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Structured Treatment Interruptions and Low Doses of IL-2 in Patients with Primary HIV Infection. Inflammatory, Virological and Immunological Outcomes
Interventions during primary HIV infection (PHI) can modify the clinical course during the chronic phase. The long-term effect of structured treatment interruptions (STI) followed by low doses of interleukin-2 (IL-2) in treated PHI patients is unknown. Twelve PHI patients with viral load (VL) 500 ce...
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| Published in: | PloS one 2015-07, Vol.10 (7), p.e0131651-e0131651 |
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| container_end_page | e0131651 |
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| creator | Sued, Omar Ambrosioni, Juan Nicolás, David Manzardo, Christian Agüero, Fernando Claramonte, Xavier Plana, Montserrat Tuset, Montserrat Pumarola, Tomás Gallart, Teresa Gatell, José María Miró, José María |
| description | Interventions during primary HIV infection (PHI) can modify the clinical course during the chronic phase. The long-term effect of structured treatment interruptions (STI) followed by low doses of interleukin-2 (IL-2) in treated PHI patients is unknown.
Twelve PHI patients with viral load (VL) 500 cells/mm3, and CD4/CD8 ratio >1, on antiretroviral therapy (ART) initiated within the first 90 days of infection and continued for at least 12 months were included. They underwent four STI and were then allocated (week 0 of the study) to ART alone or ART plus low doses of IL-2. ART was stopped once VL |
| doi_str_mv | 10.1371/journal.pone.0131651 |
| format | article |
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Twelve PHI patients with viral load (VL) <20 copies/mL, CD4 cells >500 cells/mm3, and CD4/CD8 ratio >1, on antiretroviral therapy (ART) initiated within the first 90 days of infection and continued for at least 12 months were included. They underwent four STI and were then allocated (week 0 of the study) to ART alone or ART plus low doses of IL-2. ART was stopped once VL <20 copies/mL ('final stop'). Primary endpoints were VL<3000 copies/mL and CD4 cells >500 cells/mm3 at 48 weeks; secondary endpoints were immune activation, inflammatory markers until 48 weeks and the time before resuming ART (CD4 <350 cells/mm3 or AIDS) after 'final stop', compared between groups.
Ten out of 12 patients were males, median age was 35 years and the main risk was men-who-have-sex-with-men. Only one out of 12 patients (in the STI group) maintained VL<3000 copies/mL and CD4 cells >500 cells/mm3 without ART at 48 weeks. All other virological and immunological parameters were comparable between groups at week 0, 'final stop' and week 48. However, the proportion of CD8-CD38+ cells, tumor necrosis factor and srIL-2 were higher in the IL-2 group at 'final stop' and week 24. All these differences vanished during follow-up. At 5 years after the final stop 3 out of 6 patients in the IL-2 group and 6 out of 6 patients in the STI group have resumed ART (P = 0.19).
STI and IL-2 failed to achieve virological control after ART interruption. STI were not deleterious in long-term follow-up, an important issue for eradication and functional cure trials.
