Safety, pharmacokinetics and antiviral activity of PGT121, a broadly neutralizing monoclonal antibody against HIV-1: a randomized, placebo-controlled, phase 1 clinical trial.
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| Title: | Safety, pharmacokinetics and antiviral activity of PGT121, a broadly neutralizing monoclonal antibody against HIV-1: a randomized, placebo-controlled, phase 1 clinical trial. |
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| Authors: | Stephenson KE; Center for Virology and Vaccine Research, Beth Israel Deaconess Medical Center, Boston, MA, USA.; Division of Infectious Diseases, Beth Israel Deaconess Medical Center, Boston, MA, USA.; Ragon Institute of MGH, MIT and Harvard, Cambridge, MA, USA., Julg B; Center for Virology and Vaccine Research, Beth Israel Deaconess Medical Center, Boston, MA, USA.; Ragon Institute of MGH, MIT and Harvard, Cambridge, MA, USA.; Infectious Disease Division, Massachusetts General Hospital, Boston, MA, USA., Tan CS; Center for Virology and Vaccine Research, Beth Israel Deaconess Medical Center, Boston, MA, USA.; Division of Infectious Diseases, Beth Israel Deaconess Medical Center, Boston, MA, USA., Zash R; Center for Virology and Vaccine Research, Beth Israel Deaconess Medical Center, Boston, MA, USA.; Division of Infectious Diseases, Beth Israel Deaconess Medical Center, Boston, MA, USA., Walsh SR; Center for Virology and Vaccine Research, Beth Israel Deaconess Medical Center, Boston, MA, USA., Rolle CP; Orlando Immunology Center, Orlando, FL, USA., Monczor AN; McGovern Medical School at The University of Texas Health Science Center, Houston, TX, USA., Lupo S; McGovern Medical School at The University of Texas Health Science Center, Houston, TX, USA., Gelderblom HC; International AIDS Vaccine Initiative, New York, NY, USA., Ansel JL; Center for Virology and Vaccine Research, Beth Israel Deaconess Medical Center, Boston, MA, USA., Kanjilal DG; Center for Virology and Vaccine Research, Beth Israel Deaconess Medical Center, Boston, MA, USA., Maxfield LF; Center for Virology and Vaccine Research, Beth Israel Deaconess Medical Center, Boston, MA, USA., Nkolola J; Center for Virology and Vaccine Research, Beth Israel Deaconess Medical Center, Boston, MA, USA., Borducchi EN; Center for Virology and Vaccine Research, Beth Israel Deaconess Medical Center, Boston, MA, USA., Abbink P; Center for Virology and Vaccine Research, Beth Israel Deaconess Medical Center, Boston, MA, USA., Liu J; Center for Virology and Vaccine Research, Beth Israel Deaconess Medical Center, Boston, MA, USA., Peter L; Center for Virology and Vaccine Research, Beth Israel Deaconess Medical Center, Boston, MA, USA., Chandrashekar A; Center for Virology and Vaccine Research, Beth Israel Deaconess Medical Center, Boston, MA, USA., Nityanandam R; Center for Virology and Vaccine Research, Beth Israel Deaconess Medical Center, Boston, MA, USA., Lin Z; Center for Virology and Vaccine Research, Beth Israel Deaconess Medical Center, Boston, MA, USA., Setaro A; Center for Virology and Vaccine Research, Beth Israel Deaconess Medical Center, Boston, MA, USA., Sapiente J; Center for Virology and Vaccine Research, Beth Israel Deaconess Medical Center, Boston, MA, USA., Chen Z; Ragon Institute of MGH, MIT and Harvard, Cambridge, MA, USA., Sunner L; International AIDS Vaccine Initiative, New York, NY, USA., Cassidy T; Theoretical Biology and Biophysics Group, Los Alamos National Laboratory, Los Alamos, NM, USA., Bennett C; Statistical Center for HIV/AIDS Research and Prevention, Fred Hutchinson Cancer Research Center, Seattle, WA, USA., Sato A; Statistical Center for HIV/AIDS Research and Prevention, Fred Hutchinson Cancer Research Center, Seattle, WA, USA., Mayer B; Statistical Center for HIV/AIDS Research and Prevention, Fred Hutchinson Cancer Research