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Viral efficacy maintained and safety parameters improved with a reduced dose of stavudine: a pilot study
Objectives Stavudine (d4T) is a potent but potentially toxic nucleoside reverse transcriptase inhibitor that is still widely used in developing countries. This study's aim was to determine the efficacy and safety profile of lower‐dose d4T. Methods Multi‐centre, open‐label, single‐arm, pilot, 48...
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| Published in: | HIV medicine 2008-10, Vol.9 (9), p.738-746 |
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| cites | cdi_FETCH-LOGICAL-c4476-1d697bb71894f2a9352cc8978dff4dca12a468f3090cc1f20136b931ea6d89d43 |
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| container_issue | 9 |
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| container_title | HIV medicine |
| container_volume | 9 |
| creator | Ait‐Mohand, H Bonmarchand, M Guiguet, M Slama, L Marguet, F Behin, A Amellal, B Bennai, Y Peytavin, G Calvez, V Pialoux, G Murphy, R Katlama, C |
| description | Objectives
Stavudine (d4T) is a potent but potentially toxic nucleoside reverse transcriptase inhibitor that is still widely used in developing countries. This study's aim was to determine the efficacy and safety profile of lower‐dose d4T.
Methods
Multi‐centre, open‐label, single‐arm, pilot, 48‐week study in French patients weighing >60 kg with viral load |
| doi_str_mv | 10.1111/j.1468-1293.2008.00616.x |
| format | article |
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Stavudine (d4T) is a potent but potentially toxic nucleoside reverse transcriptase inhibitor that is still widely used in developing countries. This study's aim was to determine the efficacy and safety profile of lower‐dose d4T.
Methods
Multi‐centre, open‐label, single‐arm, pilot, 48‐week study in French patients weighing >60 kg with viral load <400 HIV‐1 RNA copies/mL who were receiving d4T 40 mg twice daily and then switched to 30 mg twice daily. The primary endpoint was the proportion with plasma viral load <400 copies/mL at week 24. Secondary endpoints included the proportion with <50 copies/mL at weeks 24 and 48, changes in mitochondrial DNA, CD4 cell count and pharmacokinetics, and clinical and laboratory safety.
Results
Fifty‐seven patients enrolled. Baseline CD4 count was 584 cells/μL; viral loads were <400 copies/mL and <50 copies/mL in 100% and 89%, respectively. Prior antiretroviral drug exposure was 6.9 years, d4T exposure was 6.3 years. Fifty‐six out of 57 (98%) patients had viral load <400 copies/mL and 51 (89%) had viral load <50 copies/mL at week 24. Median CD4 count increased by 63 cells/μL at week 48 (P=0.006). At 48 weeks, total cholesterol decreased by 0.24 mmol (P=0.02), high‐density lipoprotein cholesterol by 0.15 mmol (P=0.0001) and alanine aminotransferase by 5.74 mg/dL (P=0.01). Paired baseline DNA and week 24 RNA mutations were unchanged. Mitochondrial DNA (copies/cell) content increased from 672±254 to 682±269. d4T area under the plasma concentration time curve (AUC) decreased by 31% (P=0.003) and Cmax by 44% (P=0.004). Clinical and laboratory parameters improved or were unchanged.
