Abstract

E-mail Abstract Author Add To Itinerary Session Search Abstracts Program

Session 71 Poster Session IL-2 and Other Forms of Immunotherapy Session Time: 4:30-6:30 pm Room 4E-F

518-M. Preliminary Analysis of the Safety and Immunologic Activity of Recombinant IL-2 in Children and Adolescents with HIV Infection L. V. Wood*, J. Zuckerman, S. Steinberg, D. Liewehr, E. DeCarlo, M. Beals, J. Wigginton, and the Pediatric HIV Working Group. 1NCI, NIH, Bethesda, MD Background: Quantitative and qualitative defects in immune function often persist despite treatment with highly active antiretroviral therapy (HAART). Interleukin-2 (IL-2) is a critical mediator of both cellular and humoral immune function and may contribute to the reconstitution and preservation of immune function in HIV-infected patients. Methods: This is a prospective, pilot study in which patients were observed for 8 weeks on a stable antiretroviral drug regimen prior to the addition of rIL-2 administered subcutaneously BID for 5 days every 8 weeks. Patients were enrolled sequentially into low-dose (1.0 million IU/m2/dose), then high-dose (4.5 million IU/m2/dose) cohorts and stratified according to baseline CD4 count: 200-499 cells/mm3 or > 500 cells/mm3. Results: 44 patients with CD4 counts > 200 cells/mm3 at entry (median age 10.2, range 3.5-20.3 years) received a median of 10 cycles of rIL-2 (range 1-22) during the course of the study. 8 patients went off-study prior to receipt of IL-2. A rIL-2 dose of 3.0 million IU/m2/dose sc BID was identified as the maximum tolerated dose. Despite individual fluctuations in viral loads, rIL-2 administration was not associated with acute (5 day cycle) or chronic (multiple cycles) elevations in HIV-1-RNA levels. Median increase in CD4 cell counts was 97 cells/mm3 (range: -273 to +653 cells) after 3 cycles and 118 cells/mm3 (range: -72 to +1350 cells) after 6 cycles. There was a trend of greater increases in CD4 counts associated with higher doses of rIL-2 and a baseline CD4 count of > 500 cells/mm3. Improved DTH responses to recall antigens were observed in 15 of 32 patients (47%) completing at least 3 cycles of rIL-2. The most common side effects included fever, malaise/fatigue, nasal congestion, and local injection site reactions. No new or unanticipated clinical or laboratory toxicities attributable to rIL-2 were documented during the course of this study. Conclusions: Recombinant IL-2 is safe and well tolerated, and can be administered chronically on an outpatient basis and is associated with modest increases in CD4 counts and immune function.

©2002 9th Conference on Retroviruses and Opportunistic Infections