Raltegravir 1200 mg once daily versus raltegravir 400 mg twice daily, with tenofovir disoproxil fumarate and emtricitabine, for previously untreated HIV-1 infection: a randomised, double-blind, parallel-group, phase 3, non-inferiority trial.
Identifieur interne : 000494 ( PubMed/Checkpoint ); précédent : 000493; suivant : 000495Raltegravir 1200 mg once daily versus raltegravir 400 mg twice daily, with tenofovir disoproxil fumarate and emtricitabine, for previously untreated HIV-1 infection: a randomised, double-blind, parallel-group, phase 3, non-inferiority trial.
Auteurs : Pedro Cahn [Argentine] ; Richard Kaplan [Afrique du Sud] ; Paul E. Sax [États-Unis] ; Kathleen Squires [États-Unis] ; Jean-Michel Molina [France] ; Anchalee Avihingsanon [Thaïlande] ; Winai Ratanasuwan [Thaïlande] ; Evelyn Rojas [Guatemala] ; Mohammed Rassool [Afrique du Sud] ; Mark Bloch [Australie] ; Linos Vandekerckhove [Belgique] ; Peter Ruane [États-Unis] ; Yazdan Yazdanpanah [France] ; Christine Katlama [France] ; Xia Xu [États-Unis] ; Anthony Rodgers [États-Unis] ; Lilly East [États-Unis] ; Larissa Wenning [États-Unis] ; Sandy Rawlins [États-Unis] ; Brenda Homony [États-Unis] ; Peter Sklar [États-Unis] ; Bach-Yen Nguyen [États-Unis] ; Randi Leavitt [États-Unis] ; Hedy Teppler [États-Unis]Source :
- The lancet. HIV [ 2352-3018 ] ; 2017.
Abstract
Once daily regimens are preferred for HIV-1 treatment, to facilitate adherence and improve quality of life. We compared a new once daily formulation of raltegravir to the currently marketed twice daily formulation.
DOI: 10.1016/S2352-3018(17)30128-5
PubMed: 28918877
Affiliations:
- Afrique du Sud, Argentine, Australie, Belgique, France, Guatemala, Thaïlande, États-Unis
- Californie, Massachusetts, New Jersey, Pennsylvanie, Île-de-France
- Paris
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City</wicri:regionArea><wicri:noRegion>Guatemala City</wicri:noRegion></affiliation></author><author><name sortKey="Rassool, Mohammed" sort="Rassool, Mohammed" uniqKey="Rassool M" first="Mohammed" last="Rassool">Mohammed Rassool</name><affiliation wicri:level="1"><nlm:affiliation>University of Witwatersrand, Helen Joseph Hospital, Johannesburg, South Africa.</nlm:affiliation><country xml:lang="fr">Afrique du Sud</country><wicri:regionArea>University of Witwatersrand, Helen Joseph Hospital, Johannesburg</wicri:regionArea><wicri:noRegion>Johannesburg</wicri:noRegion></affiliation></author><author><name sortKey="Bloch, Mark" sort="Bloch, Mark" uniqKey="Bloch M" first="Mark" last="Bloch">Mark Bloch</name><affiliation wicri:level="1"><nlm:affiliation>Holdsworth House Medical Practice, Sydney NSW, Australia.</nlm:affiliation><country xml:lang="fr">Australie</country><wicri:regionArea>Holdsworth House Medical Practice, Sydney NSW</wicri:regionArea><wicri:noRegion>Sydney NSW</wicri:noRegion></affiliation></author><author><name sortKey="Vandekerckhove, Linos" sort="Vandekerckhove, Linos" uniqKey="Vandekerckhove L" first="Linos" last="Vandekerckhove">Linos Vandekerckhove</name><affiliation wicri:level="1"><nlm:affiliation>Faculty of Medicine and Health Sciences, University of Ghent, Ghent, Belgium.</nlm:affiliation><country xml:lang="fr">Belgique</country><wicri:regionArea>Faculty of Medicine and Health Sciences, University of Ghent, Ghent</wicri:regionArea><wicri:noRegion>Ghent</wicri:noRegion></affiliation></author><author><name sortKey="Ruane, Peter" sort="Ruane, Peter" uniqKey="Ruane P" first="Peter" last="Ruane">Peter Ruane</name><affiliation wicri:level="2"><nlm:affiliation>Ruane Medical & Liver Health Institute, Los Angeles, CA, USA.</nlm:affiliation><country xml:lang="fr">États-Unis</country><wicri:regionArea>Ruane Medical & Liver Health Institute, Los Angeles, CA</wicri:regionArea><placeName><region type="state">Californie</region></placeName></affiliation></author><author><name sortKey="Yazdanpanah, Yazdan" sort="Yazdanpanah, Yazdan" uniqKey="Yazdanpanah Y" first="Yazdan" last="Yazdanpanah">Yazdan Yazdanpanah</name><affiliation wicri:level="3"><nlm:affiliation>Hôpital Bichat-Claude Bernard, Paris, France.