Antiviral activity and safety of aplaviroc, a CCR5 antagonist, in combination with lopinavir/ritonavir in HIV‐infected, therapy‐naïve patients: results of the EPIC study (CCR100136)
Background This phase IIb study explored the antiviral activity and safety of the investigational CC chemokine receptor 5 (CCR5) antagonist aplaviroc (APL) in antiretroviral‐naïve patients harbouring R5‐ or R5X4‐tropic virus. Methods A total of 191 patients were randomized 2:2:2:1 to one of three AP...
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| Veröffentlicht in: | HIV medicine 2009-02, Vol.10 (2), p.116-124 |
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| creator | Yeni, P LaMarca, A Berger, D Cimoch, P Lazzarin, A Salvato, P Smaill, FM Teofilo, E Madison, SJ Nichols, WG Adkison, KK Bonny, T Millard, J McCarty, D |
| description | Background
This phase IIb study explored the antiviral activity and safety of the investigational CC chemokine receptor 5 (CCR5) antagonist aplaviroc (APL) in antiretroviral‐naïve patients harbouring R5‐ or R5X4‐tropic virus.
Methods
A total of 191 patients were randomized 2:2:2:1 to one of three APL dosing regimens or to lamivudine (3TC)/zidovudine (ZDV) twice daily (bid), each in combination with lopinavir/ritonavir (LPV/r) 400 mg/100 mg bid. Efficacy, safety and pharmacokinetic parameters were assessed.
Results
This study was terminated prematurely because of APL‐associated idiosyncratic hepatotoxicity. A total of 141 patients initiated treatment early enough to have been able to complete 12 weeks on treatment [modified intent‐to‐treat (M‐ITT) population]; of these, 133 completed the 12‐week treatment phase. The proportion of subjects in the M‐ITT population with HIV‐1 RNA |
| doi_str_mv | 10.1111/j.1468-1293.2008.00660.x |
| format | Article |
| fullrecord | <record><control><sourceid>proquest_cross</sourceid><recordid>TN_cdi_proquest_miscellaneous_20338246</recordid><sourceformat>XML</sourceformat><sourcesystem>PC</sourcesystem><sourcerecordid>20338246</sourcerecordid><originalsourceid>FETCH-LOGICAL-c4480-3845dc6b6adab79abf01daa053a8f21ad120cbb1945d8ac13126dc1661212ed3</originalsourceid><addsrcrecordid>eNqNkctu1DAUhi0EoqXlFZBXCKRJ6kvGTVA3VVToSJVAqOrWOrEd6lHGDrHTNjsegTdh323fhCfBmRnBFm_8H5_vXOQfIUxJTtM5Wee0EGVGWcVzRkiZEyIEyR-eocO_iedbXWRMCHaAXoWwJoSe8oq8RAe0YnOwPESP5y7aOztAh0HNKk4YnMYBWpOkbzH0HSTAqwUGXNdflykf4Zt3NsQFtg4rv2msg2i9w_c23uLO9ylONSeDjX6rZu5ydfP7x0_rWqOi0Qscb80A_ZTeHDz9ujO4Tz2Mi-EDHkwYuxjm8YnCF19WNQ5x1BN-lzagaXcu3h-jFy10wbze30fo-uPFdX2ZXX3-tKrPrzJVFCXJeFkstRKNAA3NaQVNS6gGIEsOZcsoaMqIahpaJawERTllQisqBGWUGc2P0Ntd237w30cTotzYoEzXgTN-DJIRzktWiASWO1ANPoTBtLIf7AaGSVIiZ9vkWs7uyNkdOdsmt7bJh1T6Zj9jbDZG_yvc-5SAsx1wbzsz_Xdjmf48Cf4HEnGqWw</addsrcrecordid><sourcetype>Aggregation Database</sourcetype><iscdi>true</iscdi><recordtype>article</recordtype><pqid>20338246</pqid></control><display><type>article</type><title>Antiviral activity and safety of aplaviroc, a CCR5 antagonist, in combination with lopinavir/ritonavir in HIV‐infected, therapy‐naïve patients: results of the EPIC study (CCR100136)</title><source>Wiley Free Content</source><source>MEDLINE</source><source>IngentaConnect