AustralieFrV1, PascalFrancis, Corpus, bibRecord, 000949

A Randomized Phase 3 Study Comparing Once-Daily Elvitegravir With Twice-Daily Raltegravir in Treatment-Experienced Subjects With HIV-1 infection: 96-Week Results

Identifieur interne : 000949 ( PascalFrancis/Corpus ); précédent : 000948; suivant : 000950

A Randomized Phase 3 Study Comparing Once-Daily Elvitegravir With Twice-Daily Raltegravir in Treatment-Experienced Subjects With HIV-1 infection: 96-Week Results

Auteurs : Richard Elion ; Jean-Michel Molina ; José Ramon Arribas Lopez ; David Cooper ; Franco Maggiolo ; Edmund Wilkins ; Brian Conway ; Ya-Pei Liu ; Nicolas Margot ; Martin Rhee ; Steven L. Chuck ; Javier Szwarcberg

Source :

Journal of acquired immune deficiency syndromes : (1999) [ 1525-4135 ] ; 2013.

RBID : Pascal:13-0237578

Descripteurs français

Pascal (Inist)
- Virus HIV1, Traitement, SIDA, Efficacité, Elvitégravir, Raltégravir.

English descriptors

KwdEn :
- AIDS, Efficiency, Elvitegravir, HIV-1 virus, Raltegravir, Treatment.

Abstract

This 96-week, double-blind, active-controlled, phase 3 study, randomized subjects to elvitegravir once daily or raltegravir twice daily with a fully active, ritonavir-boosted protease inhibitor plus a third agent. The proportion of subjects randomized to elvitegravir that achieved and maintained HIV-1 RNA < 50 copies/mL through week 96 was 47.6% (167/351) compared with 45.0% (158/351) for raltegravir with a treatment difference of 2.6% (95% confidence interval: 4.6% to 9.9%). Both regimens were well tolerated, with comparable rates of adverse events and laboratory abnormalities through week 96. Once-daily elvitegravir was noninferior to twice-daily raltegravir, showed durable long-term efficacy, and was well tolerated in HIV+ treatment-experienced patients.

Notice en format standard (ISO 2709)

Pour connaître la documentation sur le format Inist Standard.

