ACTG 243

ACTG 243

• 批准号: 6245400
• 负责人: JUSTIN CHARLES. MCARTHUR
• 金额: $ 2.23万
• 依托单位: JOHNS HOPKINS UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 1997
• 资助国家: 美国
• 起止时间: 1997-03-05 至 1997-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6245400
• 关键词: antiviral agents; clinical research; clinical trials; combination chemotherapy; cytosine arabinoside; drug screening /evaluation; human subject; human therapy evaluation; intravenous administration; microorganism disease chemotherapy; progressive multifocal leukoencephalopathy

The purpose of this project was to determine the efficacy of Ara-C comparing intravenous administration to intrathecal administration in the treatment of PML along with a comparison arm receiving maximized antiretroviral therapy alone. We only had one patient active in this clinical trial during the above time period. This patient was receiving intrathecal Ara-C. The patient tolerated the study treatment well. Despite this, the PML continued to progress and the patient discontinued the study at week 6 due to the PML progression. He died ten days later due to PML progression. The previous five patients all died as well due to PML progression and none survived a sufficient length of time to complete the trial (24 weeks). We recruited 6 patients total at Hopkins for this trial. Nationwide, there were 62 patients enrolled in the study. The Protocol Safety Monitoring Board (PSMB) for the Neurological AIDS Research Consortium met on 7/2/96 to review the results of this trial. No statistical differences were noted in the survival times between the three treatment arms nor in the two Ara-C arms combined (IV plus intrathecal) vs non Ara-C. The PSMB determined that there was only a very slight chance of showing a benefit of Ara-C treatment and recommended not enrolling additional subjects as the Ara-C treatment had not been found to be effective in treating PML. The original recruitment goal was 90 subjects. There were no major safety issues regarding the use of the study medication. The Ara-C was well tolerated by the study subjects.

该项目的目的是确定阿糖胞苷的功效 比较静脉内给药与鞘内给药， PML的治疗沿着与比较臂接收最大化 抗逆转录病毒治疗 在上述期间，我们只有一名患者在本临床试验中活跃 时间段 该患者正在接受鞘内Ara-C。 患者 对研究治疗耐受良好。 尽管如此，PML继续 进展，患者在第6周因PML中止研究 进展 10天后，患者因PML进展死亡。 的 之前的5例患者也都死于PML进展， 存活足够长的时间以完成试验（24周）。 我们在霍普金斯共招募了6名患者进行本试验。全国范围内， 共有62名患者参加了这项研究。 协议安全性 神经学艾滋病研究联盟监测委员会（PSMB） 于1996年2月7日开会审查本试验的结果。 无统计学 三种治疗组的存活时间存在差异 两个Ara-C联合治疗组（IV+鞘内）与非Ara-C联合治疗组 Ara-C PSMB确定只有很小的机会 显示Ara-C治疗的益处，建议不要入组 由于尚未发现Ara-C治疗对其他受试者有影响 有效治疗PML。 最初的招聘目标是90名 科目 使用本品没有重大安全性问题， 研究药物。 研究受试者对Ara-C的耐受性良好。