Evidence map›Paper›PMID 23807273›Full record

Trial reportAIDS (London, England)2013

Dolutegravir in antiretroviral-naive adults with HIV-1: 96-week results from a randomized dose-ranging study.

Hans-Jürgen Stellbrink, Jacques Reynes, Adriano Lazzarin, Eugene Voronin, Federico Pulido, Franco Felizarta, Steve Almond, Marty St Clair, Nancy Flack, Sherene Min and 1 more

Open access · hybridAbstract readMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in AIDS (London, England), 2013. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 73 papers, 6 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
73citing papers in PubMed, 6 pooled it
9.0field-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.

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

73 citing papers in PubMed, 6 syntheses or guidelines pooled it, 160 citations in OpenAlex.

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13 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

11 authors at 7 institutions in 6 countries.

Hans-Jürgen StellbrinkICH Study Center, Hamburg, Germany. stellbrink@ich-hamburg.de
Jacques Reynes
Adriano Lazzarin
Eugene Voronin
Federico Pulido
Franco Felizarta
Steve Almond
Marty St Clair
Nancy Flack
Sherene Min
SPRING-1 Team
Research Triangle Park Foundation · USGlaxoSmithKline (Canada) · CAGlaxoSmithKline (United States) · USHôpital Gui de Chauliac · FRInfectious Clinical Hospital No. 1 · RUInfektionsmedizinisches Centrum Hamburg · DEResearch Institute Hospital 12 de Octubre · ES

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectiveTo evaluate the efficacy and safety/tolerability of dolutegravir (DTG, S/GSK1349572), a potent inhibitor of HIV integrase, through the full 96 weeks of the SPRING-1 study.

designING112276 (SPRING-1) was a 96-week, randomized, partially blinded, phase IIb dose-ranging study.

methodsTreatment-naive adults with HIV received DTG 10, 25, or 50 mg once daily or efavirenz (EFV) 600 mg once daily (control arm) combined with investigator-selected dual nucleos(t)ide reverse transcriptase inhibitor backbone regimen (tenofovir/emtricitabine or abacavir/lamivudine). The primary endpoint of the study was the proportion of participants with plasma HIV-1 RNA less than 50 copies/ml, based on time to loss of virologic response at 16 weeks (conducted for the purpose of phase III dose selection), with a planned analysis at 96 weeks. Safety and tolerability were also assessed.

resultsOf 208 participants randomized to treatment, 205 received study drug. At week 96, the proportion of participants achieving plasma HIV-1 RNA less than 50 copies/ml was 79, 78, and 88% for DTG 10, 25, and 50 mg, respectively, compared with 72% for EFV. The median increase from baseline in CD4 cells was 338 cells/μl with DTG (all treatment groups combined) compared with 301 cells/μl with EFV (P  = 0.155). No clinically significant dose-related trends in adverse events were observed, and fewer participants who received DTG withdrew because of adverse events (3%) compared with EFV (10%).

conclusionThroughout the 96 weeks of the SPRING-1 study, DTG demonstrated sustained efficacy and favorable safety/tolerability in treatment-naive individuals with HIV-1.

Indexed as

AdultAnti-HIV AgentsAntiretroviral Therapy, Highly ActiveDolutegravirFemaleHeterocyclic Compounds, 3-RingHIV-1HIV InfectionsHumansMaleOxazinesPiperazinesPyridonesRNA, ViralSingle-Blind MethodTreatment OutcomeAnti-HIV AgentsDolutegravirHeterocyclic Compounds, 3-RingOxazinesPiperazinesPyridonesRNA, Viral

Identifiers

PMID23807273
PMCPMC3694319
OpenAlexW2048514971

What OpenQuestion holds

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Registered trials

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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.