ClinicalTrials.gov NCT02300623.</description><identifier>ISSN: 1932-6203</identifier><identifier>EISSN: 1932-6203</identifier><identifier>DOI: 10.1371/journal.pone.0131651</identifier><identifier>PMID: 26186440</identifier><language>eng</language><publisher>United States: Public Library of Science</publisher><subject>Acquired immune deficiency syndrome ; Adult ; AIDS ; Anti-HIV Agents - administration & dosage ; Antiretroviral agents ; Antiretroviral drugs ; Antiretroviral therapy ; Antiretrovirals ; Care and treatment ; CD38 antigen ; CD4 antigen ; CD4 Lymphocyte Count ; CD4-Positive T-Lymphocytes - drug effects ; CD4-Positive T-Lymphocytes - immunology ; CD8 antigen ; Cell Proliferation ; Chronic infection ; Clinical trials ; Cytokines ; Drug Administration Schedule ; Drug resistance ; Drug Resistance, Viral ; Drug therapy ; Female ; Highly active antiretroviral therapy ; HIV ; HIV (Viruses) ; HIV infections ; HIV Infections - drug therapy ; HIV Infections - immunology ; HIV Infections - virology ; HIV patients ; Human immunodeficiency virus ; Humans ; Immune response ; Immunology ; Immunotherapy ; Infeccions per VIH ; Infections ; Infectious diseases ; Inflamació ; Inflammation ; Interleukin 2 ; Interleukin-2 - administration & dosage ; Interleukins ; Male ; Males ; Patient outcomes ; Patients ; Resposta immunitària ; Sexually transmitted diseases ; STD ; Treatment Outcome ; VIH (Virus) ; Viral Load</subject><ispartof>PloS one, 2015-07, Vol.10 (7), p.e0131651-e0131651</ispartof><rights>COPYRIGHT 2015 Public Library of Science</rights><rights>2015 Sued et al. This is an open access article distributed under the terms of the Creative Commons Attribution License: http://creativecommons.org/licenses/by/4.0/ (the “License”), which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited Notwithstanding the ProQuest Terms and Conditions, you may use this content in accordance with the terms of the License.</rights><rights>cc-by (c) Sued, O. et al., 2015 info:eu-repo/semantics/openAccess <a href="http://creativecommons.org/licenses/by/3.0/es">http://creativecommons.org/licenses/by/3.0/es</a></rights><rights>2015 Sued et al 2015 Sued et al</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c734t-17546a61eac0520692a18b3366637da00353934e6de28fd95b1987bbdbe64ce43</citedby><cites>FETCH-LOGICAL-c734t-17546a61eac0520692a18b3366637da00353934e6de28fd95b1987bbdbe64ce43</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://www.proquest.com/docview/1697016265/fulltextPDF?pq-origsite=primo$$EPDF$$P50$$Gproquest$$Hfree_for_read</linktopdf><linktohtml>$$Uhttps://www.proquest.com/docview/1697016265?pq-origsite=primo$$EHTML$$P50$$Gproquest$$Hfree_for_read</linktohtml><link.rule.ids>230,314,727,780,784,885,25753,27924,27925,37012,37013,44590,53791,53793,74998</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/26186440$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><contributor>Landay, Alan</contributor><creatorcontrib>Sued, Omar</creatorcontrib><creatorcontrib>Ambrosioni, Juan</creatorcontrib><creatorcontrib>Nicolás, David</creatorcontrib><creatorcontrib>Manzardo, Christian</creatorcontrib><creatorcontrib>Agüero, Fernando</creatorcontrib><creatorcontrib>Claramonte, Xavier</creatorcontrib><creatorcontrib>Plana, Montserrat</creatorcontrib><creatorcontrib>Tuset, Montserrat</creatorcontrib><creatorcontrib>Pumarola, Tomás</creatorcontrib><creatorcontrib>Gallart, Teresa</creatorcontrib><creatorcontrib>Gatell, José María</creatorcontrib><creatorcontrib>Miró, José María</creatorcontrib><title>Structured Treatment Interruptions and Low Doses of IL-2 in Patients with Primary HIV Infection. Inflammatory, Virological and Immunological Outcomes</title><title>PloS one</title><addtitle>PLoS One</addtitle><description>Interventions during primary HIV infection (PHI) can modify the clinical course during the chronic phase. The long-term effect of structured treatment interruptions (STI) followed by low doses of interleukin-2 (IL-2) in treated PHI patients is unknown.
Twelve PHI patients with viral load (VL) <20 copies/mL, CD4 cells >500 cells/mm3, and CD4/CD8 ratio >1, on antiretroviral therapy (ART) initiated within the first 90 days of infection and continued for at least 12 months were included. They underwent four STI and were then allocated (week 0 of the study) to ART alone or ART plus low doses of IL-2. ART was stopped once VL <20 copies/mL ('final stop'). Primary endpoints were VL<3000 copies/mL and CD4 cells >500 cells/mm3 at 48 weeks; secondary endpoints were immune activation, inflammatory markers until 48 weeks and the time before resuming ART (CD4 <350 cells/mm3 or AIDS) after 'final stop', compared between groups.
