This is a multi center, randomized, open label trial of low dose IL-2 in combination with continued antiretroviral (ARV) therapy vs. ARV therapy alone in HIV+ males and females, ages 18 and older with CD4 cell counts between 300 and 700 cells/mm3 and a stable ARV regimen for at least 2 months prior to study entry. Subjects may not have had a previous AIDS defining diagnosis. This study seeks to determine whether the replacement of IL-2 may help restore anti-HIV immunity in addition to overall immune competence and responses to routine protein and/or polysaccharide vaccines. Non-toxic treatment regimens using IL-2 are now available. This suggests tht IL-2 in combination with ARV agents is likely to be well tolerated over a long course of treatment and be of benefit to persons with HIV infection.

Agency
National Institute of Health (NIH)
Institute
National Center for Research Resources (NCRR)
Type
General Clinical Research Centers Program (M01)
Project #
3M01RR005096-09S1
Application #
6298307
Study Section
Project Start
1997-12-01
Project End
1999-06-30
Budget Start
1997-10-01
Budget End
1998-09-30
Support Year
9
Fiscal Year
1999
Total Cost
Indirect Cost
Name
Tulane University
Department
Type
DUNS #
City
New Orleans
State
LA
Country
United States
Zip Code
70118
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