Increase in 2-Long Terminal Repeat Circles and Decrease in D-dimer After Raltegravir Intensification in Patients With Treated HIV Infection: A Randomized, Placebo-Controlled Trial
Background. The degree to which human immunodeficiency virus (HIV) continues to replicate during antiretroviral therapy (ART) is controversial. We conducted a randomized, double-blind, placebo-controlled study to assess whether raltegravir intensification reduces low-level viral replication, as defi...
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| Veröffentlicht in: | The Journal of infectious diseases 2013-11, Vol.208 (9), p.1436-1442 |
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| creator | Hatano, Hiroyu Strain, Matthew C. Scherzer, Rebecca Bacchetti, Peter Wentworth, Deborah Hoh, Rebecca Martin, Jeffrey N. McCune, Joseph M. Neaton, James D. Tracy, Russell P. Hsue, Priscilla Y. Richman, Douglas D. Deeks, Steven G. |
| description | Background. The degree to which human immunodeficiency virus (HIV) continues to replicate during antiretroviral therapy (ART) is controversial. We conducted a randomized, double-blind, placebo-controlled study to assess whether raltegravir intensification reduces low-level viral replication, as defined by an increase in the level of 2-long terminal repeat (2-LTR) circles. Methods. Thirty-one subjects with an ART-suppressed plasma HIV RNA level of |
| doi_str_mv | 10.1093/infdis/jit453 |
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| fullrecord | <record><control><sourceid>jstor_pubme</sourceid><recordid>TN_cdi_pubmedcentral_primary_oai_pubmedcentral_nih_gov_3789577</recordid><sourceformat>XML</sourceformat><sourcesystem>PC</sourcesystem><jstor_id>42580588</jstor_id><sourcerecordid>42580588</sourcerecordid><originalsourceid>FETCH-LOGICAL-c472t-2a78c8c004ee84b353417e40266ace6c08fe8108c23f12c8ac660e553fdc998d3</originalsourceid><addsrcrecordid>eNqF0s-LEzEUB_BBFLeuHj0quQgeHDe_JsnsQShddQsFl6XqcUgzb7opmaQm6YL-W_6DprRWPXlJAu-TL-_Bq6rnBL8luGUX1g-9TRcbm3nDHlQT0jBZC0HYw2qCMaU1UW17Vj1JaYMx5kzIx9UZZa1slGom1c-5NxF0AmQ9ovUi-DVaQhyt1w7dwhZ0RjMbjYOEtO_RFfzhV3VvR4hoOuRy3mqXYR31vY1o7jP4ZAdrdLbB7_FNeYHPCX21-Q4tS0iGHl3PvxQ8gNmzSzQtKb4Po_0B_Rt047SBVahnwecYnCt-Ga12T6tHg3YJnh3v8-rzh_fL2XW9-PRxPpsuasMlzTXVUhllytAAiq9YwziRwDEVouQKg9UAimBlKBsINUobITA0DRt607aqZ-fVu0PudrcaoTel_ahdt4121PF7F7Tt_q14e9etw33HpGobKUvA62NADN92kHI32mTAOe0h7FJHRMOFwgyz_1POGVOcU1JofaAmhpQiDKeOCO72O9EddqI77ETxL_8e46R_L0EBr45AJ6PdELU35fvJScVZK9riXhzcJuUQT3VOG4VLEPsFJoLNgw</addsrcrecordid><sourcetype>Open Access Repository</sourcetype><iscdi>true</iscdi><recordtype>article</recordtype><pqid>1443384421</pqid></control><display><type>article</type><title>Increase in 2-Long Terminal Repeat Circles and Decrease in D-dimer After Raltegravir Intensification in Patients With Treated HIV Infection: A Randomized, Placebo-Controlled Trial</title><source>Jstor Complete Legacy</source><source>Oxford University Press Journals All Titles (1996-Current)</source><source>MEDLINE</source><source>Alma/SFX Local Collection</source><creator>Hatano, Hiroyu ; Strain, Matthew C. ; Scherzer, Rebecca ; Bacchetti, Peter ; Wentworth, Deborah ; Hoh, Rebecca ; Martin, Jeffrey N. ; McCune, Joseph M. ; Neaton, James D. ; Tracy, Russell P. ; Hsue, Priscilla Y. ; Richman, Douglas D. ; Deeks, Steven G.</creator><creatorcontrib>Hatano, Hiroyu ; Strain, Matthew C. ; Scherzer, Rebecca ; Bacchetti, Peter ; Wentworth, Deborah ; Hoh, Rebecca ; Martin, Jeffrey N. ; McCune, Joseph M. ; Neaton, James D. ; Tracy, Russell P. ; Hsue, Priscilla Y. ; Richman, Douglas D. ; Deeks, Steven G.</creatorcontrib><description>Background. The degree to which human immunodeficiency virus (HIV) continues to replicate during antiretroviral therapy (ART) is controversial. We conducted a randomized, double-blind, placebo-controlled study to assess whether raltegravir intensification reduces low-level viral replication, as defined by an increase in the level of 2-long terminal repeat (2-LTR) circles. Methods. Thirty-one subjects with an ART-suppressed plasma HIV RNA level of <40 copies/mL and a CD4⁺ T-cell count of ≥350 cells/mm³ for ≥1 year were randomly assigned to receive raltegravir 400 mg twice daily or placebo for 24 weeks. 