Ten out of 12 patients were males, median age was 35 years and the main risk was men-who-have-sex-with-men. Only one out of 12 patients (in the STI group) maintained VL<3000 copies/mL and CD4 cells >500 cells/mm3 without ART at 48 weeks. All other virological and immunological parameters were comparable between groups at week 0, 'final stop' and week 48. However, the proportion of CD8-CD38+ cells, tumor necrosis factor and srIL-2 were higher in the IL-2 group at 'final stop' and week 24. All these differences vanished during follow-up. At 5 years after the final stop 3 out of 6 patients in the IL-2 group and 6 out of 6 patients in the STI group have resumed ART (P = 0.19).
STI and IL-2 failed to achieve virological control after ART interruption. STI were not deleterious in long-term follow-up, an important issue for eradication and functional cure trials.
ClinicalTrials.gov NCT02300623.</description><subject>Acquired immune deficiency syndrome</subject><subject>Adult</subject><subject>AIDS</subject><subject>Anti-HIV Agents - administration & dosage</subject><subject>Antiretroviral agents</subject><subject>Antiretroviral drugs</subject><subject>Antiretroviral therapy</subject><subject>Antiretrovirals</subject><subject>Care and treatment</subject><subject>CD38 antigen</subject><subject>CD4 antigen</subject><subject>CD4 Lymphocyte Count</subject><subject>CD4-Positive T-Lymphocytes - drug effects</subject><subject>CD4-Positive T-Lymphocytes - immunology</subject><subject>CD8 antigen</subject><subject>Cell Proliferation</subject><subject>Chronic infection</subject><subject>Clinical trials</subject><subject>Cytokines</subject><subject>Drug Administration Schedule</subject><subject>Drug resistance</subject><subject>Drug Resistance, Viral</subject><subject>Drug therapy</subject><subject>Female</subject><subject>Highly active antiretroviral therapy</subject><subject>HIV</subject><subject>HIV (Viruses)</subject><subject>HIV infections</subject><subject>HIV Infections - drug therapy</subject><subject>HIV Infections - immunology</subject><subject>HIV Infections - virology</subject><subject>HIV patients</subject><subject>Human immunodeficiency virus</subject><subject>Humans</subject><subject>Immune response</subject><subject>Immunology</subject><subject>Immunotherapy</subject><subject>Infeccions per VIH</subject><subject>Infections</subject><subject>Infectious diseases</subject><subject>Inflamació</subject><subject>Inflammation</subject><subject>Interleukin 2</subject><subject>Interleukin-2 - administration & dosage</subject><subject>Interleukins</subject><subject>Male</subject><subject>Males</subject><subject>Patient outcomes</subject><subject>Patients</subject><subject>Resposta immunitària</subject><subject>Sexually transmitted diseases</subject><subject>STD</subject><subject>Treatment Outcome</subject><subject>VIH (Virus)</subject><subject>Viral Load</subject><issn>1932-6203</issn><issn>1932-6203</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2015</creationdate><recordtype>article</recordtype><sourceid>PIMPY</sourceid><sourceid>DOA</sourceid><recordid>eNqNk11v0zAUhiMEYmPwDxBYQkIg0eKvOMkN0jQ-FqlSJzZ6aznOSespiYvtMPZD-L-4bVataBcoiuIcP-9rn2OfJHlJ8JSwjHy8toPrVTtd2x6mmDAiUvIoOSYFoxNBMXt8b3yUPPP-GuOU5UI8TY6oILngHB8nfy6DG3QYHNToyoEKHfQBlX0A54Z1MLb3SPU1mtkb9Nl68Mg2qJxNKDI9ulDBRNyjGxNW6MKZTrlbdF4uokEDeqOeboat6joVrLv9gBbG2dYujVbt1rfsuqHfR-ZD0LYD_zx50qjWw4vxe5L8-Prl6ux8Mpt_K89OZxOdMR4mJEu5UIKA0jilWBRUkbxiTAjBslphzFJWMA6iBpo3dZFWpMizqqorEFwDZyfJ653vurVejhX1kogiw0RQkUai3BG1VddyvUtRWmXkNmDdUioXjG5BKsgbVhFdUE24YKzIaUZpXjVZlfGmUtHr07jaUHVQ61g6p9oD08OZ3qzk0v6SPMUCR8uThOwMtB-0dKDBaRW2wv3P5qU4o5KKLC1w1LwbF3X25wA-yM54DW2rerDDNte8EJQTFtE3_6APV2SkliombfrGxr3qjak85ZQSJooii9T0ASo-NXRGxyvbmBg_ELw_EEQmwO-wVIP3srz8_v_sfHHIvr3HrkC1YeVtO2yv9iHIx-I6672DZn8wBMtNx91VQ246To4dF2Wv7h_qXnTXYuwvzqwmag</recordid><startdate>20150717</startdate><enddate>20150717</enddate><creator>Sued, Omar</creator><creator>Ambrosioni, Juan</creator><creator>Nicolás, David</creator><creator>Manzardo, Christian</creator><creator>Agüero, Fernando</creator><creator>Claramonte, Xavier</creator><creator>Plana, Montserrat</creator><creator>Tuset, Montserrat</creator><creator>Pumarola, Tomás</creator><creator>Gallart, Teresa</creator><creator>Gatell, José María</creator><creator>Miró, José María</creator><general>Public Library of Science</general><general>Public Library of Science (PLoS)</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>IOV</scope><scope>ISR</scope><scope>3V.</scope><scope>7QG</scope><scope>7QL</scope><scope>7QO</scope><scope>7RV</scope><scope>7SN</scope><scope>7SS</scope><scope>7T5</scope><scope>7TG</scope><scope>7TM</scope><scope>7U9</scope><scope>7X2</scope><scope>7X7</scope><scope>7XB</scope><scope>88E</scope><scope>8AO</scope><scope>8C1</scope><scope>8FD</scope><scope>8FE</scope><scope>8FG</scope><scope>8FH</scope><scope>8FI</scope><scope>8FJ</scope><scope>8FK</scope><scope>ABJCF</scope><scope>ABUWG</scope><scope>AEUYN</scope><scope>AFKRA</scope><scope>ARAPS</scope><scope>ATCPS</scope><scope>AZQEC</scope><scope>BBNVY</scope><scope>BENPR</scope><scope>BGLVJ</scope><scope>BHPHI</scope><scope>C1K</scope><scope>CCPQU</scope><scope>D1I</scope><scope>DWQXO</scope><scope>FR3</scope><scope>FYUFA</scope><scope>GHDGH</scope><scope>GNUQQ</scope><scope>H94</scope><scope>HCIFZ</scope><scope>K9.</scope><scope>KB.</scope><scope>KB0</scope><scope>KL.</scope><scope>L6V</scope><scope>LK8</scope><scope>M0K</scope><scope>M0S</scope><scope>M1P</scope><scope>M7N</scope><scope>M7P</scope><scope>M7S</scope><scope>NAPCQ</scope><scope>P5Z</scope><scope>P62</scope><scope>P64</scope><scope>PATMY</scope><scope>PDBOC</scope><scope>PIMPY</scope><scope>PQEST</scope><scope>PQQKQ</scope><scope>PQUKI</scope><scope>PTHSS</scope><scope>PYCSY</scope><scope>RC3</scope><scope>7X8</scope><scope>XX2</scope><scope>5PM</scope><scope>DOA</scope></search><sort><creationdate>20150717</creationdate><title>Structured Treatment Interruptions and Low Doses of IL-2 in Patients with Primary HIV Infection. 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Xavier</au><au>Plana, Montserrat</au><au>Tuset, Montserrat</au><au>Pumarola, Tomás</au><au>Gallart, Teresa</au><au>Gatell, José María</au><au>Miró, José María</au><au>Landay, Alan</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Structured Treatment Interruptions and Low Doses of IL-2 in Patients with Primary HIV Infection. Inflammatory, Virological and Immunological Outcomes</atitle><jtitle>PloS one</jtitle><addtitle>PLoS One</addtitle><date>2015-07-17</date><risdate>2015</risdate><volume>10</volume><issue>7</issue><spage>e0131651</spage><epage>e0131651</epage><pages>e0131651-e0131651</pages><issn>1932-6203</issn><eissn>1932-6203</eissn><abstract>Interventions during primary HIV infection (PHI) can modify the clinical course during the chronic phase. The long-term effect of structured treatment interruptions (STI) followed by low doses of interleukin-2 (IL-2) in treated PHI patients is unknown.
