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: ALBERT EINSTEIN COLLEGE OF MEDICINE
• 依托单位国家: 美国
• 财政年份: 1985
• 资助国家: 美国
• 起止时间: 1985-09-01 至 1988-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/3133268
• 关键词: AIDS; B lymphocyte; antiviral antibody; child (0-11); enzyme linked immunosorbent assay; gamma globulin; human immunodeficiency virus 1; human subject; human therapy evaluation; humoral immunity; immunization; microorganism immunology; monoclonal antibody; tissue /cell culture

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.

自1981年以来，我们一直在研究艾滋病。 目前，53名儿童 47名成年艾滋病患者得到了我们的照顾 我们以前的研究 所有患者均表现为进行性体液免疫缺陷。 因此，12名成人和16名儿童接受了周期性通用 静脉注射丙种球蛋白 因此，一个戏剧性的临床改善 在一些患者中观察到，脓毒症发作完全消失 在大多数患者中。 此外，免疫学方面的有利变化 记录参数（见上一工作部分）。 结果各不相同， 然而，从一个病人到另一个病人，有时在同一个病人身上。 最近 研究表明，一些i-vGG批次对HTLV具有高抗体滴度。 本研究旨在确定i-v GG与抗HTLV是否 活性可以进一步改善临床结果。 患者将 随机接受4种治疗方案（设盲）：a）通用i-v GG，B）i-v 具有高HTLV抗体滴度的GG，c）安慰剂，d）肌内注射B型肝炎 超免疫血清（显示具有高HTLV抗体水平）。 我们将研究 治疗对1）临床病程，2）免疫应答的影响 （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）HTLV抗体的血清水平将 在治疗前和治疗过程中。 最后，我们将尝试提高 抗HTLV（人-人细胞杂交）的人单克隆抗体， 未来可能的治疗方案