Pharmacokinetics of nelfinavir in human immunodeficiency virus-infected infants
BACKGROUND.Nelfinavir dosed at ∼20 to 30 mg/kg three times a day (TID) in older children provides exposure similar to 750 mg TID in adults. However, the pharmacokinetics (PK) of nelfinavir in infants who are
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| Veröffentlicht in: | The Pediatric infectious disease journal 2001-08, Vol.20 (8), p.746-751 |
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| container_title | The Pediatric infectious disease journal |
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| creator | CAPPARELLI, EDMUND V SULLIVAN, JOHN L MOFENSON, LYNNE SMITH, ELIZABETH GRAHAM, BOBBIE BRITTO, PAULA BECKER, MARK I HOLLAND, DIANNE CONNOR, JAMES D LUZURIAGA, KATHERINE |
| description | BACKGROUND.Nelfinavir dosed at ∼20 to 30 mg/kg three times a day (TID) in older children provides exposure similar to 750 mg TID in adults. However, the pharmacokinetics (PK) of nelfinavir in infants who are |
| doi_str_mv | 10.1097/00006454-200108000-00006 |
| format | Article |
| fullrecord | <record><control><sourceid>proquest_cross</sourceid><recordid>TN_cdi_proquest_miscellaneous_72324354</recordid><sourceformat>XML</sourceformat><sourcesystem>PC</sourcesystem><sourcerecordid>72324354</sourcerecordid><originalsourceid>FETCH-LOGICAL-c3856-22ca07a7d6add6fb96964d1bb26a85c4f5b5e94b7fd30f53d29958f2a2df1dbf3</originalsourceid><addsrcrecordid>eNp1kclOxDAMhiMEYoblFVAPiFshe5sjQmwSEhzgHLlZNGHaFJIWNG9PYYblgi-W7c-LfiNUEHxKsKrO8GSSC15SjAmup6j8Sm2hORGMlljV1Taa41qRkklZz9Bezs8TwTjBu2hGSMV4xcQc3T8sIHVg-mWIbggmF70vomt9iPAWUhFisRg7iEXoujH21vlggotmVUzVMZchemcGZyfQQxzyAdrx0GZ3uPH76Onq8vHipry7v769OL8rDauFLCk1gCuorARrpW-UVJJb0jRUQi0M96IRTvGm8pZhL5ilSonaU6DWE9t4to9O1nNfUv86ujzoLmTj2hai68esK8ooZ4JPYL0GTepzTs7rlxQ6SCtNsP4UU3-LqX_EXKem1qPNjrHpnP1t3Kg3AccbALKB1ieIJuQ_HFbk6wS-xt77dnApL9vx3SW9cNAOC_3fL9kH9xiNHQ</addsrcrecordid><sourcetype>Aggregation Database</sourcetype><iscdi>true</iscdi><recordtype>article</recordtype><pqid>72324354</pqid></control><display><type>article</type><title>Pharmacokinetics of nelfinavir in human immunodeficiency virus-infected infants</title><source>MEDLINE</source><source>Journals@Ovid Complete</source><creator>CAPPARELLI, EDMUND V ; SULLIVAN, JOHN L ; MOFENSON, LYNNE ; SMITH, ELIZABETH ; GRAHAM, BOBBIE ; BRITTO, PAULA ; BECKER, MARK I ; HOLLAND, DIANNE ; CONNOR, JAMES D ; LUZURIAGA, KATHERINE</creator><creatorcontrib>CAPPARELLI, EDMUND V ; SULLIVAN, JOHN L ; MOFENSON, LYNNE ; SMITH, ELIZABETH ; GRAHAM, BOBBIE ; BRITTO, PAULA ; BECKER, MARK I ; HOLLAND, DIANNE ; CONNOR, JAMES D ; LUZURIAGA, KATHERINE ; Pediatric ACTG 356 Investigators</creatorcontrib><description>BACKGROUND.Nelfinavir dosed at ∼20 to 30 mg/kg three times a day (TID) in older children provides exposure similar to 750 mg TID in adults. However, the pharmacokinetics (PK) of nelfinavir in infants who are <2 years of age is not well-described. The objective of this study was to determine the pharmacokinetics of nelfinavir in infants <2 years of age.
METHODS.Nelfinavir concentrations were evaluated in 22 HIV-infected infants between 15 days and 2 years of age receiving nelfinavir as part of Pediatric ACTG Study 356. Nelfinavir therapy was initiated at ∼25 mg/kg TID (n = 18) or ∼55 mg/kg twice a day (n = 4) and given in combination with nevirapine, stavudine and lamivudine. PK samples were obtained predose and 1.5 and 4 h postdose at ∼6-month intervals. Eight infants (all ≤3 months of age) also had intensive PK samples collected at Week 1.
