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A Randomized, Partially Blinded Phase 2 Trial of Antiretroviral Therapy, HIV‐Specific Immunizations, and Interleukin‐2 Cycles to Promote Efficient Control of Viral Replication (ACTG A5024)
Strategies to limit life‐long dependence on antiretroviral therapy (ART) are needed. We randomized 81 human immunodeficiency virus (HIV)–infected subjects to 4 interventional arms involving continued ART plus ALVAC vCP1452 (or placebo) with or without interleukin (IL)–2 infusions. Viral load rebound...
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Published in: | The Journal of infectious diseases 2006-12, Vol.194 (12), p.1672-1676 |
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container_title | The Journal of infectious diseases |
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creator | Kilby, J. Michael Bucy, R. Pat Mildvan, Donna Fischl, Margaret Santana‐Bagur, Jorge Lennox, Jeff Pilcher, Chris Zolopa, Andrew Lawrence, Jody Pollard, Richard B. Habib, Raphaelle El Sahner, David Fox, Lawrence Aga, Evgenia Bosch, Ronald J. |
description | Strategies to limit life‐long dependence on antiretroviral therapy (ART) are needed. We randomized 81 human immunodeficiency virus (HIV)–infected subjects to 4 interventional arms involving continued ART plus ALVAC vCP1452 (or placebo) with or without interleukin (IL)–2 infusions. Viral load rebound 12 weeks after ART interruption was then analyzed to assess immune control. Fifty‐two subjects reached the study end point. ALVAC recipients had 0.5 log10 lower virologic rebounds (P=.033). IL‐2 plus vaccine boosted CD4+ T cell counts (P |
doi_str_mv | 10.1086/509508 |
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Michael ; Bucy, R. Pat ; Mildvan, Donna ; Fischl, Margaret ; Santana‐Bagur, Jorge ; Lennox, Jeff ; Pilcher, Chris ; Zolopa, Andrew ; Lawrence, Jody ; Pollard, Richard B. ; Habib, Raphaelle El ; Sahner, David ; Fox, Lawrence ; Aga, Evgenia ; Bosch, Ronald J. </creator><creatorcontrib>Kilby, J. Michael ; Bucy, R. Pat ; Mildvan, Donna ; Fischl, Margaret ; Santana‐Bagur, Jorge ; Lennox, Jeff ; Pilcher, Chris ; Zolopa, Andrew ; Lawrence, Jody ; Pollard, Richard B. ; Habib, Raphaelle El ; Sahner, David ; Fox, Lawrence ; Aga, Evgenia ; Bosch, Ronald J. ; The Adult AIDS Clinical Trials Group A5024 Protocol Team ; Adult AIDS Clinical Trials Group A5024 Protocol Team ; Adult AIDS Clinical Trials Group A5024 Protocol Team</creatorcontrib><description>Strategies to limit life‐long dependence on antiretroviral therapy (ART) are needed. We randomized 81 human immunodeficiency virus (HIV)–infected subjects to 4 interventional arms involving continued ART plus ALVAC vCP1452 (or placebo) with or without interleukin (IL)–2 infusions. Viral load rebound 12 weeks after ART interruption was then analyzed to assess immune control. Fifty‐two subjects reached the study end point. ALVAC recipients had 0.5 log10 lower virologic rebounds (P=.033). IL‐2 plus vaccine boosted CD4+ T cell counts (P<.001) but did not diminish viral rebound. Significant changes were not detected for HIV‐specific lymphoproliferative responses in any arm. This exploratory protocol provides useful clinical data for future therapeutic immunization trial design.</description><identifier>ISSN: 0022-1899</identifier><identifier>EISSN: 1537-6613</identifier><identifier>DOI: 10.1086/509508</identifier><identifier>PMID: 17109338</identifier><language>eng</language><publisher>United States: University of Chicago Press</publisher><subject><![CDATA[Adult ; AIDS ; AIDS Vaccines - administration & dosage ; Anti-HIV Agents - administration & dosage ; Anti-HIV Agents - therapeutic use ; Anti-Retroviral Agents - therapeutic use ; Antiretrovirals ; Arts ; CD4 Lymphocyte Count ; Drug Therapy, Combination ; Endpoint Determination ; HIV ; HIV Infections - immunology ; HIV Infections - therapy ; HIV Infections - virology ; HIV-1 - genetics ; HIV-1 - immunology ; HIV-1 - isolation & purification ; HIV/AIDS ; Human immunodeficiency virus ; Humans ; Immunization ; Injections, Subcutaneous ; Interleukin-2 - administration & dosage ; Interleukin-2 - analogs & derivatives ; Interleukin-2 - therapeutic use ; Medical treatment ; Placebos ; Recombinant Proteins - administration & dosage ; Recombinant Proteins - therapeutic use ; RNA, Viral - blood ; T lymphocytes ; Treatment Refusal ; Vaccination ; Viral Load]]></subject><ispartof>The Journal of infectious diseases, 2006-12, Vol.194 (12), p.1672-1676</ispartof><rights>Copyright 2006 Infectious Diseases Society of America</rights><rights>2006 by the Infectious Diseases Society of America. All rights reserved. 