Raltegravir non-inferior to nucleoside based regimens in second-line therapy with lopinavir/ritonavir over 96 weeks: a randomised open label study for the treatment of HIV-1 infection.
Identifieur interne : 002F98 ( PubMed/Corpus ); précédent : 002F97; suivant : 002F99Raltegravir non-inferior to nucleoside based regimens in second-line therapy with lopinavir/ritonavir over 96 weeks: a randomised open label study for the treatment of HIV-1 infection.
Auteurs : Janaki Amin ; Mark A. Boyd ; Nagalingeswaran Kumarasamy ; Cecilia L. Moore ; Marcello H. Losso ; Chidi A. Nwizu ; Lerato Mohapi ; Stephen J. Kerr ; Annette H. Sohn ; Hedy Teppler ; Boris Renjifo ; Jean-Michel Molina ; Sean Emery ; David A. CooperSource :
- PloS one [ 1932-6203 ] ; 2015.
English descriptors
- KwdEn :
- Adult, Drug Therapy, Combination, HIV Infections (drug therapy), HIV Integrase Inhibitors (administration & dosage), HIV Integrase Inhibitors (adverse effects), HIV Integrase Inhibitors (therapeutic use), HIV Protease Inhibitors (administration & dosage), HIV Protease Inhibitors (adverse effects), HIV Protease Inhibitors (therapeutic use), HIV-1, Humans, Lopinavir (administration & dosage), Lopinavir (adverse effects), Lopinavir (therapeutic use), Male, Raltegravir Potassium (administration & dosage), Raltegravir Potassium (adverse effects), Raltegravir Potassium (therapeutic use), Ritonavir (administration & dosage), Ritonavir (adverse effects), Ritonavir (therapeutic use), Secondary Care.
- MESH :
- chemical , administration & dosage : HIV Integrase Inhibitors, HIV Protease Inhibitors, Lopinavir, Raltegravir Potassium, Ritonavir.
- chemical , adverse effects : HIV Integrase Inhibitors, HIV Protease Inhibitors, Lopinavir, Raltegravir Potassium, Ritonavir.
- drug therapy : HIV Infections.
- chemical , therapeutic use : HIV Integrase Inhibitors, HIV Protease Inhibitors, Lopinavir, Raltegravir Potassium, Ritonavir.
- Adult, Drug Therapy, Combination, HIV-1, Humans, Male, Secondary Care.
Abstract
To determine the durability over 96 weeks of safety and efficacy of lopinavir/ritonavir (LPV/r) and raltegravir (RAL) which was demonstrated to have non-inferior efficacy relative to a regimen of LPV/r with nucleoside/nucleotide reverse transcriptase inhibitors (N(t)RTIs) (Control) in primary analysis at 48 weeks.
DOI: 10.1371/journal.pone.0118228
PubMed: 25723472
Links to Exploration step
pubmed:25723472Le document en format XML
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<author><name sortKey="Kumarasamy, Nagalingeswaran" sort="Kumarasamy, Nagalingeswaran" uniqKey="Kumarasamy N" first="Nagalingeswaran" last="Kumarasamy">Nagalingeswaran Kumarasamy</name>
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<author><name sortKey="Emery, Sean" sort="Emery, Sean" uniqKey="Emery S" first="Sean" last="Emery">Sean Emery</name>
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<sourceDesc><biblStruct><analytic><title xml:lang="en">Raltegravir non-inferior to nucleoside based regimens in second-line therapy with lopinavir/ritonavir over 96 weeks: a randomised open label study for the treatment of HIV-1 infection.</title>
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<author><name sortKey="Kumarasamy, Nagalingeswaran" sort="Kumarasamy, Nagalingeswaran" uniqKey="Kumarasamy N" first="Nagalingeswaran" last="Kumarasamy">Nagalingeswaran Kumarasamy</name>
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<author><name sortKey="Moore, Cecilia L" sort="Moore, Cecilia L" uniqKey="Moore C" first="Cecilia L" last="Moore">Cecilia L. Moore</name>
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<author><name sortKey="Losso, Marcello H" sort="Losso, Marcello H" uniqKey="Losso M" first="Marcello H" last="Losso">Marcello H. Losso</name>
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<author><name sortKey="Nwizu, Chidi A" sort="Nwizu, Chidi A" uniqKey="Nwizu C" first="Chidi A" last="Nwizu">Chidi A. Nwizu</name>
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<author><name sortKey="Mohapi, Lerato" sort="Mohapi, Lerato" uniqKey="Mohapi L" first="Lerato" last="Mohapi">Lerato Mohapi</name>
