Evidence map›Paper›PMID 20085491›Full record

Trial reportClinical infectious diseases : an official publication of the Infectious Diseases Society of America2010

Long-term efficacy and safety of Raltegravir combined with optimized background therapy in treatment-experienced patients with drug-resistant HIV infection: week 96 results of the BENCHMRK 1 and 2 Phase III trials.

Roy T Steigbigel, David A Cooper, Hedy Teppler, Joseph J Eron, Jose M Gatell, Princy N Kumar, Jurgen K Rockstroh, Mauro Schechter, Christine Katlama, Martin Markowitz and 13 more

4 registry-linked trialsAbstract readClinical Trial, Phase IIIRandomized Controlled Trial
In one paragraph

Trial report in Clinical infectious diseases : an official publication of the Infectious Diseases Society of America, 2010. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 4 registered trials, which are not on this map. Cited by 81 papers, 4 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
81citing papers in PubMed, 4 pooled it
–field-weighted citation impact
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.

NCT00293254 phase3completednot on this map

A Multicenter, Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Safety and Antiretroviral Activity of MK-0518 in Combination With an Optimized Background Therapy (OBT), Versus Optimized Background Therapy Alone, in HIV-Infected Patients With Documented Resistance to at Least 1 Drug in Each of the 3 Classes of Licensed Oral Antiretroviral Therapies

TypeinterventionalSponsorMerck Sharp & Dohme LLCRan2006 to 2011Enrolled351ConditionsHIV InfectionsArmsraltegravir potassium, Comparator: placebo
NCT00293267 phase3completednot on this map

A Multicenter, Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Safety and Antiretroviral Activity of MK-0518 in Combination With an Optimized Background Therapy (OBT), Versus Optimized Background Therapy Alone, in HIV-Infected Patients With Documented Resistance to at Least 1 Drug in Each of the 3 Classes of Licensed Oral Antiviral Therapies

TypeinterventionalSponsorMerck Sharp & Dohme LLCRan2006 to 2011Enrolled352ConditionsHIV InfectionsArmsraltegravir potassium, Comparator: Placebo
NCT01164605 naunknown statusnot on this map

Pilot Study on the Efficacy of a Two Drug, Raltegravir-based Regimen,(NRTI) Sparing Antiretroviral Treatment

TypeinterventionalSponsorSouthern California Institute for Research and EducationRan2010 to 2013Enrolled30ConditionsHIV InfectionArmsRaltegravir
NCT01989910 phase4completednot on this mapstarted 2013, after this paper: background citation

An Open Label, Randomized, Parallel Design Estimation Pilot Study to Compare the Efficacy and Safety of Raltegravir-based Versus Efavirenz-based Combination Therapy in Treatment-naïve Patients With HIV-1 Infection

TypeinterventionalSponsorTaipei Veterans General Hospital, TaiwanRan2013 to 2017Enrolled107ConditionsHIV-1 InfectionArmsRaltegravir, Efavirenz
3 · Its place in the literature

Who cites it

81 citing papers in PubMed, 4 syntheses or guidelines pooled it.

  1. Pooled it
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  9. Effect of Cabotegravir on Cardiac Repolarization in Healthy Subjects.Clinical pharmacology in drug development · 2016
    Trial
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  12. Pharmacokinetics, safety, and 48-week efficacy of oral raltegravir in HIV-1-infected children aged 2 through 18 years.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2014
    Trial
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  20. Review

21 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

23 authors.

Roy T SteigbigelState University of New York at Stony Brook, The Rockefeller University, New York, New York, USA.
David A Cooper
Hedy Teppler
Joseph J Eron
Jose M Gatell
Princy N Kumar
Jurgen K Rockstroh
Mauro Schechter
Christine Katlama
Martin Markowitz
Patrick Yeni
Mona R Loutfy
Adriano Lazzarin
Jeffrey L Lennox
Bonaventura Clotet
Jing Zhao
Hong Wan
Rand R Rhodes
Kim M Strohmaier
Richard J Barnard
Robin D Isaacs
Bach-Yen T Nguyen
BENCHMRK Study Teamsa

Funding

Transmission ProbabilityP01AI074621 · NIAID · UNIVERSITY OF CALIFORNIA, SAN DIEGO · PI RICHMAN, DOUGLAS D · 2008 to 2012
$23.1M
Primary Infection Resource Consortium (PIRC)R24AI106039 · NIAID · UNIVERSITY OF CALIFORNIA, SAN DIEGO · PI LITTLE, SUSAN JANET · 2013 to 2021
$23.1M
NIAID NIH HHS P01 AI074621NIAID NIH HHS R24 AI106039
6 · The paper itself

Abstract

BENCHMRK-1 and -2 are ongoing double-blind phase III studies of raltegravir in patients experiencing failure of antiretroviral therapy with triple-class drug-resistant human immunodeficiency virus infection. At week 96 (combined data), raltegravir (400 mg twice daily) plus optimized background therapy was generally well tolerated, with superior and durable antiretroviral and immunological efficacy, compared with optimized background therapy alone.

Indexed as

Anti-HIV AgentsCD4 Lymphocyte CountDouble-Blind MethodDrug Resistance, ViralDrug Therapy, CombinationFemaleHIV-1HIV InfectionsHumansMaleMiddle AgedPyrrolidinonesRaltegravir PotassiumRNA, ViralViral LoadAnti-HIV AgentsPyrrolidinonesRaltegravir PotassiumRNA, Viral

Identifiers

PMID20085491
PMCPMC6076431

What OpenQuestion holds

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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.