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A08	`01`	`1`	`ENG`	`@1 A Randomized Phase 3 Study Comparing Once-Daily Elvitegravir With Twice-Daily Raltegravir in Treatment-Experienced Subjects With HIV-1 infection: 96-Week Results`
A11	`01`	`1`		`@1 ELION (Richard)`
A11	`02`	`1`		`@1 MOLINA (Jean-Michel)`
A11	`03`	`1`		`@1 RAMON ARRIBAS LOPEZ (José)`
A11	`04`	`1`		`@1 COOPER (David)`
A11	`05`	`1`		`@1 MAGGIOLO (Franco)`
A11	`06`	`1`		`@1 WILKINS (Edmund)`
A11	`07`	`1`		`@1 CONWAY (Brian)`
A11	`08`	`1`		`@1 LIU (Ya-Pei)`
A11	`09`	`1`		`@1 MARGOT (Nicolas)`
A11	`10`	`1`		`@1 RHEE (Martin)`
A11	`11`	`1`		`@1 CHUCK (Steven L.)`
A11	`12`	`1`		`@1 SZWARCBERG (Javier)`
A14	`01`			`@1 Whitman-Walker Health @2 Washington, DC @3 USA @Z 1 aut.`
A14	`02`			`@1 Hospital Saint-Louis, APHP, University of Sorbonne Paris Cité, Paris 7, INSERM U941 @3 FRA @Z 2 aut.`
A14	`03`			`@1 Hospital Universitario La Paz, IdiPAZ, Servicio de Medicina Interna, Unidad VIH @2 Madrid @3 ESP @Z 3 aut.`
A14	`04`			`@1 Kirby Institute, University of New South Wales @2 Sydney @3 AUS @Z 4 aut.`
A14	`05`			`@1 Ospedali Riuniti di Bergamo @2 Bergamo @3 ITA @Z 5 aut.`
A14	`06`			`@1 North Manchester General Hospital @2 Manchester @3 GBR @Z 6 aut.`
A14	`07`			`@1 Vancouver ID Research & Care Centre @2 Vancouver @3 CAN @Z 7 aut.`
A14	`08`			`@1 Gilead Sciences, Inc. @2 Foster City, CA @3 USA @Z 8 aut. @Z 9 aut. @Z 10 aut. @Z 11 aut. @Z 12 aut.`
A17	`01`	`1`		`@1 Study 145 Team @3 INC`
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A44				`@0 0000 @1 © 2013 INIST-CNRS. All rights reserved.`
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C01	`01`		`ENG`	@0 This 96-week, double-blind, active-controlled, phase 3 study, randomized subjects to elvitegravir once daily or raltegravir twice daily with a fully active, ritonavir-boosted protease inhibitor plus a third agent. The proportion of subjects randomized to elvitegravir that achieved and maintained HIV-1 RNA < 50 copies/mL through week 96 was 47.6% (167/351) compared with 45.0% (158/351) for raltegravir with a treatment difference of 2.6% (95% confidence interval: 4.6% to 9.9%). Both regimens were well tolerated, with comparable rates of adverse events and laboratory abnormalities through week 96. Once-daily elvitegravir was noninferior to twice-daily raltegravir, showed durable long-term efficacy, and was well tolerated in HIV+ treatment-experienced patients.
C02	`01`	`X`		`@0 002A05C10`
C02	`02`	`X`		`@0 002B05C02J`
C02	`03`	`X`		`@0 002B05C02D`
C03	`01`	`X`	`FRE`	`@0 Virus HIV1 @2 NW @5 01`
C03	`01`	`X`	`ENG`	`@0 HIV-1 virus @2 NW @5 01`
C03	`01`	`X`	`SPA`	`@0 HIV-1 virus @2 NW @5 01`
C03	`02`	`X`	`FRE`	`@0 Traitement @5 05`
C03	`02`	`X`	`ENG`	`@0 Treatment @5 05`
C03	`02`	`X`	`SPA`	`@0 Tratamiento @5 05`
C03	`03`	`X`	`FRE`	`@0 SIDA @5 06`
C03	`03`	`X`	`ENG`	`@0 AIDS @5 06`
C03	`03`	`X`	`SPA`	`@0 SIDA @5 06`
C03	`04`	`X`	`FRE`	`@0 Efficacité @5 07`
C03	`04`	`X`	`ENG`	`@0 Efficiency @5 07`
C03	`04`	`X`	`SPA`	`@0 Eficacia @5 07`
C03	`05`	`X`	`FRE`	`@0 Elvitégravir @2 FR @5 14`
C03	`05`	`X`	`ENG`	`@0 Elvitegravir @2 FR @5 14`
C03	`05`	`X`	`SPA`	`@0 Elvitegravir @2 FR @5 14`
C03	`06`	`X`	`FRE`	`@0 Raltégravir @2 FR @5 15`
C03	`06`	`X`	`ENG`	`@0 Raltegravir @2 FR @5 15`
C03	`06`	`X`	`SPA`	`@0 Raltegravir @2 FR @5 15`
C07	`01`	`X`	`FRE`	`@0 Virus immunodéficience humaine @2 NW`
C07	`01`	`X`	`ENG`	`@0 Human immunodeficiency virus @2 NW`
C07	`01`	`X`	`SPA`	`@0 Human immunodeficiency virus @2 NW`
C07	`02`	`X`	`FRE`	`@0 Lentivirus @2 NW`
C07	`02`	`X`	`ENG`	`@0 Lentivirus @2 NW`
C07	`02`	`X`	`SPA`	`@0 Lentivirus @2 NW`
C07	`03`	`X`	`FRE`	`@0 Retroviridae @2 NW`
C07	`03`	`X`	`ENG`	`@0 Retroviridae @2 NW`
C07	`03`	`X`	`SPA`	`@0 Retroviridae @2 NW`
C07	`04`	`X`	`FRE`	`@0 Virus @2 NW`
C07	`04`	`X`	`ENG`	`@0 Virus @2 NW`
C07	`04`	`X`	`SPA`	`@0 Virus @2 NW`
C07	`05`	`X`	`FRE`	`@0 Virose`
C07	`05`	`X`	`ENG`	`@0 Viral disease`
C07	`05`	`X`	`SPA`	`@0 Virosis`
C07	`06`	`X`	`FRE`	`@0 Infection`
C07	`06`	`X`	`ENG`	`@0 Infection`
C07	`06`	`X`	`SPA`	`@0 Infección`
C07	`07`	`X`	`FRE`	`@0 Immunodéficit @5 13`
C07	`07`	`X`	`ENG`	`@0 Immune deficiency @5 13`
C07	`07`	`X`	`SPA`	`@0 Inmunodeficiencia @5 13`
C07	`08`	`X`	`FRE`	`@0 Immunopathologie @5 17`
C07	`08`	`X`	`ENG`	`@0 Immunopathology @5 17`
C07	`08`	`X`	`SPA`	`@0 Inmunopatología @5 17`
N21				`@1 224`
N44	`01`			`@1 OTO`
N82				`@1 OTO`