Center, Seattle, WA, USA., Perelson AS; Theoretical Biology and Biophysics Group, Los Alamos National Laboratory, Los Alamos, NM, USA., deCamp A; Statistical Center for HIV/AIDS Research and Prevention, Fred Hutchinson Cancer Research Center, Seattle, WA, USA., Priddy FH; International AIDS Vaccine Initiative, New York, NY, USA., Wagh K; Theoretical Biology and Biophysics Group, Los Alamos National Laboratory, Los Alamos, NM, USA., Giorgi EE; Theoretical Biology and Biophysics Group, Los Alamos National Laboratory, Los Alamos, NM, USA., Yates NL; Duke Human Vaccine Institute, Duke University, Durham, NC, USA.; Departments of Surgery, Immunology and Molecular Genetics and Microbiology, Duke University, Durham, NC, USA., Arduino RC; McGovern Medical School at The University of Texas Health Science Center, Houston, TX, USA., DeJesus E; Orlando Immunology Center, Orlando, FL, USA., Tomaras GD; Duke Human Vaccine Institute, Duke University, Durham, NC, USA.; Departments of Surgery, Immunology and Molecular Genetics and Microbiology, Duke University, Durham, NC, USA., Seaman MS; Center for Virology and Vaccine Research, Beth Israel Deaconess Medical Center, Boston, MA, USA., Korber B; Theoretical Biology and Biophysics Group, Los Alamos National Laboratory, Los Alamos, NM, USA.; New Mexico Consortium, Los Alamos, NM, USA., Barouch DH; Center for Virology and Vaccine Research, Beth Israel Deaconess Medical Center, Boston, MA, USA. dbarouch@bidmc.harvard.edu.; Division of Infectious Diseases, Beth Israel Deaconess Medical Center, Boston, MA, USA. dbarouch@bidmc.harvard.edu.; Ragon Institute of MGH, MIT and Harvard, Cambridge, MA, USA. dbarouch@bidmc.harvard.edu. |
| Source: | Nature medicine [Nat Med] 2021 Oct; Vol. 27 (10), pp. 1718-1724. Date of Electronic Publication: 2021 Oct 07. |
| Publication Type: | Clinical Trial, Phase I; Journal Article; Multicenter Study; Randomized Controlled Trial; Research Support, N.I.H., Extramural; Research Support, Non-U.S. Gov't |
| Journal Info: | Publisher: Nature Publishing Company Country of Publication: United States NLM ID: 9502015 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1546-170X (Electronic) Linking ISSN: 10788956 NLM ISO Abbreviation: Nat Med Subsets: MEDLINE |
| Database: | MEDLINE Ultimate |
| FullText | Text: Availability: 0 |
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| Header | DbId: mdl DbLabel: MEDLINE Ultimate An: 34621054 AccessLevel: 2 PubType: Academic Journal PubTypeId: academicJournal PreciseRelevancyScore: 0 |
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| Items | – Name: Title Label: Title Group: Ti Data: Safety, pharmacokinetics and antiviral activity of PGT121, a broadly neutralizing monoclonal antibody against HIV-1: a randomized, placebo-controlled, phase 1 clinical trial. – Name: Author Label: Authors Group: Au Data: <searchLink fieldCode="AU" term="%22Stephenson+KE%22">Stephenson KE</searchLink>; Center for Virology and Vaccine Research, Beth Israel Deaconess Medical Center, Boston, MA, USA.; Division of Infectious Diseases, Beth Israel Deaconess Medical Center, Boston, MA, USA.; Ragon Institute of MGH, MIT and Harvard, Cambridge, MA, USA.<br /><searchLink fieldCode="AU" term="%22Julg+B%22">Julg B</searchLink>; Center for Virology and Vaccine Research, Beth Israel Deaconess Medical Center, Boston, MA, USA.; Ragon Institute of MGH, MIT and Harvard, Cambridge, MA, USA.; Infectious Disease Division, Massachusetts General Hospital, Boston, MA, USA.<br /><searchLink fieldCode="AU" term="%22Tan+CS%22">Tan CS</searchLink>; Center for Virology and Vaccine Research, Beth Israel Deaconess Medical Center, Boston, MA, USA.; Division of Infectious Diseases, Beth Israel Deaconess Medical Center, Boston, MA, USA.