</nlm:affiliation><country xml:lang="fr">France</country><wicri:regionArea>Hôpital Bichat-Claude Bernard, Paris</wicri:regionArea><placeName><region type="region">Île-de-France</region><region type="old region">Île-de-France</region><settlement type="city">Paris</settlement></placeName></affiliation></author><author><name sortKey="Katlama, Christine" sort="Katlama, Christine" uniqKey="Katlama C" first="Christine" last="Katlama">Christine Katlama</name><affiliation wicri:level="3"><nlm:affiliation>Hôpital Pitié-Salpêtrière Pavillon Laveran, Paris, France.</nlm:affiliation><country xml:lang="fr">France</country><wicri:regionArea>Hôpital Pitié-Salpêtrière Pavillon Laveran, 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Jersey</region></placeName></affiliation></author><author><name sortKey="East, Lilly" sort="East, Lilly" uniqKey="East L" first="Lilly" last="East">Lilly East</name><affiliation wicri:level="2"><nlm:affiliation>Merck & Co, Inc, Kenilworth, NJ, USA.</nlm:affiliation><country xml:lang="fr">États-Unis</country><wicri:regionArea>Merck & Co, Inc, Kenilworth, NJ</wicri:regionArea><placeName><region type="state">New Jersey</region></placeName></affiliation></author><author><name sortKey="Wenning, Larissa" sort="Wenning, Larissa" uniqKey="Wenning L" first="Larissa" last="Wenning">Larissa Wenning</name><affiliation wicri:level="2"><nlm:affiliation>Merck & Co, Inc, Kenilworth, NJ, USA.</nlm:affiliation><country xml:lang="fr">États-Unis</country><wicri:regionArea>Merck & Co, Inc, Kenilworth, NJ</wicri:regionArea><placeName><region type="state">New Jersey</region></placeName></affiliation></author><author><name sortKey="Rawlins, Sandy" sort="Rawlins, Sandy" uniqKey="Rawlins S" first="Sandy" last="Rawlins">Sandy Rawlins</name><affiliation wicri:level="2"><nlm:affiliation>Merck & Co, Inc, Kenilworth, NJ, USA.</nlm:affiliation><country xml:lang="fr">États-Unis</country><wicri:regionArea>Merck & Co, Inc, Kenilworth, NJ</wicri:regionArea><placeName><region type="state">New Jersey</region></placeName></affiliation></author><author><name sortKey="Homony, Brenda" sort="Homony, Brenda" uniqKey="Homony B" first="Brenda" last="Homony">Brenda Homony</name><affiliation wicri:level="2"><nlm:affiliation>Merck & Co, Inc, Kenilworth, NJ, USA.</nlm:affiliation><country xml:lang="fr">États-Unis</country><wicri:regionArea>Merck & Co, Inc, Kenilworth, NJ</wicri:regionArea><placeName><region type="state">New Jersey</region></placeName></affiliation></author><author><name sortKey="Sklar, Peter" sort="Sklar, Peter" uniqKey="Sklar P" first="Peter" last="Sklar">Peter Sklar</name><affiliation wicri:level="2"><nlm:affiliation>Merck & Co, Inc, Kenilworth, NJ, USA.</nlm:affiliation><country xml:lang="fr">États-Unis</country><wicri:regionArea>Merck & Co, Inc, Kenilworth, NJ</wicri:regionArea><placeName><region type="state">New Jersey</region></placeName></affiliation></author><author><name sortKey="Nguyen, Bach Yen" sort="Nguyen, Bach Yen" uniqKey="Nguyen B" first="Bach-Yen" last="Nguyen">Bach-Yen Nguyen</name><affiliation wicri:level="2"><nlm:affiliation>Merck & Co, Inc, Kenilworth, NJ, USA.</nlm:affiliation><country xml:lang="fr">États-Unis</country><wicri:regionArea>Merck & Co, Inc, Kenilworth, NJ</wicri:regionArea><placeName><region type="state">New Jersey</region></placeName></affiliation></author><author><name sortKey="Leavitt, Randi" sort="Leavitt, Randi" uniqKey="Leavitt R" first="Randi" last="Leavitt">Randi Leavitt</name><affiliation wicri:level="2"><nlm:affiliation>Merck & Co, Inc, Kenilworth, NJ, USA.