Format Inist (serveur)

NO :	PASCAL 13-0237578 INIST
ET :	A Randomized Phase 3 Study Comparing Once-Daily Elvitegravir With Twice-Daily Raltegravir in Treatment-Experienced Subjects With HIV-1 infection: 96-Week Results
AU :	ELION (Richard); MOLINA (Jean-Michel); RAMON ARRIBAS LOPEZ (José); COOPER (David); MAGGIOLO (Franco); WILKINS (Edmund); CONWAY (Brian); LIU (Ya-Pei); MARGOT (Nicolas); RHEE (Martin); CHUCK (Steven L.); SZWARCBERG (Javier)
AF :	Whitman-Walker Health/Washington, DC/Etats-Unis (1 aut.); Hospital Saint-Louis, APHP, University of Sorbonne Paris Cité, Paris 7, INSERM U941/France (2 aut.); Hospital Universitario La Paz, IdiPAZ, Servicio de Medicina Interna, Unidad VIH/Madrid/Espagne (3 aut.); Kirby Institute, University of New South Wales/Sydney/Australie (4 aut.); Ospedali Riuniti di Bergamo/Bergamo/Italie (5 aut.); North Manchester General Hospital/Manchester/Royaume-Uni (6 aut.); Vancouver ID Research & Care Centre/Vancouver/Canada (7 aut.); Gilead Sciences, Inc./Foster City, CA/Etats-Unis (8 aut., 9 aut., 10 aut., 11 aut., 12 aut.)
DT :	Publication en série; Niveau analytique
SO :	Journal of acquired immune deficiency syndromes : (1999); ISSN 1525-4135; Etats-Unis; Da. 2013; Vol. 63; No. 4; Pp. 494-497; Bibl. 8 ref.
LA :	Anglais
EA :	This 96-week, double-blind, active-controlled, phase 3 study, randomized subjects to elvitegravir once daily or raltegravir twice daily with a fully active, ritonavir-boosted protease inhibitor plus a third agent. The proportion of subjects randomized to elvitegravir that achieved and maintained HIV-1 RNA < 50 copies/mL through week 96 was 47.6% (167/351) compared with 45.0% (158/351) for raltegravir with a treatment difference of 2.6% (95% confidence interval: 4.6% to 9.9%). Both regimens were well tolerated, with comparable rates of adverse events and laboratory abnormalities through week 96. Once-daily elvitegravir was noninferior to twice-daily raltegravir, showed durable long-term efficacy, and was well tolerated in HIV+ treatment-experienced patients.
CC :	002A05C10; 002B05C02J; 002B05C02D
FD :	Virus HIV1; Traitement; SIDA; Efficacité; Elvitégravir; Raltégravir
FG :	Virus immunodéficience humaine; Lentivirus; Retroviridae; Virus; Virose; Infection; Immunodéficit; Immunopathologie
ED :	HIV-1 virus; Treatment; AIDS; Efficiency; Elvitegravir; Raltegravir
EG :	Human immunodeficiency virus; Lentivirus; Retroviridae; Virus; Viral disease; Infection; Immune deficiency; Immunopathology
SD :	HIV-1 virus; Tratamiento; SIDA; Eficacia; Elvitegravir; Raltegravir
LO :	INIST-21576.354000505158740110
ID :	13-0237578

