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Abstract
QUALITY OF LIFE IN A RANDOMIZED CONTROLLED TRIAL OF HIGHLY ACTIVE ANTI-RETROVIRAL THERAPY WITH INTERMITTENT IL-2 BY IV OR SC ROUTES IN PATIENTS WITH CD4 50-350 CELLS/MM3 (ACTG 328).
WU A, MARTIN B, GELMAN R, MITSUYASU R, ACTG 328 TEAM
Background: Although IL-2 may offer immunologic and virologic benefits for patients with HIV, it may also reduce quality of life (QOL). We assessed the effects of IL-2 given by CIV or SC routes added to HAART vs HAART alone on QOL as a secondary endpoint for patients with advanced HIV.
Methods: This was part of a multicenter, randomized clinical trial. After 12 weeks on HAART alone, patients were randomized to HAART alone (n=51), HAART+CIV IL-2 x 5d q 8 wks (n=53), or HAART+SC IL-2 x 5d q 8 wks (n=54). QOL was assessed using ACTG Forms QL 601-602, which measure aspects of functioning and well-being, at weeks 12, 16, 28 and 52 of the study. Analyses compared changes in summary scores by group.
Results: As shown in the table below, at week 16, changes were small and similar for the 3 groups. At week 52, QOL summary score was improved for the SC IL-2 group vs both IV and HAART alone (P<.05)
HAART H+CIV IL-2 H+SC IL-2
QOL Summary Score week 16 -0.2 -1.7 -0.7
QOL Summary Score week 52 -2.7 -3.1 +3.7*
*p<.05
Conclusions: In this large prospective randomized study of IL-2 in advanced HIV, significant increases in CD4+ counts were seen and QOL was not significantly diminished after 40 weeks of intermittent SC IL-2. A significant QOL benefit was seen in the SC IL-2 group compared to IV IL-2 and HAART alone groups.
The 1st. IAS Conference on HIV Pathogenesis and Treatment
Abstract no.
105
Suggested Citation
"WUA, et al.
QUALITY OF LIFE IN A RANDOMIZED CONTROLLED TRIAL OF HIGHLY ACTIVE ANTI-RETROVIRAL THERAPY WITH INTERMITTENT IL-2 BY IV OR SC ROUTES IN PATIENTS WITH CD4 50-350 CELLS/MM3 (ACTG 328)..
Oral Presentation:
The 1st. IAS Conference on HIV Pathogenesis and Treatment
:
Abstract no.
105"
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