Recombinant Interleukin-2 (IL-2) in Acquired Immune Deficiency Syndrome (AIDS): Preliminary report in patients with lymphoma associated to HIV infection

In an ongoing phase II study, 12 patients with lymphoma and HIV infection were treated with zidovudine (ZDV) and recombinant interleukin-2 (rIL-2) to evaluate if this association may produce beneficial effect on the immunologic status and the outcome of lymphoma. The protocol included daily doses of rIL-2 at 6 MIU/m2 over 5 days in c.i. per week for a total 4 courses; ZDV was associated at 600 mg/d in the period under study. An improved CD4 count, exceeding 2- to 4-fold the basal count, was obtained in patients with a basal CD4 number greater than 100/microliters accompanied by a significant increase of NK and LAK activity (p less than 0.001). From the clinical point of view the reduction of tumor manifestation was proportional to CD4 basal number; 2 patients from those with CD4 greater than 100/microliters obtained a complete remission after rIL-2 and ZVD. The p24 antigen, taken as parameter of viral replication, remained invariably negative after rIL-2 and ZDV in patients already negative and became negative in 1 patient previously positive. Our conclusion is that the association of rIL-2 and AZT is safe and useful in patients with lymphoma and HIV infection.