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INTRAVENOUS GAMMAGLOBULIN FOR AIDS AND ARC PATIENTS

INTRAVENOUS GAMMAGLOBULIN FOR AIDS AND ARC PATIENTS
用于艾滋病和电弧患者的静脉注射丙种球蛋白
批准号:
3133268
负责人:
Arye Rubenstein
金额:
$19.8万
依托单位国家:
美国
项目类别:
财政年份:
1985
资助国家:
美国
项目状态:
已结题
起止时间:
1985-09-01 至 1988-08-31

项目摘要

项目成果

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中文摘要
翻译
自1981年以来,我们一直从事艾滋病的研究。目前,有53名儿童 有47名成人艾滋病患者由我们照顾。我们之前的研究 所有患者均表现为进行性体液免疫缺陷。 结果,12名成人和16名儿童接受了周期性的仿制药治疗 静脉注射丙种球蛋白。因此,临床上有了显著的改善 在一些患者中发现,脓毒症发作完全消除 在大多数患者中。此外,免疫学方面的有利变化 记录了参数(见上一工作部分)。结果各不相同, 然而,在不同的病人之间,有时是在同一个病人身上。近期 研究表明,一些I-v GG批次具有较高的HTLV抗体效价。 本研究旨在确定i-v GG是否具有抗HTLV 活动可进一步改善临床转归。病人将会是 随机分为四种治疗方案(盲法):a)通用i-v GG,b)i-v 高HTLV抗体滴度的GG,c)安慰剂,d)肌肉注射乙肝 高免疫血清(显示具有高HTLV抗体水平)。我们会研究 治疗对1)临床病程,2)免疫反应的影响 (淋巴细胞有丝分裂反应,T细胞表型),3)HTLV在 患者的淋巴细胞,4)血清HTLV抗体水平将 在治疗前和治疗期间测定。最后,我们将尝试提出 抗人-人细胞杂交瘤病毒(HTLV)的人源单抗 未来可能的治疗方案。
英文摘要
We were involved in the study of AIDS since 1981. Currently, 53 children and 47 adults with AIDS are cared for by us. Our previous studies demonstrated in all patients a progressive humoral immunodeficiency. Consequently, 12 adults and 16 children were treated by periodic generic intravenous gammaglobulin. As a result, a dramatic clinical improvement was noted in some patients and episodes of sepsis were completely abolished in most patients. In addition, favorable changes in immunological parameters were noted (see previous work section). The outcome varied, however, from patient to patient and sometimes in the same patient. Recent studies have shown that some i-v GG lots had high antibody titers to HTLV. The present study is designed to determine if i-v GG with anti-HTLV activity can further improve the clinical outcome. Patients will be randomized for four treatment regimen (blinded): a) generic i-v GG, b) i-v GG with high HTLV antibody titer, c) placebo, d) intramuscular hepatitis B hyperimmune serum (shown to have high HTLV antibody levels). We will study the effect of treatment on 1) clinical course, 2) immunological responses (lymphocyte mitogenic responses, T cell phenotypes), 3) presence of HTLV in patients's lymphocytes, 4) serum levels of HTLV antibodies will be determined before and during treatment. Finally, we will attempt to raise a human monoclonal antibody to HTLV (human-human cell hybridization) for possible future treatment protocols.
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