Assessing the safety and pharmacokinetics of the anti-HIV monoclonal antibody CAP256V2LS alone and in combination with VRC07-523LS and PGT121 in South African women: study protocol for the first-in-human CAPRISA 012B phase I clinical trial.
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| Title: | Assessing the safety and pharmacokinetics of the anti-HIV monoclonal antibody CAP256V2LS alone and in combination with VRC07-523LS and PGT121 in South African women: study protocol for the first-in-human CAPRISA 012B phase I clinical trial. |
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| Authors: | Mahomed S; Centre for the AIDS Programme of Research in South Africa (CAPRISA), Durban, South Africa Sharana.Mahomed@caprisa.org., Garrett N; Centre for the AIDS Programme of Research in South Africa (CAPRISA), Durban, South Africa.; Department of Public Health Medicine, School of Nursing and Public Health, University of KwaZulu-Natal, Durban, South Africa., Karim QA; Centre for the AIDS Programme of Research in South Africa (CAPRISA), Durban, South Africa.; Department of Epidemiology, Mailman School of Public Health, Columba University, New York, New York, USA., Zuma NY; Centre for the AIDS Programme of Research in South Africa (CAPRISA), Durban, South Africa., Capparelli E; University of California San Diego, San Diego, California, USA., Baxter C; Centre for the AIDS Programme of Research in South Africa (CAPRISA), Durban, South Africa., Gengiah T; Centre for the AIDS Programme of Research in South Africa (CAPRISA), Durban, South Africa., Archary D; Centre for the AIDS Programme of Research in South Africa (CAPRISA), Durban, South Africa., Samsunder N; Centre for the AIDS Programme of Research in South Africa (CAPRISA), Durban, South Africa., Doria-Rose N; Vaccine Research Center, National Institutes of Health, Bethesda, Maryland, USA., Moore P; Centre for the AIDS Programme of Research in South Africa (CAPRISA), Durban, South Africa.; National Institute for Communicable Diseases of the National Health Laboratory Services, Johannesburg, South Africa., Williamson C; Centre for the AIDS Programme of Research in South Africa (CAPRISA), Durban, South Africa.; National Health Laboratory Services of South Africa, Johannesburg, South Africa.; Division of Medical Virology, Institute of Infectious Disease and Molecular Medicine, University of Cape Town, Cape Town, South Africa., Barouch DH; Center for Virology and Vaccine Research, Beth Israel Deaconess Medical Center, Boston, Massachusetts, USA., Fast PE; International Aids Vaccine Initiative, New York, New York, USA., Pozzetto B; GIMAP (EA3064), University of Saint-Etienne/University of Lyon, Saint-Etienne, France., Hankins C; Amsterdam Institute for Global Health and Development, Amsterdam, The Netherlands., Carlton K; Vaccine Research Center, National Institutes of Health, Bethesda, Maryland, USA., Ledgerwood J; Vaccine Research Center, National Institutes of Health, Bethesda, Maryland, USA., Morris L; Centre for the AIDS Programme of Research in South Africa (CAPRISA), Durban, South Africa.; National Institute for Communicable Diseases of the National Health Laboratory Services, Johannesburg, South Africa., Mascola J; Vaccine Research Center, National Institutes of Health, Bethesda, Maryland, USA., Abdool Karim S; Centre for the AIDS Programme of Research in South Africa (CAPRISA), Durban, South Africa.; Department of Epidemiology, Mailman School of Public Health, Columba University, New York, New York, USA. |
| Source: | BMJ open [BMJ Open] 2020 Nov 26; Vol. 10 (11), pp. e042247. Date of Electronic Publication: 2020 Nov 26. |
| Publication Type: | Journal Article; Research Support, Non-U.S. Gov't; Clinical Trial Protocol |
| Journal Info: | Publisher: BMJ Publishing Group Ltd Country of Publication: England NLM ID: 101552874 Publication Model: Electronic Cited Medium: Internet ISSN: 2044-6055 (Electronic) Linking ISSN: 20446055 NLM ISO Abbreviation: BMJ Open Subsets: MEDLINE |
