A Randomized, Controlled 24-week Study of Intermittent Subcutaneous Interleukin-2 in HIV-1 Infected Patients in Thailand
Kiat Ruxrungtham, Surapol Suwanagool, Jorge A. Tavel, Mena Chuenyam, Eugene D. Kroon, Sasiwimol Ubolyam, Supranee Buranapraditkun, Wichai Techasathit, Yeuming Li, Sean Emery, Richard T. Davey, Lisa Fosdick, Chaiyos Kunanusont, H. Clifford Lane, Praphan Phanuphak, the Vanguard Study Group
Thai Red Cross, AIDS Research Centre, 104 Rajadamri Road, Lumpini, Bangkok,Thailand 10330
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