RESULTS.The median apparent clearance in the infants with intensive pharmacokinetic sampling was 2.7 liters/h/kg (range, 1.8 to ≥10) and was similar between twice a day and TID dosing cohorts. Overall nelfinavir concentrations at all collection times were lower in these infants than previously reported in older pediatric patients.
CONCLUSIONS.Nelfinavir concentrations in infants are highly variable and lower than those seen in adult or older pediatric populations receiving labeled dosing. Therefore it is necessary to further evaluate nelfinavir safety, effectiveness and pharmacokinetics at higher doses than used among other pediatric populations.</description><identifier>ISSN: 0891-3668</identifier><identifier>EISSN: 1532-0987</identifier><identifier>DOI: 10.1097/00006454-200108000-00006</identifier><identifier>PMID: 11734735</identifier><identifier>CODEN: PIDJEV</identifier><language>eng</language><publisher>Baltimore, MD: Lippincott Williams & Wilkins, Inc</publisher><subject>Anti-HIV Agents - pharmacokinetics ; Anti-HIV Agents - therapeutic use ; Antibiotics. Antiinfectious agents. Antiparasitic agents ; Antiviral agents ; Biological and medical sciences ; Child, Preschool ; Drug Therapy, Combination ; HIV Infections - drug therapy ; HIV Infections - virology ; HIV-1 - physiology ; Humans ; Infant ; Infant, Newborn ; Medical sciences ; Nelfinavir - pharmacokinetics ; Pharmacology. Drug treatments ; Reverse Transcriptase Inhibitors - therapeutic use ; RNA, Viral - blood</subject><ispartof>The Pediatric infectious disease journal, 2001-08, Vol.20 (8), p.746-751</ispartof><rights>2001 Lippincott Williams & Wilkins, Inc.</rights><rights>2001 INIST-CNRS</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c3856-22ca07a7d6add6fb96964d1bb26a85c4f5b5e94b7fd30f53d29958f2a2df1dbf3</citedby><cites>FETCH-LOGICAL-c3856-22ca07a7d6add6fb96964d1bb26a85c4f5b5e94b7fd30f53d29958f2a2df1dbf3</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><link.rule.ids>315,782,786,27933,27934</link.rule.ids><backlink>$$Uhttp://pascal-francis.inist.fr/vibad/index.php?action=getRecordDetail&idt=1109154$$DView record in Pascal Francis$$Hfree_for_read</backlink><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/11734735$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>CAPPARELLI, EDMUND V</creatorcontrib><creatorcontrib>SULLIVAN, JOHN L</creatorcontrib><creatorcontrib>MOFENSON, LYNNE</creatorcontrib><creatorcontrib>SMITH, ELIZABETH</creatorcontrib><creatorcontrib>GRAHAM, BOBBIE</creatorcontrib><creatorcontrib>BRITTO, PAULA</creatorcontrib><creatorcontrib>BECKER, MARK I</creatorcontrib><creatorcontrib>HOLLAND, DIANNE</creatorcontrib><creatorcontrib>CONNOR, JAMES D</creatorcontrib><creatorcontrib>LUZURIAGA, KATHERINE</creatorcontrib><creatorcontrib>Pediatric ACTG 356 Investigators</creatorcontrib><title>Pharmacokinetics of nelfinavir in human immunodeficiency virus-infected infants</title><title>The Pediatric infectious disease journal</title><addtitle>Pediatr Infect Dis J</addtitle><description>BACKGROUND.Nelfinavir dosed at ∼20 to 30 mg/kg three times a day (TID) in older children provides exposure similar to 750 mg TID in adults. However, the pharmacokinetics (PK) of nelfinavir in infants who are <2 years of age is not well-described. The objective of this study was to determine the pharmacokinetics of nelfinavir in infants <2 years of age.
METHODS.Nelfinavir concentrations were evaluated in 22 HIV-infected infants between 15 days and 2 years of age receiving nelfinavir as part of Pediatric ACTG Study 356. Nelfinavir therapy was initiated at ∼25 mg/kg TID (n = 18) or ∼55 mg/kg twice a day (n = 4) and given in combination with nevirapine, stavudine and lamivudine. PK samples were obtained predose and 1.5 and 4 h postdose at ∼6-month intervals. Eight infants (all ≤3 months of age) also had intensive PK samples collected at Week 1.