</nlm:affiliation><country xml:lang="fr">États-Unis</country><wicri:regionArea>Merck & Co, Inc, Kenilworth, NJ</wicri:regionArea><placeName><region type="state">New Jersey</region></placeName></affiliation></author><author><name sortKey="Teppler, Hedy" sort="Teppler, Hedy" uniqKey="Teppler H" first="Hedy" last="Teppler">Hedy Teppler</name><affiliation wicri:level="2"><nlm:affiliation>Merck & Co, Inc, Kenilworth, NJ, USA. Electronic address: hedy_teppler@merck.com.</nlm:affiliation><country xml:lang="fr">États-Unis</country><wicri:regionArea>Merck & Co, Inc, Kenilworth, NJ</wicri:regionArea><placeName><region type="state">New Jersey</region></placeName></affiliation></author></titleStmt><publicationStmt><idno type="wicri:source">PubMed</idno><date when="2017">2017</date><idno type="RBID">pubmed:28918877</idno><idno type="pmid">28918877</idno><idno type="doi">10.1016/S2352-3018(17)30128-5</idno><idno type="wicri:Area/PubMed/Corpus">000070</idno><idno type="wicri:explorRef" wicri:stream="PubMed" wicri:step="Corpus" wicri:corpus="PubMed">000070</idno><idno type="wicri:Area/PubMed/Curation">000070</idno><idno type="wicri:explorRef" wicri:stream="PubMed" wicri:step="Curation">000070</idno><idno type="wicri:Area/PubMed/Checkpoint">000070</idno><idno type="wicri:explorRef" wicri:stream="Checkpoint" wicri:step="PubMed">000070</idno></publicationStmt><sourceDesc><biblStruct><analytic><title xml:lang="en">Raltegravir 1200 mg once daily versus raltegravir 400 mg twice daily, with tenofovir disoproxil fumarate and emtricitabine, for previously untreated HIV-1 infection: a randomised, double-blind, parallel-group, phase 3, non-inferiority trial.</title><author><name sortKey="Cahn, Pedro" sort="Cahn, Pedro" uniqKey="Cahn P" first="Pedro" last="Cahn">Pedro Cahn</name><affiliation wicri:level="1"><nlm:affiliation>Fundación Huesped, Buenos Aires, Argentina.</nlm:affiliation><country xml:lang="fr">Argentine</country><wicri:regionArea>Fundación Huesped, Buenos Aires</wicri:regionArea><wicri:noRegion>Buenos Aires</wicri:noRegion></affiliation></author><author><name sortKey="Kaplan, Richard" sort="Kaplan, Richard" uniqKey="Kaplan R" first="Richard" last="Kaplan">Richard Kaplan</name><affiliation wicri:level="1"><nlm:affiliation>Desmond Tutu HIV Foundation, Cape Town, South Africa.</nlm:affiliation><country xml:lang="fr">Afrique du Sud</country><wicri:regionArea>Desmond Tutu HIV Foundation, Cape Town</wicri:regionArea><wicri:noRegion>Cape Town</wicri:noRegion></affiliation></author><author><name sortKey="Sax, Paul E" sort="Sax, Paul E" uniqKey="Sax P" first="Paul E" last="Sax">Paul E. Sax</name><affiliation wicri:level="2"><nlm:affiliation>Brigham & Women's Hospital, Harvard Medical School, Boston, MA, USA.</nlm:affiliation><country xml:lang="fr">États-Unis</country><wicri:regionArea>Brigham & Women's Hospital, Harvard Medical School, Boston, MA</wicri:regionArea><placeName><region type="state">Massachusetts</region></placeName></affiliation></author><author><name sortKey="Squires, Kathleen" sort="Squires, Kathleen" uniqKey="Squires K" first="Kathleen" last="Squires">Kathleen Squires</name><affiliation wicri:level="2"><nlm:affiliation>Thomas Jefferson University, Philadelphia, PA, USA.</nlm:affiliation><country xml:lang="fr">États-Unis</country><wicri:regionArea>Thomas Jefferson University, Philadelphia, PA</wicri:regionArea><placeName><region type="state">Pennsylvanie</region></placeName></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 wicri:level="3"><nlm:affiliation>Department of Infectious Diseases, Saint-Louis Hospital, APHP, University of Paris, Paris, France.</nlm:affiliation><country xml:lang="fr">France</country><wicri:regionArea>Department of Infectious Diseases, Saint-Louis Hospital, APHP, University of Paris, Paris</wicri:regionArea><placeName><region type="region">Île-de-France</region><region type="old region">Île-de-France</region><settlement type="city">Paris</settlement></placeName></affiliation></author><author><name sortKey="Avihingsanon, Anchalee" sort="Avihingsanon, Anchalee" uniqKey="Avihingsanon A" first="Anchalee" last="Avihingsanon">Anchalee Avihingsanon</name><affiliation wicri:level="1"><nlm:affiliation>HIV-NAT, Thai Red Cross AIDS Research Center and Faculty of Medicine, Chulalongkorn University, Bangkok, Thailand.