2006</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c394t-58a7344c2ab60940842d052b37fd353f2896c837a7b473953c3c8316a1cf07c33</citedby></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/17109338$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Kilby, J. Michael </creatorcontrib><creatorcontrib>Bucy, R. Pat </creatorcontrib><creatorcontrib>Mildvan, Donna </creatorcontrib><creatorcontrib>Fischl, Margaret </creatorcontrib><creatorcontrib>Santana‐Bagur, Jorge </creatorcontrib><creatorcontrib>Lennox, Jeff </creatorcontrib><creatorcontrib>Pilcher, Chris </creatorcontrib><creatorcontrib>Zolopa, Andrew </creatorcontrib><creatorcontrib>Lawrence, Jody </creatorcontrib><creatorcontrib>Pollard, Richard B. </creatorcontrib><creatorcontrib>Habib, Raphaelle El </creatorcontrib><creatorcontrib>Sahner, David </creatorcontrib><creatorcontrib>Fox, Lawrence </creatorcontrib><creatorcontrib>Aga, Evgenia </creatorcontrib><creatorcontrib>Bosch, Ronald J. </creatorcontrib><creatorcontrib>The Adult AIDS Clinical Trials Group A5024 Protocol Team</creatorcontrib><creatorcontrib>Adult AIDS Clinical Trials Group A5024 Protocol Team</creatorcontrib><creatorcontrib>Adult AIDS Clinical Trials Group A5024 Protocol Team</creatorcontrib><title>A Randomized, Partially Blinded Phase 2 Trial of Antiretroviral Therapy, HIV‐Specific Immunizations, and Interleukin‐2 Cycles to Promote Efficient Control of Viral Replication (ACTG A5024)</title><title>The Journal of infectious diseases</title><addtitle>The Journal of Infectious Diseases</addtitle><addtitle>The Journal of Infectious Diseases</addtitle><description>Strategies to limit life‐long dependence on antiretroviral therapy (ART) are needed. We randomized 81 human immunodeficiency virus (HIV)–infected subjects to 4 interventional arms involving continued ART plus ALVAC vCP1452 (or placebo) with or without interleukin (IL)–2 infusions. Viral load rebound 12 weeks after ART interruption was then analyzed to assess immune control. Fifty‐two subjects reached the study end point. ALVAC recipients had 0.5 log10 lower virologic rebounds (P=.033). IL‐2 plus vaccine boosted CD4+ T cell counts (P<.001) but did not diminish viral rebound. Significant changes were not detected for HIV‐specific lymphoproliferative responses in any arm. This exploratory protocol provides useful clinical data for future therapeutic immunization trial design.</description><subject>Adult</subject><subject>AIDS</subject><subject>AIDS Vaccines - administration & dosage</subject><subject>Anti-HIV Agents - administration & dosage</subject><subject>Anti-HIV Agents - therapeutic use</subject><subject>Anti-Retroviral Agents - therapeutic use</subject><subject>Antiretrovirals</subject><subject>Arts</subject><subject>CD4 Lymphocyte Count</subject><subject>Drug Therapy, Combination</subject><subject>Endpoint Determination</subject><subject>HIV</subject><subject>HIV Infections - immunology</subject><subject>HIV Infections - therapy</subject><subject>HIV Infections - virology</subject><subject>HIV-1 - genetics</subject><subject>HIV-1 - immunology</subject><subject>HIV-1 - isolation & purification</subject><subject>HIV/AIDS</subject><subject>Human immunodeficiency virus</subject><subject>Humans</subject><subject>Immunization</subject><subject>Injections, Subcutaneous</subject><subject>Interleukin-2 - administration & dosage</subject><subject>Interleukin-2 - analogs & derivatives</subject><subject>Interleukin-2 - therapeutic use</subject><subject>Medical treatment</subject><subject>Placebos</subject><subject>Recombinant Proteins - administration & dosage</subject><subject>Recombinant Proteins - therapeutic