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 : 002F17 ( PubMed/Curation ); précédent : 002F16; suivant : 002F18Raltegravir 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 [Australie] ; Mark A. Boyd [Australie] ; Nagalingeswaran Kumarasamy [Inde] ; Cecilia L. Moore [Australie] ; Marcello H. Losso [Argentine] ; Chidi A. Nwizu [États-Unis] ; Lerato Mohapi [Afrique du Sud] ; Stephen J. Kerr [Thaïlande] ; Annette H. Sohn [Thaïlande] ; Hedy Teppler [États-Unis] ; Boris Renjifo [États-Unis] ; Jean-Michel Molina [France] ; Sean Emery [Australie] ; David A. Cooper [Australie]Source :
- PloS one [ 1932-6203 ] ; 2015.
Descripteurs français
- KwdFr :
- Adulte, Association de médicaments, Humains, Infections à VIH (traitement médicamenteux), Inhibiteurs de l'intégrase du VIH (administration et posologie), Inhibiteurs de l'intégrase du VIH (effets indésirables), Inhibiteurs de l'intégrase du VIH (usage thérapeutique), Inhibiteurs de protéase du VIH (administration et posologie), Inhibiteurs de protéase du VIH (effets indésirables), Inhibiteurs de protéase du VIH (usage thérapeutique), Lopinavir (administration et posologie), Lopinavir (effets indésirables), Lopinavir (usage thérapeutique), Mâle, Raltégravir de potassium (administration et posologie), Raltégravir de potassium (effets indésirables), Raltégravir de potassium (usage thérapeutique), Ritonavir (administration et posologie), Ritonavir (effets indésirables), Ritonavir (usage thérapeutique), Soins secondaires, VIH-1 (Virus de l'Immunodéficience Humaine de type 1).
- MESH :
- administration et posologie : Inhibiteurs de l'intégrase du VIH, Inhibiteurs de protéase du VIH, Lopinavir, Raltégravir de potassium, Ritonavir.
- effets indésirables : Inhibiteurs de l'intégrase du VIH, Inhibiteurs de protéase du VIH, Lopinavir, Raltégravir de potassium, Ritonavir.
- traitement médicamenteux : Infections à VIH.
- usage thérapeutique : Inhibiteurs de l'intégrase du VIH, Inhibiteurs de protéase du VIH, Lopinavir, Raltégravir de potassium, Ritonavir.
- Adulte, Association de médicaments, Humains, Mâle, Soins secondaires, VIH-1 (Virus de l'Immunodéficience Humaine de type 1).
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
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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>
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<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>
</PublicationTypeList>
<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>
</MedlineJournalInfo>
<ChemicalList><Chemical><RegistryNumber>0</RegistryNumber>
<NameOfSubstance UI="D019428">HIV Integrase Inhibitors</NameOfSubstance>
</Chemical>
<Chemical><RegistryNumber>0</RegistryNumber>
<NameOfSubstance UI="D017320">HIV Protease Inhibitors</NameOfSubstance>
</Chemical>
<Chemical><RegistryNumber>2494G1JF75</RegistryNumber>
<NameOfSubstance UI="D061466">Lopinavir</NameOfSubstance>
</Chemical>
<Chemical><RegistryNumber>43Y000U234</RegistryNumber>
<NameOfSubstance UI="D000068898">Raltegravir Potassium</NameOfSubstance>
</Chemical>
<Chemical><RegistryNumber>O3J8G9O825</RegistryNumber>
<NameOfSubstance UI="D019438">Ritonavir</NameOfSubstance>
</Chemical>
</ChemicalList>
<CitationSubset>IM</CitationSubset>
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<MeshHeadingList><MeshHeading><DescriptorName UI="D000328" MajorTopicYN="N">Adult</DescriptorName>
</MeshHeading>
<MeshHeading><DescriptorName UI="D004359" MajorTopicYN="N">Drug Therapy, Combination</DescriptorName>
</MeshHeading>
<MeshHeading><DescriptorName UI="D015658" MajorTopicYN="N">HIV Infections</DescriptorName>
<QualifierName UI="Q000188" MajorTopicYN="Y">drug therapy</QualifierName>
</MeshHeading>
<MeshHeading><DescriptorName UI="D019428" MajorTopicYN="N">HIV Integrase Inhibitors</DescriptorName>
<QualifierName UI="Q000008" MajorTopicYN="N">administration & dosage</QualifierName>
<QualifierName UI="Q000009" MajorTopicYN="N">adverse effects</QualifierName>
<QualifierName UI="Q000627" MajorTopicYN="Y">therapeutic use</QualifierName>
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<MeshHeading><DescriptorName UI="D015497" MajorTopicYN="N">HIV-1</DescriptorName>
</MeshHeading>
<MeshHeading><DescriptorName UI="D006801" MajorTopicYN="N">Humans</DescriptorName>
</MeshHeading>
<MeshHeading><DescriptorName UI="D061466" MajorTopicYN="N">Lopinavir</DescriptorName>
<QualifierName UI="Q000008" MajorTopicYN="N">administration & dosage</QualifierName>
<QualifierName UI="Q000009" MajorTopicYN="N">adverse effects</QualifierName>
<QualifierName UI="Q000627" MajorTopicYN="Y">therapeutic use</QualifierName>
</MeshHeading>
<MeshHeading><DescriptorName UI="D008297" MajorTopicYN="N">Male</DescriptorName>
</MeshHeading>
<MeshHeading><DescriptorName UI="D000068898" MajorTopicYN="N">Raltegravir Potassium</DescriptorName>
<QualifierName UI="Q000008" MajorTopicYN="N">administration & dosage</QualifierName>
<QualifierName UI="Q000009" MajorTopicYN="N">adverse effects</QualifierName>
<QualifierName UI="Q000627" MajorTopicYN="Y">therapeutic use</QualifierName>
</MeshHeading>
<MeshHeading><DescriptorName UI="D019438" MajorTopicYN="N">Ritonavir</DescriptorName>
<QualifierName UI="Q000008" MajorTopicYN="N">administration & dosage</QualifierName>
<QualifierName UI="Q000009" MajorTopicYN="N">adverse effects</QualifierName>
<QualifierName UI="Q000627" MajorTopicYN="Y">therapeutic use</QualifierName>
</MeshHeading>
<MeshHeading><DescriptorName UI="D063127" MajorTopicYN="N">Secondary Care</DescriptorName>
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</MeshHeadingList>
<OtherID Source="NLM">PMC4344344</OtherID>
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<PubmedData><History><PubMedPubDate PubStatus="received"><Year>2014</Year>
<Month>04</Month>
<Day>21</Day>
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<PubMedPubDate PubStatus="accepted"><Year>2014</Year>
<Month>12</Month>
<Day>09</Day>
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