</nlm:affiliation><country xml:lang="fr">Thaïlande</country><wicri:regionArea>HIV-NAT, Thai Red Cross AIDS Research Center and Faculty of Medicine, Chulalongkorn University, Bangkok</wicri:regionArea><wicri:noRegion>Bangkok</wicri:noRegion></affiliation></author><author><name sortKey="Ratanasuwan, Winai" sort="Ratanasuwan, Winai" uniqKey="Ratanasuwan W" first="Winai" last="Ratanasuwan">Winai Ratanasuwan</name><affiliation wicri:level="1"><nlm:affiliation>Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok, Thailand.</nlm:affiliation><country xml:lang="fr">Thaïlande</country><wicri:regionArea>Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok</wicri:regionArea><wicri:noRegion>Bangkok</wicri:noRegion></affiliation></author><author><name sortKey="Rojas, Evelyn" sort="Rojas, Evelyn" uniqKey="Rojas E" first="Evelyn" last="Rojas">Evelyn Rojas</name><affiliation wicri:level="1"><nlm:affiliation>Cericap Multiclinicas, Edifico Galerías, Guatemala City, Guatemala.</nlm:affiliation><country xml:lang="fr">Guatemala</country><wicri:regionArea>Cericap Multiclinicas, Edifico Galerías, Guatemala City</wicri:regionArea><wicri:noRegion>Guatemala City</wicri:noRegion></affiliation></author><author><name sortKey="Rassool, Mohammed" sort="Rassool, Mohammed" uniqKey="Rassool M" first="Mohammed" last="Rassool">Mohammed Rassool</name><affiliation wicri:level="1"><nlm:affiliation>University of Witwatersrand, Helen Joseph Hospital, Johannesburg, South Africa.</nlm:affiliation><country xml:lang="fr">Afrique du Sud</country><wicri:regionArea>University of Witwatersrand, Helen Joseph Hospital, Johannesburg</wicri:regionArea><wicri:noRegion>Johannesburg</wicri:noRegion></affiliation></author><author><name sortKey="Bloch, Mark" sort="Bloch, Mark" uniqKey="Bloch M" first="Mark" last="Bloch">Mark Bloch</name><affiliation wicri:level="1"><nlm:affiliation>Holdsworth House Medical Practice, Sydney NSW, Australia.</nlm:affiliation><country xml:lang="fr">Australie</country><wicri:regionArea>Holdsworth House Medical Practice, Sydney NSW</wicri:regionArea><wicri:noRegion>Sydney NSW</wicri:noRegion></affiliation></author><author><name sortKey="Vandekerckhove, Linos" sort="Vandekerckhove, Linos" uniqKey="Vandekerckhove L" first="Linos" last="Vandekerckhove">Linos Vandekerckhove</name><affiliation wicri:level="1"><nlm:affiliation>Faculty of Medicine and Health Sciences, University of Ghent, Ghent, Belgium.</nlm:affiliation><country xml:lang="fr">Belgique</country><wicri:regionArea>Faculty of Medicine and Health Sciences, University of Ghent, Ghent</wicri:regionArea><wicri:noRegion>Ghent</wicri:noRegion></affiliation></author><author><name sortKey="Ruane, Peter" sort="Ruane, Peter" uniqKey="Ruane P" first="Peter" last="Ruane">Peter Ruane</name><affiliation wicri:level="2"><nlm:affiliation>Ruane Medical & Liver Health Institute, Los Angeles, CA, USA.</nlm:affiliation><country xml:lang="fr">États-Unis</country><wicri:regionArea>Ruane Medical & Liver Health Institute, Los Angeles, CA</wicri:regionArea><placeName><region type="state">Californie</region></placeName></affiliation></author><author><name sortKey="Yazdanpanah, Yazdan" sort="Yazdanpanah, Yazdan" uniqKey="Yazdanpanah Y" first="Yazdan" last="Yazdanpanah">Yazdan Yazdanpanah</name><affiliation wicri:level="3"><nlm:affiliation>Hôpital Bichat-Claude Bernard, Paris, France.