<br /><searchLink fieldCode="AU" term="%22Zash+R%22">Zash R</searchLink>; Center for Virology and Vaccine Research, Beth Israel Deaconess Medical Center, Boston, MA, USA.; Division of Infectious Diseases, Beth Israel Deaconess Medical Center, Boston, MA, USA.<br /><searchLink fieldCode="AU" term="%22Walsh+SR%22">Walsh SR</searchLink>; Center for Virology and Vaccine Research, Beth Israel Deaconess Medical Center, Boston, MA, USA.<br /><searchLink fieldCode="AU" term="%22Rolle+CP%22">Rolle CP</searchLink>; Orlando Immunology Center, Orlando, FL, USA.<br /><searchLink fieldCode="AU" term="%22Monczor+AN%22">Monczor AN</searchLink>; McGovern Medical School at The University of Texas Health Science Center, Houston, TX, USA.<br /><searchLink fieldCode="AU" term="%22Lupo+S%22">Lupo S</searchLink>; McGovern Medical School at The University of Texas Health Science Center, Houston, TX, USA.<br /><searchLink fieldCode="AU" term="%22Gelderblom+HC%22">Gelderblom HC</searchLink>; International AIDS Vaccine Initiative, New York, NY, USA.<br /><searchLink fieldCode="AU" term="%22Ansel+JL%22">Ansel JL</searchLink>; Center for Virology and Vaccine Research, Beth Israel Deaconess Medical Center, Boston, MA, USA.<br /><searchLink fieldCode="AU" term="%22Kanjilal+DG%22">Kanjilal DG</searchLink>; Center for Virology and Vaccine Research, Beth Israel Deaconess Medical Center, Boston, MA, USA.<br /><searchLink fieldCode="AU" term="%22Maxfield+LF%22">Maxfield LF</searchLink>; Center for Virology and Vaccine Research, Beth Israel Deaconess Medical Center, Boston, MA, USA.<br /><searchLink fieldCode="AU" term="%22Nkolola+J%22">Nkolola J</searchLink>; Center for Virology and Vaccine Research, Beth Israel Deaconess Medical Center, Boston, MA, USA.<br /><searchLink fieldCode="AU" term="%22Borducchi+EN%22">Borducchi EN</searchLink>; Center for Virology and Vaccine Research, Beth Israel Deaconess Medical Center, Boston, MA, USA.<br /><searchLink fieldCode="AU" term="%22Abbink+P%22">Abbink P</searchLink>; Center for Virology and Vaccine Research, Beth Israel Deaconess Medical Center, Boston, MA, USA.<br /><searchLink fieldCode="AU" term="%22Liu+J%22">Liu J</searchLink>; Center for Virology and Vaccine Research, Beth Israel Deaconess Medical Center, Boston, MA, USA.<br /><searchLink fieldCode="AU" term="%22Peter+L%22">Peter L</searchLink>; Center for Virology and Vaccine Research, Beth Israel Deaconess Medical Center, Boston, MA, USA.<br /><searchLink fieldCode="AU" term="%22Chandrashekar+A%22">Chandrashekar A</searchLink>; Center for Virology and Vaccine Research, Beth Israel Deaconess Medical Center, Boston, MA, USA.<br /><searchLink fieldCode="AU" term="%22Nityanandam+R%22">Nityanandam R</searchLink>; Center for Virology and Vaccine Research, Beth Israel Deaconess Medical Center, Boston, MA, USA.<br /><searchLink fieldCode="AU" term="%22Lin+Z%22">Lin Z</searchLink>; Center for Virology and Vaccine Research, Beth Israel Deaconess Medical Center, Boston, MA, USA.<br /><searchLink fieldCode="AU" term="%22Setaro+A%22">Setaro A</searchLink>; Center for Virology and Vaccine Research, Beth Israel Deaconess Medical Center, Boston, MA, USA.<br /><searchLink fieldCode="AU" term="%22Sapiente+J%22">Sapiente J</searchLink>; Center for Virology and Vaccine Research, Beth Israel Deaconess Medical Center, Boston, MA, USA.<br /><searchLink fieldCode="AU" term="%22Chen+Z%22">Chen Z</searchLink>; Ragon Institute of MGH, MIT and Harvard, Cambridge, MA, USA.<br /><searchLink fieldCode="AU" term="%22Sunner+L%22">Sunner L</searchLink>; International AIDS Vaccine Initiative, New York, NY, USA.<br /><searchLink fieldCode="AU" term="%22Cassidy+T%22">Cassidy T</searchLink>; Theoretical Biology and Biophysics Group, Los Alamos National Laboratory, Los Alamos, NM, USA.<br /><searchLink fieldCode="AU" term="%22Bennett+C%22">Bennett C</searchLink>; Statistical Center for HIV/AIDS Research and Prevention, Fred Hutchinson Cancer Research Center, Seattle, WA, USA.