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Clinical Trial
. 2010 Feb 23;5(2):e9334.
doi: 10.1371/journal.pone.0009334.

Effects of intermittent IL-2 alone or with peri-cycle antiretroviral therapy in early HIV infection: the STALWART study

Jorge A Tavel  1 ; INSIGHT STALWART Study Group; Abdel Babiker, Lawrence Fox, Daniela Gey, Gustavo Lopardo, Norman Markowitz, Nicholas Paton, Deborah Wentworth, Nicole Wyman
Collaborators, Affiliations
Clinical Trial

Effects of intermittent IL-2 alone or with peri-cycle antiretroviral therapy in early HIV infection: the STALWART study

Jorge A Tavel et al. PLoS One. .

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.

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Conflict of interest statement

Competing Interests: The United States government has been issued a patent for the use of rIL-2 in HIV infection naming HC Lane as a co-inventor.

Figures

Figure 1
Figure 1. STALWART study design and CONSORT flow diagram.
Figure 2
Figure 2. Median CD4+ cell count.
Figure 3
Figure 3. Time to first use of continuous antiretroviral therapy and time to first opportunistic event or death.
See this image and copyright information in PMC

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