Monoclonal antibody hNM01 in HIV-infected patients: a phase I study
hNM01 is a humanized monoclonal antibody that binds to the V 3 region of the HIV-1 envelope protein gp120. This binding leads to the activation of complement and the disruption of the viral envelope. The aim of this study was to investigate the clinical responses of the individuals when treated with...
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| Veröffentlicht in: | Journal of clinical virology 2004-12, Vol.31 (S1), p.45-47 |
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| container_title | Journal of clinical virology |
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| creator | Dezube, Bruce J. Doweiko, John P. Proper, Jo Ann Conway, Brian Hwang, Liana Terada, Masaki Leece, Barbara A. Ohno, Tsuneya Mastico, Robert A. |
| description | hNM01 is a humanized monoclonal antibody that binds to the V
3 region of the HIV-1 envelope protein gp120. This binding leads to the activation of complement and the disruption of the viral envelope.
The aim of this study was to investigate the clinical responses of the individuals when treated with the humanized antibody NMO1. In this phase I study, four HIV-1 infected patients with CD4 counts between 50 and 500
cells/μl received a total of four doses of hNM01 in an intrapatient dose escalation fashion: day 1–0.2
mg/kg, day 15–1
mg/kg, day 29–5
mg/kg, and day 43–5
mg/kg. Patients were required to have virus that reacted to hNM01 by a virion capture assay and to have a viral load ≥15,000
copies/mL.
The antibody was well-tolerated; no significant adverse events were observed even at the highest dose tolerated. None of the patient developed either human anti-hNM01 (anti-idiotype) or human anti-rat antibodies. The mean elimination half-life was 153
h (6.4 days). During hNMO1 therapy effects were observed on CD4 cell counts and plasma viral loads and further dose finding trials are necessary to better determine the therapeutic activity of hNM01 in HIV-infected individuals. |
| doi_str_mv | 10.1016/j.jcv.2004.09.003 |
| format | Article |
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3 region of the HIV-1 envelope protein gp120. This binding leads to the activation of complement and the disruption of the viral envelope.
The aim of this study was to investigate the clinical responses of the individuals when treated with the humanized antibody NMO1. In this phase I study, four HIV-1 infected patients with CD4 counts between 50 and 500
cells/μl received a total of four doses of hNM01 in an intrapatient dose escalation fashion: day 1–0.2
mg/kg, day 15–1
mg/kg, day 29–5
mg/kg, and day 43–5
mg/kg. Patients were required to have virus that reacted to hNM01 by a virion capture assay and to have a viral load ≥15,000
copies/mL.
The antibody was well-tolerated; no significant adverse events were observed even at the highest dose tolerated. None of the patient developed either human anti-hNM01 (anti-idiotype) or human anti-rat antibodies. The mean elimination half-life was 153
h (6.4 days). During hNMO1 therapy effects were observed on CD4 cell counts and plasma viral loads and further dose finding trials are necessary to better determine the therapeutic activity of hNM01 in HIV-infected individuals.</description><identifier>ISSN: 1386-6532</identifier><identifier>EISSN: 1873-5967</identifier><identifier>DOI: 10.1016/j.jcv.2004.09.003</identifier><identifier>PMID: 15567093</identifier><language>eng</language><publisher>Amsterdam: Elsevier B.V</publisher><subject>Antibodies, Monoclonal - pharmacokinetics ; Antibodies, Monoclonal - therapeutic use ; Biological and medical sciences ; Clinical study ; Complement Activation - drug effects ; Fundamental and applied biological sciences. Psychology ; HIV Envelope Protein gp120 - immunology ; HIV Envelope Protein gp120 - metabolism ; HIV infection ; HIV Infections - therapy ; Human immunodeficiency virus 1 ; Human viral diseases ; Humanized monoclonal antibody ; Humans ; Infectious diseases ; Medical sciences ; Microbiology ; Miscellaneous ; Safety ; Vaccines, antisera, therapeutical immunoglobulins and monoclonal antibodies ; Viral diseases ; Virology</subject><ispartof>Journal of clinical virology, 2004-12, Vol.31 (S1), p.45-47</ispartof><rights>2004 Elsevier B.V.</rights><rights>2005 INIST-CNRS</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c410t-d39a73f93d3d8038452d15bdcb0c8dea07a1587731506fa44ef2264318cdb84d3</citedby><cites>FETCH-LOGICAL-c410t-d39a73f93d3d8038452d15bdcb0c8dea07a1587731506fa44ef2264318cdb84d3</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktohtml>$$Uhttps://www.sciencedirect.com/science/article/pii/S1386653204002240$$EHTML$$P50$$Gelsevier$$H</linktohtml><link.rule.ids>314,776,780,3537,27901,27902,65534</link.rule.ids><backlink>$$Uhttp://pascal-francis.inist.fr/vibad/index.php?action=getRecordDetail&idt=16317966$$DView record in Pascal Francis$$Hfree_for_read</backlink><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/15567093$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Dezube, Bruce J.</creatorcontrib><creatorcontrib>Doweiko, John P.</creatorcontrib><creatorcontrib>Proper, Jo Ann</creatorcontrib><creatorcontrib>Conway, Brian</creatorcontrib><creatorcontrib>Hwang, Liana</creatorcontrib><creatorcontrib>Terada, Masaki</creatorcontrib><creatorcontrib>Leece, Barbara A.</creatorcontrib><creatorcontrib>Ohno, Tsuneya</creatorcontrib><creatorcontrib>Mastico, Robert A.</creatorcontrib><title>Monoclonal antibody hNM01 in HIV-infected patients: a phase I study</title><title>Journal of clinical virology</title><addtitle>J Clin Virol</addtitle><description>hNM01 is a humanized monoclonal antibody that binds to the V
3 region of the HIV-1 envelope protein gp120. This binding leads to the activation of complement and the disruption of the viral envelope.