Conclusions
Reduced‐dose d4T is effective with improved safety parameters.]]></description><identifier>ISSN: 1464-2662</identifier><identifier>EISSN: 1468-1293</identifier><identifier>DOI: 10.1111/j.1468-1293.2008.00616.x</identifier><identifier>PMID: 18651858</identifier><language>eng</language><publisher>Oxford, UK: Blackwell Publishing Ltd</publisher><subject>Adult ; Aged ; Antiretroviral Therapy, Highly Active - methods ; CD4 Lymphocyte Count ; combination antiretroviral therapy ; Drug Administration Schedule ; Female ; HIV Infections - drug therapy ; HIV Infections - virology ; HIV-1 ; Human immunodeficiency virus ; Humans ; Male ; Middle Aged ; mitochondrial toxicity ; nucleoside reverse transcriptase inhibitor ; Pilot Projects ; reduced‐dose stavudine ; Reverse Transcriptase Inhibitors - administration & dosage ; Reverse Transcriptase Inhibitors - pharmacokinetics ; RNA, Viral - drug effects ; Stavudine - administration & dosage ; Stavudine - pharmacokinetics ; Treatment Outcome ; Viral Load</subject><ispartof>HIV medicine, 2008-10, Vol.9 (9), p.738-746</ispartof><rights>2008 British HIV Association</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c4476-1d697bb71894f2a9352cc8978dff4dca12a468f3090cc1f20136b931ea6d89d43</citedby><cites>FETCH-LOGICAL-c4476-1d697bb71894f2a9352cc8978dff4dca12a468f3090cc1f20136b931ea6d89d43</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><link.rule.ids>314,780,784,27924,27925</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/18651858$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Ait‐Mohand, H</creatorcontrib><creatorcontrib>Bonmarchand, M</creatorcontrib><creatorcontrib>Guiguet, M</creatorcontrib><creatorcontrib>Slama, L</creatorcontrib><creatorcontrib>Marguet, F</creatorcontrib><creatorcontrib>Behin, A</creatorcontrib><creatorcontrib>Amellal, B</creatorcontrib><creatorcontrib>Bennai, Y</creatorcontrib><creatorcontrib>Peytavin, G</creatorcontrib><creatorcontrib>Calvez, V</creatorcontrib><creatorcontrib>Pialoux, G</creatorcontrib><creatorcontrib>Murphy, R</creatorcontrib><creatorcontrib>Katlama, C</creatorcontrib><title>Viral efficacy maintained and safety parameters improved with a reduced dose of stavudine: a pilot study</title><title>HIV medicine</title><addtitle>HIV Med</addtitle><description><![CDATA[Objectives
Stavudine (d4T) is a potent but potentially toxic nucleoside reverse transcriptase inhibitor that is still widely used in developing countries. This study's aim was to determine the efficacy and safety profile of lower‐dose d4T.
Methods
Multi‐centre, open‐label, single‐arm, pilot, 48‐week study in French patients weighing >60 kg with viral load <400 HIV‐1 RNA copies/mL who were receiving d4T 40 mg twice daily and then switched to 30 mg twice daily. The primary endpoint was the proportion with plasma viral load <400 copies/mL at week 24. Secondary endpoints included the proportion with <50 copies/mL at weeks 24 and 48, changes in mitochondrial DNA, CD4 cell count and pharmacokinetics, and clinical and laboratory safety.
Results
Fifty‐seven patients enrolled. Baseline CD4 count was 584 cells/μL; viral loads were <400 copies/mL and <50 copies/mL in 100% and 89%, respectively. Prior antiretroviral drug exposure was 6.9 years, d4T exposure was 6.3 years. Fifty‐six out of 57 (98%) patients had viral load <400 copies/mL and 51 (89%) had viral load <50 copies/mL at week 24. Median CD4 count increased by 63 cells/μL at week 48 (P=0.006). At 48 weeks, total cholesterol decreased by 0.24 mmol (P=0.02), high‐density lipoprotein cholesterol by 0.15 mmol (P=0.0001) and alanine aminotransferase by 5.74 mg/dL (P=0.01). Paired baseline DNA and week 24 RNA mutations were unchanged. Mitochondrial DNA (copies/cell) content increased from 672±254 to 682±269. d4T area under the plasma concentration time curve (AUC) decreased by 31% (P=0.003) and Cmax by 44% (P=0.004). Clinical and laboratory parameters improved or were unchanged.
