Objectives: To assess the immunological and virological effects, safety profile and feasibility of subcutaneous interleukin-2 (scIL-2) therapy in an HIV-infected Thai population.Design: Seventy-two patients with baseline CD4 cell count of ≥350´106/l and no history of opportunistic infection were randomized to receive antiretroviral therapy plus scIL-2 (scIL-2 group) or antiretroviral therapy alone (control group). scIL-2 was administered at one of three doses for at least 24 weeks. The main measure of treatment efficacy was change in CD4 cell count.Results: The time-weighted mean change in CD4 cell count from baseline to week 24 was +252´106/l for the scIL-2 group compared with +42´106/l for the control group (P < 0.0001). Changes in plasma HIV RNA were not signi®cantly different between the groups over the same time period: there was a 0.83 log10 copies/ml decrease for the scIL-2 group and a 0.70 log copies/ml decrease for the control group (P =0.362).Conclusions: This study provides the most extensive experience of scIL-2 therapy inHIV-1 infected women and Asians, and demonstrates the immunological ef®cacy, tolerability and feasability of scIL-2 therapy in this population. Data from this study were instrumental in guiding the selection of the scIL-2 dosing regimen for ongoing phase III trials.

AIDS Care ปี 2543, ปีที่: 14 ฉบับที่ 16 หน้า 2509-2513