Therapy of acquired immune deficiency syndrome with recombinant interleukin-2.

ABSTRACT

Recombinant human interleukin-2 (rIL-2) was administered to 87 patients with the acquired immune deficiency syndrome (AIDS) to test the hypothesis that this lymphokine would correct the underlying qualitative and quantitative deficiency in cellular immunity. Patients were divided into two groups by the presence or absence of Kaposi's sarcoma and subjects within each of these groups received intravenous rIL-2 three times weekly for eight weeks. Subjects received one of several doses which ranged from 1,000 to 2,000,000 units per square meter body surface area. Toxicity at high doses consisted of flu-like symptoms and hypotension at highest doses. Partial objective tumor regression was observed in three patients with Kaposi's sarcoma. Seventeen patients had progression of disease (new opportunistic infection or increase in Kaposi's sarcoma) during therapy. No improvement in immunologic status was observed. This study does not suggest a role for single-agent rIL-2 therapy of established AIDS but its use in less symptomatic persons or in conjunction with antiretroviral agents such as azidothymidine should be investigated.