Twelve PHI patients with viral load (VL) <20 copies/mL, CD4 cells >500 cells/mm3, and CD4/CD8 ratio >1, on antiretroviral therapy (ART) initiated within the first 90 days of infection and continued for at least 12 months were included. They underwent four STI and were then allocated (week 0 of the study) to ART alone or ART plus low doses of IL-2. ART was stopped once VL <20 copies/mL ('final stop'). Primary endpoints were VL<3000 copies/mL and CD4 cells >500 cells/mm3 at 48 weeks; secondary endpoints were immune activation, inflammatory markers until 48 weeks and the time before resuming ART (CD4 <350 cells/mm3 or AIDS) after 'final stop', compared between groups.
Ten out of 12 patients were males, median age was 35 years and the main risk was men-who-have-sex-with-men. Only one out of 12 patients (in the STI group) maintained VL<3000 copies/mL and CD4 cells >500 cells/mm3 without ART at 48 weeks. All other virological and immunological parameters were comparable between groups at week 0, 'final stop' and week 48. However, the proportion of CD8-CD38+ cells, tumor necrosis factor and srIL-2 were higher in the IL-2 group at 'final stop' and week 24. All these differences vanished during follow-up. At 5 years after the final stop 3 out of 6 patients in the IL-2 group and 6 out of 6 patients in the STI group have resumed ART (P = 0.19).
STI and IL-2 failed to achieve virological control after ART interruption. STI were not deleterious in long-term follow-up, an important issue for eradication and functional cure trials.
ClinicalTrials.gov NCT02300623.</abstract><cop>United States</cop><pub>Public Library of Science</pub><pmid>26186440</pmid><doi>10.1371/journal.pone.0131651</doi><tpages>16</tpages><oa>free_for_read</oa></addata></record> |
| fulltext | fulltext |
| identifier | ISSN: 1932-6203 |
| ispartof | PloS one, 2015-07, Vol.10 (7), p.e0131651-e0131651 |
| issn | 1932-6203 1932-6203 |
| language | eng |
| recordid | cdi_plos_journals_1697016265 |
| source | Open Access: PubMed Central; Publicly Available Content (ProQuest) |
| subjects | Acquired immune deficiency syndrome Adult AIDS Anti-HIV Agents - administration & dosage Antiretroviral agents Antiretroviral drugs Antiretroviral therapy Antiretrovirals Care and treatment CD38 antigen CD4 antigen CD4 Lymphocyte Count CD4-Positive T-Lymphocytes - drug effects CD4-Positive T-Lymphocytes - immunology CD8 antigen Cell Proliferation Chronic infection Clinical trials Cytokines Drug Administration Schedule Drug resistance Drug Resistance, Viral Drug therapy Female Highly active antiretroviral therapy HIV HIV (Viruses) HIV infections HIV Infections - drug therapy HIV Infections - immunology HIV Infections - virology HIV patients Human immunodeficiency virus Humans Immune response Immunology Immunotherapy Infeccions per VIH Infections Infectious diseases Inflamació Inflammation Interleukin 2 Interleukin-2 - administration & dosage Interleukins Male Males Patient outcomes Patients Resposta immunitària Sexually transmitted diseases STD Treatment Outcome VIH (Virus) Viral Load |
| title | Structured Treatment Interruptions and Low Doses of IL-2 in Patients with Primary HIV Infection. Inflammatory, Virological and Immunological Outcomes |
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