CLINICAL INVESTIGATION OF AIDS

艾滋病的临床研究

• 批准号: 3803172
• 负责人: H C LANE
• 金额: --
• 依托单位: NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES
• 依托单位国家: 美国
• 资助国家: 美国
• 起止时间: 至
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/3803172
• 关键词: 2'3' dideoxynucleoside; AIDS; AIDS vaccines; CD4 molecule; Cryptosporidium; HIV infections; Microsporidia; Pneumocystis; Pneumocystis pneumonia; Pseudomonas; Toxoplasma; acetylcysteine; active immunization; antiAIDS agent; antibacterial agents; antiprotozoal agents; bone marrow; clinical trials; combination chemotherapy; cytomegalovirus; diarrhea; exotoxins; foscarnet; human immunodeficiency virus 1; human subject; human therapy evaluation; immunoconjugates; lymphocyte; neutralizing antibody; passive immunization; retinitis; sulfamethoxazole; toxoplasmosis; trimethoprim; virus protein; zidovudine

An intensive effort was directed toward studying the preventive and therapeutic aspects of human immunodeficiency virus (HIV) infection and the acquired immunodeficiency syndrome (AIDS). Immunization of healthy volunteers to the gp160 envelope protein of HIV-1 was capable of inducing group specific T lymphocytes directed towards the envelope and titers of neutralizing antibodies as high as 1:8. Phase I trials of AZDU and rCD4-lgG failed to demonstrate efficacy in HIV infection. Low-dose GM-CSF reversed the neutropenia caused by interferon-alpha (IFN-alpha) plus zidovudine (ZDV) without impairing the antiretroviral activity of the combination. A randomized trial comparing therapy with ZDV versus IFN-alpha versus the combination in 180 patients with early HIV-1 infection completed accrual and will be undergoing interim analysis. A controlled trial of foscarnet demonstrated significant benefit in patients with AIDS-related cytomegalovirus retinitis. Phase I/II trials were continued of ZDV + IFN-Alpha, ZDV + IL-2, IFN-Alpha + IL-2. and DDI + IFN-Alpha. BW566C80 was shown to be effective for mild to moderate episodes of pneumocystis carinii pneumonia (PCP) as well as for salvage therapy of central nervous system (CNS) Toxoplasmosis. A multi-center phase II/III study of BW566C80 versus trimethoprim- sulfamethoxazole for treatment of PCP, and a phase 1 study of BW566C80 for treatment of cryptosporidial/microsporidial diarrhea, were also begun. Phase 1 studies of L-697,639 and L-697,661 established the safety and oral bioavailability of both agents. A randomized, double-blinded, phase II study of L-697,661 versus ZDV was initiated using surrogate markers as efficacy parameters. Phase 1 studies of N-acetyl cysteine and CD4-Pseudomonas Exotoxin (sCD4-PE-40) in HIV-infected patients were initiated. A phase 1 analysis of clarithromycin established the oral bioavailability of this agent and a study of its efficacy in MAl-infected patients was initiated. A study of azithromycin as salvage therapy in CNS Toxoplasmosis was also begun. Immunotherapy protocols involving active immunization of HIV-1 infected individuals with HIV-1 gp160 or p24 were continued, and passive immunotherapy utilizing peripheral blood lymphocytes and bone marrow from gp160 primed donors was also instituted.

强烈的努力是为了研究预防性和 人类免疫缺陷病毒（HIV）感染的治疗方面 获得的免疫缺陷综合征（AIDS）。 健康的免疫 HIV-1的GP160包膜蛋白的志愿者能够 诱导组针对信封的特异性T淋巴细胞， 中和抗体高达1：8的滴度。 第一阶段试验 Azdu和RCD4-LGG未能证明在HIV感染中的功效。 低剂量GM-CSF逆转了由干扰素-Alpha引起的中性粒细胞减少症 （IFN-Alpha）加上Zidovudine（ZDV）而不会损害抗逆转录病毒 组合的活性。 一项比较治疗的随机试验 ZDV与IFN-Alpha与180例早期患者的组合 HIV-1感染完成了应计，将进行临时 分析。 Foscarnet的对照试验表现出显着的 与AIDS相关的巨细胞病毒性视网膜炎患者的受益。阶段 I/II试验的ZDV + IFN-ALPHA，ZDV + IL-2，IFN-ALPHA + IL-2。和ddi + ifn-alpha。 BW566C80被证明对轻度有效 肺炎肺炎肺炎肺炎（PCP）和中等发作 用于挽救中枢神经系统（CNS）弓形虫病的治疗。 一个 BW566C80的多中心II/III研究 用于治疗PCP的磺胺甲恶唑和BW566C80的1期研究 为了治疗隐孢子虫/孢子型腹泻，也是 开始。 L-697,639和L-697,661的1阶段研究确定了 两种代理的安全性和口服生物利用度。 一个随机的， 启动了L-697,661与ZDV的双盲，II期研究 使用替代标记作为功效参数。 阶段1研究 N-乙酰半半胱氨酸和CD4-妊娠Exotoxin（SCD4-PE-40） 启动了感染HIV的患者。 1阶段1分析 克拉霉素建立了该药物的口服生物利用度和 启动了其在不受欢迎的患者中的功效。 一项研究 阿奇霉素作为中枢神经系统弓形虫病中的挽救疗法也开始了。 免疫疗法方案涉及感染HIV-1的主动免疫 HIV-1 GP160或P24的个体继续进行，被动 利用外周血淋巴细胞和骨髓的免疫疗法 还建立了从GP160的启动供体。