dc.contributor.author | Tavel, JA | en_US |
dc.contributor.author | INSIGHT STALWART Study Group | en_US |
dc.contributor.author | Babiker, A | en_US |
dc.contributor.author | Fox, L | en_US |
dc.contributor.author | Gey, D | en_US |
dc.contributor.author | Lopardo, G | en_US |
dc.contributor.author | Markowitz, N | en_US |
dc.contributor.author | Paton, N | en_US |
dc.contributor.author | Wentworth, D | en_US |
dc.contributor.author | Wyman, N | en_US |
dc.date.accessioned | 2020-01-08T13:45:10Z | |
dc.date.available | 2010-01-08 | en_US |
dc.date.issued | 2010-02-23 | en_US |
dc.identifier.uri | https://qmro.qmul.ac.uk/xmlui/handle/123456789/62285 | |
dc.description.abstract | 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. | en_US |
dc.description.sponsorship | STALWART was supported by grants U01 AI068641 from the National Institute of Allergy and Infectious Diseases (NIAID). | en_US |
dc.format.extent | e9334 - ? | en_US |
dc.language | eng | en_US |
dc.language.iso | en | en_US |
dc.relation.ispartof | PLoS One | en_US |
dc.rights | Creative Commons Attribution License | |
dc.rights | Attribution 3.0 United States | * |
dc.rights.uri | http://creativecommons.org/licenses/by/3.0/us/ | * |
dc.subject | Adult | en_US |
dc.subject | Anti-HIV Agents | en_US |
dc.subject | Atazanavir Sulfate | en_US |
dc.subject | CD4 Lymphocyte Count | en_US |
dc.subject | Carbamates | en_US |
dc.subject | Drug Administration Schedule | en_US |
dc.subject | Drug Therapy, Combination | en_US |
dc.subject | Female | en_US |
dc.subject | Fever | en_US |
dc.subject | HIV Infections | en_US |
dc.subject | Humans | en_US |
dc.subject | Interleukin-2 | en_US |
dc.subject | Lopinavir | en_US |
dc.subject | Male | en_US |
dc.subject | Nausea | en_US |
dc.subject | Oligopeptides | en_US |
dc.subject | Opportunistic Infections | en_US |
dc.subject | Organophosphates | en_US |
dc.subject | Pyridines | en_US |
dc.subject | Pyrimidinones | en_US |
dc.subject | Ritonavir | en_US |
dc.subject | Sulfonamides | en_US |
dc.subject | Treatment Outcome | en_US |
dc.title | Effects of intermittent IL-2 alone or with peri-cycle antiretroviral therapy in early HIV infection: the STALWART study. | en_US |
dc.type | Article | |
dc.identifier.doi | 10.1371/journal.pone.0009334 | en_US |
pubs.author-url | https://www.ncbi.nlm.nih.gov/pubmed/20186278 | en_US |
pubs.issue | 2 | en_US |
pubs.notes | Not known | en_US |
pubs.publication-status | Published online | en_US |
pubs.volume | 5 | en_US |
dcterms.dateAccepted | 2010-01-08 | en_US |
rioxxterms.funder | Default funder | en_US |
rioxxterms.identifier.project | Default project | en_US |