Conclusions
Reduced‐dose d4T is effective with improved safety parameters.]]></description><subject>Adult</subject><subject>Aged</subject><subject>Antiretroviral Therapy, Highly Active - methods</subject><subject>CD4 Lymphocyte Count</subject><subject>combination antiretroviral therapy</subject><subject>Drug Administration Schedule</subject><subject>Female</subject><subject>HIV Infections - drug therapy</subject><subject>HIV Infections - virology</subject><subject>HIV-1</subject><subject>Human immunodeficiency virus</subject><subject>Humans</subject><subject>Male</subject><subject>Middle Aged</subject><subject>mitochondrial toxicity</subject><subject>nucleoside reverse transcriptase inhibitor</subject><subject>Pilot Projects</subject><subject>reduced‐dose stavudine</subject><subject>Reverse Transcriptase Inhibitors - administration & dosage</subject><subject>Reverse Transcriptase Inhibitors - pharmacokinetics</subject><subject>RNA, Viral - drug effects</subject><subject>Stavudine - administration & dosage</subject><subject>Stavudine - pharmacokinetics</subject><subject>Treatment Outcome</subject><subject>Viral Load</subject><issn>1464-2662</issn><issn>1468-1293</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2008</creationdate><recordtype>article</recordtype><recordid>eNqNkEtPAyEUhYnR-Kj-BcPK3YxcmDJg3BjjKzFxo90SyiPSzHQqzGjn30tto1tJCBfOuQf4EMJASsjjclFCxUUBVLKSEiJKQjjwcr2Hjn-F_Z-6Kijn9AidpLQgBGomySE6AsGnIKbiGL3PQtQNdt4Ho82IWx2WfZ7OYr20OGnv-hGvdNSt611MOLSr2H1m-Sv071jj6Oxg8tZ2yeHO49Trz8HmgKssrkLT9flosOMpOvC6Se5st07Q2_3d6-1j8fzy8HR781yYqqp5AZbLej6vQcjKUy3ZlBojZC2s95U1GqjOH_SMSGIMeEqA8blk4DS3QtqKTdDFNjc_82NwqVdtSMY1jV66bkgKJKOilpCNYms0sUspOq9WMbQ6jgqI2lBWC7WBqTYw1Yay-qGs1rn1fHfHMG-d_WvcYc2G663hKzRu_Hewenya5YJ9AxWri_g</recordid><startdate>200810</startdate><enddate>200810</enddate><creator>Ait‐Mohand, H</creator><creator>Bonmarchand, M</creator><creator>Guiguet, M</creator><creator>Slama, L</creator><creator>Marguet, F</creator><creator>Behin, A</creator><creator>Amellal, B</creator><creator>Bennai, Y</creator><creator>Peytavin, G</creator><creator>Calvez, V</creator><creator>Pialoux, G</creator><creator>Murphy, R</creator><creator>Katlama, C</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>7TM</scope><scope>7U9</scope><scope>H94</scope></search><sort><creationdate>200810</creationdate><title>Viral efficacy maintained and safety parameters improved with a reduced dose of stavudine: a pilot study</title><author>Ait‐Mohand, H ; Bonmarchand, M ; Guiguet, M ; Slama, L ; Marguet, F ; Behin, A ; Amellal, B ; Bennai, Y ; Peytavin, G ; Calvez, V ; Pialoux, G ; Murphy, R ; Katlama, C</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c4476-1d697bb71894f2a9352cc8978dff4dca12a468f3090cc1f20136b931ea6d89d43</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2008</creationdate><topic>Adult</topic><topic>Aged</topic><topic>Antiretroviral Therapy, Highly Active - methods</topic><topic>CD4 Lymphocyte Count</topic><topic>combination antiretroviral therapy</topic><topic>Drug Administration Schedule</topic><topic>Female</topic><topic>HIV Infections - drug therapy</topic><topic>HIV Infections - virology</topic><topic>HIV-1</topic><topic>Human immunodeficiency virus</topic><topic>Humans</topic><topic>Male</topic><topic>Middle Aged</topic><topic>mitochondrial toxicity</topic><topic>nucleoside reverse transcriptase inhibitor</topic><topic>Pilot Projects</topic><topic>reduced‐dose stavudine</topic><topic>Reverse Transcriptase Inhibitors - administration & dosage</topic><topic>Reverse Transcriptase Inhibitors - pharmacokinetics</topic><topic>RNA, Viral - drug effects</topic><topic>Stavudine - administration & dosage</topic><topic>Stavudine - pharmacokinetics</topic><topic>Treatment Outcome</topic><topic>Viral Load</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Ait‐Mohand, H</creatorcontrib><creatorcontrib>Bonmarchand, M</creatorcontrib><creatorcontrib>Guiguet, M</creatorcontrib><creatorcontrib>Slama, L</creatorcontrib><creatorcontrib>Marguet, F</creatorcontrib><creatorcontrib>Behin, A</creatorcontrib><creatorcontrib>Amellal, B</creatorcontrib><creatorcontrib>Bennai, Y</creatorcontrib><creatorcontrib>Peytavin, G</creatorcontrib><creatorcontrib>Calvez, V</creatorcontrib><creatorcontrib>Pialoux, G</creatorcontrib><creatorcontrib>Murphy, R</creatorcontrib><creatorcontrib>Katlama, C</creatorcontrib><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>Nucleic