| Database: | MEDLINE Ultimate |
| FullText | Text: Availability: 0 |
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| Header | DbId: mdl DbLabel: MEDLINE Ultimate An: 33243815 AccessLevel: 2 PubType: Academic Journal PubTypeId: academicJournal PreciseRelevancyScore: 0 |
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| Items | – Name: Title Label: Title Group: Ti Data: Assessing the safety and pharmacokinetics of the anti-HIV monoclonal antibody CAP256V2LS alone and in combination with VRC07-523LS and PGT121 in South African women: study protocol for the first-in-human CAPRISA 012B phase I clinical trial. – Name: Author Label: Authors Group: Au Data: <searchLink fieldCode="AU" term="%22Mahomed+S%22">Mahomed S</searchLink>; Centre for the AIDS Programme of Research in South Africa (CAPRISA), Durban, South Africa Sharana.Mahomed@caprisa.org.<br /><searchLink fieldCode="AU" term="%22Garrett+N%22">Garrett N</searchLink>; Centre for the AIDS Programme of Research in South Africa (CAPRISA), Durban, South Africa.; Department of Public Health Medicine, School of Nursing and Public Health, University of KwaZulu-Natal, Durban, South Africa.<br /><searchLink fieldCode="AU" term="%22Karim+QA%22">Karim QA</searchLink>; Centre for the AIDS Programme of Research in South Africa (CAPRISA), Durban, South Africa.; Department of Epidemiology, Mailman School of Public Health, Columba University, New York, New York, USA.<br /><searchLink fieldCode="AU" term="%22Zuma+NY%22">Zuma NY</searchLink>; Centre for the AIDS Programme of Research in South Africa (CAPRISA), Durban, South Africa.<br /><searchLink fieldCode="AU" term="%22Capparelli+E%22">Capparelli E</searchLink>; University of California San Diego, San Diego, California, USA.<br /><searchLink fieldCode="AU" term="%22Baxter+C%22">Baxter C</searchLink>; Centre for the AIDS Programme of Research in South Africa (CAPRISA), Durban, South Africa.<br /><searchLink fieldCode="AU" term="%22Gengiah+T%22">Gengiah T</searchLink>; Centre for the AIDS Programme of Research in South Africa (CAPRISA), Durban, South Africa.<br /><searchLink fieldCode="AU" term="%22Archary+D%22">Archary D</searchLink>; Centre for the AIDS Programme of Research in South Africa (CAPRISA), Durban, South Africa.<br /><searchLink fieldCode="AU" term="%22Samsunder+N%22">Samsunder N</searchLink>; Centre for the AIDS Programme of Research in South Africa (CAPRISA), Durban, South Africa.<br /><searchLink fieldCode="AU" term="%22Doria-Rose+N%22">Doria-Rose N</searchLink>; Vaccine Research Center, National Institutes of Health, Bethesda, Maryland, USA.<br /><searchLink fieldCode="AU" term="%22Moore+P%22">Moore P</searchLink>; Centre for the AIDS Programme of Research in South Africa (CAPRISA), Durban, South Africa.; National Institute for Communicable Diseases of the National Health Laboratory Services, Johannesburg, South Africa.<br /><searchLink fieldCode="AU" term="%22Williamson+C%22">Williamson C</searchLink>; Centre for the AIDS Programme of Research in South Africa (CAPRISA), Durban, South Africa.; National Health Laboratory Services of South Africa, Johannesburg, South Africa.; Division of Medical Virology, Institute of Infectious Disease and Molecular Medicine, University of Cape Town, Cape Town, South Africa.<br /><searchLink fieldCode="AU" term="%22Barouch+DH%22">Barouch DH</searchLink>; Center for Virology and Vaccine Research, Beth Israel Deaconess Medical Center, Boston, Massachusetts, USA.<br /><searchLink fieldCode="AU" term="%22Fast+PE%22">Fast PE</searchLink>; International Aids Vaccine Initiative, New York, New York, USA.<br /><searchLink fieldCode="AU" term="%22Pozzetto+B%22">Pozzetto B</searchLink>; GIMAP (EA3064), University of Saint-Etienne/University of Lyon, Saint-Etienne, France.