Quality of life in a clinical trial of highly active antiretroviral therapy alone or with intravenous or subcutaneous interleukin-2 administration.
OBJECTIVE
To assess the impact of subcutaneous and intravenous interleukin-2 (IL-2) on health-related quality of life (HRQOL) in adults with HIV-1 receiving highly active antiretroviral therapy (HAART).


METHODS
Randomized clinical trial.


METHODS
Twenty-two institutions from the Adult AIDS Clinical Trials Group.


METHODS
One hundred forty-eight HIV-infected adults randomized, with baseline HRQOL data.


METHODS
HAART (indinavir plus 2 nucleoside analogues) for 12 weeks, followed by 72 weeks of continued HAART alone, HAART plus subcutaneous IL-2, or HAART plus intravenous IL-2.


METHODS
Scores for 8 dimensions of HRQOL, an unweighted summary score, and a visual analogue health rating score.


RESULTS
The IL-2 subcutaneous group had the best mean change in 6 of 8 dimension subscales and in the summary scale at 28 weeks (16 weeks after baseline). At 52 weeks, the IL-2 subcutaneous group had the best mean change in all the subscales and the summary scale. The differences were statistically significant for 3 subscales and the summary scale. Midcycle changes were statistically significantly worse for the subcutaneous IL-2 group for 4 subscales and the summary scale.


CONCLUSIONS
We found evidence of a short-term but not long-term adverse impact of IL-2 on HRQOL and some evidence of long-term benefit for the subcutaneous group.
Martin
Barbara K
BK
The Johns Hopkins Bloomberg School of Public Health, Baltimore, MD 21205, USA. bmartin@jhsph.edu
Wu
Albert W
AW
Gelman
Rebecca
R
Mitsuyasu
Ronald T
RT
D000163:Acquired Immunodeficiency Syndrome / Q000188:drug therapy*; D000328:Adult; D023241:Antiretroviral Therapy, Highly Active; D004359:Drug Therapy, Combination; D006801:Humans; D007275:Injections, Intravenous; D007279:Injections, Subcutaneous; D007376:Interleukin-2 / Q000008:administration & dosage*; D011788:Quality of Life
D007376:Interleukin-2