Links to Exploration step

Pascal:13-0237578

Le document en format XML

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<author><name sortKey="Margot, Nicolas" sort="Margot, Nicolas" uniqKey="Margot N" first="Nicolas" last="Margot">Nicolas Margot</name>
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<author><name sortKey="Chuck, Steven L" sort="Chuck, Steven L" uniqKey="Chuck S" first="Steven L." last="Chuck">Steven L. Chuck</name>
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<author><name sortKey="Szwarcberg, Javier" sort="Szwarcberg, Javier" uniqKey="Szwarcberg J" first="Javier" last="Szwarcberg">Javier Szwarcberg</name>
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<sourceDesc><biblStruct><analytic><title xml:lang="en" level="a">A Randomized Phase 3 Study Comparing Once-Daily Elvitegravir With Twice-Daily Raltegravir in Treatment-Experienced Subjects With HIV-1 infection: 96-Week Results</title>
<author><name sortKey="Elion, Richard" sort="Elion, Richard" uniqKey="Elion R" first="Richard" last="Elion">Richard Elion</name>
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<author><name sortKey="Molina, Jean Michel" sort="Molina, Jean Michel" uniqKey="Molina J" first="Jean-Michel" last="Molina">Jean-Michel Molina</name>
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<s3>FRA</s3>
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</inist:fA14>
</affiliation>
</author>
<author><name sortKey="Ramon Arribas Lopez, Jose" sort="Ramon Arribas Lopez, Jose" uniqKey="Ramon Arribas Lopez J" first="José" last="Ramon Arribas Lopez">José Ramon Arribas Lopez</name>
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<author><name sortKey="Cooper, David" sort="Cooper, David" uniqKey="Cooper D" first="David" last="Cooper">David Cooper</name>
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<s2>Sydney</s2>
<s3>AUS</s3>
<sZ>4 aut.</sZ>
</inist:fA14>
</affiliation>
</author>
<author><name sortKey="Maggiolo, Franco" sort="Maggiolo, Franco" uniqKey="Maggiolo F" first="Franco" last="Maggiolo">Franco Maggiolo</name>
<affiliation><inist:fA14 i1="05"><s1>Ospedali Riuniti di Bergamo</s1>
<s2>Bergamo</s2>
<s3>ITA</s3>
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</inist:fA14>
</affiliation>
</author>
<author><name sortKey="Wilkins, Edmund" sort="Wilkins, Edmund" uniqKey="Wilkins E" first="Edmund" last="Wilkins">Edmund Wilkins</name>
<affiliation><inist:fA14 i1="06"><s1>North Manchester General Hospital</s1>
<s2>Manchester</s2>
<s3>GBR</s3>
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</affiliation>
</author>
<author><name sortKey="Conway, Brian" sort="Conway, Brian" uniqKey="Conway B" first="Brian" last="Conway">Brian Conway</name>
<affiliation><inist:fA14 i1="07"><s1>Vancouver ID Research & Care Centre</s1>
<s2>Vancouver</s2>
<s3>CAN</s3>
<sZ>7 aut.</sZ>
</inist:fA14>
</affiliation>
</author>
<author><name sortKey="Liu, Ya Pei" sort="Liu, Ya Pei" uniqKey="Liu Y" first="Ya-Pei" last="Liu">Ya-Pei Liu</name>
<affiliation><inist:fA14 i1="08"><s1>Gilead Sciences, Inc.</s1>
<s2>Foster City, CA</s2>
<s3>USA</s3>
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<author><name sortKey="Margot, Nicolas" sort="Margot, Nicolas" uniqKey="Margot N" first="Nicolas" last="Margot">Nicolas Margot</name>
<affiliation><inist:fA14 i1="08"><s1>Gilead Sciences, Inc.</s1>
<s2>Foster City, CA</s2>
<s3>USA</s3>
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<sZ>9 aut.</sZ>
