Persistence of Virological Benefits Following Directly Administered Antiretroviral Therapy Among Drug Users: Results From a Randomized Controlled Trial

BACKGROUND:Although directly administered antiretroviral therapy (DAART) has demonstrated impressive biological benefits compared with self-administered therapy (SAT) among drug users, the persistence of DAART after transition to SAT has not been examined. METHODS:We conducted a community-based, pro...

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Veröffentlicht in:Journal of acquired immune deficiency syndromes (1999) 2009-02, Vol.50 (2), p.176-181
Hauptverfasser: Maru, Duncan Smith-Rohrberg, Bruce, Robert Douglas, Walton, Mary, Springer, Sandra A, Altice, Frederick L
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container_title Journal of acquired immune deficiency syndromes (1999)
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creator Maru, Duncan Smith-Rohrberg
Bruce, Robert Douglas
Walton, Mary
Springer, Sandra A
Altice, Frederick L
description BACKGROUND:Although directly administered antiretroviral therapy (DAART) has demonstrated impressive biological benefits compared with self-administered therapy (SAT) among drug users, the persistence of DAART after transition to SAT has not been examined. METHODS:We conducted a community-based, prospective, randomized controlled trial of 6 months of DAART compared with SAT. The primary outcome was the proportion of subjects who achieved virological success at 6 months postintervention, defined as either a 1.0 log10 reduction from baseline or HIV-1 RNA
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METHODS:We conducted a community-based, prospective, randomized controlled trial of 6 months of DAART compared with SAT. The primary outcome was the proportion of subjects who achieved virological success at 6 months postintervention, defined as either a 1.0 log10 reduction from baseline or HIV-1 RNA &lt;400 copies per milliliter. Secondary outcomes included the change from baseline in HIV-1 RNA and CD4 lymphocyte count. RESULTS:Of the 53 subjects in the SAT arm and 88 subjects in the DAART arm, 52 and 82, respectively, provided blood samples at 6 months postintervention. The DAART (n = 88) and SAT (n = 53) arms did not differ on virological success (DAART 58.0% vs. SAT 56.6%, P = 0.64), mean reduction in log10 HIV-1 RNA (−0.79 vs. −0.31 log10 copies/mL, P = 0.53), or mean change in CD4 lymphocyte count (+60.2 vs. −15.4 cells/mL, P = 0.12). In the multivariate analysis, only high levels of social support significantly predicted virological success. CONCLUSIONS:This analysis, from the first randomized controlled trial of DAART among active drug users, failed to show the persistence of the DAART intervention at improving virological outcomes. Additional strategies are needed to ensure the on-treatment benefits persist following the cessation of DAART.</description><identifier>ISSN: 1525-4135</identifier><identifier>EISSN: 1944-7884</identifier><identifier>DOI: 10.1097/QAI.0b013e3181938e7e</identifier><identifier>PMID: 19131891</identifier><identifier>CODEN: JDSRET</identifier><language>eng</language><publisher>Hagerstown, MD: Lippincott Williams &amp; Wilkins, Inc</publisher><subject>Acquired immune deficiency syndrome ; Adult ; AIDS ; Anti-HIV Agents - administration &amp; dosage ; Anti-HIV Agents - therapeutic use ; Antiretroviral drugs ; antiretroviral therapy ; Biological and medical sciences ; CD4 antigen ; CD4 Lymphocyte Count ; Cell number ; Directly Observed Therapy ; Drug abuse ; Drug therapy ; Drug use ; Female ; Fundamental and applied biological sciences. Psychology ; HIV Infections - complications ; HIV Infections - drug therapy ; HIV Infections - virology ; HIV-1 - drug effects ; HIV-1 - genetics ; HIV-1 - physiology ; Human immunodeficiency virus 1 ; Human viral diseases ; Humans ; Infectious diseases ; Male ; Medical research ; Medical sciences ; Microbiology ; Middle Aged ; Miscellaneous ; Multivariate analysis ; Patient Compliance ; Ribonucleic acid ; RNA ; RNA, Viral - blood ; Self Administration ; Social interactions ; Social Support ; Substance-Related Disorders - complications ; Treatment Outcome ; Viral diseases ; Viral diseases of the lymphoid tissue and the blood. 