Cookies on this website
We use cookies to ensure that we give you the best experience on our website. If you click 'Continue' we'll assume that you are happy to receive all cookies and you won't see this message again. Click 'Find out more' for information on how to change your cookie settings.

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.

Original publication

DOI

10.1371/journal.pone.0009334

Type

Journal article

Journal

PLoS One

Publication Date

23/02/2010

Volume

5

Keywords

Adult, Anti-HIV Agents, Atazanavir Sulfate, CD4 Lymphocyte Count, Carbamates, Drug Administration Schedule, Drug Therapy, Combination, Female, Fever, HIV Infections, Humans, Interleukin-2, Lopinavir, Male, Nausea, Oligopeptides, Opportunistic Infections, Organophosphates, Pyridines, Pyrimidinones, Ritonavir, Sulfonamides, Treatment Outcome