The aim of this study was to investigate the clinical responses of the individuals when treated with the humanized antibody NMO1. In this phase I study, four HIV-1 infected patients with CD4 counts between 50 and 500
cells/μl received a total of four doses of hNM01 in an intrapatient dose escalation fashion: day 1–0.2
mg/kg, day 15–1
mg/kg, day 29–5
mg/kg, and day 43–5
mg/kg. Patients were required to have virus that reacted to hNM01 by a virion capture assay and to have a viral load ≥15,000
copies/mL.
The antibody was well-tolerated; no significant adverse events were observed even at the highest dose tolerated. None of the patient developed either human anti-hNM01 (anti-idiotype) or human anti-rat antibodies. The mean elimination half-life was 153
h (6.4 days). During hNMO1 therapy effects were observed on CD4 cell counts and plasma viral loads and further dose finding trials are necessary to better determine the therapeutic activity of hNM01 in HIV-infected individuals.</description><subject>Antibodies, Monoclonal - pharmacokinetics</subject><subject>Antibodies, Monoclonal - therapeutic use</subject><subject>Biological and medical sciences</subject><subject>Clinical study</subject><subject>Complement Activation - drug effects</subject><subject>Fundamental and applied biological sciences. Psychology</subject><subject>HIV Envelope Protein gp120 - immunology</subject><subject>HIV Envelope Protein gp120 - metabolism</subject><subject>HIV infection</subject><subject>HIV Infections - therapy</subject><subject>Human immunodeficiency virus 1</subject><subject>Human viral diseases</subject><subject>Humanized monoclonal antibody</subject><subject>Humans</subject><subject>Infectious diseases</subject><subject>Medical sciences</subject><subject>Microbiology</subject><subject>Miscellaneous</subject><subject>Safety</subject><subject>Vaccines, antisera, therapeutical immunoglobulins and monoclonal antibodies</subject><subject>Viral diseases</subject><subject>Virology</subject><issn>1386-6532</issn><issn>1873-5967</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2004</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNqFkMtOwzAQRS0E4v0BbJA3sEuYieNHYIUqHpV4bICt5diOcJUmJU6R-ve4aiV2sJpZnHtndAg5Q8gRUFzN8pn9zguAMocqB2A75BCVZBmvhNxNO1MiE5wVB-QoxhkAclbKfXKAnAsJFTskk-e-623bd6alphtD3bsV_Xx5BqSho4_Tjyx0jbejd3RhxuC7MV5TQxefJno6pXFcutUJ2WtMG_3pdh6T9_u7t8lj9vT6MJ3cPmW2RBgzxyojWVMxx5wCpkpeOOS1szVY5bwBaZArKRlyEI0pS98UhSgZKutqVTp2TC43vYuh_1r6OOp5iNa3rel8v4xaSGRF4v8FUUrFgYsE4ga0Qx_j4Bu9GMLcDCuNoNeK9UwnxXqtWEOlk-KUOd-WL-u5d7-JrdMEXGwBE61pm8F0NsRfTjCUlVgfv9lwPjn7Dn7Q0SbB1rswJOPa9eGPN34AE_eWmg</recordid><startdate>20041201</startdate><enddate>20041201</enddate><creator>Dezube, Bruce J.</creator><creator>Doweiko, John P.</creator><creator>Proper, Jo Ann</creator><creator>Conway, Brian</creator><creator>Hwang, Liana</creator><creator>Terada, Masaki</creator><creator>Leece, Barbara A.</creator><creator>Ohno, Tsuneya</creator><creator>Mastico, Robert A.</creator><general>Elsevier B.V</general><general>Elsevier Science</general><scope>IQODW</scope><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>7U9</scope><scope>H94</scope><scope>7X8</scope></search><sort><creationdate>20041201</creationdate><title>Monoclonal antibody hNM01 in HIV-infected patients: a phase I study</title><author>Dezube, Bruce J. ; Doweiko, John P. ; Proper, Jo Ann ; Conway, Brian ; Hwang, Liana ; Terada, Masaki ; Leece, Barbara A. ; Ohno, Tsuneya ; Mastico, Robert A.