The safety, plasma pharmacokinetics, and antiviral activity of subcutaneous enfuvirtide (T-20), a peptide inhibitor of gp41-mediated virus fusion, in HIV-infected adults
Enfuvirtide (T-20) is a novel antiretroviral agent that blocks HIV-1 cell fusion. A 28-day randomized dose-comparison study was conducted to determine the safety, pharmacokinetics, and antiviral activity of enfuvirtide in 78 HIV-infected adults, most with extensive treatment experience. Patients rec...
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| Veröffentlicht in: | AIDS research and human retroviruses 2002-07, Vol.18 (10), p.685-693 |
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| creator | KILBY, J. Michael LALEZARI, Jacob P VALENTINE, Fred SAAG, Michael S NELSON, Emily L SISTA, Prakash R DUSEK, Alex ERON, Joseph J CARLSON, Margrit COHEN, Calvin ARDUINO, Roberto C GOODGAME, Jeffrey C GALLANT, Joel E VOLBERDING, Paul MURPHY, Robert L |
| description | Enfuvirtide (T-20) is a novel antiretroviral agent that blocks HIV-1 cell fusion. A 28-day randomized dose-comparison study was conducted to determine the safety, pharmacokinetics, and antiviral activity of enfuvirtide in 78 HIV-infected adults, most with extensive treatment experience. Patients received enfuvirtide, added to a failing regimen, either by continuous subcutaneous infusion (CSI: 12.5, 25, 50 or 100 mg/day) or by subcutaneous (SC) injection (50 or 100 mg twice daily). Dose-related decreases in viral load were observed, with a maximum mean reduction from baseline of 1.6 log(10) copies/ml (p< 0.001) seen in the 100 mg bid SC group. Most responses diminished by 28 days. Plasma pharmacokinetics and antiviral responses were more consistent for SC injection than for CSI because of technical difficulties experienced with CSI. Injection site reactions were common but generally mild. These results indicate that enfuvirtide is a promising new therapeutic agent for HIV-infected patients, including those with prior antiretroviral treatment. |
| doi_str_mv | 10.1089/088922202760072294 |
| format | Article |
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Michael ; LALEZARI, Jacob P ; VALENTINE, Fred ; SAAG, Michael S ; NELSON, Emily L ; SISTA, Prakash R ; DUSEK, Alex ; ERON, Joseph J ; CARLSON, Margrit ; COHEN, Calvin ; ARDUINO, Roberto C ; GOODGAME, Jeffrey C ; GALLANT, Joel E ; VOLBERDING, Paul ; MURPHY, Robert L</creator><creatorcontrib>KILBY, J. Michael ; LALEZARI, Jacob P ; VALENTINE, Fred ; SAAG, Michael S ; NELSON, Emily L ; SISTA, Prakash R ; DUSEK, Alex ; ERON, Joseph J ; CARLSON, Margrit ; COHEN, Calvin ; ARDUINO, Roberto C ; GOODGAME, Jeffrey C ; GALLANT, Joel E ; VOLBERDING, Paul ; MURPHY, Robert L</creatorcontrib><description>Enfuvirtide (T-20) is a novel antiretroviral agent that blocks HIV-1 cell fusion. A 28-day randomized dose-comparison study was conducted to determine the safety, pharmacokinetics, and antiviral activity of enfuvirtide in 78 HIV-infected adults, most with extensive treatment experience. Patients received enfuvirtide, added to a failing regimen, either by continuous subcutaneous infusion (CSI: 12.5, 25, 50 or 100 mg/day) or by subcutaneous (SC) injection (50 or 100 mg twice daily). Dose-related decreases in viral load were observed, with a maximum mean reduction from baseline of 1.6 log(10) copies/ml (p< 0.001) seen in the 100 mg bid SC group. Most responses diminished by 28 days. Plasma pharmacokinetics and antiviral responses were more consistent for SC injection than for CSI because of technical difficulties experienced with CSI. Injection site reactions were common but generally mild. These results indicate that enfuvirtide is a promising new therapeutic agent for HIV-infected patients, including those with prior antiretroviral treatment.