<affiliation><nlm:affiliation>University of the Witwatersrand and Baragwanath Hospital, Johannesburg, South Africa.</nlm:affiliation>
</affiliation>
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<author><name sortKey="Kerr, Stephen J" sort="Kerr, Stephen J" uniqKey="Kerr S" first="Stephen J" last="Kerr">Stephen J. Kerr</name>
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<author><name sortKey="Sohn, Annette H" sort="Sohn, Annette H" uniqKey="Sohn A" first="Annette H" last="Sohn">Annette H. Sohn</name>
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<author><name sortKey="Teppler, Hedy" sort="Teppler, Hedy" uniqKey="Teppler H" first="Hedy" last="Teppler">Hedy Teppler</name>
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</affiliation>
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<author><name sortKey="Renjifo, Boris" sort="Renjifo, Boris" uniqKey="Renjifo B" first="Boris" last="Renjifo">Boris Renjifo</name>
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</affiliation>
</author>
<author><name sortKey="Molina, Jean Michel" sort="Molina, Jean Michel" uniqKey="Molina J" first="Jean-Michel" last="Molina">Jean-Michel Molina</name>
<affiliation><nlm:affiliation>Service des Maladies Infectieuses, Hôpital Saint Louis, Assistance Publique-Hôpitaux de Paris, Paris, France.</nlm:affiliation>
</affiliation>
</author>
<author><name sortKey="Emery, Sean" sort="Emery, Sean" uniqKey="Emery S" first="Sean" last="Emery">Sean Emery</name>
<affiliation><nlm:affiliation>The Kirby Institute, UNSW Australia, Sydney, Australia.</nlm:affiliation>
</affiliation>
</author>
<author><name sortKey="Cooper, David A" sort="Cooper, David A" uniqKey="Cooper D" first="David A" last="Cooper">David A. Cooper</name>
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<series><title level="j">PloS one</title>
<idno type="eISSN">1932-6203</idno>
<imprint><date when="2015" type="published">2015</date>
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<term>Drug Therapy, Combination</term>
<term>HIV Infections (drug therapy)</term>
<term>HIV Integrase Inhibitors (administration & dosage)</term>
<term>HIV Integrase Inhibitors (adverse effects)</term>
<term>HIV Integrase Inhibitors (therapeutic use)</term>
<term>HIV Protease Inhibitors (administration & dosage)</term>
<term>HIV Protease Inhibitors (adverse effects)</term>
<term>HIV Protease Inhibitors (therapeutic use)</term>
<term>HIV-1</term>
<term>Humans</term>
<term>Lopinavir (administration & dosage)</term>
<term>Lopinavir (adverse effects)</term>
<term>Lopinavir (therapeutic use)</term>
<term>Male</term>
<term>Raltegravir Potassium (administration & dosage)</term>
<term>Raltegravir Potassium (adverse effects)</term>
<term>Raltegravir Potassium (therapeutic use)</term>
<term>Ritonavir (administration & dosage)</term>
<term>Ritonavir (adverse effects)</term>
<term>Ritonavir (therapeutic use)</term>
<term>Secondary Care</term>
</keywords>
<keywords scheme="MESH" type="chemical" qualifier="administration & dosage" xml:lang="en"><term>HIV Integrase Inhibitors</term>
<term>HIV Protease Inhibitors</term>
<term>Lopinavir</term>
<term>Raltegravir Potassium</term>
<term>Ritonavir</term>
</keywords>
<keywords scheme="MESH" type="chemical" qualifier="adverse effects" xml:lang="en"><term>HIV Integrase Inhibitors</term>
<term>HIV Protease Inhibitors</term>
<term>Lopinavir</term>
<term>Raltegravir Potassium</term>
<term>Ritonavir</term>
</keywords>
<keywords scheme="MESH" qualifier="drug therapy" xml:lang="en"><term>HIV Infections</term>
</keywords>
<keywords scheme="MESH" type="chemical" qualifier="therapeutic use" xml:lang="en"><term>HIV Integrase Inhibitors</term>
<term>HIV Protease Inhibitors</term>
<term>Lopinavir</term>
<term>Raltegravir Potassium</term>
<term>Ritonavir</term>
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<term>Drug Therapy, Combination</term>
<term>HIV-1</term>
<term>Humans</term>
<term>Male</term>
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<front><div type="abstract" xml:lang="en">To determine the durability over 96 weeks of safety and efficacy of lopinavir/ritonavir (LPV/r) and raltegravir (RAL) which was demonstrated to have non-inferior efficacy relative to a regimen of LPV/r with nucleoside/nucleotide reverse transcriptase inhibitors (N(t)RTIs) (Control) in primary analysis at 48 weeks.</div>