2-LTR circles were analyzed by droplet digital polymerase chain reaction at weeks 0, 1, 2, and 8. Results. The median duration of ART suppression was 3.8 years. The raltegravir group had a significant increase in the level of 2-LTR circles, compared to the placebo group. The week 1 to 0 ratio was 8.8-fold higher (P = .0025) and the week 2 to 0 ratio was 5.7-fold higher (P = .023) in the raltegravir vs. placebo group. Intensification also led to a statistically significant decrease in the D-dimer level, compared to placebo (P = .045). Conclusions. Raltegravir intensification resulted in a rapid increase in the level of 2-LTR circles in a proportion of subjects, indicating that low-level viral replication persists in some individuals even after long-term ART. Intensification also reduced the D-dimer level, a coagulation biomarker that is predictive of morbidity and mortality among patients receiving treatment for HIV infection.</description><identifier>ISSN: 0022-1899</identifier><identifier>EISSN: 1537-6613</identifier><identifier>DOI: 10.1093/infdis/jit453</identifier><identifier>PMID: 23975885</identifier><identifier>CODEN: JIDIAQ</identifier><language>eng</language><publisher>Oxford: Oxford University Press</publisher><subject>AIDS ; Antiretroviral Therapy, Highly Active ; Antiretrovirals ; Biological and medical sciences ; Biological markers ; Biomarkers - blood ; DNA ; Drug Administration Schedule ; Female ; Fibrin Fibrinogen Degradation Products - metabolism ; Fundamental and applied biological sciences. Psychology ; HIV ; HIV 1 ; HIV infections ; HIV Infections - blood ; HIV Infections - drug therapy ; HIV Infections - virology ; HIV Integrase Inhibitors - administration & dosage ; HIV Long Terminal Repeat - genetics ; HIV-1 - drug effects ; HIV-1 - genetics ; HIV/AIDS ; Human immunodeficiency virus ; Human viral diseases ; Humans ; Infectious diseases ; Major and Brief Reports ; Male ; Medical sciences ; Microbiology ; Middle Aged ; Placebos ; Pyrrolidinones - administration & dosage ; Raltegravir Potassium ; RNA ; T lymphocytes ; Treatment Outcome ; Viral diseases ; Viral diseases of the lymphoid tissue and the blood. Aids ; Virus Replication - drug effects</subject><ispartof>The Journal of infectious diseases, 2013-11, Vol.208 (9), p.1436-1442</ispartof><rights>Copyright © 2013 Oxford University Press on behalf of the Infectious Diseases Society of America</rights><rights>2014 INIST-CNRS</rights><rights>The Author 2013. Published by Oxford University Press on behalf of the Infectious Diseases Society of America. All rights reserved. For Permissions, please e-mail: . 2013</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c472t-2a78c8c004ee84b353417e40266ace6c08fe8108c23f12c8ac660e553fdc998d3</citedby><cites>FETCH-LOGICAL-c472t-2a78c8c004ee84b353417e40266ace6c08fe8108c23f12c8ac660e553fdc998d3</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://www.jstor.org/stable/pdf/42580588$$EPDF$$P50$$Gjstor$$H</linktopdf><linktohtml>$$Uhttps://www.jstor.org/stable/42580588$$EHTML$$P50$$Gjstor$$H</linktohtml><link.rule.ids>230,314,776,780,799,881,27901,27902,57992,58225</link.rule.ids><backlink>$$Uhttp://pascal-francis.inist.fr/vibad/index.php?action=getRecordDetail&idt=27843969$$DView record in Pascal Francis$$Hfree_for_read</backlink><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/23975885$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Hatano, Hiroyu</creatorcontrib><creatorcontrib>Strain, Matthew C.</creatorcontrib><creatorcontrib>Scherzer, Rebecca</creatorcontrib><creatorcontrib>Bacchetti, Peter</creatorcontrib><creatorcontrib>Wentworth, Deborah</creatorcontrib><creatorcontrib>Hoh, Rebecca</creatorcontrib><creatorcontrib>Martin, Jeffrey N.</creatorcontrib><creatorcontrib>McCune, Joseph M.</creatorcontrib><creatorcontrib>Neaton, James D.</creatorcontrib><creatorcontrib>Tracy, Russell P.