Free/Open Access Journals</source><source>Elektronische Zeitschriftenbibliothek - Frei zugängliche E-Journals</source><source>Wiley Online Library All Journals</source><creator>Yeni, P ; LaMarca, A ; Berger, D ; Cimoch, P ; Lazzarin, A ; Salvato, P ; Smaill, FM ; Teofilo, E ; Madison, SJ ; Nichols, WG ; Adkison, KK ; Bonny, T ; Millard, J ; McCarty, D</creator><creatorcontrib>Yeni, P ; LaMarca, A ; Berger, D ; Cimoch, P ; Lazzarin, A ; Salvato, P ; Smaill, FM ; Teofilo, E ; Madison, SJ ; Nichols, WG ; Adkison, KK ; Bonny, T ; Millard, J ; McCarty, D ; EPIC (CCR100136) study team ; the EPIC (CCR100136) study team</creatorcontrib><description>Background
This phase IIb study explored the antiviral activity and safety of the investigational CC chemokine receptor 5 (CCR5) antagonist aplaviroc (APL) in antiretroviral‐naïve patients harbouring R5‐ or R5X4‐tropic virus.
Methods
A total of 191 patients were randomized 2:2:2:1 to one of three APL dosing regimens or to lamivudine (3TC)/zidovudine (ZDV) twice daily (bid), each in combination with lopinavir/ritonavir (LPV/r) 400 mg/100 mg bid. Efficacy, safety and pharmacokinetic parameters were assessed.
Results
This study was terminated prematurely because of APL‐associated idiosyncratic hepatotoxicity. A total of 141 patients initiated treatment early enough to have been able to complete 12 weeks on treatment [modified intent‐to‐treat (M‐ITT) population]; of these, 133 completed the 12‐week treatment phase. The proportion of subjects in the M‐ITT population with HIV‐1 RNA <400 copies/mL at week 12 was 50, 48, 54 and 75% in the APL 200 mg bid, APL 400 mg bid, APL 800 mg once a day (qd) and 3TC/ZDV arms, respectively. Similar responses were seen in the few subjects harbouring R5X4‐tropic virus (n=17). Common clinical adverse events (AEs) were diarrhoea, nausea, fatigue and headache. APL demonstrated nonlinear pharmacokinetics with high interpatient variability.
Conclusions
While target plasma concentrations of APL were achieved, the antiviral activity of APL+LPV/r did not appear to be comparable to that of 3TC/ZDV+LPV/r.</description><identifier>ISSN: 1464-2662</identifier><identifier>EISSN: 1468-1293</identifier><identifier>DOI: 10.1111/j.1468-1293.2008.00660.x</identifier><identifier>PMID: 19200175</identifier><language>eng</language><publisher>Oxford, UK: Blackwell Publishing Ltd</publisher><subject>873140 ; Adult ; Aged ; aplaviroc ; Benzoates - pharmacokinetics ; Benzoates - toxicity ; CC chemokine receptor (CCR) 5‐tropic virus ; Drug Administration Schedule ; Drug Therapy, Combination ; Female ; HIV infection ; HIV Infections - drug therapy ; HIV Infections - immunology ; HIV Infections - virology ; HIV Protease Inhibitors - pharmacokinetics ; HIV Protease Inhibitors - therapeutic use ; HIV-1 - immunology ; Human immunodeficiency virus 1 ; Humans ; Lopinavir ; Male ; Middle Aged ; Piperazines - pharmacokinetics ; Piperazines - toxicity ; Pyrimidinones - pharmacokinetics ; Pyrimidinones - therapeutic use ; Receptors, CCR5 - therapeutic use ; Ritonavir - pharmacokinetics ; Ritonavir - therapeutic use ; RNA, Viral - immunology ; Spiro Compounds - pharmacokinetics ; Spiro Compounds - toxicity ; Young Adult</subject><ispartof>HIV medicine, 2009-02, Vol.10 (2), p.116-124</ispartof><rights>2009 British HIV Association</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c4480-3845dc6b6adab79abf01daa053a8f21ad120cbb1945d8ac13126dc1661212ed3</citedby><cites>FETCH-LOGICAL-c4480-3845dc6b6adab79abf01daa053a8f21ad120cbb1945d8ac13126dc1661212ed3</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://onlinelibrary.wiley.com/doi/pdf/10.1111%2Fj.1468-1293.2008.00660.x$$EPDF$$P50$$Gwiley$$H</linktopdf><linktohtml>$$Uhttps://onlinelibrary.wiley.com/doi/full/10.1111%2Fj.1468-1293.2008.00660.x$$EHTML$$P50$$Gwiley$$H</linktohtml><link.rule.ids>314,776,780,1411,1427,27901,27902,45550,45551,46384,46808</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/19200175$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Yeni, P</creatorcontrib><creatorcontrib>LaMarca, A</creatorcontrib><creatorcontrib>Berger, D</creatorcontrib><creatorcontrib>Cimoch, P</creatorcontrib><creatorcontrib>Lazzarin, A</creatorcontrib><creatorcontrib>Salvato, P</creatorcontrib><creatorcontrib>Smaill, FM</creatorcontrib><creatorcontrib>Teofilo, E</creatorcontrib><creatorcontrib>Madison, SJ</creatorcontrib><creatorcontrib>Nichols, WG</creatorcontrib><creatorcontrib>Adkison, KK</creatorcontrib><creatorcontrib>Bonny, T</creatorcontrib><creatorcontrib>Millard, J</creatorcontrib><creatorcontrib>McCarty, D</creatorcontrib><creatorcontrib>EPIC (CCR100136) study team</creatorcontrib><creatorcontrib>the EPIC (CCR100136) study team</creatorcontrib><title>Antiviral activity and safety of aplaviroc, a CCR5 antagonist, in combination with lopinavir/ritonavir in HIV‐infected, therapy‐naïve patients: results of the EPIC study (CCR100136)</title><title>HIV medicine</title><addtitle>HIV Med</addtitle><description>Background
This phase IIb study explored the antiviral activity and safety of the investigational CC chemokine receptor 5 (CCR5) antagonist aplaviroc (APL) in antiretroviral‐naïve patients harbouring R5‐ or R5X4‐tropic virus.
Methods
A total of 191 patients were randomized 2:2:2:1 to one of three APL dosing regimens or to lamivudine (3TC)/zidovudine (ZDV) twice daily (bid), each in combination with lopinavir/ritonavir (LPV/r) 400 mg/100 mg bid. Efficacy, safety and pharmacokinetic parameters were assessed.
Results
This study was terminated prematurely because of APL‐associated idiosyncratic hepatotoxicity. A total of 141 patients initiated treatment early enough to have been able to complete 12 weeks on treatment [modified intent‐to‐treat (M‐ITT) population]; of these, 133 completed the 12‐week treatment phase. The proportion of subjects in the M‐ITT population with HIV‐1 RNA <400 copies/mL at week 12 was 50, 48, 54 and 75% in the APL 200 mg bid, APL 400 mg bid, APL 800 mg once a day (qd) and 3TC/ZDV arms, respectively. Similar responses were seen in the few subjects harbouring R5X4‐tropic virus (n=17). Common clinical adverse events (AEs) were diarrhoea, nausea, fatigue and headache. APL demonstrated nonlinear pharmacokinetics with high interpatient variability.
