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

527-M. Interleukin-2 (IL-2) Added to HAART in Primary HIV Infection Enhances Anti-HIV Immune Responses F. Hecht*1, J. Kahn1, B. Martinez-Marino1, M. Altfeld2, L. Liu1, McGrath1, R. Gascon1, M. Busch1,3, B. Walker 2, and J. Levy1 1Univ. of California, San Francisco; 2Harvard Univ., Boston, MA; and 3Blood Ctrs. of the Pacific, San Francisco, CA Background: The aim of this study is to determine whether adding IL-2 to HAART in treatment of primary HIV improves immune responses to HIV and virologic and clinical outcomes. IL-2 may directly enhance anti-HIV cellular immune responses, and through increasing expression of HIV antigens it may elicit immune responses while the immune system is protected by HAART. Methods: Participants start on HAART within 12 months of HIV infection. Subjects receive treatment with Combivir (zidovudine and lamivudine) and nelfinavir. Subjects are randomized without blinding to receive IL-2 once the HIV-1 RNA is < 500 copies/mL, or HAART alone. 7.5 million units of IL-2 are given SQ twice daily for 5 days every 8 weeks for 6 cycles. The following immunologic parameters are measured: CD4 count, memory/naïve subsets, CTL responses (by ELISPOT), CD8+ non-cytotoxic anti-HIV response (CNAR). Results: Of 43 subjects in this ongoing trial, 18 received IL-2 and 25 are controls. At week 48 from start of HAART, the mean CD4 count was 1669 in the IL-2 group compared with 686 in controls (p < 0.001); both memory and naïve cells were increased. HIV RNA was < 50 copies in 87% of the IL-2 group at week 48, compared with 70% of controls (p> 0.05). In persons in whom analysis is complete, CTL responses developed to new epitopes in 3 of 5 persons in the IL-2 group, 1 of whom had had a brief treatment interruption. In comparison, only 1 of 7 controls developed responses to new epitopes, and this occurred following a treatment interruption. 10 of 13 (77%) subjects in the IL-2 group had > 50% suppression of HIV replication on a CNAR assay, compared to 8 of 21 (38%) HAART without IL-2 (p=0.06). Conclusions: Subjects with primary infection achieved higher CD4 cell counts when IL-2 was added to HAART. HIV RNA levels remained similar in both groups. Both cytoxic and non-cytoxic CD8+ anti-HIV responses were enhanced with IL-2.

©2002 9th Conference on Retroviruses and Opportunistic Infections