</front>
</TEI>
<pubmed><MedlineCitation Status="MEDLINE" Owner="NLM"><PMID Version="1">25723472</PMID>
<DateCreated><Year>2015</Year>
<Month>02</Month>
<Day>28</Day>
</DateCreated>
<DateCompleted><Year>2016</Year>
<Month>01</Month>
<Day>18</Day>
</DateCompleted>
<DateRevised><Year>2015</Year>
<Month>09</Month>
<Day>22</Day>
</DateRevised>
<Article PubModel="Electronic-eCollection"><Journal><ISSN IssnType="Electronic">1932-6203</ISSN>
<JournalIssue CitedMedium="Internet"><Volume>10</Volume>
<Issue>2</Issue>
<PubDate><Year>2015</Year>
</PubDate>
</JournalIssue>
<Title>PloS one</Title>
<ISOAbbreviation>PLoS ONE</ISOAbbreviation>
</Journal>
<ArticleTitle>Raltegravir non-inferior to nucleoside based regimens in second-line therapy with lopinavir/ritonavir over 96 weeks: a randomised open label study for the treatment of HIV-1 infection.</ArticleTitle>
<Pagination><MedlinePgn>e0118228</MedlinePgn>
</Pagination>
<ELocationID EIdType="doi" ValidYN="Y">10.1371/journal.pone.0118228</ELocationID>
<Abstract><AbstractText Label="OBJECTIVE" NlmCategory="OBJECTIVE">To determine the durability over 96 weeks of safety and efficacy of lopinavir/ritonavir (LPV/r) and raltegravir (RAL) which was demonstrated to have non-inferior efficacy relative to a regimen of LPV/r with nucleoside/nucleotide reverse transcriptase inhibitors (N(t)RTIs) (Control) in primary analysis at 48 weeks.</AbstractText>
<AbstractText Label="DESIGN" NlmCategory="METHODS">Open label, centrally randomised trial.</AbstractText>
<AbstractText Label="SETTING" NlmCategory="METHODS">Recruitment was from 37 primary and secondary care sites from Africa, Asia, Australia, Europe and Latin America.</AbstractText>
<AbstractText Label="SUBJECTS" NlmCategory="METHODS">541 HIV-1 infected adults virologically failing first-line non-NRTI + 2N(t)RTI, with no previous exposure to protease inhibitors or integrase strand transfer inhibitors were analysed, 425 completed 96 weeks follow up on randomised therapy.</AbstractText>
<AbstractText Label="INTERVENTION" NlmCategory="METHODS">Randomisation was 1:1 to Control or RAL.</AbstractText>
<AbstractText Label="MAIN OUTCOME MEASURES" NlmCategory="METHODS">Differences between the proportion of participants with plasma HIV-1 RNA (VL) <200 copies/mL by intention to treat were compared with a non-inferiority margin of -12%. Differences in biochemical, haematological and metabolic changes were assessed using T-tests.</AbstractText>
<AbstractText Label="RESULTS" NlmCategory="RESULTS">VL <200 copies/mL at 96 weeks was: RAL 80.4%, Control 76.0% (difference: 4.4 [95%CI -2.6, 11.3]) and met non-inferiority criteria. The RAL arm had a significantly higher mean change (difference Control-RAL; 95%CI) in haemoglobin (-2.9; -5.7, -1.1), total lymphocytes (-0.2; -0.3, -0.0), total cholesterol (-0.5; -0.8, -0.3), HDL cholesterol (-0.1; -0.1, -0.0) and LDL cholesterol (-0.3; -0.5, -0.2).</AbstractText>
<AbstractText Label="CONCLUSION" NlmCategory="CONCLUSIONS">At 96 weeks, both RAL and Control maintained efficacy greater than 75% and continued to demonstrate similar safety profiles. These results support the use of a combination LPV/r and RAL regimen as an option following failure of 1st line NNRTI + 2N(t)RTIs.</AbstractText>
<AbstractText Label="TRIAL REGISTRATION" NlmCategory="BACKGROUND">ClinicalTrials.gov NCT00931463.</AbstractText>
</Abstract>
<AuthorList CompleteYN="Y"><Author ValidYN="Y"><LastName>Amin</LastName>
<ForeName>Janaki</ForeName>
<Initials>J</Initials>
<AffiliationInfo><Affiliation>The Kirby Institute, UNSW Australia, Sydney, Australia.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Boyd</LastName>
<ForeName>Mark A</ForeName>
<Initials>MA</Initials>
<AffiliationInfo><Affiliation>The Kirby Institute, UNSW Australia, Sydney, Australia.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Kumarasamy</LastName>
<ForeName>Nagalingeswaran</ForeName>
<Initials>N</Initials>
<AffiliationInfo><Affiliation>Y. R. Gaitonde Centre for AIDS Research and Education, Chennai, India.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Moore</LastName>