RESULTS.The median apparent clearance in the infants with intensive pharmacokinetic sampling was 2.7 liters/h/kg (range, 1.8 to ≥10) and was similar between twice a day and TID dosing cohorts. Overall nelfinavir concentrations at all collection times were lower in these infants than previously reported in older pediatric patients.
CONCLUSIONS.Nelfinavir concentrations in infants are highly variable and lower than those seen in adult or older pediatric populations receiving labeled dosing. Therefore it is necessary to further evaluate nelfinavir safety, effectiveness and pharmacokinetics at higher doses than used among other pediatric populations.</description><subject>Anti-HIV Agents - pharmacokinetics</subject><subject>Anti-HIV Agents - therapeutic use</subject><subject>Antibiotics. Antiinfectious agents. Antiparasitic agents</subject><subject>Antiviral agents</subject><subject>Biological and medical sciences</subject><subject>Child, Preschool</subject><subject>Drug Therapy, Combination</subject><subject>HIV Infections - drug therapy</subject><subject>HIV Infections - virology</subject><subject>HIV-1 - physiology</subject><subject>Humans</subject><subject>Infant</subject><subject>Infant, Newborn</subject><subject>Medical sciences</subject><subject>Nelfinavir - pharmacokinetics</subject><subject>Pharmacology. Drug treatments</subject><subject>Reverse Transcriptase Inhibitors - therapeutic use</subject><subject>RNA, Viral - blood</subject><issn>0891-3668</issn><issn>1532-0987</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2001</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNp1kclOxDAMhiMEYoblFVAPiFshe5sjQmwSEhzgHLlZNGHaFJIWNG9PYYblgi-W7c-LfiNUEHxKsKrO8GSSC15SjAmup6j8Sm2hORGMlljV1Taa41qRkklZz9Bezs8TwTjBu2hGSMV4xcQc3T8sIHVg-mWIbggmF70vomt9iPAWUhFisRg7iEXoujH21vlggotmVUzVMZchemcGZyfQQxzyAdrx0GZ3uPH76Onq8vHipry7v769OL8rDauFLCk1gCuorARrpW-UVJJb0jRUQi0M96IRTvGm8pZhL5ilSonaU6DWE9t4to9O1nNfUv86ujzoLmTj2hai68esK8ooZ4JPYL0GTepzTs7rlxQ6SCtNsP4UU3-LqX_EXKem1qPNjrHpnP1t3Kg3AccbALKB1ieIJuQ_HFbk6wS-xt77dnApL9vx3SW9cNAOC_3fL9kH9xiNHQ</recordid><startdate>200108</startdate><enddate>200108</enddate><creator>CAPPARELLI, EDMUND V</creator><creator>SULLIVAN, JOHN L</creator><creator>MOFENSON, LYNNE</creator><creator>SMITH, ELIZABETH</creator><creator>GRAHAM, BOBBIE</creator><creator>BRITTO, PAULA</creator><creator>BECKER, MARK I</creator><creator>HOLLAND, DIANNE</creator><creator>CONNOR, JAMES D</creator><creator>LUZURIAGA, KATHERINE</creator><general>Lippincott Williams & Wilkins, Inc</general><general>Lippincott</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>7X8</scope></search><sort><creationdate>200108</creationdate><title>Pharmacokinetics of nelfinavir in human immunodeficiency virus-infected infants</title><author>CAPPARELLI, EDMUND V ; SULLIVAN, JOHN L ; MOFENSON, LYNNE ; SMITH, ELIZABETH ; GRAHAM, BOBBIE ; BRITTO, PAULA ; BECKER, MARK I ; HOLLAND, DIANNE ; CONNOR, JAMES D ; LUZURIAGA, KATHERINE</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c3856-22ca07a7d6add6fb96964d1bb26a85c4f5b5e94b7fd30f53d29958f2a2df1dbf3</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2001</creationdate><topic>Anti-HIV Agents - pharmacokinetics</topic><topic>Anti-HIV Agents - therapeutic use</topic><topic>Antibiotics. Antiinfectious agents. Antiparasitic agents</topic><topic>Antiviral agents</topic><topic>Biological and medical sciences</topic><topic>Child, Preschool</topic><topic>Drug Therapy, Combination</topic><topic>HIV Infections - drug therapy</topic><topic>HIV Infections - virology</topic><topic>HIV-1 - physiology</topic><topic>Humans</topic><topic>Infant</topic><topic>Infant, Newborn</topic><topic>Medical sciences</topic><topic>Nelfinavir - pharmacokinetics</topic><topic>Pharmacology. Drug treatments</topic><topic>Reverse Transcriptase Inhibitors - therapeutic use</topic><topic>RNA, Viral - blood</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>CAPPARELLI, EDMUND V</creatorcontrib><creatorcontrib>SULLIVAN, JOHN