Outpatient continuous intravenous interleukin-2 or subcutaneous, polyethylene glycol-modified interleukin-2 in human immunodeficiency virus-infected patients: a randomized, controlled, multicenter study. Australian IL-2 Study Group.
The safety and activity of outpatient-based continuous intravenous interleukin-2 (CIV IL-2) or a slow-release, polyethylene glycol (PEG)-modified IL-2 were studied in human immunodeficiency virus (HIV)-infected persons with CD4 cell counts between 200 and 500/mm3. One hundred fifteen patients were randomized to antiretroviral therapy plus cyclical CIV IL-2 (n = 27), subcutaneous PEG IL-2 (n = 58), or no IL-2 (n = 30). Toxicity withdrawal rates were low (4% for CIV IL-2 and 7% for PEG IL-2). There were median CD4 cell count increases of 359 and 44 cells/mm3 and a decline of 46 cells/mm3 in the 3 groups, respectively, over 1 year (P < .0001 for each intergroup comparison). CD4 cell count increases were greatest in those with lower HIV RNA load. Delayed-type hypersensitivity scores increased and HLA-DR expression on CD8 cells decreased significantly with IL-2 therapy. HIV RNA levels were unaffected. IL-2 therapy may expand the existing immune repertoire but not immediately reconstitute lost immune function.
Carr
A
A
HIV Medicine Unit, St Vincent's Hospital, Sydney, Australia. acarr@stvincents.com.au
Emery
S
S
Lloyd
A
A
Hoy
J
J
Garsia
R
R
French
M
M
Stewart
G
G
Fyfe
G
G
Cooper
D A
DA
D000328:Adult; D000553:Ambulatory Care; D018791:CD4 Lymphocyte Count; D004333:Drug Administration Routes; D005260:Female; D015658:HIV Infections / Q000188:drug therapy* / Q000276:immunology; D006801:Humans; D006968:Hypersensitivity, Delayed; D007376:Interleukin-2 / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use*; D008297:Male; D011092:Polyethylene Glycols; D012367:RNA, Viral / Q000097:blood
D007376:Interleukin-2; D012367:RNA, Viral; C067245:interleukin-2, polyethylene glycol-modified; D011092:Polyethylene Glycols