title: Effects of intermittent IL-2 alone or with peri-cycle antiretroviral therapy in early HIV infection: the STALWART study.
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.
  
  
  METHODS
  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.
  
  
  RESULTS
  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.
  
  
  BACKGROUND
  ClinicalTrials.gov NCT00110812.
authors.affiliation: National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, Maryland, United States of America.
authors.forename: Jorge A
authors.initials: JA
authors.lastname: Tavel
authors.forename: Abdel
authors.initials: A
authors.lastname: Babiker
authors.forename: Lawrence
authors.initials: L
authors.lastname: Fox
authors.forename: Daniela
authors.initials: D
authors.lastname: Gey
authors.forename: Gustavo
authors.initials: G
authors.lastname: Lopardo
authors.forename: Norman
authors.initials: N
authors.lastname: Markowitz
authors.forename: Nicholas
authors.initials: N
authors.lastname: Paton
authors.forename: Deborah
authors.initials: D
authors.lastname: Wentworth
authors.forename: Nicole
authors.initials: N
authors.lastname: Wyman
mesh_terms: D000328:Adult; D019380:Anti-HIV Agents / Q000009:adverse effects / Q000627:therapeutic use*; D000069446:Atazanavir Sulfate; D018791:CD4 Lymphocyte Count; D002219:Carbamates / Q000627:therapeutic use; D004334:Drug Administration Schedule; D004359:Drug Therapy, Combination; D005260:Female; D005334:Fever / Q000139:chemically induced; D005663:Furans; D015658:HIV Infections / Q000188:drug therapy* / Q000276:immunology; D006801:Humans; D007376:Interleukin-2 / Q000009:adverse effects / Q000627:therapeutic use*; D061466:Lopinavir; D008297:Male; D009325:Nausea / Q000139:chemically induced; D009842:Oligopeptides / Q000627:therapeutic use; D009894:Opportunistic Infections / Q000139:chemically induced; D010755:Organophosphates / Q000627:therapeutic use; D011725:Pyridines / Q000627:therapeutic use; D011744:Pyrimidinones / Q000627:therapeutic use; D019438:Ritonavir / Q000627:therapeutic use; D013449:Sulfonamides / Q000627:therapeutic use; D016896:Treatment Outcome
chemical_list: D019380:Anti-HIV Agents; D002219:Carbamates; D005663:Furans; D007376:Interleukin-2; D009842:Oligopeptides; D010755:Organophosphates; D011725:Pyridines; D011744:Pyrimidinones; D013449:Sulfonamides; D061466:Lopinavir; D000069446:Atazanavir Sulfate; D019438:Ritonavir; C426859:fosamprenavir