</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c410t-d39a73f93d3d8038452d15bdcb0c8dea07a1587731506fa44ef2264318cdb84d3</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2004</creationdate><topic>Antibodies, Monoclonal - pharmacokinetics</topic><topic>Antibodies, Monoclonal - therapeutic use</topic><topic>Biological and medical sciences</topic><topic>Clinical study</topic><topic>Complement Activation - drug effects</topic><topic>Fundamental and applied biological sciences. Psychology</topic><topic>HIV Envelope Protein gp120 - immunology</topic><topic>HIV Envelope Protein gp120 - metabolism</topic><topic>HIV infection</topic><topic>HIV Infections - therapy</topic><topic>Human immunodeficiency virus 1</topic><topic>Human viral diseases</topic><topic>Humanized monoclonal antibody</topic><topic>Humans</topic><topic>Infectious diseases</topic><topic>Medical sciences</topic><topic>Microbiology</topic><topic>Miscellaneous</topic><topic>Safety</topic><topic>Vaccines, antisera, therapeutical immunoglobulins and monoclonal antibodies</topic><topic>Viral diseases</topic><topic>Virology</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Dezube, Bruce J.</creatorcontrib><creatorcontrib>Doweiko, John P.</creatorcontrib><creatorcontrib>Proper, Jo Ann</creatorcontrib><creatorcontrib>Conway, Brian</creatorcontrib><creatorcontrib>Hwang, Liana</creatorcontrib><creatorcontrib>Terada, Masaki</creatorcontrib><creatorcontrib>Leece, Barbara A.</creatorcontrib><creatorcontrib>Ohno, Tsuneya</creatorcontrib><creatorcontrib>Mastico, Robert A.</creatorcontrib><collection>Pascal-Francis</collection><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>Virology and AIDS Abstracts</collection><collection>AIDS and Cancer Research Abstracts</collection><collection>MEDLINE - Academic</collection><jtitle>Journal of clinical virology</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Dezube, Bruce J.</au><au>Doweiko, John P.</au><au>Proper, Jo Ann</au><au>Conway, Brian</au><au>Hwang, Liana</au><au>Terada, Masaki</au><au>Leece, Barbara A.</au><au>Ohno, Tsuneya</au><au>Mastico, Robert A.</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Monoclonal antibody hNM01 in HIV-infected patients: a phase I study</atitle><jtitle>Journal of clinical virology</jtitle><addtitle>J Clin Virol</addtitle><date>2004-12-01</date><risdate>2004</risdate><volume>31</volume><issue>S1</issue><spage>45</spage><epage>47</epage><pages>45-47</pages><issn>1386-6532</issn><eissn>1873-5967</eissn><abstract>hNM01 is a humanized monoclonal antibody that binds to the V
3 region of the HIV-1 envelope protein gp120. This binding leads to the activation of complement and the disruption of the viral envelope.
The aim of this study was to investigate the clinical responses of the individuals when treated with the humanized antibody NMO1. In this phase I study, four HIV-1 infected patients with CD4 counts between 50 and 500
cells/μl received a total of four doses of hNM01 in an intrapatient dose escalation fashion: day 1–0.2
mg/kg, day 15–1
mg/kg, day 29–5
mg/kg, and day 43–5
mg/kg. Patients were required to have virus that reacted to hNM01 by a virion capture assay and to have a viral load ≥15,000
copies/mL.
The antibody was well-tolerated; no significant adverse events were observed even at the highest dose tolerated. None of the patient developed either human anti-hNM01 (anti-idiotype) or human anti-rat antibodies. The mean elimination half-life was 153
h (6.4 days). During hNMO1 therapy effects were observed on CD4 cell counts and plasma viral loads and further dose finding trials are necessary to better determine the therapeutic activity of hNM01 in HIV-infected individuals.</abstract><cop>Amsterdam</cop><pub>Elsevier B.V</pub><pmid>15567093</pmid><doi>10.1016/j.jcv.2004.09.003</doi><tpages>3</tpages></addata></record> |
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| subjects | Antibodies, Monoclonal - pharmacokinetics Antibodies, Monoclonal - therapeutic use Biological and medical sciences Clinical study Complement Activation - drug effects Fundamental and applied biological sciences. Psychology HIV Envelope Protein gp120 - immunology HIV Envelope Protein gp120 - metabolism HIV infection HIV Infections - therapy Human immunodeficiency virus 1 Human viral diseases Humanized monoclonal antibody Humans Infectious diseases Medical sciences Microbiology Miscellaneous Safety Vaccines, antisera, therapeutical immunoglobulins and monoclonal antibodies Viral diseases Virology |
| title | Monoclonal antibody hNM01 in HIV-infected patients: a phase I study |
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