Concomitant therapy with subcutaneous interleukin-2 and zidovudine plus didanosine in patients with early stage HIV infection

A phase II study was performed to evaluate the feasibility and activity of subcutaneous (SC) interleukin-2 (IL-2) administration plus zidovudine (ZDV) and didanosine (ddI) in patients with early stage HIV infection. Between O ctober 1995 and October 1996, 12 patients completed 6 cycles of the followi ng scheduled therapy: ZDV plus ddI and SC self-administration of 6 mIU of I L-2 at days 1 to 5 and 8 to 12 of a 28-day cycle for a total of 6 cycles (2 4 weeks). After 6 cycles, patients received only ZDV plus ddI and they were observed up for an additional 24 weeks. Our schedule was well tolerated as an outpatient regimen and led to a significant elevation in CD4 count, whi ch lasted for 24 weeks after the end of IL-2 therapy. Moreover, CD4/CD25, a s well as CD4/CD45RO and CD4/CD45RA, cell levels were significantly increas ed at the end of the therapy and remained significantly elevated after 24 w eeks. During the 6 cycles, HIV-associated viremia was significantly decreas ed and, accordingly, we observed a significant decline of proviral DNA in p eripheral blood mononuclear cells (PBMCs). During follow-up, 10 of 12 treat ed patients continued to show levels of HIV-related viremia <500 copies/ml. Our results demonstrated that IL-2 and ZDV plus ddI is a well tolerated an d effective therapy for patients with HIV in early stages of the disease.