</nlm:affiliation><country xml:lang="fr">France</country><wicri:regionArea>Hôpital Bichat-Claude Bernard, Paris</wicri:regionArea><placeName><region type="region">Île-de-France</region><region type="old region">Île-de-France</region><settlement type="city">Paris</settlement></placeName></affiliation></author><author><name sortKey="Katlama, Christine" sort="Katlama, Christine" uniqKey="Katlama C" first="Christine" last="Katlama">Christine Katlama</name><affiliation wicri:level="3"><nlm:affiliation>Hôpital Pitié-Salpêtrière Pavillon Laveran, Paris, France.</nlm:affiliation><country xml:lang="fr">France</country><wicri:regionArea>Hôpital Pitié-Salpêtrière Pavillon Laveran, Paris</wicri:regionArea><placeName><region type="region">Île-de-France</region><region type="old region">Île-de-France</region><settlement type="city">Paris</settlement></placeName></affiliation></author><author><name sortKey="Xu, Xia" sort="Xu, Xia" uniqKey="Xu X" first="Xia" last="Xu">Xia Xu</name><affiliation wicri:level="2"><nlm:affiliation>Merck & Co, Inc, Kenilworth, NJ, USA.</nlm:affiliation><country xml:lang="fr">États-Unis</country><wicri:regionArea>Merck & Co, Inc, Kenilworth, NJ</wicri:regionArea><placeName><region type="state">New Jersey</region></placeName></affiliation></author><author><name sortKey="Rodgers, Anthony" sort="Rodgers, Anthony" uniqKey="Rodgers A" first="Anthony" last="Rodgers">Anthony Rodgers</name><affiliation wicri:level="2"><nlm:affiliation>Merck & Co, Inc, Kenilworth, NJ, USA.</nlm:affiliation><country xml:lang="fr">États-Unis</country><wicri:regionArea>Merck & Co, Inc, Kenilworth, NJ</wicri:regionArea><placeName><region type="state">New Jersey</region></placeName></affiliation></author><author><name sortKey="East, Lilly" sort="East, Lilly" uniqKey="East L" first="Lilly" last="East">Lilly East</name><affiliation wicri:level="2"><nlm:affiliation>Merck & Co, Inc, Kenilworth, NJ, USA.</nlm:affiliation><country xml:lang="fr">États-Unis</country><wicri:regionArea>Merck & Co, Inc, Kenilworth, NJ</wicri:regionArea><placeName><region type="state">New Jersey</region></placeName></affiliation></author><author><name sortKey="Wenning, Larissa" sort="Wenning, Larissa" uniqKey="Wenning L" first="Larissa" last="Wenning">Larissa Wenning</name><affiliation wicri:level="2"><nlm:affiliation>Merck & Co, Inc, Kenilworth, NJ, USA.</nlm:affiliation><country xml:lang="fr">États-Unis</country><wicri:regionArea>Merck & Co, Inc, Kenilworth, NJ</wicri:regionArea><placeName><region type="state">New Jersey</region></placeName></affiliation></author><author><name sortKey="Rawlins, Sandy" sort="Rawlins, Sandy" uniqKey="Rawlins S" first="Sandy" last="Rawlins">Sandy Rawlins</name><affiliation wicri:level="2"><nlm:affiliation>Merck & Co, Inc, Kenilworth, NJ, USA.</nlm:affiliation><country xml:lang="fr">États-Unis</country><wicri:regionArea>Merck & Co, Inc, Kenilworth, NJ</wicri:regionArea><placeName><region type="state">New Jersey</region></placeName></affiliation></author><author><name sortKey="Homony, Brenda" sort="Homony, Brenda" uniqKey="Homony B" first="Brenda" last="Homony">Brenda Homony</name><affiliation wicri:level="2"><nlm:affiliation>Merck & Co, Inc, Kenilworth, NJ, USA.</nlm:affiliation><country xml:lang="fr">États-Unis</country><wicri:regionArea>Merck & Co, Inc, Kenilworth, NJ</wicri:regionArea><placeName><region type="state">New Jersey</region></placeName></affiliation></author><author><name sortKey="Sklar, Peter" sort="Sklar, Peter" uniqKey="Sklar P" first="Peter" last="Sklar">Peter Sklar</name><affiliation wicri:level="2"><nlm:affiliation>Merck & Co, Inc, Kenilworth, NJ, USA.</nlm:affiliation><country xml:lang="fr">États-Unis</country><wicri:regionArea>Merck & Co, Inc, Kenilworth, NJ</wicri:regionArea><placeName><region type="state">New Jersey</region></placeName></affiliation></author><author><name sortKey="Nguyen, Bach Yen" sort="Nguyen, Bach Yen" uniqKey="Nguyen B" first="Bach-Yen" last="Nguyen">Bach-Yen Nguyen</name><affiliation wicri:level="2"><nlm:affiliation>Merck & Co, Inc, Kenilworth, NJ, USA.