L</creatorcontrib><creatorcontrib>MOFENSON, LYNNE</creatorcontrib><creatorcontrib>SMITH, ELIZABETH</creatorcontrib><creatorcontrib>GRAHAM, BOBBIE</creatorcontrib><creatorcontrib>BRITTO, PAULA</creatorcontrib><creatorcontrib>BECKER, MARK I</creatorcontrib><creatorcontrib>HOLLAND, DIANNE</creatorcontrib><creatorcontrib>CONNOR, JAMES D</creatorcontrib><creatorcontrib>LUZURIAGA, KATHERINE</creatorcontrib><creatorcontrib>Pediatric ACTG 356 Investigators</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>MEDLINE - Academic</collection><jtitle>The Pediatric infectious disease journal</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>CAPPARELLI, EDMUND V</au><au>SULLIVAN, JOHN L</au><au>MOFENSON, LYNNE</au><au>SMITH, ELIZABETH</au><au>GRAHAM, BOBBIE</au><au>BRITTO, PAULA</au><au>BECKER, MARK I</au><au>HOLLAND, DIANNE</au><au>CONNOR, JAMES D</au><au>LUZURIAGA, KATHERINE</au><aucorp>Pediatric ACTG 356 Investigators</aucorp><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Pharmacokinetics of nelfinavir in human immunodeficiency virus-infected infants</atitle><jtitle>The Pediatric infectious disease journal</jtitle><addtitle>Pediatr Infect Dis J</addtitle><date>2001-08</date><risdate>2001</risdate><volume>20</volume><issue>8</issue><spage>746</spage><epage>751</epage><pages>746-751</pages><issn>0891-3668</issn><eissn>1532-0987</eissn><coden>PIDJEV</coden><abstract>BACKGROUND.Nelfinavir dosed at ∼20 to 30 mg/kg three times a day (TID) in older children provides exposure similar to 750 mg TID in adults. However, the pharmacokinetics (PK) of nelfinavir in infants who are <2 years of age is not well-described. The objective of this study was to determine the pharmacokinetics of nelfinavir in infants <2 years of age.
METHODS.Nelfinavir concentrations were evaluated in 22 HIV-infected infants between 15 days and 2 years of age receiving nelfinavir as part of Pediatric ACTG Study 356. Nelfinavir therapy was initiated at ∼25 mg/kg TID (n = 18) or ∼55 mg/kg twice a day (n = 4) and given in combination with nevirapine, stavudine and lamivudine. PK samples were obtained predose and 1.5 and 4 h postdose at ∼6-month intervals. Eight infants (all ≤3 months of age) also had intensive PK samples collected at Week 1.
RESULTS.The median apparent clearance in the infants with intensive pharmacokinetic sampling was 2.7 liters/h/kg (range, 1.8 to ≥10) and was similar between twice a day and TID dosing cohorts. Overall nelfinavir concentrations at all collection times were lower in these infants than previously reported in older pediatric patients.
CONCLUSIONS.Nelfinavir concentrations in infants are highly variable and lower than those seen in adult or older pediatric populations receiving labeled dosing. Therefore it is necessary to further evaluate nelfinavir safety, effectiveness and pharmacokinetics at higher doses than used among other pediatric populations.</abstract><cop>Baltimore, MD</cop><cop>Philadelphia, PA</cop><cop>Hagerstown, MD</cop><pub>Lippincott Williams & Wilkins, Inc</pub><pmid>11734735</pmid><doi>10.1097/00006454-200108000-00006</doi><tpages>6</tpages></addata></record> |
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| identifier | ISSN: 0891-3668 |
| ispartof | The Pediatric infectious disease journal, 2001-08, Vol.20 (8), p.746-751 |
| issn | 0891-3668 1532-0987 |
| language | eng |
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| source | MEDLINE; Journals@Ovid Complete |
| subjects | Anti-HIV Agents - pharmacokinetics Anti-HIV Agents - therapeutic use Antibiotics. Antiinfectious agents. Antiparasitic agents Antiviral agents Biological and medical sciences Child, Preschool Drug Therapy, Combination HIV Infections - drug therapy HIV Infections - virology HIV-1 - physiology Humans Infant Infant, Newborn Medical sciences Nelfinavir - pharmacokinetics Pharmacology. Drug treatments Reverse Transcriptase Inhibitors - therapeutic use RNA, Viral - blood |
| title | Pharmacokinetics of nelfinavir in human immunodeficiency virus-infected infants |
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