</creatorcontrib><creatorcontrib>Hsue, Priscilla Y.</creatorcontrib><creatorcontrib>Richman, Douglas D.</creatorcontrib><creatorcontrib>Deeks, Steven G.</creatorcontrib><title>Increase in 2-Long Terminal Repeat Circles and Decrease in D-dimer After Raltegravir Intensification in Patients With Treated HIV Infection: A Randomized, Placebo-Controlled Trial</title><title>The Journal of infectious diseases</title><addtitle>J Infect Dis</addtitle><description>Background. The degree to which human immunodeficiency virus (HIV) continues to replicate during antiretroviral therapy (ART) is controversial. We conducted a randomized, double-blind, placebo-controlled study to assess whether raltegravir intensification reduces low-level viral replication, as defined by an increase in the level of 2-long terminal repeat (2-LTR) circles. Methods. Thirty-one subjects with an ART-suppressed plasma HIV RNA level of <40 copies/mL and a CD4⁺ T-cell count of ≥350 cells/mm³ for ≥1 year were randomly assigned to receive raltegravir 400 mg twice daily or placebo for 24 weeks. 2-LTR circles were analyzed by droplet digital polymerase chain reaction at weeks 0, 1, 2, and 8. Results. The median duration of ART suppression was 3.8 years. The raltegravir group had a significant increase in the level of 2-LTR circles, compared to the placebo group. The week 1 to 0 ratio was 8.8-fold higher (P = .0025) and the week 2 to 0 ratio was 5.7-fold higher (P = .023) in the raltegravir vs. placebo group. Intensification also led to a statistically significant decrease in the D-dimer level, compared to placebo (P = .045). Conclusions. Raltegravir intensification resulted in a rapid increase in the level of 2-LTR circles in a proportion of subjects, indicating that low-level viral replication persists in some individuals even after long-term ART. Intensification also reduced the D-dimer level, a coagulation biomarker that is predictive of morbidity and mortality among patients receiving treatment for HIV infection.</description><subject>AIDS</subject><subject>Antiretroviral Therapy, Highly Active</subject><subject>Antiretrovirals</subject><subject>Biological and medical sciences</subject><subject>Biological markers</subject><subject>Biomarkers - blood</subject><subject>DNA</subject><subject>Drug Administration Schedule</subject><subject>Female</subject><subject>Fibrin Fibrinogen Degradation Products - metabolism</subject><subject>Fundamental and applied biological sciences. Psychology</subject><subject>HIV</subject><subject>HIV 1</subject><subject>HIV infections</subject><subject>HIV Infections - blood</subject><subject>HIV Infections - drug therapy</subject><subject>HIV Infections - virology</subject><subject>HIV Integrase Inhibitors - administration & dosage</subject><subject>HIV Long Terminal Repeat - genetics</subject><subject>HIV-1 - drug effects</subject><subject>HIV-1 - genetics</subject><subject>HIV/AIDS</subject><subject>Human immunodeficiency virus</subject><subject>Human viral diseases</subject><subject>Humans</subject><subject>Infectious diseases</subject><subject>Major and Brief Reports</subject><subject>Male</subject><subject>Medical sciences</subject><subject>Microbiology</subject><subject>Middle Aged</subject><subject>Placebos</subject><subject>Pyrrolidinones - administration & dosage</subject><subject>Raltegravir Potassium</subject><subject>RNA</subject><subject>T lymphocytes</subject><subject>Treatment Outcome</subject><subject>Viral diseases</subject><subject>Viral diseases of the lymphoid tissue and the blood. Aids</subject><subject>Virus Replication - drug effects</subject><issn>0022-1899</issn><issn>1537-6613</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2013</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNqF0s-LEzEUB_BBFLeuHj0quQgeHDe_JsnsQShddQsFl6XqcUgzb7opmaQm6YL-W_6DprRWPXlJAu-TL-_Bq6rnBL8luGUX1g-9TRcbm3nDHlQT0jBZC0HYw2qCMaU1UW17Vj1JaYMx5kzIx9UZZa1slGom1c-5NxF0AmQ9ovUi-DVaQhyt1w7dwhZ0RjMbjYOEtO_RFfzhV3VvR4hoOuRy3mqXYR31vY1o7jP4ZAdrdLbB7_FNeYHPCX21-Q4tS0iGHl3PvxQ8gNmzSzQtKb4Po_0B_Rt047SBVahnwecYnCt-Ga12T6tHg3YJnh3v8-rzh_fL2XW9-PRxPpsuasMlzTXVUhllytAAiq9YwziRwDEVouQKg9UAimBlKBsINUobITA0DRt607aqZ-fVu0PudrcaoTel_ahdt4121PF7F7Tt_q14e9etw33HpGobKUvA62NADN92kHI32mTAOe0h7FJHRMOFwgyz_1POGVOcU1JofaAmhpQiDKeOCO72O9EddqI77ETxL_8e46R_L0EBr45AJ6PdELU35fvJScVZK9riXhzcJuUQT3VOG4VLEPsFJoLNgw</recordid><startdate>20131101</startdate><enddate>20131101</enddate><creator>Hatano, Hiroyu</creator><creator>Strain, Matthew C.