</description><identifier>ISSN: 0889-2229</identifier><identifier>EISSN: 1931-8405</identifier><identifier>DOI: 10.1089/088922202760072294</identifier><identifier>PMID: 12167274</identifier><identifier>CODEN: ARHRE7</identifier><language>eng</language><publisher>Larchmont, NY: Liebert</publisher><subject>Acquired Immunodeficiency Syndrome - drug therapy ; Acquired Immunodeficiency Syndrome - immunology ; Acquired Immunodeficiency Syndrome - virology ; Adult ; Anti-HIV Agents - adverse effects ; Antibiotics. Antiinfectious agents. Antiparasitic agents ; Antiviral agents ; Biological and medical sciences ; CD4 Lymphocyte Count ; Dose-Response Relationship, Drug ; HIV Envelope Protein gp41 - adverse effects ; HIV Envelope Protein gp41 - therapeutic use ; HIV-1 - genetics ; Human viral diseases ; Humans ; Infectious diseases ; Injections, Subcutaneous ; Medical sciences ; Middle Aged ; Peptide Fragments - adverse effects ; Peptide Fragments - pharmacokinetics ; Peptide Fragments - therapeutic use ; Pharmacology. Drug treatments ; RNA, Viral - blood ; Viral diseases ; Viral diseases of the lymphoid tissue and the blood. Aids</subject><ispartof>AIDS research and human retroviruses, 2002-07, Vol.18 (10), p.685-693</ispartof><rights>2002 INIST-CNRS</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c455t-ee66179bcd8d6c01fb290aa7358d7ea98e5fd9de53d6a57ab1a36e8a75e250bc3</citedby><cites>FETCH-LOGICAL-c455t-ee66179bcd8d6c01fb290aa7358d7ea98e5fd9de53d6a57ab1a36e8a75e250bc3</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><link.rule.ids>315,782,786,3044,27931,27932</link.rule.ids><backlink>$$Uhttp://pascal-francis.inist.fr/vibad/index.php?action=getRecordDetail&idt=13800760$$DView record in Pascal Francis$$Hfree_for_read</backlink><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/12167274$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>KILBY, J. Michael</creatorcontrib><creatorcontrib>LALEZARI, Jacob P</creatorcontrib><creatorcontrib>VALENTINE, Fred</creatorcontrib><creatorcontrib>SAAG, Michael S</creatorcontrib><creatorcontrib>NELSON, Emily L</creatorcontrib><creatorcontrib>SISTA, Prakash R</creatorcontrib><creatorcontrib>DUSEK, Alex</creatorcontrib><creatorcontrib>ERON, Joseph J</creatorcontrib><creatorcontrib>CARLSON, Margrit</creatorcontrib><creatorcontrib>COHEN, Calvin</creatorcontrib><creatorcontrib>ARDUINO, Roberto C</creatorcontrib><creatorcontrib>GOODGAME, Jeffrey C</creatorcontrib><creatorcontrib>GALLANT, Joel E</creatorcontrib><creatorcontrib>VOLBERDING, Paul</creatorcontrib><creatorcontrib>MURPHY, Robert L</creatorcontrib><title>The safety, plasma pharmacokinetics, and antiviral activity of subcutaneous enfuvirtide (T-20), a peptide inhibitor of gp41-mediated virus fusion, in HIV-infected adults</title><title>AIDS research and human retroviruses</title><addtitle>AIDS Res Hum Retroviruses</addtitle><description>Enfuvirtide (T-20) is a novel antiretroviral agent that blocks HIV-1 cell fusion. A 28-day randomized dose-comparison study was conducted to determine the safety, pharmacokinetics, and antiviral activity of enfuvirtide in 78 HIV-infected adults, most with extensive treatment experience. Patients received enfuvirtide, added to a failing regimen, either by continuous subcutaneous infusion (CSI: 12.5, 25, 50 or 100 mg/day) or by subcutaneous (SC) injection (50 or 100 mg twice daily). Dose-related decreases in viral load were observed, with a maximum mean reduction from baseline of 1.6 log(10) copies/ml (p< 0.001) seen in the 100 mg bid SC group. Most responses diminished by 28 days. Plasma pharmacokinetics and antiviral responses were more consistent for SC injection than for CSI because of technical difficulties experienced with CSI. Injection site reactions were common but generally mild. These results indicate that enfuvirtide is a promising new therapeutic agent for HIV-infected patients, including those with prior antiretroviral treatment.