title: Quality of life in a clinical trial of highly active antiretroviral therapy alone or with intravenous or subcutaneous interleukin-2 administration.
abstract: 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.
authors.affiliation: The Johns Hopkins Bloomberg School of Public Health, Baltimore, MD 21205, USA. bmartin@jhsph.edu
authors.forename: Barbara K
authors.initials: BK
authors.lastname: Martin
authors.forename: Albert W
authors.initials: AW
authors.lastname: Wu
authors.forename: Rebecca
authors.initials: R
authors.lastname: Gelman
authors.forename: Ronald T
authors.initials: RT
authors.lastname: Mitsuyasu
mesh_terms: 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
chemical_list: D007376:Interleukin-2