Conclusions
While target plasma concentrations of APL were achieved, the antiviral activity of APL+LPV/r did not appear to be comparable to that of 3TC/ZDV+LPV/r.</description><subject>873140</subject><subject>Adult</subject><subject>Aged</subject><subject>aplaviroc</subject><subject>Benzoates - pharmacokinetics</subject><subject>Benzoates - toxicity</subject><subject>CC chemokine receptor (CCR) 5‐tropic virus</subject><subject>Drug Administration Schedule</subject><subject>Drug Therapy, Combination</subject><subject>Female</subject><subject>HIV infection</subject><subject>HIV Infections - drug therapy</subject><subject>HIV Infections - immunology</subject><subject>HIV Infections - virology</subject><subject>HIV Protease Inhibitors - pharmacokinetics</subject><subject>HIV Protease Inhibitors - therapeutic use</subject><subject>HIV-1 - immunology</subject><subject>Human immunodeficiency virus 1</subject><subject>Humans</subject><subject>Lopinavir</subject><subject>Male</subject><subject>Middle Aged</subject><subject>Piperazines - pharmacokinetics</subject><subject>Piperazines - toxicity</subject><subject>Pyrimidinones - pharmacokinetics</subject><subject>Pyrimidinones - therapeutic use</subject><subject>Receptors, CCR5 - therapeutic use</subject><subject>Ritonavir - pharmacokinetics</subject><subject>Ritonavir - therapeutic use</subject><subject>RNA, Viral - immunology</subject><subject>Spiro Compounds - pharmacokinetics</subject><subject>Spiro Compounds - toxicity</subject><subject>Young Adult</subject><issn>1464-2662</issn><issn>1468-1293</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2009</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNqNkctu1DAUhi0EoqXlFZBXCKRJ6kvGTVA3VVToSJVAqOrWOrEd6lHGDrHTNjsegTdh323fhCfBmRnBFm_8H5_vXOQfIUxJTtM5Wee0EGVGWcVzRkiZEyIEyR-eocO_iedbXWRMCHaAXoWwJoSe8oq8RAe0YnOwPESP5y7aOztAh0HNKk4YnMYBWpOkbzH0HSTAqwUGXNdflykf4Zt3NsQFtg4rv2msg2i9w_c23uLO9ylONSeDjX6rZu5ydfP7x0_rWqOi0Qscb80A_ZTeHDz9ujO4Tz2Mi-EDHkwYuxjm8YnCF19WNQ5x1BN-lzagaXcu3h-jFy10wbze30fo-uPFdX2ZXX3-tKrPrzJVFCXJeFkstRKNAA3NaQVNS6gGIEsOZcsoaMqIahpaJawERTllQisqBGWUGc2P0Ntd237w30cTotzYoEzXgTN-DJIRzktWiASWO1ANPoTBtLIf7AaGSVIiZ9vkWs7uyNkdOdsmt7bJh1T6Zj9jbDZG_yvc-5SAsx1wbzsz_Xdjmf48Cf4HEnGqWw</recordid><startdate>200902</startdate><enddate>200902</enddate><creator>Yeni, P</creator><creator>LaMarca, A</creator><creator>Berger, D</creator><creator>Cimoch, P</creator><creator>Lazzarin, A</creator><creator>Salvato, P</creator><creator>Smaill, FM</creator><creator>Teofilo, E</creator><creator>Madison, SJ</creator><creator>Nichols, WG</creator><creator>Adkison, KK</creator><creator>Bonny, T</creator><creator>Millard, J</creator><creator>McCarty, D</creator><general>Blackwell Publishing Ltd</general><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>7T7</scope><scope>7U9</scope><scope>8FD</scope><scope>C1K</scope><scope>FR3</scope><scope>H94</scope><scope>P64</scope></search><sort><creationdate>200902</creationdate><title>Antiviral activity and safety of aplaviroc, a CCR5 antagonist, in combination with lopinavir/ritonavir in HIV‐infected, therapy‐naïve patients: results of the EPIC study (CCR100136)</title><author>Yeni, P ; LaMarca, A ; Berger, D ; Cimoch, P ; Lazzarin, A ; Salvato, P ; Smaill, FM ; Teofilo, E ; Madison, SJ ; Nichols, WG ; Adkison, KK ; Bonny, T ; Millard, J ; McCarty, D</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c4480-3845dc6b6adab79abf01daa053a8f21ad120cbb1945d8ac13126dc1661212ed3</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2009</creationdate><topic>873140</topic><topic>Adult</topic><topic>Aged</topic><topic>aplaviroc</topic><topic>Benzoates - pharmacokinetics</topic><topic>Benzoates - toxicity</topic><topic>CC chemokine receptor (CCR) 5‐tropic virus</topic><topic>Drug Administration Schedule</topic><topic>Drug Therapy, Combination</topic><topic>Female</topic><topic>HIV infection</topic><topic>HIV Infections - drug therapy</topic><topic>HIV Infections - immunology</topic><topic>HIV Infections - virology</topic><topic>HIV Protease Inhibitors - pharmacokinetics</topic><topic>HIV Protease Inhibitors - therapeutic use</topic><topic>HIV-1 - immunology</topic><topic>Human immunodeficiency virus 1</topic><topic>Humans</topic><topic>Lopinavir</topic><topic>Male</topic><topic>Middle Aged</topic><topic>Piperazines - pharmacokinetics</topic><topic>Piperazines - toxicity</topic><topic>Pyrimidinones - pharmacokinetics</topic><topic>Pyrimidinones - therapeutic use</topic><topic>Receptors, CCR5 - therapeutic use</topic><topic>Ritonavir - pharmacokinetics</topic><topic>Ritonavir - therapeutic use</topic><topic>RNA, Viral - immunology</topic><topic>Spiro Compounds - pharmacokinetics</topic><topic>Spiro Compounds - toxicity</topic><topic>Young Adult</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Yeni, P</creatorcontrib><creatorcontrib>LaMarca, A</creatorcontrib><creatorcontrib>Berger, D</creatorcontrib><creatorcontrib>Cimoch, P</creatorcontrib><creatorcontrib>Lazzarin, A</creatorcontrib><creatorcontrib>Salvato, P</creatorcontrib><creatorcontrib>Smaill, FM</creatorcontrib><creatorcontrib>Teofilo, E</creatorcontrib><creatorcontrib>Madison, SJ</creatorcontrib><creatorcontrib>Nichols, WG</creatorcontrib><creatorcontrib>Adkison, KK</creatorcontrib><creatorcontrib>Bonny, T</creatorcontrib><creatorcontrib>Millard, J</creatorcontrib><creatorcontrib>McCarty, D</creatorcontrib><creatorcontrib>EPIC (CCR100136) study team</creatorcontrib><creatorcontrib>the EPIC (CCR100136) study team</creatorcontrib><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>Industrial and Applied Microbiology Abstracts (Microbiology A)</collection><collection>Virology and AIDS Abstracts</collection><collection>Technology Research Database</collection><collection>Environmental Sciences and Pollution Management</collection><collection>Engineering Research Database</collection><collection>AIDS and Cancer Research Abstracts</collection><collection>Biotechnology and BioEngineering Abstracts</collection><jtitle>HIV medicine</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Yeni, P</au><au>LaMarca, A</au><au>Berger, D</au><au>Cimoch, P</au><au>Lazzarin, A</au><au>Salvato, P</au><au>Smaill, FM</au><au>Teofilo, E</au><au>Madison, SJ</au><au>Nichols, WG</au><au>Adkison, KK</au><au>Bonny, T</au><au>Millard, J</au><au>McCarty, D</au><aucorp>EPIC (CCR100136) study team</aucorp><aucorp>the EPIC (CCR100136) study team</aucorp><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Antiviral activity and safety of aplaviroc, a CCR5 antagonist, in combination with lopinavir/ritonavir in HIV‐infected, therapy‐naïve patients: results of the EPIC study (CCR100136)</atitle><jtitle>HIV medicine</jtitle><addtitle>HIV Med</addtitle><date>2009-02</date><risdate>2009</risdate><volume>10</volume><issue>2</issue><spage>116</spage><epage>124</epage><pages>116-124</pages><issn>1464-2662</issn><eissn>1468-1293</eissn><abstract>Background
This phase IIb study explored the antiviral activity and safety of the investigational CC chemokine receptor 5 (CCR5) antagonist aplaviroc (APL) in antiretroviral‐naïve patients harbouring R5‐ or R5X4‐tropic virus.
