TY - JOUR
T1 - Outpatient continuous intravenous interleukin-2 or subcutaneous, polyethylene glycol-modified interleukin-2 in human immunodeficiency virus- infected patients
T2 - A randomized, controlled, multicenter study
AU - Carr, Andrew
AU - Emery, Scan
AU - Lloyd, Andrew
AU - Hoy, Jennifer
AU - Garsia, Roger
AU - French, Martyn
AU - Stewart, Graeme
AU - Fyfe, Gwendolyn
AU - Cooper, David A.
N1 - Funding Information:
Received 19 February 1998; revised 5 May 1998. Presented in part: XI International Conference on AIDS, Vancouver, Canada, July 1996 (abstract We.B.292). Written, informed consent was obtained from each participant, and the study protocol was approved by each institution’s research ethics committee. Financial support: The National Centre in HIV Epidemiology and Clinical Research is supported by the Commonwealth Department of Health and Family Services through the Australian National Council on AIDS and Related Diseases and its Research Advisory Committee. The trial was sponsored by a grant from Chiron Corp. Reprints or correspondence: Dr. Andrew Carr, HIV Medicine Unit, St. Vincent’s Hospital, Sydney, 2010, Australia ([email protected]). * Present affiliation: Genentech, South San Francisco, Califiornia. † Study group members are listed after text.
PY - 1998
Y1 - 1998
N2 - 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.
AB - 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.
UR - http://www.scopus.com/inward/record.url?scp=0031680651&partnerID=8YFLogxK
U2 - 10.1086/515653
DO - 10.1086/515653
M3 - Article
C2 - 9806026
AN - SCOPUS:0031680651
SN - 0022-1899
VL - 178
SP - 992
EP - 999
JO - Journal of Infectious Diseases
JF - Journal of Infectious Diseases
IS - 4
ER -