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</inist:fA14>
</affiliation>
</author>
<author><name sortKey="Rhee, Martin" sort="Rhee, Martin" uniqKey="Rhee M" first="Martin" last="Rhee">Martin Rhee</name>
<affiliation><inist:fA14 i1="08"><s1>Gilead Sciences, Inc.</s1>
<s2>Foster City, CA</s2>
<s3>USA</s3>
<sZ>8 aut.</sZ>
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<author><name sortKey="Chuck, Steven L" sort="Chuck, Steven L" uniqKey="Chuck S" first="Steven L." last="Chuck">Steven L. Chuck</name>
<affiliation><inist:fA14 i1="08"><s1>Gilead Sciences, Inc.</s1>
<s2>Foster City, CA</s2>
<s3>USA</s3>
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</author>
<author><name sortKey="Szwarcberg, Javier" sort="Szwarcberg, Javier" uniqKey="Szwarcberg J" first="Javier" last="Szwarcberg">Javier Szwarcberg</name>
<affiliation><inist:fA14 i1="08"><s1>Gilead Sciences, Inc.</s1>
<s2>Foster City, CA</s2>
<s3>USA</s3>
<sZ>8 aut.</sZ>
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</author>
</analytic>
<series><title level="j" type="main">Journal of acquired immune deficiency syndromes : (1999)</title>
<title level="j" type="abbreviated">J. acquir. immune defic. syndr. : (1999)</title>
<idno type="ISSN">1525-4135</idno>
<imprint><date when="2013">2013</date>
</imprint>
</series>
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<seriesStmt><title level="j" type="main">Journal of acquired immune deficiency syndromes : (1999)</title>
<title level="j" type="abbreviated">J. acquir. immune defic. syndr. : (1999)</title>
<idno type="ISSN">1525-4135</idno>
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<profileDesc><textClass><keywords scheme="KwdEn" xml:lang="en"><term>AIDS</term>
<term>Efficiency</term>
<term>Elvitegravir</term>
<term>HIV-1 virus</term>
<term>Raltegravir</term>
<term>Treatment</term>
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<keywords scheme="Pascal" xml:lang="fr"><term>Virus HIV1</term>
<term>Traitement</term>
<term>SIDA</term>
<term>Efficacité</term>
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<front><div type="abstract" xml:lang="en">This 96-week, double-blind, active-controlled, phase 3 study, randomized subjects to elvitegravir once daily or raltegravir twice daily with a fully active, ritonavir-boosted protease inhibitor plus a third agent. The proportion of subjects randomized to elvitegravir that achieved and maintained HIV-1 RNA < 50 copies/mL through week 96 was 47.6% (167/351) compared with 45.0% (158/351) for raltegravir with a treatment difference of 2.6% (95% confidence interval: 4.6% to 9.9%). Both regimens were well tolerated, with comparable rates of adverse events and laboratory abnormalities through week 96. Once-daily elvitegravir was noninferior to twice-daily raltegravir, showed durable long-term efficacy, and was well tolerated in HIV+ treatment-experienced patients.</div>
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<fA08 i1="01" i2="1" l="ENG"><s1>A Randomized Phase 3 Study Comparing Once-Daily Elvitegravir With Twice-Daily Raltegravir in Treatment-Experienced Subjects With HIV-1 infection: 96-Week Results</s1>
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<fA11 i1="03" i2="1"><s1>RAMON ARRIBAS LOPEZ (José)</s1>
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<fA14 i1="01"><s1>Whitman-Walker Health</s1>
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<fA14 i1="04"><s1>Kirby Institute, University of New South Wales</s1>
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<s3>AUS</s3>
