Abstract
BackgroundThe 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.MethodologyParticipants not on continuous ART with ≥300 CD4+ cells/mm3 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 FindingsA 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).ConclusionsIL-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 RegistrationClinicalTrials.gov NCT00110812
Highlights
Antiretroviral therapy (ART) has led to significant suppression of HIV replication and improvement in both morbidity and mortality in patients with HIV-infection [1,2,3]
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
The use of IL-2 with antiretrovirals in the pre-antiretroviral therapy (ART) era was associated with transient rises in plasma HIV RNA levels in some study participants, no clinical trial of IL-2 in HIV-infected patients has demonstrated a significant sustained increase in either plasma HIV RNA or intracellular HIV DNA in IL-2 recipients compared to controls
Summary
Antiretroviral therapy (ART) has led to significant suppression of HIV replication and improvement in both morbidity and mortality in patients with HIV-infection [1,2,3]. Once ART has been started, lifelong therapy is required since treatment interruptions are associated with an increased risk of disease progression or death [10]. These limitations of ART have underscored the need to explore adjuvant or alternative therapeutic strategies for the treatment of HIV infection. A number of randomized controlled trials have shown that the use of recombinant interleukin-2 (IL-2) with ART leads to significant and sustained increases in CD4+ counts in HIV-infected patients [11,12,13,14,15,16,17,18,19,20,21,22]. 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
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