Pooled analysis of 3 randomized, controlled trials of interleukin-2 therapy in adult human immunodeficiency virus type 1 disease.
We collected human immunodeficiency virus (HIV) disease progression, survival, most recent CD4 cell count, and plasma HIV RNA levels from patients (n=157) who participated in randomized clinical trials of interleukin (IL)-2 that commenced before 1995. Data were available for 155 (99%) patients. Statistical analyses were based on the intention-to-treat principle. Median follow-up was 28 months and 30 months for control and IL-2 patients, respectively. Twenty-five (16%) patients developed AIDS or died during follow-up (16 control patients vs. 9 IL-2 patients; R2=0.57; P=.22). Mean change from baseline CD4 cell count was significantly higher in patients randomized to receive IL-2 (368 vs. 153 cells/microL; P=.003). Mean change from baseline plasma HIV RNA was significantly lower in patients randomized to receive IL-2 (-0.98 vs. -0.63 log copies/mL; P=.004). Significant improvements in CD4 cell count and plasma HIV RNA in recipients of IL-2 relative to control patients were associated with a nonsignificant trend toward improved clinical outcome.
National Centre in HIV Epidemiology and Clinical Research, Sydney, NSW 2010, Australia. semery@nchecr.unsw.edu.au.
S
S
Emery
W B
WB
Capra
D A
DA
Cooper
R T
RT
Mitsuyasu
J A
JA
Kovacs
P
P
Vig
M
M
Smolskis
L D
LD
Saravolatz
H C
HC
Lane
G A
GA
Fyfe
P T
PT
Curtin
D000328:Adult; D018791:CD4 Lymphocyte Count; D005260:Female; D015658:HIV Infections / Q000188:drug therapy* / Q000401:mortality; D015497:HIV-1; D006801:Humans; D007376:Interleukin-2 / Q000627:therapeutic use*; D008297:Male; D012367:RNA, Viral / Q000097:blood; D019562:Viral Load
D007376:Interleukin-2; D012367:RNA, Viral