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METHODS:We conducted a community-based, prospective, randomized controlled trial of 6 months of DAART compared with SAT. The primary outcome was the proportion of subjects who achieved virological success at 6 months postintervention, defined as either a 1.0 log10 reduction from baseline or HIV-1 RNA &lt;400 copies per milliliter. Secondary outcomes included the change from baseline in HIV-1 RNA and CD4 lymphocyte count. RESULTS:Of the 53 subjects in the SAT arm and 88 subjects in the DAART arm, 52 and 82, respectively, provided blood samples at 6 months postintervention. The DAART (n = 88) and SAT (n = 53) arms did not differ on virological success (DAART 58.0% vs. SAT 56.6%, P = 0.64), mean reduction in log10 HIV-1 RNA (−0.79 vs. −0.31 log10 copies/mL, P = 0.53), or mean change in CD4 lymphocyte count (+60.2 vs. −15.4 cells/mL, P = 0.12). In the multivariate analysis, only high levels of social support significantly predicted virological success. CONCLUSIONS:This analysis, from the first randomized controlled trial of DAART among active drug users, failed to show the persistence of the DAART intervention at improving virological outcomes. Additional strategies are needed to ensure the on-treatment benefits persist following the cessation of DAART.</description><subject>Acquired immune deficiency syndrome</subject><subject>Adult</subject><subject>AIDS</subject><subject>Anti-HIV Agents - administration &amp; dosage</subject><subject>Anti-HIV Agents - therapeutic use</subject><subject>Antiretroviral drugs</subject><subject>antiretroviral therapy</subject><subject>Biological and medical sciences</subject><subject>CD4 antigen</subject><subject>CD4 Lymphocyte Count</subject><subject>Cell number</subject><subject>Directly Observed Therapy</subject><subject>Drug abuse</subject><subject>Drug therapy</subject><subject>Drug use</subject><subject>Female</subject><subject>Fundamental and applied biological sciences. Psychology</subject><subject>HIV Infections - complications</subject><subject>HIV Infections - drug therapy</subject><subject>HIV Infections - virology</subject><subject>HIV-1 - drug effects</subject><subject>HIV-1 - genetics</subject><subject>HIV-1 - physiology</subject><subject>Human immunodeficiency virus 1</subject><subject>Human viral diseases</subject><subject>Humans</subject><subject>Infectious diseases</subject><subject>Male</subject><subject>Medical research</subject><subject>Medical sciences</subject><subject>Microbiology</subject><subject>Middle Aged</subject><subject>Miscellaneous</subject><subject>Multivariate analysis</subject><subject>Patient Compliance</subject><subject>Ribonucleic acid</subject><subject>RNA</subject><subject>RNA, Viral - blood</subject><subject>Self Administration</subject><subject>Social interactions</subject><subject>Social Support</subject><subject>Substance-Related Disorders - complications</subject><subject>Treatment Outcome</subject><subject>Viral diseases</subject><subject>Viral diseases of the lymphoid tissue and the blood. Aids</subject><subject>Virology</subject><issn>1525-4135</issn><issn>1944-7884</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2009</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNp9kdFuFCEUhifGxtbqGxhDTPRuKgzMAF6YrKvVJk3UZustYZgzu1QGVpjppr6Iryvb3VTthVecwPf_5xz-onhG8AnBkr_-Ojs7wS0mFCgRRFIBHB4UR0QyVnIh2MNc11VdMkLrw-JxSlcYk4Yx-ag4JJJkkSRHxa8vEJNNI3gDKPTom43BhaU12qF34KG3Y0KnwbmwsX6J3tsIZnQ3aNYN1m91ETo082O-H2O4tjHrFiuIep2ZIWwlcVqiy5TbvEEXkCa3NYxhQBpdaN-Fwf7MFvPgs965XC6i1e5JcdBrl-Dp_jwuLk8_LOafyvPPH8_ms_PS1IxCWbGm19xQrNsW95IAkdzUbdsx4IyzNv-K6DA1WFS47mkt-rqtdFsJTg2rmp4eF293vuupHaAzkMfQTq2jHXS8UUFb9e-Ltyu1DNeqajiWsskGr_YGMfyYII1qsMmAc9pDmJKqsGww5iKDL-6BV2GKPi-nKkqbWhBOM8R2kIkhpQj93SQEq23sKseu7seeZc__3uKPaJ9zBl7uAZ1ytH3U3th0x1WEcFLfbiN23Ca4nG367qYNRLUC7cbV_2f4Ddp2zK8</recordid><startdate>200902</startdate><enddate>200902</enddate><creator>Maru, Duncan Smith-Rohrberg</creator><creator>Bruce, Robert Douglas</creator><creator>Walton, Mary</creator><creator>Springer, Sandra A</creator><creator>Altice, Frederick L</creator><general>Lippincott Williams &amp; Wilkins, Inc</general><general>Lippincott Williams &amp; Wilkins</general><general>Lippincott Williams &amp; Wilkins Ovid Technologies</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>7T2</scope><scope>7T5</scope><scope>7TK</scope><scope>7U7</scope><scope>7U9</scope><scope>C1K</scope><scope>H94</scope><scope>K9.</scope><scope>5PM</scope></search><sort><creationdate>200902</creationdate><title>Persistence of Virological Benefits Following Directly Administered Antiretroviral Therapy Among Drug Users: Results From a Randomized Controlled Trial</title><author>Maru, Duncan Smith-Rohrberg ; Bruce, Robert Douglas ; Walton, Mary ; Springer, Sandra A ; Altice, Frederick L</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c543e-246fa7c30abb0f91e197c5bbd4e7474b38e8d03c08205f358f5b2ab2873c426f3</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2009</creationdate><topic>Acquired immune deficiency syndrome</topic><topic>Adult</topic><topic>AIDS</topic><topic>Anti-HIV Agents - administration &amp; dosage</topic><topic>Anti-HIV Agents - therapeutic use</topic><topic>Antiretroviral drugs</topic><topic>antiretroviral therapy</topic><topic>Biological and medical sciences</topic><topic>CD4 antigen</topic><topic>CD4 Lymphocyte Count</topic><topic>Cell number</topic><topic>Directly Observed Therapy</topic><topic>Drug abuse</topic><topic>Drug therapy</topic><topic>Drug use</topic><topic>Female</topic><topic>Fundamental and applied biological sciences. 