Document Detail


Quality of life in a clinical trial of highly active antiretroviral therapy alone or with intravenous or subcutaneous interleukin-2 administration.
MedLine Citation:
PMID:  16280697     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
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). DESIGN: Randomized clinical trial. SETTING: Twenty-two institutions from the Adult AIDS Clinical Trials Group. PATIENTS: 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. OUTCOME MEASURES: 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:
Barbara K Martin; Albert W Wu; Rebecca Gelman; Ronald T Mitsuyasu;
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Publication Detail:
Type:  Clinical Trial; Journal Article; Randomized Controlled Trial; Research Support, N.I.H., Extramural; Research Support, Non-U.S. Gov't    
Journal Detail:
Title:  Journal of acquired immune deficiency syndromes (1999)     Volume:  40     ISSN:  1525-4135     ISO Abbreviation:  J. Acquir. Immune Defic. Syndr.     Publication Date:  2005 Dec 
Date Detail:
Created Date:  2005-11-10     Completed Date:  2006-01-10     Revised Date:  2007-11-14    
Medline Journal Info:
Nlm Unique ID:  100892005     Medline TA:  J Acquir Immune Defic Syndr     Country:  United States    
Other Details:
Languages:  eng     Pagination:  428-33     Citation Subset:  IM; X    
Affiliation:
The Johns Hopkins Bloomberg School of Public Health, Baltimore, MD 21205, USA. bmartin@jhsph.edu
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MeSH Terms
Descriptor/Qualifier:
Acquired Immunodeficiency Syndrome / drug therapy*
Adult
Antiretroviral Therapy, Highly Active*
Drug Therapy, Combination
Humans
Injections, Intravenous
Injections, Subcutaneous
Interleukin-2 / administration & dosage*
Quality of Life*
Grant Support
ID/Acronym/Agency:
AI-25859/AI/NIAID NIH HHS; AI-25868/AI/NIAID NIH HHS; AI-25879/AI/NIAID NIH HHS; AI-25903/AI/NIAID NIH HHS; AI-25924/AI/NIAID NIH HHS; AI-27658/AI/NIAID NIH HHS; AI-27659/AI/NIAID NIH HHS; AI-27660/AI/NIAID NIH HHS; AI-27661/AI/NIAID NIH HHS; AI-27663/AI/NIAID NIH HHS; AI-27665/AI/NIAID NIH HHS; AI-27666/AI/NIAID NIH HHS; AI-27668/AI/NIAID NIH HHS; AI-27673/AI/NIAID NIH HHS; AI-27767/AI/NIAID NIH HHS; AI-32770/AI/NIAID NIH HHS; AI-32775/AI/NIAID NIH HHS; AI-32782/AI/NIAID NIH HHS; AI-34853/AI/NIAID NIH HHS; AI-36219/AI/NIAID NIH HHS; AI-38844/AI/NIAID NIH HHS; AI-39156/AI/NIAID NIH HHS; AI-46370/AI/NIAID NIH HHS; AI-46386/AI/NIAID NIH HHS; AI-50410/AI/NIAID NIH HHS; RR-00046/RR/NCRR NIH HHS; RR-00047/RR/NCRR NIH HHS; RR-00052/RR/NCRR NIH HHS; RR-00865/RR/NCRR NIH HHS; RR-05096/RR/NCRR NIH HHS; U01 AI-38858/AI/NIAID NIH HHS
Chemical
Reg. No./Substance:
0/Interleukin-2

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