</creator><creator>Scherzer, Rebecca</creator><creator>Bacchetti, Peter</creator><creator>Wentworth, Deborah</creator><creator>Hoh, Rebecca</creator><creator>Martin, Jeffrey N.</creator><creator>McCune, Joseph M.</creator><creator>Neaton, James D.</creator><creator>Tracy, Russell P.</creator><creator>Hsue, Priscilla Y.</creator><creator>Richman, Douglas D.</creator><creator>Deeks, Steven G.</creator><general>Oxford University Press</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><scope>7U9</scope><scope>H94</scope><scope>5PM</scope></search><sort><creationdate>20131101</creationdate><title>Increase in 2-Long Terminal Repeat Circles and Decrease in D-dimer After Raltegravir Intensification in Patients With Treated HIV Infection: A Randomized, Placebo-Controlled Trial</title><author>Hatano, Hiroyu ; Strain, Matthew C. ; Scherzer, Rebecca ; Bacchetti, Peter ; Wentworth, Deborah ; Hoh, Rebecca ; Martin, Jeffrey N. ; McCune, Joseph M. ; Neaton, James D. ; Tracy, Russell P. ; Hsue, Priscilla Y. ; Richman, Douglas D. ; Deeks, Steven G.</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c472t-2a78c8c004ee84b353417e40266ace6c08fe8108c23f12c8ac660e553fdc998d3</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2013</creationdate><topic>AIDS</topic><topic>Antiretroviral Therapy, Highly Active</topic><topic>Antiretrovirals</topic><topic>Biological and medical sciences</topic><topic>Biological markers</topic><topic>Biomarkers - blood</topic><topic>DNA</topic><topic>Drug Administration Schedule</topic><topic>Female</topic><topic>Fibrin Fibrinogen Degradation Products - metabolism</topic><topic>Fundamental and applied biological sciences. Psychology</topic><topic>HIV</topic><topic>HIV 1</topic><topic>HIV infections</topic><topic>HIV Infections - blood</topic><topic>HIV Infections - drug therapy</topic><topic>HIV Infections - virology</topic><topic>HIV Integrase Inhibitors - administration & dosage</topic><topic>HIV Long Terminal Repeat - genetics</topic><topic>HIV-1 - drug effects</topic><topic>HIV-1 - genetics</topic><topic>HIV/AIDS</topic><topic>Human immunodeficiency virus</topic><topic>Human viral diseases</topic><topic>Humans</topic><topic>Infectious diseases</topic><topic>Major and Brief Reports</topic><topic>Male</topic><topic>Medical sciences</topic><topic>Microbiology</topic><topic>Middle Aged</topic><topic>Placebos</topic><topic>Pyrrolidinones - administration & dosage</topic><topic>Raltegravir Potassium</topic><topic>RNA</topic><topic>T lymphocytes</topic><topic>Treatment Outcome</topic><topic>Viral diseases</topic><topic>Viral diseases of the lymphoid tissue and the blood. Aids</topic><topic>Virus Replication - drug effects</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Hatano, Hiroyu</creatorcontrib><creatorcontrib>Strain, Matthew C.</creatorcontrib><creatorcontrib>Scherzer, Rebecca</creatorcontrib><creatorcontrib>Bacchetti, Peter</creatorcontrib><creatorcontrib>Wentworth, Deborah</creatorcontrib><creatorcontrib>Hoh, Rebecca</creatorcontrib><creatorcontrib>Martin, Jeffrey N.</creatorcontrib><creatorcontrib>McCune, Joseph M.</creatorcontrib><creatorcontrib>Neaton, James D.</creatorcontrib><creatorcontrib>Tracy, Russell P.</creatorcontrib><creatorcontrib>Hsue, Priscilla Y.</creatorcontrib><creatorcontrib>Richman, Douglas D.</creatorcontrib><creatorcontrib>Deeks, Steven G.</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><collection>Virology and AIDS Abstracts</collection><collection>AIDS and Cancer Research Abstracts</collection><collection>PubMed Central (Full Participant titles)</collection><jtitle>The Journal of infectious diseases</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Hatano, Hiroyu</au><au>Strain, Matthew C.