use</subject><subject>RNA, Viral - blood</subject><subject>T lymphocytes</subject><subject>Treatment Refusal</subject><subject>Vaccination</subject><subject>Viral Load</subject><issn>0022-1899</issn><issn>1537-6613</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2006</creationdate><recordtype>article</recordtype><recordid>eNqFkcGO0zAURSMEYsoAfwAyGwRSA892HMfLUk2nlYqoShkhNpHrOBrPJHGwHURnxSfwSXwLX4Jpq5kVYvX03j3v3sVNkqcY3mAo8rcMBIPiXjLCjPI0zzG9n4wACElxIcRJ8sj7KwDIaM4fJieYYxCUFqPk1wStZVfZ1tzoaoxW0gUjm2aH3jWmq3SFVpfSa0TQxsU7sjWadME4HZz9Zly8bC61k_1ujOaLi98_fn7stTK1UWjRtkNnbmQwtvNjFDPQogvaNXq4Nl0kCZruVKM9ChatnG1t0Oisjq9GdwFNbRcj9oEX-5y17huj9nbo1WS6OUcTBiR7_Th5UMvG6yfHeZp8mp1tpvN0-eF8MZ0sU0VFFlJWSE6zTBG5zUFkUGSkAka2lNcVZbQmhchVQbnk24xTwaiiccW5xKoGrig9TV4efHtnvw7ah7I1XummkZ22gy_zAjPO4-P_QCwYIRnwO1A5673Tddk700q3KzGUf0stD6VG8PnRcdi2urrDji1G4MUBsEP_b5NnB-bKB-tuKQpQMJGLqKcH3figv9_q0l2XOaeclfPPX0o648vZ-zWUQP8AGD6_Uw</recordid><startdate>20061215</startdate><enddate>20061215</enddate><creator>Kilby, J. Michael </creator><creator>Bucy, R. Pat </creator><creator>Mildvan, Donna </creator><creator>Fischl, Margaret </creator><creator>Santana‐Bagur, Jorge </creator><creator>Lennox, Jeff </creator><creator>Pilcher, Chris </creator><creator>Zolopa, Andrew </creator><creator>Lawrence, Jody </creator><creator>Pollard, Richard B. </creator><creator>Habib, Raphaelle El </creator><creator>Sahner, David </creator><creator>Fox, Lawrence </creator><creator>Aga, Evgenia </creator><creator>Bosch, Ronald J. </creator><general>University of Chicago Press</general><scope>BSCLL</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>7T5</scope><scope>7U9</scope><scope>H94</scope><scope>7X8</scope></search><sort><creationdate>20061215</creationdate><title>A Randomized, Partially Blinded Phase 2 Trial of Antiretroviral Therapy, HIV‐Specific Immunizations, and Interleukin‐2 Cycles to Promote Efficient Control of Viral Replication (ACTG A5024)</title><author>Kilby, J. Michael ; Bucy, R. Pat ; Mildvan, Donna ; Fischl, Margaret ; Santana‐Bagur, Jorge ; Lennox, Jeff ; Pilcher, Chris ; Zolopa, Andrew ; Lawrence, Jody ; Pollard, Richard B. ; Habib, Raphaelle El ; Sahner, David ; Fox, Lawrence ; Aga, Evgenia ; Bosch, Ronald J. </author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c394t-58a7344c2ab60940842d052b37fd353f2896c837a7b473953c3c8316a1cf07c33</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2006</creationdate><topic>Adult</topic><topic>AIDS</topic><topic>AIDS Vaccines - administration & dosage</topic><topic>Anti-HIV Agents - administration & dosage</topic><topic>Anti-HIV Agents - therapeutic use</topic><topic>Anti-Retroviral Agents - therapeutic use</topic><topic>Antiretrovirals</topic><topic>Arts</topic><topic>CD4 Lymphocyte Count</topic><topic>Drug Therapy, Combination</topic><topic>Endpoint Determination</topic><topic>HIV</topic><topic>HIV Infections - immunology</topic><topic>HIV Infections - therapy</topic><topic>HIV Infections - virology</topic><topic>HIV-1 - genetics</topic><topic>HIV-1 - immunology</topic><topic>HIV-1 - isolation & purification</topic><topic>HIV/AIDS</topic><topic>Human immunodeficiency virus</topic><topic>Humans</topic><topic>Immunization</topic><topic>Injections, Subcutaneous</topic><topic>Interleukin-2 - administration & dosage</topic><topic>Interleukin-2 - analogs & derivatives</topic><topic>Interleukin-2 - therapeutic use</topic><topic>Medical treatment</topic><topic>Placebos</topic><topic>Recombinant Proteins - administration & dosage</topic><topic>Recombinant Proteins - therapeutic use</topic><topic>RNA, Viral - blood</topic><topic>T lymphocytes</topic><topic>Treatment Refusal</topic><topic>Vaccination</topic><topic>Viral Load</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Kilby, J. Michael </creatorcontrib><creatorcontrib>Bucy, R. Pat </creatorcontrib><creatorcontrib>Mildvan, Donna </creatorcontrib><creatorcontrib>Fischl, Margaret </creatorcontrib><creatorcontrib>Santana‐Bagur, Jorge </creatorcontrib><creatorcontrib>Lennox, Jeff </creatorcontrib><creatorcontrib>Pilcher, Chris </creatorcontrib><creatorcontrib>Zolopa, Andrew </creatorcontrib><creatorcontrib>Lawrence, Jody </creatorcontrib><creatorcontrib>Pollard, Richard B. </creatorcontrib><creatorcontrib>Habib, Raphaelle El </creatorcontrib><creatorcontrib>Sahner, David </creatorcontrib><creatorcontrib>Fox, Lawrence </creatorcontrib><creatorcontrib>Aga, Evgenia </creatorcontrib><creatorcontrib>Bosch, Ronald J. </creatorcontrib><creatorcontrib>The Adult AIDS Clinical Trials Group A5024 Protocol Team</creatorcontrib><creatorcontrib>Adult AIDS Clinical Trials Group A5024 Protocol Team</creatorcontrib><creatorcontrib>Adult AIDS Clinical Trials Group A5024 Protocol Team</creatorcontrib><collection>Istex</collection><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>Immunology Abstracts</collection><collection>Virology and AIDS Abstracts</collection><collection>AIDS and Cancer Research Abstracts</collection><collection>MEDLINE - Academic</collection><jtitle>The Journal of infectious diseases</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Kilby, J. Michael </au><au>Bucy, R. Pat </au><au>Mildvan, Donna </au><au>Fischl, Margaret </au><au>Santana‐Bagur, Jorge </au><au>Lennox, Jeff </au><au>Pilcher, Chris </au><au>Zolopa, Andrew </au><au>Lawrence, Jody </au><au>Pollard, Richard B. </au><au>Habib, Raphaelle El </au><au>Sahner, David </au><au>Fox, Lawrence </au><au>Aga, Evgenia </au><au>Bosch, Ronald J. </au><aucorp>The Adult AIDS Clinical Trials Group A5024 Protocol Team</aucorp><aucorp>Adult AIDS Clinical Trials Group A5024 Protocol Team</aucorp><aucorp>Adult AIDS Clinical Trials Group A5024 Protocol Team</aucorp><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>A Randomized, Partially Blinded Phase 2 Trial of Antiretroviral Therapy, HIV‐Specific Immunizations, and Interleukin‐2 Cycles to Promote Efficient Control of Viral Replication (ACTG A5024)</atitle><jtitle>The Journal of infectious diseases</jtitle><stitle>The Journal of Infectious Diseases</stitle><addtitle>The Journal of Infectious Diseases</addtitle><date>2006-12-15</date><risdate>2006</risdate><volume>194</volume><issue>12</issue><spage>1672</spage><epage>1676</epage><pages>1672-1676</pages><issn>0022-1899</issn><eissn>1537-6613</eissn><abstract>Strategies to limit life‐long dependence on antiretroviral therapy (ART) are needed. We randomized 81 human immunodeficiency virus (HIV)–infected subjects to 4 interventional arms involving continued ART plus ALVAC vCP1452 (or placebo) with or without interleukin (IL)–2 infusions. Viral load rebound 12 weeks after ART interruption was then analyzed to assess immune control. Fifty‐two subjects reached the study end point. ALVAC recipients had 0.5 log10 lower virologic rebounds (P=.033). IL‐2 plus vaccine boosted CD4+ T cell counts (P<.001) but did not diminish viral rebound. Significant changes were not detected for HIV‐specific lymphoproliferative responses in any arm. This exploratory protocol provides useful clinical data for future therapeutic immunization trial design.</abstract><cop>United States</cop><pub>University of Chicago Press</pub><pmid>17109338</pmid><doi>10.1086/509508</doi><tpages>5</tpages></addata></record> |
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subjects | Adult AIDS AIDS Vaccines - administration & dosage Anti-HIV Agents - administration & dosage Anti-HIV Agents - therapeutic use Anti-Retroviral Agents - therapeutic use Antiretrovirals Arts CD4 Lymphocyte Count Drug Therapy, Combination Endpoint Determination HIV HIV Infections - immunology HIV Infections - therapy HIV Infections - virology HIV-1 - genetics HIV-1 - immunology HIV-1 - isolation & purification HIV/AIDS Human immunodeficiency virus Humans Immunization Injections, Subcutaneous Interleukin-2 - administration & dosage Interleukin-2 - analogs & derivatives Interleukin-2 - therapeutic use Medical treatment Placebos Recombinant Proteins - administration & dosage Recombinant Proteins - therapeutic use RNA, Viral - blood T lymphocytes Treatment Refusal Vaccination Viral Load |
title | A Randomized, Partially Blinded Phase 2 Trial of Antiretroviral Therapy, HIV‐Specific Immunizations, and Interleukin‐2 Cycles to Promote Efficient Control of Viral Replication (ACTG A5024) |
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