</nlm:affiliation><country xml:lang="fr">États-Unis</country><wicri:regionArea>Merck & Co, Inc, Kenilworth, NJ</wicri:regionArea><placeName><region type="state">New Jersey</region></placeName></affiliation></author><author><name sortKey="Leavitt, Randi" sort="Leavitt, Randi" uniqKey="Leavitt R" first="Randi" last="Leavitt">Randi Leavitt</name><affiliation wicri:level="2"><nlm:affiliation>Merck & Co, Inc, Kenilworth, NJ, USA.</nlm:affiliation><country xml:lang="fr">États-Unis</country><wicri:regionArea>Merck & Co, Inc, Kenilworth, NJ</wicri:regionArea><placeName><region type="state">New Jersey</region></placeName></affiliation></author><author><name sortKey="Teppler, Hedy" sort="Teppler, Hedy" uniqKey="Teppler H" first="Hedy" last="Teppler">Hedy Teppler</name><affiliation wicri:level="2"><nlm:affiliation>Merck & Co, Inc, Kenilworth, NJ, USA. Electronic address: hedy_teppler@merck.com.</nlm:affiliation><country xml:lang="fr">États-Unis</country><wicri:regionArea>Merck & Co, Inc, Kenilworth, NJ</wicri:regionArea><placeName><region type="state">New Jersey</region></placeName></affiliation></author></analytic><series><title level="j">The lancet. HIV</title><idno type="eISSN">2352-3018</idno><imprint><date when="2017" type="published">2017</date></imprint></series></biblStruct></sourceDesc></fileDesc><profileDesc><textClass></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en">Once daily regimens are preferred for HIV-1 treatment, to facilitate adherence and improve quality of life. We compared a new once daily formulation of raltegravir to the currently marketed twice daily formulation.</div></front></TEI><pubmed><MedlineCitation Status="In-Process" Owner="NLM"><PMID Version="1">28918877</PMID><DateCreated><Year>2017</Year><Month>09</Month><Day>18</Day></DateCreated><DateRevised><Year>2017</Year><Month>11</Month><Day>03</Day></DateRevised><Article PubModel="Print-Electronic"><Journal><ISSN IssnType="Electronic">2352-3018</ISSN><JournalIssue CitedMedium="Internet"><Volume>4</Volume><Issue>11</Issue><PubDate><Year>2017</Year><Month>Nov</Month></PubDate></JournalIssue><Title>The lancet. HIV</Title><ISOAbbreviation>Lancet HIV</ISOAbbreviation></Journal><ArticleTitle>Raltegravir 1200 mg once daily versus raltegravir 400 mg twice daily, with tenofovir disoproxil fumarate and emtricitabine, for previously untreated HIV-1 infection: a randomised, double-blind, parallel-group, phase 3, non-inferiority trial.</ArticleTitle><Pagination><MedlinePgn>e486-e494</MedlinePgn></Pagination><ELocationID EIdType="pii" ValidYN="Y">S2352-3018(17)30128-5</ELocationID><ELocationID EIdType="doi" ValidYN="Y">10.1016/S2352-3018(17)30128-5</ELocationID><Abstract><AbstractText Label="BACKGROUND" NlmCategory="BACKGROUND">Once daily regimens are preferred for HIV-1 treatment, to facilitate adherence and improve quality of life. We compared a new once daily formulation of raltegravir to the currently marketed twice daily formulation.</AbstractText><AbstractText Label="METHODS" NlmCategory="METHODS">In this randomised, double-blind, parallel-group, phase 3, non-inferiority study, we enrolled participants aged 18 years or older with HIV-1 RNA of 1000 or more copies per mL and no previous antiretroviral treatment at 139 sites worldwide. We randomly assigned participants (2:1) via an interactive voice and web response system to raltegravir 1200 mg (two 600 mg tablets) orally once daily or raltegravir 400 mg (one tablet) orally twice daily, each with tenofovir disoproxil fumarate and emtricitabine orally once daily, for up to 96 weeks. A computer-generated allocation schedule stratified randomisation by screening HIV-1 RNA value and co-infection with hepatitis B or C. Participants, sponsor personnel, investigators, and study site personnel involved in the treatment or evaluation of the participants were unaware of the treatment group assignments. The primary endpoint was the proportion of participants with HIV-1 RNA less than 40 copies per mL at week 48 assessed with the US Food and Drug Administration Snapshot algorithm. Non-inferiority was concluded if the lower bound of the two-sided 95% CI was greater than -10%. We assessed efficacy and safety in all participants who received one dose or more of study treatment. This study is registered with ClinicalTrials.gov, number NCT02131233.