<br /><searchLink fieldCode="AU" term="%22Hankins+C%22">Hankins C</searchLink>; Amsterdam Institute for Global Health and Development, Amsterdam, The Netherlands.<br /><searchLink fieldCode="AU" term="%22Carlton+K%22">Carlton K</searchLink>; Vaccine Research Center, National Institutes of Health, Bethesda, Maryland, USA.<br /><searchLink fieldCode="AU" term="%22Ledgerwood+J%22">Ledgerwood J</searchLink>; Vaccine Research Center, National Institutes of Health, Bethesda, Maryland, USA.<br /><searchLink fieldCode="AU" term="%22Morris+L%22">Morris L</searchLink>; Centre for the AIDS Programme of Research in South Africa (CAPRISA), Durban, South Africa.; National Institute for Communicable Diseases of the National Health Laboratory Services, Johannesburg, South Africa.<br /><searchLink fieldCode="AU" term="%22Mascola+J%22">Mascola J</searchLink>; Vaccine Research Center, National Institutes of Health, Bethesda, Maryland, USA.<br /><searchLink fieldCode="AU" term="%22Abdool+Karim+S%22">Abdool Karim S</searchLink>; Centre for the AIDS Programme of Research in South Africa (CAPRISA), Durban, South Africa.; Department of Epidemiology, Mailman School of Public Health, Columba University, New York, New York, USA. – Name: TitleSource Label: Source Group: Src Data: <searchLink fieldCode="JN" term="%22101552874%22">BMJ open</searchLink> [BMJ Open] 2020 Nov 26; Vol. 10 (11), pp. e042247. <i>Date of Electronic Publication: </i>2020 Nov 26. – Name: TypePub Label: Publication Type Group: TypPub Data: Journal Article; Research Support, Non-U.S. Gov't; Clinical Trial Protocol – Name: TitleSource Label: Journal Info Group: Src Data: <i>Publisher: </i><searchLink fieldCode="PB" term="%22BMJ+Publishing+Group+Ltd%22">BMJ Publishing Group Ltd </searchLink><i>Country of Publication: </i>England <i>NLM ID: </i>101552874 <i>Publication Model: </i>Electronic <i>Cited Medium: </i>Internet <i>ISSN: </i>2044-6055 (Electronic) <i>Linking ISSN: </i><searchLink fieldCode="IS" term="%2220446055%22">20446055 </searchLink><i>NLM ISO Abbreviation: </i>BMJ Open <i>Subsets: </i>MEDLINE |
| PLink | https://search.ebscohost.com/login.aspx?direct=true&site=eds-live&db=mdl&AN=33243815 |
| RecordInfo | BibRecord: BibEntity: Identifiers: – Type: doi Value: 10.1136/bmjopen-2020-042247 Languages: – Code: eng Text: English PhysicalDescription: Pagination: StartPage: e042247 Titles: – TitleFull: Assessing the safety and pharmacokinetics of the anti-HIV monoclonal antibody CAP256V2LS alone and in combination with VRC07-523LS and PGT121 in South African women: study protocol for the first-in-human CAPRISA 012B phase I clinical trial. Type: main BibRelationships: HasContributorRelationships: – PersonEntity: Name: NameFull: Mahomed S – PersonEntity: Name: NameFull: Garrett N – PersonEntity: Name: NameFull: Karim QA – PersonEntity: Name: NameFull: Zuma NY – PersonEntity: Name: NameFull: Capparelli E – PersonEntity: Name: NameFull: Baxter C – PersonEntity: Name: NameFull: Gengiah T – PersonEntity: Name: NameFull: Archary D – PersonEntity: Name: NameFull: Samsunder N – PersonEntity: Name: NameFull: Doria-Rose N – PersonEntity: Name: NameFull: Moore P – PersonEntity: Name: NameFull: Williamson C – PersonEntity: Name: NameFull: Barouch DH – PersonEntity: Name: NameFull: Fast PE – PersonEntity: Name: NameFull: Pozzetto B – PersonEntity: Name: NameFull: Hankins C – PersonEntity: Name: NameFull: Carlton K – PersonEntity: Name: NameFull: Ledgerwood J – PersonEntity: Name: NameFull: Morris L – PersonEntity: Name: NameFull: Mascola J – PersonEntity: Name: NameFull: Abdool Karim S IsPartOfRelationships: – BibEntity: Dates: – D: 26 M: 11 Text: 2020 Nov 26 Type: published Y: 2020 Identifiers: – Type: issn-electronic Value: 2044-6055 Numbering: – Type: volume Value: 10 – Type: issue Value: 11 Titles: – TitleFull: BMJ open Type: main |
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