</au><au>Scherzer, Rebecca</au><au>Bacchetti, Peter</au><au>Wentworth, Deborah</au><au>Hoh, Rebecca</au><au>Martin, Jeffrey N.</au><au>McCune, Joseph M.</au><au>Neaton, James D.</au><au>Tracy, Russell P.</au><au>Hsue, Priscilla Y.</au><au>Richman, Douglas D.</au><au>Deeks, Steven G.</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Increase in 2-Long Terminal Repeat Circles and Decrease in D-dimer After Raltegravir Intensification in Patients With Treated HIV Infection: A Randomized, Placebo-Controlled Trial</atitle><jtitle>The Journal of infectious diseases</jtitle><addtitle>J Infect Dis</addtitle><date>2013-11-01</date><risdate>2013</risdate><volume>208</volume><issue>9</issue><spage>1436</spage><epage>1442</epage><pages>1436-1442</pages><issn>0022-1899</issn><eissn>1537-6613</eissn><coden>JIDIAQ</coden><abstract>Background. The degree to which human immunodeficiency virus (HIV) continues to replicate during antiretroviral therapy (ART) is controversial. We conducted a randomized, double-blind, placebo-controlled study to assess whether raltegravir intensification reduces low-level viral replication, as defined by an increase in the level of 2-long terminal repeat (2-LTR) circles. Methods. Thirty-one subjects with an ART-suppressed plasma HIV RNA level of <40 copies/mL and a CD4⁺ T-cell count of ≥350 cells/mm³ for ≥1 year were randomly assigned to receive raltegravir 400 mg twice daily or placebo for 24 weeks. 2-LTR circles were analyzed by droplet digital polymerase chain reaction at weeks 0, 1, 2, and 8. Results. The median duration of ART suppression was 3.8 years. The raltegravir group had a significant increase in the level of 2-LTR circles, compared to the placebo group. The week 1 to 0 ratio was 8.8-fold higher (P = .0025) and the week 2 to 0 ratio was 5.7-fold higher (P = .023) in the raltegravir vs. placebo group. Intensification also led to a statistically significant decrease in the D-dimer level, compared to placebo (P = .045). Conclusions. Raltegravir intensification resulted in a rapid increase in the level of 2-LTR circles in a proportion of subjects, indicating that low-level viral replication persists in some individuals even after long-term ART. Intensification also reduced the D-dimer level, a coagulation biomarker that is predictive of morbidity and mortality among patients receiving treatment for HIV infection.</abstract><cop>Oxford</cop><pub>Oxford University Press</pub><pmid>23975885</pmid><doi>10.1093/infdis/jit453</doi><tpages>7</tpages><oa>free_for_read</oa></addata></record> |
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| ispartof | The Journal of infectious diseases, 2013-11, Vol.208 (9), p.1436-1442 |
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| subjects | AIDS Antiretroviral Therapy, Highly Active Antiretrovirals Biological and medical sciences Biological markers Biomarkers - blood DNA Drug Administration Schedule Female Fibrin Fibrinogen Degradation Products - metabolism Fundamental and applied biological sciences. Psychology HIV HIV 1 HIV infections HIV Infections - blood HIV Infections - drug therapy HIV Infections - virology HIV Integrase Inhibitors - administration & dosage HIV Long Terminal Repeat - genetics HIV-1 - drug effects HIV-1 - genetics HIV/AIDS Human immunodeficiency virus Human viral diseases Humans Infectious diseases Major and Brief Reports Male Medical sciences Microbiology Middle Aged Placebos Pyrrolidinones - administration & dosage Raltegravir Potassium RNA T lymphocytes Treatment Outcome Viral diseases Viral diseases of the lymphoid tissue and the blood. Aids Virus Replication - drug effects |
| title | Increase in 2-Long Terminal Repeat Circles and Decrease in D-dimer After Raltegravir Intensification in Patients With Treated HIV Infection: A Randomized, Placebo-Controlled Trial |
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