</AbstractText><AbstractText Label="FINDINGS" NlmCategory="RESULTS">Between May 26, 2014, and Dec 5, 2014, 802 participants were enrolled and randomly assigned, 533 to once daily treatment and 269 to twice daily; 797 received study therapy, 531 once daily and 266 twice daily. At week 48, 472 (89%) of 531 once daily recipients and 235 (88%) of 266 twice daily recipients achieved HIV-1 RNA less than 40 copies per mL (treatment difference 0·5%, 95% CI -4·2 to 5·2). Drug-related adverse events occurred in 130 (24%) of 531 participants in the once daily group (one of which was serious; none led to treatment discontinuation) and 68 (26%) of 266 participants in the twice daily group (two of which were serious; two led to treatment discontinuation). The most common drug-related adverse events were nausea (39 [7%] vs 18 [7%]), headache (16 [3%] vs 12 [5%]), and dizziness (12 [2%] vs eight [3%]). No treatment-related deaths were reported.</AbstractText><AbstractText Label="INTERPRETATION" NlmCategory="CONCLUSIONS">A once daily raltegravir 1200 mg regimen was non-inferior compared with raltegravir 400 mg twice daily for initial treatment of HIV-1 infection. These results support the use of raltegravir 1200 mg once daily for first-line therapy.</AbstractText><AbstractText Label="FUNDING" NlmCategory="BACKGROUND">Merck & Co, Inc.</AbstractText><CopyrightInformation>Copyright © 2017 Elsevier Ltd. All rights reserved.</CopyrightInformation></Abstract><AuthorList CompleteYN="Y"><Author ValidYN="Y"><LastName>Cahn</LastName><ForeName>Pedro</ForeName><Initials>P</Initials><AffiliationInfo><Affiliation>Fundación Huesped, Buenos Aires, Argentina.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Kaplan</LastName><ForeName>Richard</ForeName><Initials>R</Initials><AffiliationInfo><Affiliation>Desmond Tutu HIV Foundation, Cape Town, South Africa.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Sax</LastName><ForeName>Paul E</ForeName><Initials>PE</Initials><AffiliationInfo><Affiliation>Brigham & Women's Hospital, Harvard Medical School, Boston, MA, USA.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Squires</LastName><ForeName>Kathleen</ForeName><Initials>K</Initials><AffiliationInfo><Affiliation>Thomas Jefferson University, Philadelphia, PA, USA.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Molina</LastName><ForeName>Jean-Michel</ForeName><Initials>JM</Initials><AffiliationInfo><Affiliation>Department of Infectious Diseases, Saint-Louis Hospital, APHP, University of Paris, Paris, France.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Avihingsanon</LastName><ForeName>Anchalee</ForeName><Initials>A</Initials><AffiliationInfo><Affiliation>HIV-NAT, Thai Red Cross AIDS Research Center and Faculty of Medicine, Chulalongkorn University, Bangkok, Thailand.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Ratanasuwan</LastName><ForeName>Winai</ForeName><Initials>W</Initials><AffiliationInfo><Affiliation>Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok, Thailand.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Rojas</LastName><ForeName>Evelyn</ForeName><Initials>E</Initials><AffiliationInfo><Affiliation>Cericap Multiclinicas, Edifico Galerías, Guatemala City, Guatemala.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Rassool</LastName><ForeName>Mohammed</ForeName><Initials>M</Initials><AffiliationInfo><Affiliation>University of Witwatersrand, Helen Joseph Hospital, Johannesburg, South Africa.