</description><subject>Acquired Immunodeficiency Syndrome - drug therapy</subject><subject>Acquired Immunodeficiency Syndrome - immunology</subject><subject>Acquired Immunodeficiency Syndrome - virology</subject><subject>Adult</subject><subject>Anti-HIV Agents - adverse effects</subject><subject>Antibiotics. Antiinfectious agents. Antiparasitic agents</subject><subject>Antiviral agents</subject><subject>Biological and medical sciences</subject><subject>CD4 Lymphocyte Count</subject><subject>Dose-Response Relationship, Drug</subject><subject>HIV Envelope Protein gp41 - adverse effects</subject><subject>HIV Envelope Protein gp41 - therapeutic use</subject><subject>HIV-1 - genetics</subject><subject>Human viral diseases</subject><subject>Humans</subject><subject>Infectious diseases</subject><subject>Injections, Subcutaneous</subject><subject>Medical sciences</subject><subject>Middle Aged</subject><subject>Peptide Fragments - adverse effects</subject><subject>Peptide Fragments - pharmacokinetics</subject><subject>Peptide Fragments - therapeutic use</subject><subject>Pharmacology. Drug treatments</subject><subject>RNA, Viral - blood</subject><subject>Viral diseases</subject><subject>Viral diseases of the lymphoid tissue and the blood. Aids</subject><issn>0889-2229</issn><issn>1931-8405</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2002</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNplkU1rFTEUhoMo9rb6B1xINorCHZtkJpNkWYq1hYKba7fDmeTEG50vJ5nC_Un-SzPeC110ERJOnueFw0vIO86-cKbNJdPaCCGYUDVjSghTvSAbbkpe6IrJl2SzAkUmzBk5j_EXYyzz8jU544LXSqhqQ_7u9kgjeEyHLZ06iD3QaQ9zD3b8HQZMwcYthcHlk8JjmKGjYNdXOtDR07i0dkkw4LhEioNfMpKCQ_ppVwj2Oat0wun_JAz70IY0zqv3c6p40aMLkNDRLGXdLzGMwzaD9PbuoQiDR7v-glu6FN-QVx66iG9P9wX5cfN1d31b3H__dnd9dV_YSspUINY1V6a1TrvaMu5bYRiAKqV2CsFolN4Zh7J0NUgFLYeyRg1KopCsteUF-XjMnebxz4IxNX2IFrvuuGTDdVVpqUwGxRG08xjjjL6Z5tDDfGg4a9aCmucFZen9KX1p8_pPyqmRDHw4ARAtdH6GwYb4xJU6R9Ws_Ac0m5rP</recordid><startdate>20020701</startdate><enddate>20020701</enddate><creator>KILBY, J. Michael</creator><creator>LALEZARI, Jacob P</creator><creator>VALENTINE, Fred</creator><creator>SAAG, Michael S</creator><creator>NELSON, Emily L</creator><creator>SISTA, Prakash R</creator><creator>DUSEK, Alex</creator><creator>ERON, Joseph J</creator><creator>CARLSON, Margrit</creator><creator>COHEN, Calvin</creator><creator>ARDUINO, Roberto C</creator><creator>GOODGAME, Jeffrey C</creator><creator>GALLANT, Joel E</creator><creator>VOLBERDING, Paul</creator><creator>MURPHY, Robert L</creator><general>Liebert</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></search><sort><creationdate>20020701</creationdate><title>The safety, plasma pharmacokinetics, and antiviral activity of subcutaneous enfuvirtide (T-20), a peptide inhibitor of gp41-mediated virus fusion, in HIV-infected adults</title><author>KILBY, J. Michael ; LALEZARI, Jacob P ; VALENTINE, Fred ; SAAG, Michael S ; NELSON, Emily L ; SISTA, Prakash R ; DUSEK, Alex ; ERON, Joseph J ; CARLSON, Margrit ; COHEN, Calvin ; ARDUINO, Roberto C ; GOODGAME, Jeffrey C ; GALLANT, Joel E ; VOLBERDING, Paul ; MURPHY, Robert L</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c455t-ee66179bcd8d6c01fb290aa7358d7ea98e5fd9de53d6a57ab1a36e8a75e250bc3</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2002</creationdate><topic>Acquired Immunodeficiency Syndrome - drug therapy</topic><topic>Acquired Immunodeficiency Syndrome - immunology</topic><topic>Acquired Immunodeficiency Syndrome - virology</topic><topic>Adult</topic><topic>Anti-HIV Agents - adverse effects</topic><topic>Antibiotics. Antiinfectious agents. Antiparasitic agents</topic><topic>Antiviral agents</topic><topic>Biological and medical sciences</topic><topic>CD4 Lymphocyte Count</topic><topic>Dose-Response Relationship, Drug</topic><topic>HIV Envelope Protein gp41 - adverse effects</topic><topic>HIV Envelope Protein gp41 - therapeutic use</topic><topic>HIV-1 - genetics</topic><topic>Human viral diseases</topic><topic>Humans</topic><topic>Infectious diseases</topic><topic>Injections, Subcutaneous</topic><topic>Medical sciences</topic><topic>Middle Aged</topic><topic>Peptide Fragments - adverse effects</topic><topic>Peptide Fragments - pharmacokinetics</topic><topic>Peptide Fragments - therapeutic use</topic><topic>Pharmacology. Drug treatments</topic><topic>RNA, Viral - blood</topic><topic>Viral diseases</topic><topic>Viral diseases of the lymphoid tissue and the blood. Aids</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>KILBY, J. Michael</creatorcontrib><creatorcontrib>LALEZARI, Jacob P</creatorcontrib><creatorcontrib>VALENTINE, Fred</creatorcontrib><creatorcontrib>SAAG, Michael S</creatorcontrib><creatorcontrib>NELSON, Emily