<br /><searchLink fieldCode="AU" term="%22Sato+A%22">Sato A</searchLink>; Statistical Center for HIV/AIDS Research and Prevention, Fred Hutchinson Cancer Research Center, Seattle, WA, USA.<br /><searchLink fieldCode="AU" term="%22Mayer+B%22">Mayer B</searchLink>; Statistical Center for HIV/AIDS Research and Prevention, Fred Hutchinson Cancer Research Center, Seattle, WA, USA.<br /><searchLink fieldCode="AU" term="%22Perelson+AS%22">Perelson AS</searchLink>; Theoretical Biology and Biophysics Group, Los Alamos National Laboratory, Los Alamos, NM, USA.<br /><searchLink fieldCode="AU" term="%22deCamp+A%22">deCamp A</searchLink>; Statistical Center for HIV/AIDS Research and Prevention, Fred Hutchinson Cancer Research Center, Seattle, WA, USA.<br /><searchLink fieldCode="AU" term="%22Priddy+FH%22">Priddy FH</searchLink>; International AIDS Vaccine Initiative, New York, NY, USA.<br /><searchLink fieldCode="AU" term="%22Wagh+K%22">Wagh K</searchLink>; Theoretical Biology and Biophysics Group, Los Alamos National Laboratory, Los Alamos, NM, USA.<br /><searchLink fieldCode="AU" term="%22Giorgi+EE%22">Giorgi EE</searchLink>; Theoretical Biology and Biophysics Group, Los Alamos National Laboratory, Los Alamos, NM, USA.<br /><searchLink fieldCode="AU" term="%22Yates+NL%22">Yates NL</searchLink>; Duke Human Vaccine Institute, Duke University, Durham, NC, USA.; Departments of Surgery, Immunology and Molecular Genetics and Microbiology, Duke University, Durham, NC, USA.<br /><searchLink fieldCode="AU" term="%22Arduino+RC%22">Arduino RC</searchLink>; McGovern Medical School at The University of Texas Health Science Center, Houston, TX, USA.<br /><searchLink fieldCode="AU" term="%22DeJesus+E%22">DeJesus E</searchLink>; Orlando Immunology Center, Orlando, FL, USA.<br /><searchLink fieldCode="AU" term="%22Tomaras+GD%22">Tomaras GD</searchLink>; Duke Human Vaccine Institute, Duke University, Durham, NC, USA.; Departments of Surgery, Immunology and Molecular Genetics and Microbiology, Duke University, Durham, NC, USA.<br /><searchLink fieldCode="AU" term="%22Seaman+MS%22">Seaman MS</searchLink>; Center for Virology and Vaccine Research, Beth Israel Deaconess Medical Center, Boston, MA, USA.<br /><searchLink fieldCode="AU" term="%22Korber+B%22">Korber B</searchLink>; Theoretical Biology and Biophysics Group, Los Alamos National Laboratory, Los Alamos, NM, USA.; New Mexico Consortium, Los Alamos, NM, USA.<br /><searchLink fieldCode="AU" term="%22Barouch+DH%22">Barouch DH</searchLink>; Center for Virology and Vaccine Research, Beth Israel Deaconess Medical Center, Boston, MA, USA. dbarouch@bidmc.harvard.edu.; Division of Infectious Diseases, Beth Israel Deaconess Medical Center, Boston, MA, USA. dbarouch@bidmc.harvard.edu.; Ragon Institute of MGH, MIT and Harvard, Cambridge, MA, USA. dbarouch@bidmc.harvard.edu. – Name: TitleSource Label: Source Group: Src Data: <searchLink fieldCode="JN" term="%229502015%22">Nature medicine</searchLink> [Nat Med] 2021 Oct; Vol. 27 (10), pp. 1718-1724. <i>Date of Electronic Publication: </i>2021 Oct 07. – Name: TypePub Label: Publication Type Group: TypPub Data: Clinical Trial, Phase I; Journal Article; Multicenter Study; Randomized Controlled Trial; Research Support, N.I.H., Extramural; Research Support, Non-U.S. Gov't – Name: TitleSource Label: Journal Info Group: Src Data: <i>Publisher: </i><searchLink fieldCode="PB" term="%22Nature+Publishing+Company%22">Nature Publishing Company </searchLink><i>Country of Publication: </i>United States <i>NLM ID: </i>9502015 <i>Publication Model: </i>Print-Electronic <i>Cited Medium: </i>Internet <i>ISSN: </i>1546-170X (Electronic) <i>Linking ISSN: </i><searchLink fieldCode="IS" term="%2210788956%22">10788956 </searchLink><i>NLM ISO Abbreviation: </i>Nat Med <i>Subsets: </i>MEDLINE |
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