Losso M, Belloso W, Benetucci J, Cahn P, Lasala M, Lopardo G, Salomon H, Saracco M, Emery S, Allende M, Law M, Davey R, Lane HC; Conference on Retroviruses and Opportunistic Infections.
Program Abstr 6th Conf Retrovir Oppor Infect Conf Retrovir Oppor Infect 6th 1999 Chic Ill. 1999 Jan 31-Feb 4; 6th: 134 (abstract no. 354).
Hospital J.M. Ramos, Buenos Aires, Argentina.
The objectives of this study were to determine the safety of scIL2 administration and to compare the effects of therapy with scIL2 plus ARV versus ARV alone on CD4 cell counts and plasma HIV-RNA levels. A phase II, randomized, dose finding, open label study was conducted in patients with a CD4+ cell count > 350/mm3 and no history of AIDS defining ilnesses. 73 patients were randomized to receive ARV (n=37) or ARV plus scIL2 (n=36) at escalating doses of 1.5 MIU, 4.5 MIU and 7.5 MIU. 44% of IL2 and 51% of control patients were treated with HAART. IL-2 was delivered bid in cycles of 5 days every eight weeks for a total of 3 cycles. Results at 24 weeks are summarized in the table below. Values are the mean change from baseline for each sc IL2 group minus control group values. Treatment arm CD4(cells/mm3) bDNA (log cps/ml). (Table: see text) The most common side effects of IL-2 cycles were fever (64%), malaise (55%) and rash (38%). Two gr, IV events were possibly related to IL2 (erythema multiforme and fever). Permanent discontinuation was required in one patient. Eleven cycles were interrupted in three patients. We conclude from these data that scIL2 therapy is generally well tolerated and significantly increases the CD4+ cell count without significant changes in plasma HIV-RNA level. Long term evaluation of IL-2 efficacy is presently underway.
Publication Types:
Keywords:
- AIDS Vaccines
- Acquired Immunodeficiency Syndrome
- Antiretroviral Therapy, Highly Active
- CD4 Lymphocyte Count
- HIV Infections
- HIV Seropositivity
- Humans
- Interleukin-2
- methods
Other ID:
UI: 102189011
From Meeting Abstracts