L</creatorcontrib><creatorcontrib>SISTA, Prakash R</creatorcontrib><creatorcontrib>DUSEK, Alex</creatorcontrib><creatorcontrib>ERON, Joseph J</creatorcontrib><creatorcontrib>CARLSON, Margrit</creatorcontrib><creatorcontrib>COHEN, Calvin</creatorcontrib><creatorcontrib>ARDUINO, Roberto C</creatorcontrib><creatorcontrib>GOODGAME, Jeffrey C</creatorcontrib><creatorcontrib>GALLANT, Joel E</creatorcontrib><creatorcontrib>VOLBERDING, Paul</creatorcontrib><creatorcontrib>MURPHY, Robert L</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><jtitle>AIDS research and human retroviruses</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>KILBY, J. Michael</au><au>LALEZARI, Jacob P</au><au>VALENTINE, Fred</au><au>SAAG, Michael S</au><au>NELSON, Emily L</au><au>SISTA, Prakash R</au><au>DUSEK, Alex</au><au>ERON, Joseph J</au><au>CARLSON, Margrit</au><au>COHEN, Calvin</au><au>ARDUINO, Roberto C</au><au>GOODGAME, Jeffrey C</au><au>GALLANT, Joel E</au><au>VOLBERDING, Paul</au><au>MURPHY, Robert L</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>The safety, plasma pharmacokinetics, and antiviral activity of subcutaneous enfuvirtide (T-20), a peptide inhibitor of gp41-mediated virus fusion, in HIV-infected adults</atitle><jtitle>AIDS research and human retroviruses</jtitle><addtitle>AIDS Res Hum Retroviruses</addtitle><date>2002-07-01</date><risdate>2002</risdate><volume>18</volume><issue>10</issue><spage>685</spage><epage>693</epage><pages>685-693</pages><issn>0889-2229</issn><eissn>1931-8405</eissn><coden>ARHRE7</coden><abstract>Enfuvirtide (T-20) is a novel antiretroviral agent that blocks HIV-1 cell fusion. A 28-day randomized dose-comparison study was conducted to determine the safety, pharmacokinetics, and antiviral activity of enfuvirtide in 78 HIV-infected adults, most with extensive treatment experience. Patients received enfuvirtide, added to a failing regimen, either by continuous subcutaneous infusion (CSI: 12.5, 25, 50 or 100 mg/day) or by subcutaneous (SC) injection (50 or 100 mg twice daily). Dose-related decreases in viral load were observed, with a maximum mean reduction from baseline of 1.6 log(10) copies/ml (p< 0.001) seen in the 100 mg bid SC group. Most responses diminished by 28 days. Plasma pharmacokinetics and antiviral responses were more consistent for SC injection than for CSI because of technical difficulties experienced with CSI. Injection site reactions were common but generally mild. These results indicate that enfuvirtide is a promising new therapeutic agent for HIV-infected patients, including those with prior antiretroviral treatment.</abstract><cop>Larchmont, NY</cop><pub>Liebert</pub><pmid>12167274</pmid><doi>10.1089/088922202760072294</doi><tpages>9</tpages></addata></record> |
| fulltext | fulltext |
| identifier | ISSN: 0889-2229 |
| ispartof | AIDS research and human retroviruses, 2002-07, Vol.18 (10), p.685-693 |
| issn | 0889-2229 1931-8405 |
| language | eng |
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| source | Mary Ann Liebert Online Subscription; MEDLINE; Alma/SFX Local Collection |
| subjects | Acquired Immunodeficiency Syndrome - drug therapy Acquired Immunodeficiency Syndrome - immunology Acquired Immunodeficiency Syndrome - virology Adult Anti-HIV Agents - adverse effects Antibiotics. Antiinfectious agents. Antiparasitic agents Antiviral agents Biological and medical sciences CD4 Lymphocyte Count Dose-Response Relationship, Drug HIV Envelope Protein gp41 - adverse effects HIV Envelope Protein gp41 - therapeutic use HIV-1 - genetics Human viral diseases Humans Infectious diseases Injections, Subcutaneous Medical sciences Middle Aged Peptide Fragments - adverse effects Peptide Fragments - pharmacokinetics Peptide Fragments - therapeutic use Pharmacology. Drug treatments RNA, Viral - blood Viral diseases Viral diseases of the lymphoid tissue and the blood. Aids |
| title | The safety, plasma pharmacokinetics, and antiviral activity of subcutaneous enfuvirtide (T-20), a peptide inhibitor of gp41-mediated virus fusion, in HIV-infected adults |
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