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Bloch</LastName><ForeName>Mark</ForeName><Initials>M</Initials><AffiliationInfo><Affiliation>Holdsworth House Medical Practice, Sydney NSW, Australia.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Vandekerckhove</LastName><ForeName>Linos</ForeName><Initials>L</Initials><AffiliationInfo><Affiliation>Faculty of Medicine and Health Sciences, University of Ghent, Ghent, Belgium.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Ruane</LastName><ForeName>Peter</ForeName><Initials>P</Initials><AffiliationInfo><Affiliation>Ruane Medical & Liver Health Institute, Los Angeles, CA, USA.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Yazdanpanah</LastName><ForeName>Yazdan</ForeName><Initials>Y</Initials><AffiliationInfo><Affiliation>Hôpital Bichat-Claude Bernard, Paris, France.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Katlama</LastName><ForeName>Christine</ForeName><Initials>C</Initials><AffiliationInfo><Affiliation>Hôpital Pitié-Salpêtrière Pavillon Laveran, Paris, France.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Xu</LastName><ForeName>Xia</ForeName><Initials>X</Initials><AffiliationInfo><Affiliation>Merck & Co, Inc, Kenilworth, NJ, USA.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Rodgers</LastName><ForeName>Anthony</ForeName><Initials>A</Initials><AffiliationInfo><Affiliation>Merck & Co, Inc, Kenilworth, NJ, USA.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>East</LastName><ForeName>Lilly</ForeName><Initials>L</Initials><AffiliationInfo><Affiliation>Merck & Co, Inc, Kenilworth, NJ, USA.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Wenning</LastName><ForeName>Larissa</ForeName><Initials>L</Initials><AffiliationInfo><Affiliation>Merck & Co, Inc, Kenilworth, NJ, USA.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Rawlins</LastName><ForeName>Sandy</ForeName><Initials>S</Initials><AffiliationInfo><Affiliation>Merck & Co, Inc, Kenilworth, NJ, USA.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Homony</LastName><ForeName>Brenda</ForeName><Initials>B</Initials><AffiliationInfo><Affiliation>Merck & Co, Inc, Kenilworth, NJ, USA.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Sklar</LastName><ForeName>Peter</ForeName><Initials>P</Initials><AffiliationInfo><Affiliation>Merck & Co, Inc, Kenilworth, NJ, USA.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Nguyen</LastName><ForeName>Bach-Yen</ForeName><Initials>BY</Initials><AffiliationInfo><Affiliation>Merck & Co, Inc, Kenilworth, NJ, USA.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Leavitt</LastName><ForeName>Randi</ForeName><Initials>R</Initials><AffiliationInfo><Affiliation>Merck & Co, Inc, Kenilworth, NJ, USA.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Teppler</LastName><ForeName>Hedy</ForeName><Initials>H</Initials><AffiliationInfo><Affiliation>Merck & Co, Inc, Kenilworth, NJ, USA. Electronic address: hedy_teppler@merck.com.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><CollectiveName>ONCEMRK Study Group</CollectiveName></Author></AuthorList><Language>eng</Language><PublicationTypeList><PublicationType UI="D016428">Journal Article</PublicationType></PublicationTypeList><ArticleDate DateType="Electronic"><Year>2017</Year><Month>09</Month><Day>11</Day></ArticleDate></Article><MedlineJournalInfo><Country>Netherlands</Country><MedlineTA>Lancet HIV</MedlineTA><NlmUniqueID>101645355</NlmUniqueID><ISSNLinking>2352-3018</ISSNLinking></MedlineJournalInfo><InvestigatorList><Investigator ValidYN="Y"><LastName>Cahn</LastName><ForeName>P E</ForeName><Initials>PE</Initials></Investigator><Investigator ValidYN="Y"><LastName>Cassetti</LastName><ForeName>I</ForeName><Initials>I</Initials></Investigator><Investigator ValidYN="Y"><LastName>Losso</LastName><ForeName>M</ForeName><Initials>M</Initials></Investigator><Investigator 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