Effects of intermittent IL-2 alone or with peri-cycle antiretroviral therapy in early HIV infection: the STALWART study.
<h4>Background</h4>The Study of Aldesleukin with and without antiretroviral therapy (STALWART) evaluated whether intermittent interleukin-2 (IL-2) alone or with antiretroviral therapy (ART) around IL-2 cycles increased CD4(+) counts compared to no therapy.<h4>Methodology</h4>...
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Public Library of Science (PLoS)
2010-02-01
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| Series: | PLoS ONE |
| Online Access: | https://journals.plos.org/plosone/article/file?id=10.1371/journal.pone.0009334&type=printable |
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| author | Jorge A Tavel INSIGHT STALWART Study Group Abdel Babiker Lawrence Fox Daniela Gey Gustavo Lopardo Norman Markowitz Nicholas Paton Deborah Wentworth Nicole Wyman |
| author_facet | Jorge A Tavel INSIGHT STALWART Study Group Abdel Babiker Lawrence Fox Daniela Gey Gustavo Lopardo Norman Markowitz Nicholas Paton Deborah Wentworth Nicole Wyman |
| author_sort | Jorge A Tavel |
| collection | DOAJ |
| description | <h4>Background</h4>The Study of Aldesleukin with and without antiretroviral therapy (STALWART) evaluated whether intermittent interleukin-2 (IL-2) alone or with antiretroviral therapy (ART) around IL-2 cycles increased CD4(+) counts compared to no therapy.<h4>Methodology</h4>Participants not on continuous ART with > or = 300 CD4(+) cells/mm(3) were randomized to: no treatment; IL-2 for 5 consecutive days every 8 weeks for 3 cycles; or the same IL-2 regimen with 10 days of ART administered around each IL-2 cycle. CD4(+) counts, HIV RNA, and HIV progression events were collected monthly.<h4>Principal findings</h4>A total of 267 participants were randomized. At week 32, the mean CD4(+) count was 134 cells greater in the IL-2 alone group (p<0.001), and 133 cells greater in the IL-2 plus ART group (p<0.001) compared to the no therapy group. Twelve participants in the IL-2 groups compared to 1 participant in the group assigned to no therapy experienced an opportunistic event or died (HR 5.84, CI: 0.59 to 43.57; p = 0.009).<h4>Conclusions</h4>IL-2 alone or with peri-cycle HAART increases CD4(+) counts but was associated with a greater number of opportunistic events or deaths compared to no therapy. These results call into question the immunoprotective significance of IL-2-induced CD4(+) cells.<h4>Trial registration</h4>ClinicalTrials.gov NCT00110812. |
| format | Article |
| id | doaj-art-fff474632b3342f48fa59bd301fcac40 |
| institution | DOAJ |
| issn | 1932-6203 |
| language | English |
| publishDate | 2010-02-01 |
| publisher | Public Library of Science (PLoS) |
| record_format | Article |
| series | PLoS ONE |
| spelling | doaj-art-fff474632b3342f48fa59bd301fcac402025-08-20T03:07:40ZengPublic Library of Science (PLoS)PLoS ONE1932-62032010-02-0152e933410.1371/journal.pone.0009334Effects of intermittent IL-2 alone or with peri-cycle antiretroviral therapy in early HIV infection: the STALWART study.Jorge A TavelINSIGHT STALWART Study GroupAbdel BabikerLawrence FoxDaniela GeyGustavo LopardoNorman MarkowitzNicholas PatonDeborah WentworthNicole Wyman<h4>Background</h4>The Study of Aldesleukin with and without antiretroviral therapy (STALWART) evaluated whether intermittent interleukin-2 (IL-2) alone or with antiretroviral therapy (ART) around IL-2 cycles increased CD4(+) counts compared to no therapy.<h4>Methodology</h4>Participants not on continuous ART with > or = 300 CD4(+) cells/mm(3) were randomized to: no treatment; IL-2 for 5 consecutive days every 8 weeks for 3 cycles; or the same IL-2 regimen with 10 days of ART administered around each IL-2 cycle. CD4(+) counts, HIV RNA, and HIV progression events were collected monthly.<h4>Principal findings</h4>A total of 267 participants were randomized. At week 32, the mean CD4(+) count was 134 cells greater in the IL-2 alone group (p<0.001), and 133 cells greater in the IL-2 plus ART group (p<0.001) compared to the no therapy group. Twelve participants in the IL-2 groups compared to 1 participant in the group assigned to no therapy experienced an opportunistic event or died (HR 5.84, CI: 0.59 to 43.57; p = 0.009).<h4>Conclusions</h4>IL-2 alone or with peri-cycle HAART increases CD4(+) counts but was associated with a greater number of opportunistic events or deaths compared to no therapy. These results call into question the immunoprotective significance of IL-2-induced CD4(+) cells.<h4>Trial registration</h4>ClinicalTrials.gov NCT00110812.https://journals.plos.org/plosone/article/file?id=10.1371/journal.pone.0009334&type=printable |
| spellingShingle | Jorge A Tavel INSIGHT STALWART Study Group Abdel Babiker Lawrence Fox Daniela Gey Gustavo Lopardo Norman Markowitz Nicholas Paton Deborah Wentworth Nicole Wyman Effects of intermittent IL-2 alone or with peri-cycle antiretroviral therapy in early HIV infection: the STALWART study. PLoS ONE |
| title | Effects of intermittent IL-2 alone or with peri-cycle antiretroviral therapy in early HIV infection: the STALWART study. |
| title_full | Effects of intermittent IL-2 alone or with peri-cycle antiretroviral therapy in early HIV infection: the STALWART study. |
| title_fullStr | Effects of intermittent IL-2 alone or with peri-cycle antiretroviral therapy in early HIV infection: the STALWART study. |
| title_full_unstemmed | Effects of intermittent IL-2 alone or with peri-cycle antiretroviral therapy in early HIV infection: the STALWART study. |
| title_short | Effects of intermittent IL-2 alone or with peri-cycle antiretroviral therapy in early HIV infection: the STALWART study. |
| title_sort | effects of intermittent il 2 alone or with peri cycle antiretroviral therapy in early hiv infection the stalwart study |
| url | https://journals.plos.org/plosone/article/file?id=10.1371/journal.pone.0009334&type=printable |
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