Buimovici-Klein E, Ong K R, Lange M, Englard A, McKinley G F, Reddy M, Grieco M H, Cooper L Z
AIDS Res. 1986 Fall;2(4):279-83. doi: 10.1089/aid.1.1986.2.279.
HPA-23 was used in a parallel, multiple dose study in patients with Centers for Disease Control (CDC)-defined AIDS. Sixteen patients were divided into four dosage groups, receiving 0.25, 0.5, 1.0, or 2.0 mg/kg HPA-23 respectively, by rapid IV infusion five days/week for eight weeks. Blood was collected before, at weeks 1, 3, and 7 of treatment, and two weeks post-therapy. Patient peripheral blood lymphocytes (PBL) were cultivated in the presence of fresh PBL from a healthy donor for 30 days. Media were changed and reverse transcriptase activity (RTA) was tested every four to five days. The results showed a significant decrease in RTA in patients treated with a dose of 0.5 or 1 mg/kg, but only a slight decrease in patients who received the lowest dose. In the group treated with the 2 mg/kg dose, two patients had toxic reactions and were discontinued; the other two showed a slight decrease in RTA. In 40% of treated patients, RTA did not increase again two weeks after the end of treatment. No significant immunologic and clinical changes were noticed during the observation period. In vitro experiments of Con A stimulated PBL in presence and absence of HPA-23 showed an increase in proliferation in the presence of the drug.
HPA - 23被用于一项针对疾病控制中心（CDC）定义的艾滋病患者的平行多剂量研究。16名患者被分为四个剂量组，分别接受0.25、0.5、1.0或2.0mg/kg的HPA - 23，通过快速静脉输注，每周五天，持续八周。在治疗前、治疗第1、3和7周以及治疗后两周采集血液。患者外周血淋巴细胞（PBL）与健康供体的新鲜PBL一起培养30天。每四到五天更换培养基并检测逆转录酶活性（RTA）。结果显示，接受0.5或1mg/kg剂量治疗的患者RTA显著下降，但接受最低剂量的患者只有轻微下降。在接受2mg/kg剂量治疗的组中，两名患者出现毒性反应并停药；另外两名患者RTA略有下降。40%的接受治疗的患者在治疗结束两周后RTA没有再次升高。在观察期内未发现明显的免疫和临床变化。在有和没有HPA - 23存在的情况下对伴刀豆球蛋白A刺激的PBL进行的体外实验表明，在有该药物存在时增殖增加。