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Aids</topic><topic>Virology</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Maru, Duncan Smith-Rohrberg</creatorcontrib><creatorcontrib>Bruce, Robert Douglas</creatorcontrib><creatorcontrib>Walton, Mary</creatorcontrib><creatorcontrib>Springer, Sandra A</creatorcontrib><creatorcontrib>Altice, Frederick L</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>Health and Safety Science Abstracts (Full archive)</collection><collection>Immunology Abstracts</collection><collection>Neurosciences Abstracts</collection><collection>Toxicology Abstracts</collection><collection>Virology and AIDS Abstracts</collection><collection>Environmental Sciences and Pollution Management</collection><collection>AIDS and Cancer Research Abstracts</collection><collection>ProQuest Health &amp; Medical Complete (Alumni)</collection><collection>PubMed Central (Full Participant titles)</collection><jtitle>Journal of acquired immune deficiency syndromes (1999)</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Maru, Duncan Smith-Rohrberg</au><au>Bruce, Robert Douglas</au><au>Walton, Mary</au><au>Springer, Sandra A</au><au>Altice, Frederick L</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Persistence of Virological Benefits Following Directly Administered Antiretroviral Therapy Among Drug Users: Results From a Randomized Controlled Trial</atitle><jtitle>Journal of acquired immune deficiency syndromes (1999)</jtitle><addtitle>J Acquir Immune Defic Syndr</addtitle><date>2009-02</date><risdate>2009</risdate><volume>50</volume><issue>2</issue><spage>176</spage><epage>181</epage><pages>176-181</pages><issn>1525-4135</issn><eissn>1944-7884</eissn><coden>JDSRET</coden><abstract>BACKGROUND:Although directly administered antiretroviral therapy (DAART) has demonstrated impressive biological benefits compared with self-administered therapy (SAT) among drug users, the persistence of DAART after transition to SAT has not been examined. METHODS:We conducted a community-based, prospective, randomized controlled trial of 6 months of DAART compared with SAT. The primary outcome was the proportion of subjects who achieved virological success at 6 months postintervention, defined as either a 1.0 log10 reduction from baseline or HIV-1 RNA &lt;400 copies per milliliter. Secondary outcomes included the change from baseline in HIV-1 RNA and CD4 lymphocyte count. RESULTS:Of the 53 subjects in the SAT arm and 88 subjects in the DAART arm, 52 and 82, respectively, provided blood samples at 6 months postintervention. The DAART (n = 88) and SAT (n = 53) arms did not differ on virological success (DAART 58.0% vs. SAT 56.6%, P = 0.64), mean reduction in log10 HIV-1 RNA (−0.79 vs. −0.31 log10 copies/mL, P = 0.53), or mean change in CD4 lymphocyte count (+60.2 vs. −15.4 cells/mL, P = 0.12). In the multivariate analysis, only high levels of social support significantly predicted virological success. CONCLUSIONS:This analysis, from the first randomized controlled trial of DAART among active drug users, failed to show the persistence of the DAART intervention at improving virological outcomes. Additional strategies are needed to ensure the on-treatment benefits persist following the cessation of DAART.</abstract><cop>Hagerstown, MD</cop><pub>Lippincott Williams &amp; Wilkins, Inc</pub><pmid>19131891</pmid><doi>10.1097/QAI.0b013e3181938e7e</doi><tpages>6</tpages><oa>free_for_read</oa></addata></record>
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subjects Acquired immune deficiency syndrome
Adult
AIDS
Anti-HIV Agents - administration & dosage
Anti-HIV Agents - therapeutic use
Antiretroviral drugs
antiretroviral therapy
Biological and medical sciences
CD4 antigen
CD4 Lymphocyte Count
Cell number
Directly Observed Therapy
Drug abuse
Drug therapy
Drug use
Female
Fundamental and applied biological sciences. Psychology
HIV Infections - complications
HIV Infections - drug therapy
HIV Infections - virology
HIV-1 - drug effects
HIV-1 - genetics
HIV-1 - physiology
Human immunodeficiency virus 1
Human viral diseases
Humans
Infectious diseases
Male
Medical research
Medical sciences
Microbiology
Middle Aged
Miscellaneous
Multivariate analysis
Patient Compliance
Ribonucleic acid
RNA
RNA, Viral - blood
Self Administration
Social interactions
Social Support
Substance-Related Disorders - complications
Treatment Outcome
Viral diseases
Viral diseases of the lymphoid tissue and the blood. Aids
Virology
title Persistence of Virological Benefits Following Directly Administered Antiretroviral Therapy Among Drug Users: Results From a Randomized Controlled Trial
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