Effects of intermittent IL-2 alone or with peri-cycle antiretroviral therapy in early HIV infection: the STALWART study.
BACKGROUND: 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. METHODOLOGY: Participants not on continuous ART wi...
| मुख्य लेखकों: | , , , , , , , , |
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| स्वरूप: | Journal article |
| भाषा: | English |
| प्रकाशित: |
2010
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| _version_ | 1826291143545978880 |
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| author | Tavel, J Babiker, A Fox, L Gey, D Lopardo, G Markowitz, N Paton, N Wentworth, D Wyman, N |
| author_facet | Tavel, J Babiker, A Fox, L Gey, D Lopardo, G Markowitz, N Paton, N Wentworth, D Wyman, N |
| author_sort | Tavel, J |
| collection | OXFORD |
| description | BACKGROUND: 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. METHODOLOGY: 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. PRINCIPAL FINDINGS: 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). CONCLUSIONS: 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. TRIAL REGISTRATION: ClinicalTrials.gov NCT00110812. |
| first_indexed | 2024-03-07T02:54:58Z |
| format | Journal article |
| id | oxford-uuid:aef3f5ca-a828-42a6-b782-9f2e9ba8babc |
| institution | University of Oxford |
| language | English |
| last_indexed | 2024-03-07T02:54:58Z |
| publishDate | 2010 |
| record_format | dspace |
| spelling | oxford-uuid:aef3f5ca-a828-42a6-b782-9f2e9ba8babc2022-03-27T03:46:21ZEffects of intermittent IL-2 alone or with peri-cycle antiretroviral therapy in early HIV infection: the STALWART study.Journal articlehttp://purl.org/coar/resource_type/c_dcae04bcuuid:aef3f5ca-a828-42a6-b782-9f2e9ba8babcEnglishSymplectic Elements at Oxford2010Tavel, JBabiker, AFox, LGey, DLopardo, GMarkowitz, NPaton, NWentworth, DWyman, NBACKGROUND: 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. METHODOLOGY: 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. PRINCIPAL FINDINGS: 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). CONCLUSIONS: 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. TRIAL REGISTRATION: ClinicalTrials.gov NCT00110812. |
| spellingShingle | Tavel, J Babiker, A Fox, L Gey, D Lopardo, G Markowitz, N Paton, N Wentworth, D Wyman, N Effects of intermittent IL-2 alone or with peri-cycle antiretroviral therapy in early HIV infection: the STALWART study. |
| 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 |
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