Methods
A total of 191 patients were randomized 2:2:2:1 to one of three APL dosing regimens or to lamivudine (3TC)/zidovudine (ZDV) twice daily (bid), each in combination with lopinavir/ritonavir (LPV/r) 400 mg/100 mg bid. Efficacy, safety and pharmacokinetic parameters were assessed.
Results
This study was terminated prematurely because of APL‐associated idiosyncratic hepatotoxicity. A total of 141 patients initiated treatment early enough to have been able to complete 12 weeks on treatment [modified intent‐to‐treat (M‐ITT) population]; of these, 133 completed the 12‐week treatment phase. The proportion of subjects in the M‐ITT population with HIV‐1 RNA <400 copies/mL at week 12 was 50, 48, 54 and 75% in the APL 200 mg bid, APL 400 mg bid, APL 800 mg once a day (qd) and 3TC/ZDV arms, respectively. Similar responses were seen in the few subjects harbouring R5X4‐tropic virus (n=17). Common clinical adverse events (AEs) were diarrhoea, nausea, fatigue and headache. APL demonstrated nonlinear pharmacokinetics with high interpatient variability.
Conclusions
While target plasma concentrations of APL were achieved, the antiviral activity of APL+LPV/r did not appear to be comparable to that of 3TC/ZDV+LPV/r.</abstract><cop>Oxford, UK</cop><pub>Blackwell Publishing Ltd</pub><pmid>19200175</pmid><doi>10.1111/j.1468-1293.2008.00660.x</doi><tpages>9</tpages><oa>free_for_read</oa></addata></record> |
| fulltext | fulltext |
| identifier | ISSN: 1464-2662 |
| ispartof | HIV medicine, 2009-02, Vol.10 (2), p.116-124 |
| issn | 1464-2662 1468-1293 |
| language | eng |
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| source | Wiley Free Content; MEDLINE; IngentaConnect Free/Open Access Journals; Elektronische Zeitschriftenbibliothek - Frei zugängliche E-Journals; Wiley Online Library All Journals |
| subjects | 873140 Adult Aged aplaviroc Benzoates - pharmacokinetics Benzoates - toxicity CC chemokine receptor (CCR) 5‐tropic virus Drug Administration Schedule Drug Therapy, Combination Female HIV infection HIV Infections - drug therapy HIV Infections - immunology HIV Infections - virology HIV Protease Inhibitors - pharmacokinetics HIV Protease Inhibitors - therapeutic use HIV-1 - immunology Human immunodeficiency virus 1 Humans Lopinavir Male Middle Aged Piperazines - pharmacokinetics Piperazines - toxicity Pyrimidinones - pharmacokinetics Pyrimidinones - therapeutic use Receptors, CCR5 - therapeutic use Ritonavir - pharmacokinetics Ritonavir - therapeutic use RNA, Viral - immunology Spiro Compounds - pharmacokinetics Spiro Compounds - toxicity Young Adult |
| title | Antiviral activity and safety of aplaviroc, a CCR5 antagonist, in combination with lopinavir/ritonavir in HIV‐infected, therapy‐naïve patients: results of the EPIC study (CCR100136) |
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