<sZ>4 aut.</sZ>
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<fA14 i1="05"><s1>Ospedali Riuniti di Bergamo</s1>
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<fC02 i1="01" i2="X"><s0>002A05C10</s0>
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<fC07 i1="06" i2="X" l="SPA"><s0>Infección</s0>
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<s5>13</s5>
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<server><NO>PASCAL 13-0237578 INIST</NO>
<ET>A Randomized Phase 3 Study Comparing Once-Daily Elvitegravir With Twice-Daily Raltegravir in Treatment-Experienced Subjects With HIV-1 infection: 96-Week Results</ET>
<AU>ELION (Richard); MOLINA (Jean-Michel); RAMON ARRIBAS LOPEZ (José); COOPER (David); MAGGIOLO (Franco); WILKINS (Edmund); CONWAY (Brian); LIU (Ya-Pei); MARGOT (Nicolas); RHEE (Martin); CHUCK (Steven L.); SZWARCBERG (Javier)</AU>
<AF>Whitman-Walker Health/Washington, DC/Etats-Unis (1 aut.); Hospital Saint-Louis, APHP, University of Sorbonne Paris Cité, Paris 7, INSERM U941/France (2 aut.); Hospital Universitario La Paz, IdiPAZ, Servicio de Medicina Interna, Unidad VIH/Madrid/Espagne (3 aut.); Kirby Institute, University of New South Wales/Sydney/Australie (4 aut.); Ospedali Riuniti di Bergamo/Bergamo/Italie (5 aut.); North Manchester General Hospital/Manchester/Royaume-Uni (6 aut.); Vancouver ID Research & Care Centre/Vancouver/Canada (7 aut.); Gilead Sciences, Inc./Foster City, CA/Etats-Unis (8 aut., 9 aut., 10 aut., 11 aut., 12 aut.)</AF>
<DT>Publication en série; Niveau analytique</DT>
<SO>Journal of acquired immune deficiency syndromes : (1999); ISSN 1525-4135; Etats-Unis; Da. 2013; Vol. 63; No. 4; Pp. 494-497; Bibl. 8 ref.</SO>
<LA>Anglais</LA>
<EA>This 96-week, double-blind, active-controlled, phase 3 study, randomized subjects to elvitegravir once daily or raltegravir twice daily with a fully active, ritonavir-boosted protease inhibitor plus a third agent. The proportion of subjects randomized to elvitegravir that achieved and maintained HIV-1 RNA < 50 copies/mL through week 96 was 47.6% (167/351) compared with 45.0% (158/351) for raltegravir with a treatment difference of 2.6% (95% confidence interval: 4.6% to 9.9%). Both regimens were well tolerated, with comparable rates of adverse events and laboratory abnormalities through week 96. Once-daily elvitegravir was noninferior to twice-daily raltegravir, showed durable long-term efficacy, and was well tolerated in HIV+ treatment-experienced patients.</EA>
<CC>002A05C10; 002B05C02J; 002B05C02D</CC>
<FD>Virus HIV1; Traitement; SIDA; Efficacité; Elvitégravir; Raltégravir</FD>
<FG>Virus immunodéficience humaine; Lentivirus; Retroviridae; Virus; Virose; Infection; Immunodéficit; Immunopathologie</FG>
<ED>HIV-1 virus; Treatment; AIDS; Efficiency; Elvitegravir; Raltegravir</ED>
<EG>Human immunodeficiency virus; Lentivirus; Retroviridae; Virus; Viral disease; Infection; Immune deficiency; Immunopathology</EG>
<SD>HIV-1 virus; Tratamiento; SIDA; Eficacia; Elvitegravir; Raltegravir</SD>
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A Randomized Phase 3 Study Comparing Once-Daily Elvitegravir With Twice-Daily Raltegravir in Treatment-Experienced Subjects With HIV-1 infection: 96-Week Results

A Randomized Phase 3 Study Comparing Once-Daily Elvitegravir With Twice-Daily Raltegravir in Treatment-Experienced Subjects With HIV-1 infection: 96-Week Results

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