Acids Abstracts</collection><collection>Virology and AIDS Abstracts</collection><collection>AIDS and Cancer Research Abstracts</collection><jtitle>HIV medicine</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Ait‐Mohand, H</au><au>Bonmarchand, M</au><au>Guiguet, M</au><au>Slama, L</au><au>Marguet, F</au><au>Behin, A</au><au>Amellal, B</au><au>Bennai, Y</au><au>Peytavin, G</au><au>Calvez, V</au><au>Pialoux, G</au><au>Murphy, R</au><au>Katlama, C</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Viral efficacy maintained and safety parameters improved with a reduced dose of stavudine: a pilot study</atitle><jtitle>HIV medicine</jtitle><addtitle>HIV Med</addtitle><date>2008-10</date><risdate>2008</risdate><volume>9</volume><issue>9</issue><spage>738</spage><epage>746</epage><pages>738-746</pages><issn>1464-2662</issn><eissn>1468-1293</eissn><abstract><![CDATA[Objectives
Stavudine (d4T) is a potent but potentially toxic nucleoside reverse transcriptase inhibitor that is still widely used in developing countries. This study's aim was to determine the efficacy and safety profile of lower‐dose d4T.
Methods
Multi‐centre, open‐label, single‐arm, pilot, 48‐week study in French patients weighing >60 kg with viral load <400 HIV‐1 RNA copies/mL who were receiving d4T 40 mg twice daily and then switched to 30 mg twice daily. The primary endpoint was the proportion with plasma viral load <400 copies/mL at week 24. Secondary endpoints included the proportion with <50 copies/mL at weeks 24 and 48, changes in mitochondrial DNA, CD4 cell count and pharmacokinetics, and clinical and laboratory safety.
Results
Fifty‐seven patients enrolled. Baseline CD4 count was 584 cells/μL; viral loads were <400 copies/mL and <50 copies/mL in 100% and 89%, respectively. Prior antiretroviral drug exposure was 6.9 years, d4T exposure was 6.3 years. Fifty‐six out of 57 (98%) patients had viral load <400 copies/mL and 51 (89%) had viral load <50 copies/mL at week 24. Median CD4 count increased by 63 cells/μL at week 48 (P=0.006). At 48 weeks, total cholesterol decreased by 0.24 mmol (P=0.02), high‐density lipoprotein cholesterol by 0.15 mmol (P=0.0001) and alanine aminotransferase by 5.74 mg/dL (P=0.01). Paired baseline DNA and week 24 RNA mutations were unchanged. Mitochondrial DNA (copies/cell) content increased from 672±254 to 682±269. d4T area under the plasma concentration time curve (AUC) decreased by 31% (P=0.003) and Cmax by 44% (P=0.004). Clinical and laboratory parameters improved or were unchanged.
Conclusions
Reduced‐dose d4T is effective with improved safety parameters.]]></abstract><cop>Oxford, UK</cop><pub>Blackwell Publishing Ltd</pub><pmid>18651858</pmid><doi>10.1111/j.1468-1293.2008.00616.x</doi><tpages>9</tpages><oa>free_for_read</oa></addata></record> |
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| ispartof | HIV medicine, 2008-10, Vol.9 (9), p.738-746 |
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| source | Wiley-Blackwell Read & Publish Collection |
| subjects | Adult Aged Antiretroviral Therapy, Highly Active - methods CD4 Lymphocyte Count combination antiretroviral therapy Drug Administration Schedule Female HIV Infections - drug therapy HIV Infections - virology HIV-1 Human immunodeficiency virus Humans Male Middle Aged mitochondrial toxicity nucleoside reverse transcriptase inhibitor Pilot Projects reduced‐dose stavudine Reverse Transcriptase Inhibitors - administration & dosage Reverse Transcriptase Inhibitors - pharmacokinetics RNA, Viral - drug effects Stavudine - administration & dosage Stavudine - pharmacokinetics Treatment Outcome Viral Load |
| title | Viral efficacy maintained and safety parameters improved with a reduced dose of stavudine: a pilot study |
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