INTERLEUKIN 2 BY SUBCUTANEOUS INJECTION COMBINED WITH ANTIRETROVIRAL THERAPY

点击翻译按钮获取中文摘要

ACTG 248 is a multi-center, randomized, open-label trial of a single dose regimen of IL-2 in combination with continued antiretroviral therapy versus antiretroviral therapy alone i subjects with CD4+ cell count 300-700 cells/mm3 and at least 3 consecutive months stable antiretroviral therapy immediately preceding enrollment. A toal of 104 subjects will be enrolled into this study. Subjects willthen be randomized to receive open label IL-2 (1 million IU/d) b subcutaneous infection to rotating sites plus continued antiretroviral therapy versus continued antiretroviral therapy alone. the duration of the initial treatment period (Step 1) will be for 24 weeks. After initiation of the study medications, which will include instructions in self-administration by subcantaneous injection for the IL-2 treatment group, subjects will be followed according the the schedule outlined in Sections 4.2 throught 4.5. This trial is planned to be an entirely outpatient study. At each study visit, subjects will be monitored for indications of toxicity or adverse events. Dosage reduction of IL-2 will be employed for subjective or objective toxicities. All subjects who interrupt antiretroviral therapy must discontinue IL-2 for the same period. Immunologic and virologic markers as well as other laboartory evaluations will be performed as outlined in Sections 4.2 through 4.5.