<ForeName>Cecilia L</ForeName>
<Initials>CL</Initials>
<AffiliationInfo><Affiliation>The Kirby Institute, UNSW Australia, Sydney, Australia.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Losso</LastName>
<ForeName>Marcello H</ForeName>
<Initials>MH</Initials>
<AffiliationInfo><Affiliation>Hospital JM Ramos Mejia, Buenos Aires, Argentina.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Nwizu</LastName>
<ForeName>Chidi A</ForeName>
<Initials>CA</Initials>
<AffiliationInfo><Affiliation>Institute of Human Virology, University of Maryland School of Medicine, Baltimore, United States of America.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Mohapi</LastName>
<ForeName>Lerato</ForeName>
<Initials>L</Initials>
<AffiliationInfo><Affiliation>University of the Witwatersrand and Baragwanath Hospital, Johannesburg, South Africa.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Kerr</LastName>
<ForeName>Stephen J</ForeName>
<Initials>SJ</Initials>
<AffiliationInfo><Affiliation>UNSW Australia, The HIV Netherlands Australia Thailand Research Collaboration, Bangkok, Thailand.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Sohn</LastName>
<ForeName>Annette H</ForeName>
<Initials>AH</Initials>
<AffiliationInfo><Affiliation>TREAT Asia, amfAR, The Foundation for AIDS Research, Bangkok, Thailand.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Teppler</LastName>
<ForeName>Hedy</ForeName>
<Initials>H</Initials>
<AffiliationInfo><Affiliation>Merck Research Laboratories, Merck Sharp & Dohme, Whitehouse Station, New Jersey, United States of America.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Renjifo</LastName>
<ForeName>Boris</ForeName>
<Initials>B</Initials>
<AffiliationInfo><Affiliation>Global Medical Affairs Virology, Abbvie, North Chicago, Illinois, United States of America.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Molina</LastName>
<ForeName>Jean-Michel</ForeName>
<Initials>JM</Initials>
<AffiliationInfo><Affiliation>Service des Maladies Infectieuses, Hôpital Saint Louis, Assistance Publique-Hôpitaux de Paris, Paris, France.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Emery</LastName>
<ForeName>Sean</ForeName>
<Initials>S</Initials>
<AffiliationInfo><Affiliation>The Kirby Institute, UNSW Australia, Sydney, Australia.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Cooper</LastName>
<ForeName>David A</ForeName>
<Initials>DA</Initials>
<AffiliationInfo><Affiliation>The Kirby Institute, UNSW Australia, Sydney, Australia.</Affiliation>
</AffiliationInfo>
</Author>
</AuthorList>
<Language>eng</Language>
<DataBankList CompleteYN="Y"><DataBank><DataBankName>ClinicalTrials.gov</DataBankName>
<AccessionNumberList><AccessionNumber>NCT00931463</AccessionNumber>
</AccessionNumberList>
</DataBank>
</DataBankList>
<PublicationTypeList><PublicationType UI="D016428">Journal Article</PublicationType>
<PublicationType UI="D016449">Randomized Controlled Trial</PublicationType>
<PublicationType UI="D013485">Research Support, Non-U.S. Gov't</PublicationType>
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<ArticleDate DateType="Electronic"><Year>2015</Year>
<Month>02</Month>
<Day>27</Day>
</ArticleDate>
</Article>
<MedlineJournalInfo><Country>United States</Country>
<MedlineTA>PLoS One</MedlineTA>
<NlmUniqueID>101285081</NlmUniqueID>
<ISSNLinking>1932-6203</ISSNLinking>
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<ChemicalList><Chemical><RegistryNumber>0</RegistryNumber>
<NameOfSubstance UI="D019428">HIV Integrase Inhibitors</NameOfSubstance>
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<Chemical><RegistryNumber>0</RegistryNumber>
<NameOfSubstance UI="D017320">HIV Protease Inhibitors</NameOfSubstance>
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<Chemical><RegistryNumber>2494G1JF75</RegistryNumber>
<NameOfSubstance UI="D061466">Lopinavir</NameOfSubstance>
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<Chemical><RegistryNumber>43Y000U234</RegistryNumber>
<NameOfSubstance UI="D000068898">Raltegravir Potassium</NameOfSubstance>
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