were the mean change from baseline in plasma HIV-1 RNA at day 8 and the proportion of subjects with HIV-1 RNA <50 c/mL at week 24.

resultsMean change in HIV-1 RNA at day 8 was -1.43 log10 c/mL, and 69% of subjects achieved <50 c/mL at week 24. Multivariate analyses demonstrated a strong association between baseline DTG susceptibility and response. Response was most reduced in subjects with Q148 + ≥2 resistance-associated mutations. DTG 50 mg BID had a low (3%) discontinuation rate due to adverse events, similar to INI-naive subjects receiving DTG 50 mg once daily.

conclusionsDTG 50 mg BID-based therapy was effective in this highly treatment-experienced population with INI-resistant virus. CLINICAL TRIALS REGISTRATION: www.clinicaltrials.gov (NCT01328041) and http://www.gsk-clinicalstudywww.gsk-clinicalstudyregister.com (112574).

Indexed as

Drug Resistance, ViralAdultAnti-HIV AgentsDolutegravirFemaleHeterocyclic Compounds, 3-RingHIV-1HIV InfectionsHumansMaleMiddle AgedOxazinesPilot ProjectsPiperazinesPyridonesPyrrolidinonesAnti-HIV AgentsDolutegravirelvitegravirHeterocyclic Compounds, 3-RingOxazinesPiperazinesPyridonesPyrrolidinonesQuinolonesRaltegravir PotassiumRNA, ViraldolutegravirDTGelvitegravir resistanceintegrase inhibitorraltegravir resistance

Identifiers

PMID24446523
PMCPMC4091579
OpenAlexW2133117185

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
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.